Advances in trans-radial
interventions
Sotirios Patsilinakos
Cardiology Department
Konstantopoulio, Athens, Greece
Impact of Major Bleed and MI after Elective and Urgent PCI
Stone GW. J Inv Cardiol 2004;16(suppl G):12–17.
Time from Randomization in Days
Cu
mu
lative
% M
ort
alit
y
With MI 5.7%
Without major bleed 2.0%
Without MI 1.9%
With major bleed 8.8%
1-Year Mortality (N=6,012)
R I V A L 30-Day Death According to Bleeding
OASIS Registry, OASIS-2, CURE
J Eikelboom et al Circulation 2006
02
46
81
01
21
4
0 5 10 15 20 25 30
Bleeding
No Bleeding
No. at Risk
No Bleeding
Bleeding
33676 33419 33157 32990 32879 32769 32710
470 (1.4%)
459 440 430 420 410 408
Cum
ula
tive E
vents
, %
Days
R I V A L Bleeding is Associated with an Increased
30-Day Mortality in NSTEMI Patients
Rao et al. Am J Cardiol 2005;96:1200-1206
N=26,452 ACS patients from
GUSTO IIb, PURSUIT and PARAGON A & B
Log-rank p values are 0.0001 for all 4 categories, 0.20 for no bleeding vs. mild bleeding, 0.0001 for
mild vs. moderate bleeding, and 0.001 for moderate vs. severe bleeding.
Adjusted HR
(95% CI)
% Death
2.9% 1.0
3.5% 1.6 (1.3-1.9)
5.9% 2.7 (2.3-3.4)
25.7% 10.6 (8.3-13.6)
GUSTO bleeding None Mild Moderate Severe
0 5 10 15 20 25 30
0.70
0.75
0.80
0.85
0.90
0.95
1.00
Days to Death
Cu
mu
lative
su
rviv
al
R I V A L
Bleeding is associated with
Death and Ischemic Events
Eikelboom JW et al. Circulation 2006;114(8):774-82.
HR 5.37 (3.97-7.26)
HR 4.44 (3.16-6.24)
HR 6.46 (3.54-11.79)
N=34,146
OASIS Registry,
OASIS 2, CURE trials
Stone G, et al, NEJM 2008;358 : 2218 - 30
Bleeding Within 30 Days is a Powerful and Independent Predictor of 1-year Death After PCI
Ndrepepa G. JACC 2008;51:690-7 * Calculated for a 10-year increase in age.
5,384 patients from 4 RCT on the value of abciximab after pretreatment with
600 mg of clopidogrel: ISAR-REACT, SWEET, SMART-2 and REACT-2
“Our study demonstrates a strong relationship between the 30-day frequency of bleeding
and 1-year mortality after PCI and supports the inclusion of periprocedural bleeding in a
30-day quadruple endpoint for the assessment of outcome after PCI.”
Variable Hazard Ratio (95% CI) P Value
Bleeding within 30 days 2.96(1.96-4.48) <0.001
Myocardial infarction within 30 days 2.29(1.52-3.46) <0.001
Urgent revascularization within 30 days 2.49(1.16-5.35) 0.019
Age (years)* 2.27(1.78-2.89) <0.001
Diabetes 1.47(1.11-1.96) 0.008
Multivessel coronary disease 2.72(1.56-4.67) <0.001
Elevated troponin 1.77(1.27-2.47) <0.001
Left ventricular ejection fraction 0.71(0.60-0.85) <0.001
Creatinine level 1.10(1.06-1.14) <0.001
Bleeding Within 30 Days is a Powerful and Independent Predictor of 1-year Death After PCI
Ndrepepa G. JACC 2008;51:690-7 * Calculated for a 10-year increase in age.
5,384 patients from 4 RCT on the value of abciximab after pretreatment with
600 mg of clopidogrel: ISAR-REACT, SWEET, SMART-2 and REACT-2
“Our study demonstrates a strong relationship between the 30-day frequency of bleeding
and 1-year mortality after PCI and supports the inclusion of periprocedural bleeding in a
30-day quadruple endpoint for the assessment of outcome after PCI.”
