Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial

JACC: Cardiovascular Interventions

Volumn 10, Issue 13, 2017, Pages 1357-1365

  Rodés Cabau, Josep ^a   Masson, Jean Bernard ^b   Welsh, Robert C ^c   Garcia del Blanco, Bruno ^d   Pelletier, Marc ^e   Webb, John G ^f   Al Qoofi, Faisal ^g   Généreux, Philippe ^h   Maluenda, Gabriel ⁱ   Thoenes, Martin ^j   Paradis, Jean Michel ^a   Chamandi, Chekrallah ^a   Serra, Vicenç ^d   Dumont, Eric ^a   Côté, Mélanie ^a  

^a LAVAL UNIVERSITY   (Canada)

^b CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

^c MAZANKOWSKI ALBERTA HEART INSTITUTE   (Canada)

^d HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^e SAINT JOHN REGIONAL HOSPITAL   (Canada)

^f ST PAUL S HOSPITAL   (Canada)

^g FOOTHILLS HOSPITAL   (Canada)

^h HÔPITAL DU SACRÉ COEUR DE MONTRÉAL   (Canada)

ⁱ HOSPITAL SAN BORJA ARRIARÁN   (Chile)

^j Léman Research Institute   (Switzerland)

more..

Author keywords

aortic stenosis; aspirin; bleeding; clopidogrel; stroke; transcatheter aortic valve replacement

Indexed keywords

ACETYLSALICYLIC ACID; ACETYLSALICYLIC ACID PLUS CLOPIDOGREL; PANTOPRAZOLE; ANTITHROMBOCYTIC AGENT; CLOPIDOGREL; FIBRINOLYTIC AGENT; TICLOPIDINE;

AGED; ANTICOAGULANT THERAPY; ARTICLE; BLOOD CLOTTING TIME; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DUAL ANTIPLATELET THERAPY; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HEART INFARCTION; HEART INFARCTION PREVENTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PERCUTANEOUS AORTIC VALVE; POSTOPERATIVE HEMORRHAGE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRANSIENT ISCHEMIC ATTACK; TRANSTHORACIC ECHOCARDIOGRAPHY; ANALOGS AND DERIVATIVES; AORTIC VALVE; BLEEDING; CANADA; CHEMICALLY INDUCED; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; DEVICES; EARLY TERMINATION OF CLINICAL TRIAL; EUROPE; HEART VALVE PROSTHESIS; KAPLAN MEIER METHOD; MORTALITY; PROSTHESIS DESIGN; RISK FACTOR; SOUTH AMERICA; SURGERY; THROMBOSIS; TIME FACTOR; TRANSLUMINAL VALVULOPLASTY; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; AORTIC VALVE; ASPIRIN; BALLOON VALVULOPLASTY; CANADA; DRUG THERAPY, COMBINATION; EARLY TERMINATION OF CLINICAL TRIALS; EUROPE; FEMALE; FIBRINOLYTIC AGENTS; HEART VALVE PROSTHESIS; HEMORRHAGE; HUMANS; ISCHEMIC ATTACK, TRANSIENT; KAPLAN-MEIER ESTIMATE; MALE; MYOCARDIAL INFARCTION; PLATELET AGGREGATION INHIBITORS; PROSTHESIS DESIGN; RISK FACTORS; SOUTH AMERICA; STROKE; THROMBOSIS; TICLOPIDINE; TIME FACTORS; TRANSCATHETER AORTIC VALVE REPLACEMENT; TREATMENT OUTCOME;

EID: 85019990518     PISSN: 19368798     EISSN: 18767605     Source Type: Journal    
DOI: 10.1016/j.jcin.2017.04.014     Document Type: Article

References (33)

