practice intersection: how i approach thrombus in my daily clinical practice
DESCRIPTION
Alexandre Abizaid. TCT 2012 Congress. Find more presentations on our web site.TRANSCRIPT
EvidencePractice
Intersection How I Approach
Thrombus in My Daily Clinical
Practice (and Why)
SOLACI in Partnership with TCT Snapshot of Latin America
Practice and Research
Room D235-236
Ricardo A Costa
Alexandre Abizaid Instituto Dante Pazzanese de Cardiologia
Sao Paulo Brazil
Monday October 21st 2012 ndash From 613 to 625 pm
I Ricardo A Costa DO NOT have a
financial interestarrangement or affiliation
with one or more organizations that could
be perceived as a real or apparent conflict
of interest in the context of the subject of
this presentation
DISCLOSURE STATEMENT
Thrombotic Lesions
Thrombotic Lesions
No-Reflow A Multifactorial
Phenomenon
Vasoconstrictor Thrombotic Mechanical
Serotonin Release
Vasoconstriction
bull Aggregates of
Platelets
Neutrophils Red
Blood Cells
bull Cellular and
Intersticial edema
Microvascular
Occlusion
Distal
Embolization
bull Spontaneous
bull During
reperfusion Tx
Mechanical
Occlusion
Distal Embolization in STEMI
Distal Embolization occurs in approximately 14
of patients who underwent primary angioplasty
No DE N=167 (861)
DE N=27 (139)
P value
Patency 151 (92) 19 (73) 0009
LVEF () 51 plusmn 9 42 plusmn 14 0005
LDH (Q72) 847 plusmn 631 1612 plusmn 1008 0001
Mortality 15 (9) 12 (44) lt 0001
DeathRe-MI 239 215 048
Proximal LCx
filling defect at
primary PCI site
Distal Thromboemboli
Henriques JPS et al Eur Heart J 2002231112-1117
Importance of TIMI-3 Flow
Stone GW et al Circulation 2001104636
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
I Ricardo A Costa DO NOT have a
financial interestarrangement or affiliation
with one or more organizations that could
be perceived as a real or apparent conflict
of interest in the context of the subject of
this presentation
DISCLOSURE STATEMENT
Thrombotic Lesions
Thrombotic Lesions
No-Reflow A Multifactorial
Phenomenon
Vasoconstrictor Thrombotic Mechanical
Serotonin Release
Vasoconstriction
bull Aggregates of
Platelets
Neutrophils Red
Blood Cells
bull Cellular and
Intersticial edema
Microvascular
Occlusion
Distal
Embolization
bull Spontaneous
bull During
reperfusion Tx
Mechanical
Occlusion
Distal Embolization in STEMI
Distal Embolization occurs in approximately 14
of patients who underwent primary angioplasty
No DE N=167 (861)
DE N=27 (139)
P value
Patency 151 (92) 19 (73) 0009
LVEF () 51 plusmn 9 42 plusmn 14 0005
LDH (Q72) 847 plusmn 631 1612 plusmn 1008 0001
Mortality 15 (9) 12 (44) lt 0001
DeathRe-MI 239 215 048
Proximal LCx
filling defect at
primary PCI site
Distal Thromboemboli
Henriques JPS et al Eur Heart J 2002231112-1117
Importance of TIMI-3 Flow
Stone GW et al Circulation 2001104636
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Thrombotic Lesions
Thrombotic Lesions
No-Reflow A Multifactorial
Phenomenon
Vasoconstrictor Thrombotic Mechanical
Serotonin Release
Vasoconstriction
bull Aggregates of
Platelets
Neutrophils Red
Blood Cells
bull Cellular and
Intersticial edema
Microvascular
Occlusion
Distal
Embolization
bull Spontaneous
bull During
reperfusion Tx
Mechanical
Occlusion
Distal Embolization in STEMI
Distal Embolization occurs in approximately 14
of patients who underwent primary angioplasty
No DE N=167 (861)
DE N=27 (139)
P value
Patency 151 (92) 19 (73) 0009
LVEF () 51 plusmn 9 42 plusmn 14 0005
LDH (Q72) 847 plusmn 631 1612 plusmn 1008 0001
Mortality 15 (9) 12 (44) lt 0001
DeathRe-MI 239 215 048
Proximal LCx
filling defect at
primary PCI site
Distal Thromboemboli
Henriques JPS et al Eur Heart J 2002231112-1117
Importance of TIMI-3 Flow
Stone GW et al Circulation 2001104636
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Thrombotic Lesions
No-Reflow A Multifactorial
Phenomenon
Vasoconstrictor Thrombotic Mechanical
Serotonin Release
Vasoconstriction
bull Aggregates of
Platelets
Neutrophils Red
Blood Cells
bull Cellular and
Intersticial edema
Microvascular
Occlusion
Distal
Embolization
bull Spontaneous
bull During
reperfusion Tx
Mechanical
Occlusion
Distal Embolization in STEMI
Distal Embolization occurs in approximately 14
of patients who underwent primary angioplasty
No DE N=167 (861)
DE N=27 (139)
P value
Patency 151 (92) 19 (73) 0009
LVEF () 51 plusmn 9 42 plusmn 14 0005
LDH (Q72) 847 plusmn 631 1612 plusmn 1008 0001
Mortality 15 (9) 12 (44) lt 0001
DeathRe-MI 239 215 048
Proximal LCx
filling defect at
primary PCI site
Distal Thromboemboli
Henriques JPS et al Eur Heart J 2002231112-1117
Importance of TIMI-3 Flow
Stone GW et al Circulation 2001104636