Variable Hazard Ratio (95% CI) P Value
Bleeding within 30 days 2.96(1.96-4.48) <0.001
Myocardial infarction within 30 days 2.29(1.52-3.46) <0.001
Urgent revascularization within 30 days 2.49(1.16-5.35) 0.019
Age (years)* 2.27(1.78-2.89) <0.001
Diabetes 1.47(1.11-1.96) 0.008
Multivessel coronary disease 2.72(1.56-4.67) <0.001
Elevated troponin 1.77(1.27-2.47) <0.001
Left ventricular ejection fraction 0.71(0.60-0.85) <0.001
Creatinine level 1.10(1.06-1.14) <0.001
R I V A LBlood Transfusion is Associated with
an Increased 30-Day Mortality in NSTEMI
Rao et al. JAMA 2004;292:1555-62
N=24,112 ACS patients from GUSTO IIb, PURSUIT and PARAGON
*Adjusted for baseline characteristics, bleeding and transfusion propensity and nadir hematocrit
HR=3.94*;
95%CI: 3.26 to 4.75
30-day
death rate
Transfusion
No Transfusion
Cum
ula
tive m
ort
alit
y
Log-rank p<0.001
0
0.02
0.04
0.06
0.08
0.10
5 10 15 20 25 30
Day
8.00%
3.08%
The landmark message from these and other
studies, which was incorporated into the 2007
NSTEACS Guidelines, is that prevention of
bleeding MUST be regarded at least as important
as the prevention of major ischemic events, such as
myocardial infarction.
Major bleeding (with or without blood product transfusions) has emerged as a powerful independent predictor of early and late mortality in pts with NSTEMI, STEMI and is at
least as important as MI and myocardial
reinfarction
ACCESS Study
Radial Brachial Femoral p
Approach failure (%) 7 4.3 0.3 <0.001
Procedural success (%) 91.7 90.7 90.7 NS
Equipment:
Guiding cath. (n) 1.3 1.3 1.3 NS
Balloons (n) 1.3 1.3 1.3 NS
Stenting (%) 4.7 7 4.7 NS
Procedural time (Min) 40+24 39+25 38+24 NS
Fluoro. Time (Min 13+11 12+10 11+10 0.06
Hospital stay (days) 1.5+2.5 1.8+3.8 1.8+4.2 NS
Kiemeneij JACC 1997;29:1269-75
R I V A L
Prior Meta-analysis of 23 RCTs
of Radial vs. Femoral (N=7030)
Radial better Femoral better1.0
PCI Procedure Failure
Death
Death, MI or stroke
Major bleeding
1.31 (0.87-1.96)
0.74 (0.42-1.30)
0.71 (0.49-1.01)
0.27 (0.16-0.45)
Jolly SS, et al. Am Heart J 2009;157:132-40.
Bleeding is an independent predictor of outcome
Reducing bleeding improves outcome
The Therapeutic Hypothesis in the Radial World
R I V A LOCTOPLUS: Primary endpoint, Intention to treat analysis
Femoral Radial p value
n= 185 192
Vasc. Surgery (%) 0 0.5 ns
Transfusion (%) 1.6 1.0 ns
Hb drop > 3g/DL (%) 3.8 0.5 0.063
False aneurysm compression (%) 1.1 0.5 ns
Arm or leg ischemia (%) 0 0 ns
Forearm compartment syndrom (%) 0 0 ns
Large hematoma* (%) 6.5 1.6 0.031
COMPOSITE END-POINT $ (%) 6.5 1.6 0.029
Hematoma (%) 11.4 3.5 0.003
CVA (%) 0.6 0 Ns
$ surgery, transfusion, Hb loss>3g/100ml-Ht loss>10%, ischemia, FA, vasc.
Complic. leading to discharge delay *Large hematoma: discharge delay
R I V A L
NSTE-ACS and STEMI(n=7021)
Radial Access(n=3507)
Femoral Access(n=3514)
Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days
Randomization
RIVAL Study Design
Key Inclusion:
• Intact dual circulation of hand required
• Interventionalist experienced with both (minimum 50 radial
procedures in last year)
Jolly SS et al. Am Heart J. 2011;161:254-60.
