tavi and adjunctive pharmacological therapy: … and adjunctive pharmacological therapy: current...
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TAVI and Adjunctive Pharmacological Therapy:
Current Practice and Future Perspectives
Α-Δ. ΜΑΥΡΟΓΙΑΝΝΗ
ΚΑΡΔΙΟΛΟΓΟΣ
AIMOΔΥΝΑΜIΚΟ ΕΡΓΑΣΤΗΡΙΟ
Γ.Ν.Θ. «Γ.ΠΑΠΑΝΙΚΟΛΑΟΥ»
ΘΕΣΣΑΛΟΝΙΚΗ
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Disclosure Statement of Financial Interest
none whatsoever…
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Evolution of Devices (2002 - 2015)Prosthesis with CE Mark Approval
EDWARDS SAPIEN THV EDWARDS SAPIEN XT SYMETIS ACURATE
TA
SJM PORTICO DIRECT FLOW
MEDICAL
BSC LOTUS EDWARDS
SAPIEN 3
MEDTRONIC
EVOLUT R
MEDTRONIC COREVALVE JENAVALVE MEDTRONIC
ENGAGER
SYMETIS ACURATE
NEO
2007 2010 2011 2012 2013 2014 2015
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TAVI at the Antipodes of the Risk Spectrum:
Mortality at 30-days in FDA Approved Studies 2010 - 2015
Pilgrim T., Windecker S.
Transcatheter Aortic Valve Replacement: Lessons Gained From Extreme-Risk Patients.
J Am Coll Cardiol. 2015 Sep 22;66(12):1335-8
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The Majority of AS Patients Indicated Per Guidelines
Remain Untreated
Sources: Nkomo 2006, Livanainen 1996, Aronow 1991, Bach 2007, Freed 2010, Lung 2007, Pellikka 2005, Internal estimates
Estimated U.S. AVR Penetration
In Severe, Symptomatic Patients
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TAVI Present Guidelines
Indication for AVR Heart Valve Team
Low Intermediate
Surgical Risk
Surgical
AVR (I)
High
Surgical Risk
Prohibitive
Surgical Risk
TAVR
(II a)
Predicted post TAVR
Survival > 1 year
TAVR
(I)
Palliative
Care
Bridge to
TAVR or SAVR
for severe
symptoms
BAV (IIa)
Nishimura RA. et al.
2014 AHA/ACC guideline for the management of patients with valvular heart disease:
a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.
J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185
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Stroke in TAVI
DAPT SINGLE ANTIPLATELET
DOACs
Stortecky S., Windecker S.
Stroke: an infrequent but devastating complication in cardiovascular interventions.
Circulation. 2012 Dec 18;126(25):2921-4
STROKE
PROTECTION
STRATEGY
MINIMAL TOUCH TECHNIQUE
EMBOLIC PROTECTION DEVICE
NEW GENERATION VALVE PROSTHESIS
INTRA AND PERIPROCEDURAL ANTITHROMBOTIC THERAPY
PTS. WITH SR
PTS. WITH AFib
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Stroke in TAVI
Nombela-Franco L. et al.
Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation.
Circulation. 2012 Dec 18;126(25):3041-53
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What Lies Within?
75
52 53
32
21 20
1210
0
10
20
30
40
50
60
70
80
pts.+ debris aortic wall/valve thrombusoverall
collagenoustissue
valve tissue thrombusisolated
amorphouscalcium
foreign boby
Van Mieghem NM. et al.
Histopathology of embolic debris captured during transcatheter aortic valve replacement.
Circulation. 2013 Jun 4;127(22):2194-201
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TAVI: Rate of Stroke at 30 Days
0
0,5
1
1,5
2
2,5
3
3,5
4
4,5
5
SOURCE 2012 PARTNER Coh 1.2011
German Registry2011
ADVANCE 1 2012 US CORE VALVE2014
PARTNER II Si3
Petronio SA.
euroPCR 2016
2,50%
4,70%
2,80%
3,30%
4,90%
1,00%
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TAVI: Neuroimaging
0
10
20
30
40
50
60
70
80
90
Rhodes Cabau JACC 2011 Ghanem JACC 2010 Arnold JACC Int. 2010 Kahlert Circulation 2010 Astarci EJCTS 2011
68.0% 68.0% 69.0%72.7%
84.0%
Daneault B. et al.
Stroke associated with surgical and transcatheter treatment of aortic stenosis: a comprehensive review.