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
No-Reflow A Multifactorial
Phenomenon
Vasoconstrictor Thrombotic Mechanical
Serotonin Release
Vasoconstriction
bull Aggregates of
Platelets
Neutrophils Red
Blood Cells
bull Cellular and
Intersticial edema
Microvascular
Occlusion
Distal
Embolization
bull Spontaneous
bull During
reperfusion Tx
Mechanical
Occlusion
Distal Embolization in STEMI
Distal Embolization occurs in approximately 14
of patients who underwent primary angioplasty
No DE N=167 (861)
DE N=27 (139)
P value
Patency 151 (92) 19 (73) 0009
LVEF () 51 plusmn 9 42 plusmn 14 0005
LDH (Q72) 847 plusmn 631 1612 plusmn 1008 0001
Mortality 15 (9) 12 (44) lt 0001
DeathRe-MI 239 215 048
Proximal LCx
filling defect at
primary PCI site
Distal Thromboemboli
Henriques JPS et al Eur Heart J 2002231112-1117
Importance of TIMI-3 Flow
Stone GW et al Circulation 2001104636
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Distal Embolization in STEMI
Distal Embolization occurs in approximately 14
of patients who underwent primary angioplasty
No DE N=167 (861)
DE N=27 (139)
P value
Patency 151 (92) 19 (73) 0009
LVEF () 51 plusmn 9 42 plusmn 14 0005
LDH (Q72) 847 plusmn 631 1612 plusmn 1008 0001
Mortality 15 (9) 12 (44) lt 0001
DeathRe-MI 239 215 048
Proximal LCx
filling defect at
primary PCI site
Distal Thromboemboli
Henriques JPS et al Eur Heart J 2002231112-1117
Importance of TIMI-3 Flow
Stone GW et al Circulation 2001104636
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Importance of TIMI-3 Flow
Stone GW et al Circulation 2001104636
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI
AMISTAD -2 Trial
Kloner RA et al Eur Heart J 2006272400-2405
2118 Patients with
Anterior STEMI amp Reperfusion
Therapy within 6 Hrs of Symptoms
Placebo
Adenosine
50 μgKgmin
X 3h
Fibrinolysis or PTCA
Follow-up for 6 months
Infarct size (5 d)
(243 patients)
Adenosine
70 μgKgmin
X 3h
26 23
11
P=0028
P=NS
57
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI random to abciximab vs placebo or control
30-D
ay E
ven
ts
()
34
24 19
10
41 47
011 006
p=0047
OR 068
[047099]
p=003
OR 056
[033094]
P=036
OR 116
[085159]
P=096
OR 097
[031301]
De Luca G et al JAMA 20052931759-1765
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3949 pts with AMI wi 12h undergoing primary (7)
or rescue (1) PCI rand to abciximab vs placebo or control
De Luca G et al JAMA 20052931759-1765
Mo
rta
lity
34
24
62
44
p=0047
OR 068
[047 099]
P=001
OR 069
[052 092]
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus
(n=77) Abciximab followed by 12-hour infusion
of
LV
Assessed by Delayed MRI
Primary End-Points
151
234
11 11
01
34
P=002
P=001
P=0006
IV Abciximab IC Abciximab
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Intracoronary vs Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H et al Circulation 200811849-57
P=006
30-Day MACE
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI lt 6h Sx onset undergoing primary or rescue PCI rand to PCI with balloon
occlusion and aspiration distal protection (Guardwire Plus n=252) or PCI without distal protection
(n=249)
Stone GW et al JAMA 20052931063-1072
P=040 P=014
Rates of Complete (gt 70) STR at Different Time Points
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW et al JAMA 20052931063-1072
34 33 24
13 21
04
25 39
63 58
09 17
161
143
10 11
P = NS for all comparisons
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI
DEDICATION Trial
Kelbaek H et al J Am Coll Cardiol 200851899-905
54
32
26 25
16
03
19
06 10
06
76 72
P=NS
Conventional PCI (n=301) Distal Protection (Filterwire) (n=302)
P=NS for all comparisons
Conclusion Distal protection failed to significantly improve ST-segment resolution 90 min after PCI compared to PCI alone in patients with large STEMI
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution X AMINE ST Trial
201 pts with STEMI lt 12h randomized to Thrombectomy (X-Sizer) prior to stent
implantation vs Standard PCI with no thrombectomy
mm
75
49 678
526
96 89
30 31
P = 0033
P = 0037 P = NS P = NS Primary End-Point
Predictors of STR gt 50 by
Multivariate Analysis
Younger Age
Non Anterior MI
Use of X-Sizer thrombus aspiration device
Short time from Symptoms Onset
Lefegravevre T et al J Am Coll Cardiol 200546246-252
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI DEAR-MI
Silva-Orrego P et al J Am Coll Cardiol 2006481552-1559
148 consecutive STEMI Pts with Sx lt 12h randomized to PPCI (n=74) or
Thrombus Aspiration (Pronto Catheter) before PPCI (n=74)
68
50
88
44
89
78 790 plusmn 132
910 plusmn 128
Plt005 Plt00001 P=NS Plt00001
PPCI Thrombus Aspiration + PPCI
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