Blinded Adjudication of Outcomes
R I V A L
Operator Volume
Procedure Characteristics
Radial (n=3507)
Femoral (n=3514)
HR (95% CI)P
value
Operator Annual Volume
PCI/year (median, IQR)
300 (190, 400)
300 (190,400)
Percent Radial PCI(median, IQR)
40 (25,70)
40(25, 70)
PCI Success 95.4 95.2 1.01 (0.95-1.07) 0.83
• Vascular closure devices used in 26% of Femoral group
R I V A L
Other Outcomes
Radial(n=3507)
%
Femoral(n=3514)
%HR 95% CI P
Major Vascular Access Site Complications
1.4 3.7 0.37 0.27-0.52 <0.0001
Other Definitions of Major Bleeding
TIMI Non-CABG Major Bleeding
0.5 0.5 1.00 0.53-1.89 1.00
ACUITY Non-CABG Major Bleeding*
1.9 4.5 0.43 0.32-0.57 <0.0001
* Post Hoc analysis
R I V A L
Other Outcomes
Radial(n=3507)
%
Femoral (n=3514)
%HR 95% CI P
Death 1.3 1.5 0.86 0.58-1.29 0.47
MI 1.7 1.9 0.92 0.65-1.31 0.65
Stroke 0.6 0.4 1.43 0.72-2.83 0.30
Stent Thrombosis 0.7 1.2 0.63 0.34-1.17 0.14
R I V A L
Other Outcomes
Radial(n=3507)
Femoral (n=3514)
P
Access site Cross-over (%) 7.6 2.0 <0.0001
PCI Procedure duration (min) 35 34 0.62
Fluoroscopy time (min) 9.3 8.0 <0.0001
Persistent pain at access site >2 weeks (%)
2.6 3.1 0.22
Patient prefers assigned access site for next procedure (%)
90 49 <0.0001
• Symptomatic radial occlusion requiring medical attention 0.2% in radial group
Death, MI, Stroke or non-CABG major Bleed
Subgroups: Primary OutcomeR I V A L
0.251.00 4.00
Radial better Femoral better
Hazard Ratio (95% CI)
<75≥75
FemaleMale
<2525-35>35
≤70
70-142.5>142.5
Lowest TertileMiddle TertileHighest Tertile
NSTE-ACSSTEMI
Age
Gender
BMI
Radial PCI Volume by Operator
Radial PCI Volume by Centre
Diagnosis at presentation
Overall
0.786
0.356
0.637
0.536
0.021
0.025
Interactionp-value
R I V A L
Conclusion
No significant difference between radial and
femoral access in primary outcome of death, MI,
stroke or non-CABG major bleeding
Rates of primary outcome appeared to be lower
with radial compared to femoral access in high
volume radial centres and STEMI
Radial had fewer major vascular complications with
similar PCI success
R I V A L
Conclusion
No significant difference between radial and
femoral access in primary outcome of death, MI,
stroke or non-CABG major bleeding
Rates of primary outcome appeared to be lower
with radial compared to femoral access in high
volume radial centres and STEMI
Radial had fewer major vascular complications with
similar PCI success
Radial versus Femoral
Randomized Investigation
in ST Elevation Acute
Coronary Syndrome
the RIFLE STEACS study
Principal investigators:Enrico Romagnoli, MD PhDGiuseppe Biondi-Zoccai, MD
Giuseppe Sangiorgi, MD
F R
R I V A L
RIFLE STEACS - flow chartDesign
• DESIGN:
Prospective, randomized (1:1),
parallel group, multi-center trial.
• INCLUSION CRITERIA:
all ST Elevation Myocardial
infarction (STEMI) eligible for
primary percutaneous coronary
intervention.
• ESCLUSION CRITERIA:
contraindication to any of both
percutaneous arterial access.
international normalized ratio (INR)
> 2.0.
