Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: The OPTIDUAL randomized trial

European Heart Journal

Volumn 37, Issue 4, 2016, Pages 365-374

  Helft, Gerard ^a,b   Steg, Philippe Gabriel ^c,d,e   Le Feuvre, Claude ^a   Georges, Jean Louis ^f   Carrie, Didier ^g   Dreyfus, Xavier ^h   Furber, Alain ⁱ   Leclercq, Florence ^j   Eltchaninoff, Helene ^k,l   Falquier, Jean François ^m   Henry, Patrick ⁿ   Cattan, Simon ^o   Sebagh, Laurent ^p   Michel, Pierre Louis ^a   Tuambilangana, Albert ^q   Hammoudi, Nadjib ^a,b   Boccara, Franck ^a,l   Cayla, Guillaume ^r   Douard, Herve ^s   Diallo, Abdourahmane ^t   Berman, Emmanuel ^a   Komajda, Michel ^a,b   Metzger, Jean Philippe ^a   Vicaut, Eric ^t,u   more..

^a ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^b PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^c UNIVERSITÉ PARIS DESCARTES   (France)

^d BICHAT HOSPITAL   (France)

^e ROYAL BROMPTON HOSPITAL   (United Kingdom)

^f CENTRE HOSPITALIER DE VERSAILLES   (France)

^g CHU RANGUEIL   (France)

^h Espace Medical Mounier   (France)

ⁱ ANGERS UNIVERSITY HOSPITAL   (France)

^j MONTPELLIER UNIVERSITY HOSPITAL   (France)

^k ROUEN UNIVERSITY HOSPITAL   (France)

^l INSERM   (France)

^m Polyclinique de Bergerac   (France)

ⁿ HÔPITAL LARIBOISIÈRE   (France)

^o Centre Hospitalier Intercommunal Le Raincy Montfermeil   (France)

^p Hopital Prive de l'Ouest Parisien   (France)

^q Hopital Cherbourg   (France)

^r NÎMES UNIVERSITY HOSPITAL   (France)

^s BORDEAUX UNIVERSITY HOSPITAL   (France)

^t SAINT LOUIS HOSPITAL   (France)

^u CRIN   (France)

more..

Author keywords

Bleeding; Clopidogrel; Drug eluting stent; Dual antiplatelet therapy; Myocardial infarction; Randomized trial

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; EVEROLIMUS; PACLITAXEL; RAPAMYCIN; ZOTAROLIMUS; ANTITHROMBOCYTIC AGENT; TICLOPIDINE;

ACUTE CORONARY SYNDROME; ADULT; AGED; ARTICLE; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DRUG ELUTING STENT; EVEROLIMUS ELUTING CORONARY STENT; FEMALE; FOLLOW UP; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PACLITAXEL ELUTING CORONARY STENT; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIROLIMUS ELUTING CORONARY STENT; ZOTAROLIMUS ELUTING CORONARY STENT; AFTERCARE; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DRUG ADMINISTRATION; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; TREATMENT OUTCOME;

ACUTE CORONARY SYNDROME; ADULT; AFTERCARE; CORONARY ARTERY DISEASE; DRUG ADMINISTRATION SCHEDULE; DRUG-ELUTING STENTS; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; PLATELET AGGREGATION INHIBITORS; TICLOPIDINE; TREATMENT OUTCOME;

EID: 84960454667     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehv481     Document Type: Article

References (32)

1. Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and efficacy of sirolimus-and paclitaxel-eluting coronary stents. N Engl J Med 2007;356:998-1008.
2. Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007;356: 1020-1029.
3. Claessen BE, Henriques JP, Jaffer FA, Mehran R, Piek JJ, Dangas GD. Stent thrombosis: a clinical perspective. JACC Cardiovasc Interv 2014;7:1081-1092.
4. Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation 2011;124:e574-e651.
5. Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014;35:2541-2619.
6. Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med 2010;362:1374-1382.
7. Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fucà G, Kubbajeh MD, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R. Shortversus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation 2012;125:2015-2026.
8. Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation 2012;125:505-513.
9. Kim BK, Hong MK, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Kang TS, Park BE, Kang WC, Lee SH, Yoon JH, Hong BK, Kwon HM, Jang Y, RESET Investigators. A new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation). J Am Coll Cardiol 2012;60:1340-1348.
10. Cassese S, Byrne RA, Tada T, King LA, Kastrati A. Clinical impact of extended dual antiplatelet therapy after percutaneous coronary interventions in the drug-eluting stent era: a meta-analysis of randomized trials. Eur Heart J 2012;33:3078-3087.
11. Schulz-Schupke S, Byrne RA, Ten Berg JM, Neumann FJ, Han Y, Adriaenssens T, Tolg R, Seyfarth M, Maeng M, Zrenner B, Jacobshagen C, Mudra H, von Hodenberg E, Wohrle J, Angiolillo DJ, von Merzljak B, Rifatov N, Kufner S, Morath T, Feuchtenberger A, Ibrahim T, Janssen PW, Valina C, Li Y, Desmet W, Abdel-Wahab M, Tiroch K, Hengstenberg C, Bernlochner I, Fischer M, Schunkert H, Laugwitz KL, Schomig A, Mehilli J, Kastrati A. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting. Eur Heart J 2015;36:1252-1263.
12. Gilard M, Barragan P, Noryani AA, Noor HA, Majwal T, Hovasse T, Castellant P, Schneeberger M, Maillard L, Bressolette E, Wojcik J, Delarche N, Blanchard D, Jouve B, Ormezzano O, Paganelli F, Levy G, Sainsous J, Carrie D, Furber A, Berland J, Darremont O, Le Breton H, Lyuycx-Bore A, Gommeaux A, Cassat C, Kermarrec A, Cazaux P, Druelles P, Dauphin R, Armengaud J, Dupouy P, Champagnac D, Ohlmann P, Endresen K, Benamer H, Kiss RG, Ungi I, Boschat J, Morice MC. 6-Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin: The Randomized, Multicenter ITALIC Trial. J Am Coll Cardiol 2015;65:777-786.
13. Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM, DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 2014;371:2155-2166.
14. Raber L, Magro M, Stefanini GG, Kalesan B, van Domburg RT, Onuma Y, Wenaweser P, Daemen J, Meier B, Juni P, Serruys PW, Windecker S. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study. Circulation 2012;125:1110-1121.
15. Lee CW, Ahn JM, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Han S, Lee SG, Seong IW, Rha SW, Jeong MH, Lim DS, Yoon JH, Hur SH, Choi YS, Yang JY, Lee NH, Kim HS, Lee BK, Kim KS, Lee SU, Chae JK, Cheong SS, Suh IW, Park HS, Nah DY, Jeon DS, Seung KB, Lee K, Jang JS, Park SJ. Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial. Circulation 2014;129:304-312.
16. Helft G, Le Feuvre C, Georges JL, Carrie D, Leclercq F, Eltchaninoff H, Furber A, Prunier F, Sebagh L, Cattan S, Cayla G, Vicaut E, Metzger JP. Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial. Trials 2013;14:56.
17. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, the Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. Eur Heart J 2012;33:2551-2567.
18. Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005;3: 692-694.
19. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, SerruysPW, Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-2351.
20. The GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993;329: 673-682.
21. Rao AK, Pratt C, Berke A, Jaffe A, Ockene I, Schreiber TL, Bell WR, Knatterud G, Robertson TL, Terrin ML. Thrombolysis in Myocardial Infarction (TIMI) Trial-phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol 1988;11:1-11.
22. Robins JM, Hernan MA, Brumback B. Marginal structural models and causal inference in epidemiology. Epidemiology 2000;11:550-560.
23. Harvard School of Public Health. Harvard School of Public Health Programon Causal Inference: Software-marginal structural Cox model in SAS. https://cdn1.sph. harvard.edu/wp-content/uploads/sites/148/2012/10/samplemsmcox.txt. (10 August 2015).
24. Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW, PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med 2011;364:226-235.
25. Palmerini T, Sangiorgi D, Valgimigli M, Biondi-Zoccai G, Feres F, Abizaid A, Costa RA, Hong MK, Kim BK, Jang Y, Kim HS, Park KW, Mariani A, Della Riva D, Genereux P, Leon MB, Bhatt DL, Bendetto U, Rapezzi C, StoneGW. Short-versus long-term dual antiplatelet therapy after drug-eluting stent implantation: an individual patient data pairwise and network meta-analysis. J Am Coll Cardiol 2015;65: 1092-1102.
26. Navarese EP, Andreotti F, Schulze V, Kolodziejczak M, Buffon A, Brouwer M, Costa F, Kowalewski M, Parati G, Lip GY, Kelm M, Valgimigli M. Optimal duration of dual antiplatelet therapy after percutaneous coronary intervention with drug eluting stents: meta-analysis of randomised controlled trials. BMJ 2015;350:h1618.
27. Giustino G, Baber U, Sartori S, Mehran R, Mastoris I, Kini AS, Sharma SK, Pocock SJ, Dangas GD. Duration of dual antiplatelet therapy after drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Cardiol 2015;65:1298-1310.
28. Elmariah S, Mauri L, Doros G, Galper BZ, O'Neill KE, Steg PG, Kereiakes DJ, Yeh RW. Extended duration dual antiplatelet therapy and mortality: a systematic review and meta-analysis. Lancet 2015;385:792-798.
29. Palmerini T, Benedetto U, Bacchi-Reggiani L, Della Riva D, Biondi-Zoccai G, Feres F, Abizaid A, Hong MK, Kim BK, Jang Y, Kim HS, Park KW, Genereux P, Bhatt DL, Orlandi C, De Servi S, Petrou M, Rapezzi C, Stone GW. Mortality in patients treated with extended duration dual antiplatelet therapy after drug-eluting stent implantation: a pairwise and Bayesian network meta-analysis of randomised trials. Lancet 2015;385:2371-2382.
30. Jeger RV, Pfisterer ME, Sorensen R, von Felten S, Alber H, Bonetti PO, Eberli F, Erne P, Pedrazzini G, Rickli H, Galatius S, Kaiser CA, BASKET and BASKET-PROVE investigators. Tradeoff between bleeding and stent thrombosis in different dual antiplatelet therapy regimes: Importance of case fatality rates and effective treatment durations. Am Heart J 2014;168:698-705.
31. Berger PB, Bhatt DL, Fuster V, Steg PG, Fox KA, Shao M, Brennan DM, Hacke W, Montalescot G, Steinhubl SR, Topol EJ, CHARISMA Investigators. Bleeding complications with dual antiplatelet therapy among patients with stable vascular disease or risk factors for vascular disease: results from the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial. Circulation 2010;121:2575-2583.
32. Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS, PEGASUS-TIMI Steering Committee Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med 2015;372:1791-1800.