1071 STEMI
pts
Thrombus Aspiration
(n=535)
Conventional PCI
(n=536)
Thrombus Aspiration
(n=530)
Conventional PCI
(n=530)
R 1-Year FU
P lt 0001
Pati
en
ts (
)
Thrombus Aspiration Conventional PCI
Primary End-Point Myocardial Blush Grade
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Thrombus Aspiration During PCI
in AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Pati
en
ts (
)
Thrombus aspiration Conventional PCI
P lt 0001
ST-Segment Elevation Resolution
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Thrombus Aspiration During PCI in
AMI Study TAPAS
Svillas T et al N Engl J Med 2008358557-567
Time (days)
0 100 200 300 400
Mort
alit
y (
)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p =
0040
30 days
40 vs 21 P=007
1-Year Mortality
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials
Bavry AA et al Eur Heart J 2008292989-3001
27
44
53
28 31
34
Incidence of Mortality According to the Type of Device Used
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
What is the best therapy to prevent
distal embolization
bull Pharmacotherapy
bull Distal Protection
bull Thromboaspiration
bull New Devices
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
ClearWayTM Perfusion Balloon
bull What is ClearWay RX
ndash Rapid Exchange therapeutic infusion
catheter
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
1019
80
1054
685
912855
0
20
40
60
80
100
120
Total Clearway Inf Guid Cath
Inf
Basal Post Abcix
Basal and FU Thrombus score by OCT p=00015 p= NS
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
MGuardtrade Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
bull Bare metal stent (stainless
steel) - Strut width 100 microm
bull Balloon-expandable
bull Protection net (mesh sleeve
fibers of
poliethyleneterephthalate)
Fiber width 20 microm
bull Net aperture size (150x180 microm)
20 ndash 40mm diameter (every 025)
10 ndash 38mm length
MGuardtrade Stent
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
INSPIRE trial Brazilian Experience
Primary
Endpoint
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12month MACE
Late loss
6-month FU
QCA+ IVUS
IVUS + QCA
Subset
analysis
QCA post
stent
Flow wire
PRE amp POST
stent
Myocardial
blush
TIMI frame
count
TIMI frame
count
Myocardial
blush
Register 30 pts w
de novo lesions
in SVG or native coronaries
w potential to flow disturbance
+ 30 pts w
the same profile
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
In-Hospital Results 50 SVG 35 of lesions w visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb gt
3x
MACE
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
CASE 1
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
WP
OCLUSAtildeO POacuteS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Aspiration
WP
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
After aspiration
WP
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Pre Final result
PREacute POacuteS
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
CASE 2
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Baseline Angiogram
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
bull Premedication (ASA + Clop + UFH)
bull Thrombus aspiration - Exportreg
bull GP IIbIIIa ndash Abciximab
bull No predilatation
bull Stent MGuardreg
bull No postdilatation
Strategy
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
bull Exportreg AP Aspiration catheter
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
large thrombus burden
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Results post-aspiration
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
bull MGuardstent 30 x 15 mm
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Results post stent
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
CASE 3
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Baseline Angiogram
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Baseline Angiogram
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
bull Premedication (ASA + Clopidogrel)
bull Anti-thrombin with Enoxaparin for 7 days
bull Repeat coronary angiography and PCI to SVG
Strategy
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
7 DAYS AFTER
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
bull MGuard stent 35 x 29 mm
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Results post stent
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data
Conclusions Recomendations
bull Pharmacotherapy
IC injection of Abciximab and Adenosine
bull Distal Protection
No significant advantages in acute MI
bull Thromboaspiration
Most cases significant improvement
bull New Devices promising data