1001 patients enrolled between January 2009
and July 2011 in 4 clinical sites in Italy
Clinical follow-up at 1
month in 100%
Femoral arm
(N=501)
Radial arm
(N=500)
Femoral arm
(N=534)
Radial arm
(N=467)
Clinical follow-up at 1
month in 100%
Intention-to-treat analysis
NACE MACCE Bleedings
femoral arm radial armp = 0.003
• Net Adverse Clinical Event (NACE) = MACCE + bleeding
30-day NACE rate
RIFLE STEACS – results
p = 0.029 p = 0.026
21.0%
11.4%
7.2%
12.2%
7.8%
13.6%
NACE MACCE Bleedings
femoral arm radial armp = 0.003
• Net Adverse Clinical Event (NACE) = MACCE + bleeding
• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of cardiac
death, myocardial infarction, target lesion revascularization, stroke
30-day NACE rate
RIFLE STEACS – results
p = 0.029 p = 0.026
21.0%
11.4%
7.2%
12.2%
7.8%
13.6%
30-day bleeding rate
RIFLE STEACS – results
p = 1.000
12.2%
6.8%
2.6%
5.4% 5.2%
p = 0.026
Bleedings Access site related Non access site related
femoral arm radial arm
7.8%
47%
p = 0.002
Cardiac death Myocardial
Infarction
Target Lesion
Revascularization
Cerebrovascular
Accident
femoral arm radial armp = 0.020
30-day MACCE rate
RIFLE STEACS – results
p = 1.000 p = 0.604 p = 0.725
9.2%
5.2%
1.4% 1.2% 1.8%1.2% 0.6% 0.8%
p = 0.7
30-day MACE
STEMI RADIAL - results
p = 0.64
p = 0.72
p = 1.0
4.2%
3.5%3.1%
2.3%
0.8%1.2%
0.3% 0.3%
MACE = composite of death, myocardial infarction and stroke
p = 0.0028
30-day NACE
STEMI RADIAL - results
p = 0.7
p = 0.0001
11.0%
7.2%
1.4%
4.2%3.5%
4.6%
Net Adverse Clinical Event (NACE) = MACE + major bleeding
MACE = composite of death, myocardial infarction and stroke
80%
58%
Transradial approach: the best
way to reduce the vascular
complication rate and the cost,
and to improve patient comfort
Institut Cardiovasculaire Paris Sud
Transradial approach: the best way to reduce the vascular complication rate and the cost, and to improve
patient comfort
R I V A L
Myths of TRANSRADIAL APPROACH
1. Delay in accessing the radial artery
2. Spasms and other anatomical problems
3. Poor guiding catheter support
4. Difficulty in CTO lesions
5. Difficulty in complex lesions
6. Difficulty in using aspiration systems
7. Difficulty in using rotablator and other devices
8. Difficulty in CABG patients
Myths of TRANSRADIAL APPROACH
1. Delay in accessing the radial artery
2. Spasms and other anatomical problems
3. Poor guiding catheter support
4. Difficulty in CTO lesions
5. Difficulty in complex lesions
6. Difficulty in using aspiration systems
7. Difficulty in using rotablator and other devices
8. Difficulty in CABG patients
•High volume center: >146 radial PCI/year/ median operator at centre
•Medium volume center: 61-146 radial PCI/year/ median operator at centre
•Low volume center: ≤60 radial PCI/year/ median operator at centre
RADIAL EXPERIENCE
Transradial Approach Failure in Relation to Volume
y = -1,2931Ln(x) + 11,464
0
1
2
3
4
5
6
7
8
0 400 800 1200 1600 2000 2400 2800
p= 0.002
%
*Failure to enter ascending aortaY. Louvard, unpublished
Myths of TRANSRADIAL APPROACH
1. Delay in accessing the radial artery
2. Spasms and other anatomical problems
3. Poor guiding catheter support
4. Difficulty in CTO lesions
5. Difficulty in complex lesions
6. Difficulty in using aspiration systems
7. Difficulty in using rotablator and other devices
8. Difficulty in CABG patients
Predictive Factors of Radial Approach
FailureSuccess Failure* p
n= 2347 53
Age (years) 61.6+11.3 65+11.2 0.03
Male (%) 84 73.7 0.068
Hypertension (%) 42.2 43.4 ns
Dyslipidemia (%) 72.9 69.8 ns
Diabetes (%) 8.4 13.2 ns
Smoking (%) 26.9 22.6 ns
Left radial (%) 3.2 18.9 0.000