J Am Coll Cardiol. 2011 Nov 15;58(21):2143-50
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TAVI vs SAVR in High-risk Patients
New Onset Atrial Fibrillation
0
5
10
15
20
25
30
35
PARTNER 1 newonset AFIB 30 days PARTNER 1 new
onset AFIB 1 year CORE VALVE HIGHRISK new onset
AFIB 30 daysCORE VALVE HIGH
RISK new onsetAFIB 1 year
New Onset Atrial Fibrilation
TAVI SAVR
Windecker S.
euroPCR 2015
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Comorbidities:
Atrial Fibrillation in TAVI Patients
0
5
10
15
20
25
30
35
40
45
50
Piazza 2008 Webb 2009 Leon 2010 Leon 2010 Smith 2011 Smith 2011 Tamburino2011
Bullesfeld2011
29
41,1
32,9
48,8
40,842,7
16,4
39,7
Stefanini G.
euroPCR 2015
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Variables Mean (min–max)
Age (years) 82 (50–98)
Male sex (%) 44 (24–57)
Diabetes (%) 28 (23–35)
Hypertension 60 (36–85)
Prior coronary
disease (%)
54 (41-69)
Prior CABG (%) 25 (14-45)
Chronic renal
failure (%)
35 (20–62)
COPD (%) 26 (21–30)
Prior stroke (%) 9 (7–11)
Peripheral vascular
disease (%)
19 (7–35)
TA 30 (11–50)
TF 11 (4–19)
Porcelain aorta (%) 12 (7-18)
Frailty (%) 21 (17–25)
Mean CHADS2 score ~3
Clinical Experience – Published Registries
Patient Characteristics
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TAVI and Coronary Artery Disease
59
65
73
2023
44
11
17
31
0
10
20
30
40
50
60
70
80
Gasparato et al. Wenaweser et al. Abdul Wahab et al.
CAD PCI pre TAVI DES
Gasparetto et al. CCI 2013
Wenaweser et al. Eurointervention 2012
Abdul-Wahab et al. Am J Cardio 2012
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67 y/o Male Physician s/p TAVI with 29mm Sapien 3 Valve
Day 1 TTE
Gradient 10 mmHg
4 months post TAVI
Gradient 23 mmHg
Worsening shortness of breath 4 months post-TAVR
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Leaflet Thickening/ Restricted Leaflet Motion Noted on 4D VR-CT
Restricted leaflet motion
Hypoattenuating lesions
Leaflet motion restored following anticoagulation with warfarin (INR 2-3)
Repeat CT performed after 3 months
Resolution of symptoms with anticoagulation
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Risk of THV Thrombosis
None 0 (0/1)
(0.0–97.5)
Aspirin only 25.0 (4/16)
(7.2–52.3)
Clopidogrel only 12.5 (2/16)
(1.5–38.3)
Aspirin+clopidogrel 9.7 (19/195)
(6.0–14.8)
Warfarin only 7.1 (2/28)
(0.9–23.5)
Warfarin+aspirin 1.0 (1/96)
(0.0–5.7)
Warfarin+clopidogrel 0 (0/41)
(0.0–8.6)
Warfarin+aspirin+
clopidogrel
0 (0/6)
(0.0–45.9)
NOAC only 0 (0/5)
(0.0–52.2)
Warfarin, part of post-
TAVR
antithrombotic
therapy*
Yes 1.8 (3/171)
(0.4–5.0)
No 10.7 (25/234)
(7.0–15.4)
J Am Coll Cardiol. 2016 Nov 8;68(19):2059-2069
Transcatheter Aortic Valve Thrombosis:
Incidence, Predisposing Factors, and Clinical Implications.
Hansson NC. et al.
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TAVI: Risk of Ischaemic and Bleeding Complication
Nijenhuis VJ. et al.
Antithrombotic treatment in patients undergoing transcatheter aortic valve implantation (TAVI).
Thromb Haemost. 2015 Apr;113(4):674-85
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Major Late Bleeding: Etiology
40,8
15,5
7,8 6,3
3,5 2,1 2,1 2,1
1,4 0,7
23,2
0
5
10
15
20
25
30
35
40
45
Généreux P. et al.
Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement.
J Am Coll Cardiol. 2014 Dec 23;64(24):2605-15
142 Major Late Bleedings
(incidence 5.9%)
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AFIB and MLB after TAVI: Cumulative Risk
Généreux P. et al.
Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement.
J Am Coll Cardiol. 2014 Dec 23;64(24):2605-15
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Current Recommendations for Anti-Thrombotic Therapy Following
Transcatheter Aortic Valve Implantation
ACCF/AATS/SCAI/
STS
expert consensus(a)
AHA/ACC
Guidelines(b)
CCS
position statement(c)
ESC/EACTS
guidelines(d)
Long-term
anti-thrombotic
treatment
Aspirin 81 mg/day
indefinitely
Lifelong aspirin 75–
100 mg daily
(Class IIb;
level of evidence: C)
Low-dose aspirin
indefinitely
Low-dose aspirin
indefinitely
Post-procedural
anti-thrombotic
treatment
Aspirin 81 mg/
day + clopidogrel
75 mg/day for 3–6
months
If warfarin indicated
then no clopidogrel
Aspirin 75–100 mg/
day + clopidogrel
75 mg/day for
6 months
ASA 80 mg/
day + thienopyridine
for 1–3 months
If oral anticoagulant
indicated (AF),
avoid triple therapy
unless indication
exists
Low-dose aspirin + a
thienopyridine
early after TAVI
In patients in AF, a
combination of VKA
and aspirin or
thienopyridine is
generally used,
but should be
weighed against
increased risk of
bleeding
a.J Am Coll Cardiol 2012;59:1200–125
b.Circulation 2014;129:e521–e643
c.Can J Cardiol 2012;28:520–5284
d.Eur Heart J 2012;33:2451–2496
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Single vs. Dual Antiplatelet Therapy Following TAVI
Iung B., Rodés-Cabau J.