1. Khatri, P.J., Webb, J.G., Rodés-Cabau, J., et al. Adverse effects associated with transcatheter aortic valve implantation: a meta-analysis of contemporary studies. Ann Intern Med 158 (2013), 35–46.
2. Holmes, D.R. Jr., Mack, M.J., Kaul, S., et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol 59 (2012), 1200–1254.
3. Webb, J., Rodés-Cabau, J., Fremes, S., et al. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol 28 (2012), 520–528.
4. Vahanian, A., Alfieri, O., Andreotti, F., et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 33 (2012), 2451–2496.
5. Lip, G., Nieuwlaat, R., Pisters, R., Lane, D.A., Crijns, H.J., Refining clinical risk stratification for predicting stroke and thromboembolism in AF using a novel risk factor-based approach: the Euro Heart Survey on atrial fibrillation. Chest 137 (2010), 263–272.
6. Rodés-Cabau, J., Dauerman, H.L., Cohen, M.G., et al. Antithrombotic treatment in transcatheter aortic valve implantation: insights for cerebrovascular and bleeding events. J Am Coll Cardiol 62 (2013), 2349–2359.
7. Shehab, N., Sperling, L.S., Kegler, S.R., et al. National estimates of emergency department visits for hemorrhage-related adverse events from clopidogrel plus aspirin and from warfarin. Arch Intern Med 170 (2010), 1926–1933.
8. Delaney, J.A., Opatrny, L., Brophy, J.M., et al. Drug interactions between antithrombotic medications and the risk of gastrointestinal bleeding. CMAJ 177 (2007), 347–351.
9. Miyazaki, Y., Suwannasom, P., Sotomi, Y., et al. Single or dual antiplatelet therapy after PCI. Nat Rev Cardiol 14 (2017), 294–303.
10. Kappetein, A.P., Head, S.J., Genereux, P., et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 60 (2012), 1438–1454.
11. Hioki, H., Watanabe, Y., Kozuma, K., et al. Pre-procedural dual antiplatelet therapy in patients undergoing transcatheter aortic valve implantation increases risk of bleeding. Heart 103 (2017), 361–367.
12. Ichibori, Y., Mizote, I., Maeda, K., et al. Clinical outcomes and bioprosthetic valve function after transcatheter aortic valve implantation under dual antiplatelet therapy vs. aspirin alone. Circ J 81 (2017), 397–404.
13. Czerwińska-Jelonkiewicz, K., Zembala, M., Dąbrowski, M., et al. Can TAVI patients receive aspirin monotherapy as patients after surgical aortic bioprosthesis implantation? Data from the Polish Registry—POL-TAVI. Int J Cardiol 227 (2017), 305–311.
14. Mangieri, A., Jabbour, R.J., Montalto, C., et al. Single-antiplatelet therapy in patients with contraindication to dual-antiplatelet therapy after transcatheter aortic valve implantation. Am J Cardiol 119 (2017), 1088–1093.
15. Durand, E., Blanchard, D., Chassaing, S., et al. Comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 113 (2014), 355–360.
16. Ussia, G.P., Scarabelli, M., Mulè, M., et al. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 108 (2011), 1772–1776.
17. Stabile, E., Pucciarelli, A., Cota, L., et al. SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation. Int J Cardiol 174 (2014), 624–627.
18. Hassell, M.E., Hildick-Smith, D., Durand, E., et al. Antiplatelet therapy following transcatheter aortic valve implantation. Heart 101 (2015), 1118–1125.
19. Gandhi, S., Schwalm, J.D., Velianou, J.L., Natarajan, M.K., Farkouh, M.E., Comparison of dual-antiplatelet therapy to mono-antiplatelet therapy after transcatheter aortic valve implantation: systematic review and meta-analysis. Can J Cardiol 31 (2015), 775–784.
20. Nombela-Franco, L., Webb, J.G., de Jaegere, P.P., et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation 126 (2012), 3041–3053.
21. Van Mieghem, N.M., Schipper, M.E., Ladich, E., et al. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation 127 (2013), 2194–2201.
22. Kahlert, P., Al-Rashid, F., Dottger, P., et al. Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study. Circulation 126 (2012), 1245–1255.
23. Haussig, S., Mangner, N., Dwyer, M.G., et al. Effect of a cerebral protection device on brain lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis: the CLEAN-TAVI randomized clinical trial. JAMA 316 (2016), 592–601.
24. Kapadia, S.R., Kodali, S., Makkar, R., et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol 69 (2017), 367–377.
25. Auffret, V., Regueiro, A., Del Trigo, M., et al. Predictors of early cerebrovascular events in patients with aortic stenosis undergoing transcatheter aortic valve replacement. J Am Coll Cardiol 68 (2016), 673–684.
26. Miller, D.C., Blackstone, E.H., Mack, M.J., et al. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg 143 (2012), 832–843.
27. Lazar, H.L., Transcatheter aortic valves—where do we go from here?. N Engl J Med 363 (2010), 1667–1668.
28. Généreux, P., Cohen, D.J., Williams, M.R., et al. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I trial. J Am Coll Cardiol 63 (2014), 1100–1109.
29. Redfors B, Watson BM, McAndrew T, et al. Mortality, length of stay, and cost implications of procedural bleeding after percutaneous interventions using large-bore catheters. JAMA Cardiol 2017. In press.
30. Généreux, P., Giustino, G., Witzenbichler, B., et al. Incidence, predictors, and impact of post-discharge bleeding after percutaneous coronary intervention. J Am Coll Cardiol 66 (2015), 1036–1045.
31. Connolly, S., Pogue, J., Hart, R., et al. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet 367 (2006), 1903–1912.
32. Puri, R., Auffret, V., Rodés-Cabau, J., Bioprosthetic valve thrombosis. J Am Coll Cardiol 69 (2017), 2193–2211.
33. Chakravarty, T., Sondergaard, L., Friedman, J., et al. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet, 2017 In press.