Re-radial (%) 21.9 17 ns
N° of Same Radial (n) 1.3+0.7 1.3+0.6 ns
N° Dis. Coro. Vessels (n) 1.8+0.8 1.7+0.7 ns
Weight (kg) 76.9+13.5 72.8+13.8 0.029
Height (cm) 169.3+8.3 166.4+10.3 0.03
*Failure to enter ascending aorta
0
1
2
3
4
5
6
<40 y
n=64
40-49 y
n=298
50-59 y
n=606
60-69 y
n=779
70-79 y
n=552
> 80 y
n=110
Radial approach failure rate%
Radial Approach Failure Rate
in Relation to Age
Y. Louvard, unpublished
Radial Approach Failure Rate in Relation to Weight
0
1
2
3
4
5
6
7
8
9
10
<50 kg 50-59 kg 60-69 kg 70-79 kg 80-89 kg 90-99 kg 100-09 kg >110 kg
Total Male Female
Y. Louvard, unpublished
R I V A L
Tortuous Right Subclavian Artery:
Prevalence and Predictive Factors
2,341 consecutive right radial approaches
Prevalence (%) 10.8
Cross-over to Left Radial or Femoral (%) 4
Complications (%) 0
Independent predictive factors:
OR 95% CI p
Hypertension 1.6 1.3-2.1 <0.0003
Age 1.4 1.2-1.7 0.0001
BMI 1.2 1.0-1.4 0.015
Cha CCVI 2002; 56: abst 69
Conclusions
LRA for coronary angiography and interventions is associated with slight but
significant lower fluoroscopy time and radiation dose compared to RRA
The LRA advantage seems to be confined to operators at the beginning of
learning curve (fellows) and to be more pronounced in older patients
PoliclinicoCASILINO
TALENT study (left vs right radial)
PCI Group
11.8
11.1
Gy/c
m2
0
10
12P= 0.23
153
132
Fluoroscopy time
0
130
160
se
co
nd
s
P= 0.034
Height <160 cm
(n=236)
RRA (n= 132)
LRA (n= 104)
Dose Area Product (Fluoroscopy)
183
167
Fluoroscopy time
0
170
200
se
co
nd
s
P= 0.001
14.7
11.5
0
10
15
P= 0.001
Age ≥75 years
(n=343)
RRA (n= 168)
LRA (n= 175)
Dose Area Product (Fluoroscopy)
Gy/c
m2
Results
Konstantopoulio/KAT hemodynamic dpts
80-year old man from the STEMI-RADIAL trial :
Radial PCI one week after randomization to femoral primary PCI
Myths of TRANSRADIAL APPROACH
1. Delay in accessing the radial artery
2. Spasms and other anatomical problems
3. Poor guiding catheter support
4. Difficulty in CTO lesions
5. Difficulty in complex lesions
6. Difficulty in using aspiration systems
7. Difficulty in using rotablator and other devices
8. Difficulty in CABG patients
“Mother and child” technique - quideliner
Konstantopoulio hemodynamic dpt
“Mother and child” technique - quideliner
Konstantopoulio hemodynamic dpt
Myths of TRANSRADIAL APPROACH
1. Delay in accessing the radial artery
2. Spasms and other anatomical problems
3. Poor guiding catheter support
4. Difficulty in CTO lesions
5. Difficulty in complex lesions
6. Difficulty in using aspiration systems
7. Difficulty in using rotablator and other devices
8. Difficulty in CABG patients
Radial Artery Diameter (Ultrasound)n=120
0
10
20
30
40
50
<2,1mm 2,1-2,4mm 2,5-2,7mm 2,8-3,1mm >3,1mm
2,9+0,6 mm
5f 6f 7f 8f
Myths of TRANSRADIAL APPROACH
1. Delay in accessing the radial artery
2. Spasms and other anatomical problems
3. Poor guiding catheter support
4. Difficulty in CTO lesions
5. Difficulty in complex lesions
6. Difficulty in using aspiration systems
7. Difficulty in using rotablator and other devices
8. Difficulty in CABG patients
bifurcation: RRA – XB 3,5 6F
Konstantopoulio hemodynamic dpt
Konstantopoulio hemodynamic dpt
bifurcation: RRA – XB 3,5 7F
bifurcation: RRA – XB 3,5 7F
Konstantopoulio hemodynamic dpt
LM-distal trifurcation: RRA – XB 3,5 7F
technique - quideliner
Konstantopoulio hemodynamic dpt
Radial Artery Diameter (Ultrasound)n=120
0
10
20
30
40
50
<2,1mm 2,1-2,4mm 2,5-2,7mm 2,8-3,1mm >3,1mm
2,9+0,6 mm
5f 6f 7f 8f
R I V A L
Catheters / Devices/ Technique Compatibility
Catheter Size Devices Techniques Radial Compatibility