The optimal management of anti-thrombotic therapy after valve replacement: certainties and uncertainties.
Eur Heart J. 2014 Nov 7;35(42):2942-9
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Do We Really Need DAPT?
Hassell ME. et al.
Antiplatelet therapy following transcatheter aortic valve implantation.
Heart. 2015 Jul;101(14):1118-25
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Triple Therapy Following TAVI
7,8
8,8
10,6
0
2
4
6
8
10
12
DAPT OAC+single APT OAC+DAPT
Death
1,3
0
4
0
0,5
1
1,5
2
2,5
3
3,5
4
4,5
DAPT OAC+single APT OAC+DAPT
Stroke/ Embolism
0,9 0,9
2,7
0
0,5
1
1,5
2
2,5
3
DAPT OAC+single APT OAC+DAPT
Major Bleeding
Dual antiplatelet
(n=993)
OAC + mono antiplatelet
(n=171)
OAC + dual antiplatelet
(n=237)
Zeymer U et al.
Antithrombotic therapy after transfemoral aortic valve implantation (TAVI). Potential hazard of triple therapy. (Abstract)
Eur Heart J 2011; 32 Suppl:900
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AF - TAVI
Antithrombotic Treatment
PARTNER Trial (a) ACC/STS Recommendations (b) CCS Statement (c)
Preprocedural ASA 81 mg
Clopidogrel 600 mg_ _
Periprocedural UFH
ACT 250 sec
Reversal with protamine: optional
Bivalirudin- not allowed
UFH
ACT 300sec
Reversal with protamine recommended
Bivalirudin not mentioned
_
Postprocedural ASA 81 mg/ day +
Clopidogrel 75 mg/ day x 90 d
If warfarin indicated (Afib) then no
clopidogrel
ASA 81 mg/ day +
Clopidogrel 75 mg/ day x 3_6 mo.
If warfarin indicated (Afib) then no
clopidogrel
Indefinite low dose ASA generally
recommended +TNP x 1-3 mo.
If oral anticoagulant indicated (Afib), avoid
triple therapy unless definite indication
exists
a. N Engl J Med 2010;363:1597–607
a. N Engl J Med 2011;364: 2187–98
b. Am J Cardiol 2005;96:1379–83
c. J Am Coll Cardiol 2012;59:1200–54
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The Future?
Pros Cons
DOACs
Apixaban/Rivaroxaban Rapid onset and predictable
anticoagulation
No antidote, > bleeding risk
Dabigatran Rapid onset and predictable
anticoagulation
No experience with antidote in
this setting
New P2Y12 inhibitors
Prasugrel Rapid onset, > potency,
<interpatient variability
Unknown if > degree of
platelet inhibition is usefull,
contraindicated if prior CVE, >
bleeding risk
Ticagrelor Rapid onset, > potency,
<interpatient variability
Unknown if > degree of
platelet inhibition is usefull,
BID dose, dyspnoea, >
bleeding risk
Rodés-Cabau J. et al.
Antithrombotic treatment in transcatheter aortic valve implantation: insights for cerebrovascular and bleeding events.
J Am Coll Cardiol. 2013 Dec 24;62(25):2349-59
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Ongoing/ Upcoming Studies
Trial ARTE(a) ATLANTIS(b) GALILEO(c) POPular-TAVI(d)
Design RCT RCT RCT RCT
Planned N 200 1500 1500 1000
Study regimen Clopid 3 m
ASA 6 m
Apixaban ASA 3 m +
Rivaroxaban 12 m
Aspirin alone /
OAC alone
Control regimen ASA 6 m Standard of care
(DAPT/SAPT/OAC)
Clopid 3 m +
ASA 12 m
Aspirin/OAC +
Clopid 3m
Primary EP Death, MI, CVA or
major bleed @ 1y
Death, MI, stroke, TIA,
systemic embolism,
intracardiac or
bioprosthesis
thrombus, DVT, PE,
major bleed @ 6m
Death, stroke, MI,
valve thrombosis, PE,
DVT and systemic
embolism @1y
Any bleeding @1y
a.NCT01559298
b.NCT02664649
c.NCT02556203
d.NCT02247128
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