5f Balloons < 5 mm
Stents < 4.5 mm
Ivus
Rota 1.25 mm
No Kissing Balloon
100%
6f All Coronary balloons
All Coronary stents
Cutting Balloon
Rota < 1.75 mm
Protection device(EPI…)
Kissing Balloon
86.9%
7f Angioguard
Rota 2 mm
Kissing Stent76.9%
8f Percusurge
Simpson
Rota >2 mm
64.7%
Myths of TRANSRADIAL APPROACH
1. Delay in accessing the radial artery
2. Spasms and other anatomical problems
3. Poor guiding catheter support
4. Difficulty in CTO lesions
5. Difficulty in complex lesions
6. Difficulty in using aspiration systems
7. Difficulty in using rotablator and other devices
8. Difficulty in CABG patients
RCA: Aspiration device – anjiojet, XBRCA 6F
Konstantopoulio hemodynamic dpt
Myths of TRANSRADIAL APPROACH
1. Delay in accessing the radial artery
2. Spasms and other anatomical problems
3. Poor guiding catheter support
4. Difficulty in CTO lesions
5. Difficulty in complex lesions
6. Difficulty in using aspiration systems
7. Difficulty in using rotablator and other devices
8. Difficulty in CABG patients
R I V A L
Catheters / Devices/ Technique Compatibility
Catheter Size Devices Techniques Radial Compatibility
5f Balloons < 5 mm
Stents < 4.5 mm
Ivus
Rota 1.25 mm
No Kissing Balloon
100%
6f All Coronary balloons
All Coronary stents
Cutting Balloon
Rota < 1.75 mm
Protection device(EPI…)
Kissing Balloon
86.9%
7f Angioguard
Rota 2 mm
Kissing Stent76.9%
8f Percusurge
Simpson
Rota >2 mm
64.7%
Myths of TRANSRADIAL APPROACH
1. Delay in accessing the radial artery
2. Spasms and other anatomical problems
3. Poor guiding catheter support
4. Difficulty in CTO lesions
5. Difficulty in complex lesions
6. Difficulty in using aspiration systems
7. Difficulty in using rotablator and other devices
8. Difficulty in CABG patients
LIMA via RRA
Konstantopoulio hemodynamic dpt
Konstantopoulio hemodynamic dpt
LIMA via RRA
LIMA via RRA
Konstantopoulio hemodynamic dpt
Real problems of TRANSRADIAL APPROACH
1. Most centers have no formal TRA program
2. Operators fear technical failure and care for fluoroscopy time
3. Ruin of radial graft after transradial catheterization
4. Post-procedure occlussion of radial artery
Real problems of TRANSRADIAL APPROACH
1. Most centers have no formal TRA program
2. Operators fear technical failure and care for fluoroscopy time
3. Ruin of radial graft after transradial catheterization
4. Post-procedure occlussion of radial artery
R I V A L
•High volume center: >146 radial PCI/year/ median operator at centre
•Medium volume center: 61-146 radial PCI/year/ median operator at centre
•Low volume center: ≤60 radial PCI/year/ median operator at centre
RADIAL EXPERIENCE
Transradial Approach Failure in Relation to Volume
y = -1,2931Ln(x) + 11,464
0
1
2
3
4
5
6
7
8
0 400 800 1200 1600 2000 2400 2800
p= 0.002
%
*Failure to enter ascending aortaY. Louvard, unpublished
R I V A L
Other Outcomes
Radial(n=3507)
Femoral (n=3514)
P
Access site Cross-over (%) 7.6 2.0 <0.0001
PCI Procedure duration (min) 35 34 0.62
Fluoroscopy time (min) 9.3 8.0 <0.0001
Persistent pain at access site >2 weeks (%)
2.6 3.1 0.22
Patient prefers assigned access site for next procedure (%)
90 49 <0.0001
• Symptomatic radial occlusion requiring medical attention 0.2% in radial group
Real problems of TRANSRADIAL APPROACH
1. Most centers have no formal TRA program
2. Operators fear technical failure and care for fluoroscopy time
3. Ruin of radial graft after transradial catheterization
4. Post-procedure occlussion of radial artery
R I V A L
Use of the radial artery graft after transradial
catheterization: is it suitable as a bypass conduit?
67 pts underwent isolated CABG using the radial artery (RA)
preop. transradial no transradial p value
catheterization catheterization
N= 22 45
Stenosis-free graft patency
Left mammary artery (%) 88 90 0.87
Radial artery (%) 77 98 0.017
Saphenous vein (%) 87 84 0.42
Intimal hyperplasia of RA (%) 68 39 0.046
Kamiya Ann Thorac Surg. 2003; 76(5): 1505-9
R I V A L
Use of the radial artery graft after transradial
catheterization: is it suitable as a bypass conduit?
67 pts underwent isolated CABG using the radial artery (RA)
preop. transradial no transradial p value
catheterization catheterization
N= 22 45
Stenosis-free graft patency
Left mammary artery (%) 88 90 0.87
Radial artery (%) 77 98 0.017
Saphenous vein (%) 87 84 0.42
Intimal hyperplasia of RA (%) 68 39 0.046
Kamiya Ann Thorac Surg. 2003; 76(5): 1505-9
R I V A L
IVUS after transradial approach
JACC 2003;41;1109-14
Early ultrasonic results
Pre-procedure Post-procedure p
Diameter (mm) 3.64 ± 0.74 3.55 ± 0.77 ns
Upstream flow (cm/sec) 29.13 ± 9.51 30.8 ± 11.26 ns
Downstream flow(cm/sec) 28.73 ± 11.84 ns
Duration (mn) 2.92 ± 0.55 3.35 ± 0.83 ns
270 patients
4 radial occluded (1.3%) :
- 2 with a negative flow
- 2 without flow
J. Monsegu
R I V A L Radial Artery/Sheath Diameter Ratio: A
Predictor of Severe Radial Artery Flow
Reduction
0
2
4
6
8
10
12
14
Radial Inner
Diameter / Sheath
>1
Radial Inner
Diameter / Sheath
<1
Severe Radial Flow Reduction
Saïto CCVI 46: 173-178, 1999
Real problems of TRANSRADIAL APPROACH
1. Most centers have no formal TRA program
2. Operators fear technical failure and care for fluoroscopy time
3. Ruin of radial graft after transradial catheterization
4. Post-procedure occlussion of radial artery
Thrombotic occlusion of the radial artery:
3-6% in trials with mandatory doppler (Mann 1996, BRAFE Stent 1997, ACCESS 1997)
0-9% loss of radial pulse in the others
Radial Artery Occlussion
R I V A LReduction of RAO
Introducer vs radial artery size
Procedure manipulations
Post procedure artery compression
0
2
4
6
8
10
12
14
Radial Inner
Diameter / Sheath
>1
Radial Inner
Diameter / Sheath
<1
Severe Radial Flow Reduction
Damn
Femoral!Hi hi hi,
mine was randomized
to radial
I guess,
It’s just not
my day
R I V A L
Casual approach is dangerous…
Even for this job….
Clear Choice
TRANSRADIAL ROUTE IS THE CLEAR
OPTION FOR ALMOST ALL PATIENTS
Only after your “new
learning curve” is over
BUT:
Radial access: just another
artery?ACCESS Study
Randomised comparison of different access sites
Experienced operators
No difference in procedural or fluoroscopy times
Radial Brachial Femoral
PCI’s (n) 300 300 300
Coronary cannulation 93% 95.7% 99.7%
Procedural success 91.7% 90.7% 90.7%
Length of stay (days) 1.5(2.5) 1.8(3.8) 1.8(4.2)
Major access site complications 0 2.3 2.0
JACC 1997; 29: 1269-75. Amsterdam, NL
Radial access: just another
artery?Multiple procedures
812 patients
1438 procedures
6F – 45%
5F – 55%
Failed procedures
(%)
5th3rd2nd
30103.5Men
50207.9Women
CCVI 2001;54: 204-8. Fukuoka, Japan
Radial access: just another
artery?Difficult radial anatomy – small vessels (1) Randomised trial of 5Fr vs 6Fr transradial
PCI in 171 patients with a +ve Allen test
5Fr 6Fr
Procedural success 95.4% 92.9%
Failed coronary cannulation 1.1% 4.8%
Minor haematoma 1.1% 4.8%
Radial occlusion 1.1% 5.9%
CCVI 2002; 57: 172-6. Greifswa, FRG
Radial access: just another
artery?GP IIb/IIIa inhibitors
150 consecutive patients treated with GPIIb/IIIa inhibitors
Radial Femoral
PCI’s (n) 83 67
Event free @ 1/12 94% 94%
Length of stay (days) 5.0 4.9
Major access site bleeding
0 5 (7.4%)
Eur Heart J 2000; 21: 662-7. Toulouse, Fr.
Radial Artery Diameter (Ultrasound)n=120
0
10
20
30
40
50
<2,1mm 2,1-2,4mm 2,5-2,7mm 2,8-3,1mm >3,1mm
2,9+0,6 mm
5f 6f 7f 8f
Y. Louvard unpublished
Procedure- and Non-Procedure-Related Bleeds are Associated with an higher 30-Day Mortality in NSTEMI
Procedure-related
GUSTO bleeds
Non-procedure-related
GUSTO bleeds
Ris
k o
f death
(hazard
Ratio)
None
1.0
Mild
1.3
Severe
16.5
0
5
20
10
15
None
1.0
Mild
2.1
Moderate
2.5
Severe
10.9
Moderate
3.7
Rao et al. Am J Cardiol 2005;96:1200-1206
N=26,452 ACS patients from
GUSTO IIb, PURSUIT and PARAGON A & B
R I V A L Major Bleeding is Associated with an Increased
Risk of Hospital Death in ACS Patients
Moscucci et al. Eur Heart J 2003;24:1815-23
GRACE Registry in 24,045 ACS patients
*After adjustment for comorbidities, clinical presentation and hospital therapies
**p<0.001 for differences in unadjusted death rates
OR (95% CI)
1.64 (1.18 to 2.28*)
0
Overall ACS UA NSTEMI STEMI
10
20
30
40
**
** **
**
5.1
18.6
3.0
16.1
5.3
15.3
7.0
22.8
Inhospital death
(%
)
In hospital major bleeding YesNo
Variable Groups O.R. (95% CI) p-value
Creatinine clearance
<30 mL/min 7.21 (2.53–20.51)
<0.000130–60 mL/min 3.34 (1.92–5.78)
60–90 mL/min 1.57 (0.96–2.57)
CHF Yes 4.38 (2.83–6.78) <0.0001
Major Bleeding Yes 3.26 (1.78–5.96) 0.0001
MI @30day Yes 2.77 (1.62–4.75) 0.0002
Urg Revasc @30d Yes 2.77 (1.15–6.71) .024
Hx angina Yes 2.18 (1.25–3.81) 0.006
Prior MI Yes 1.81 (1.09–3.03) 0.023
Diabetes Yes 1.64 (1.10–2.44) 0.015
Predictors of 1-year Mortality
after Elective and Urgent PCI
Stone GW. J Inv Cardiol 2004;16(suppl G):12–17.
Transradial Approach [LEft vs right]
aNd procedural Times during
percutaneous coronary
procedures: TALENT study
ALESSANDRO SCIAHBASI, MD
UO Cardiologia, Policlinico Casilino – ASL RM B, Rome, Italy
R I V A L
Definitions
Major Bleeding (CURRENT/OASIS 7)
• Fatal
• > 2 units of Blood transfusion
• Hypotension requiring inotropes
• Leading to hemoglobin drop of ≥ 5 g/dl
• Requiring surgical intervention
• ICH or Intraocular bleeding leading to significant vision loss
MajorVascular Access Site Complications
• Large hematoma
• Pseudoaneurysm requiring closure
• AV fistula
• Other vascular surgery related to the access site
R I V A L
Site of Non-CABG Major Bleeds
(RIVAL definition)
*Sites of Non Access site Bleed: Gastrointestinal (most common site), ICH,
Pericardial Tamponade and Other
R I V A L
Use of the radial artery graft after transradial
catheterization: is it suitable as a bypass
conduit?
67 pts underwent isolated CABG using the radial artery (RA)
preop. transradial no transradial p value
catheterization catheterization
N= 22 45
Stenosis-free graft patency
Left mammary artery (%) 88 90 = 0.87
Radial artery (%) 77 98 = 0.017
Saphenous vein (%) 87 84 = 0.42
Intimal hyperplasia of RA (%) 68 39 = 0.046
Kamiya Ann Thorac Surg. 2003; 76(5): 1505-9