Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial

The Lancet - Tập 381 - Trang 1107-1115 - 2013
Willem JM Dewilde1, Tom Oirbans2, Freek WA Verheugt3, Johannes C Kelder2, Bart JGL De Smet4, Jean-Paul Herrman3, Tom Adriaenssens5, Mathias Vrolix6, Antonius ACM Heestermans7, Marije M Vis8, Jan GP Tijsen8, Arnoud W van 't Hof9, Jurriën M ten Berg2
1Department of Cardiology, Twee Steden Hospital, Tilburg, Netherlands
2Department of Cardiology, St. Antonius Hospital, Nieuwegein, Netherlands
3Department of Cardiology, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, Netherlands
4Department of Cardiology, University Medical Center Groningen, Groningen and Meander Hospital, Amersfoort, Netherlands
5Department of Cardiology, Catholic University of Leuven, Leuven, Belgium
6Department of Cardiology, Hospital Oost-Limburg (ZOL), Genk, Belgium
7Department of Cardiology, Medical Center Alkmaar, Alkmaar, Netherlands
8Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
9Department of Cardiology, Isala Hospital, Zwolle, Netherlands

Tài liệu tham khảo

American College of Cardiology/American Heart Association Task Force on Practice Guidelines, 2006, Circulation, 114, e84, 10.1161/CIRCULATIONAHA.106.176857 Camm, 2010, Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC), Eur Heart J, 31, 2369, 10.1093/eurheartj/ehq278 Lip, 2010, Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary intervention/stenting, Thromb Haemost, 103, 13, 10.1160/TH09-08-0580 Hansen, 2010, Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel in patients with atrial fibrillation, Arch Intern Med, 170, 1433, 10.1001/archinternmed.2010.271 Smith, 2006, Circulation, 113, 156, 10.1161/CIRCULATIONAHA.105.170815 Karjalainen, 2007, Safety and efficacy of combined antiplatelet-warfarin therapy after coronary stenting, Eur Heart J, 28, 726, 10.1093/eurheartj/ehl488 Orford, 2004, Safety and efficacy of aspirin, clopidogrel, and warfarin after coronary stent placement in patient with an indication for anticoagulation, Am Heart J, 147, 463, 10.1016/j.ahj.2003.06.004 Doyle, 2009, Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention: implications for contemporary practice, J Am Coll Cardiol, 53, 2019, 10.1016/j.jacc.2008.12.073 Roldán, 2008, Contra: ‘Antithrombotic therapy with warfarin, aspirin and clopidogrel is the recommended regimen in anticoagulated patients who present with an acute coronary syndrome and/or undergo percutaneous coronary interventions’. Not for everybody, Thromb Haemost, 100, 754, 10.1160/TH08-06-0363 Connolly, 2006, 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, 1903, 10.1016/S0140-6736(06)68845-4 Lip, 2008, Managing the anticoagulated patient with atrial fibrillation at high risk of stroke who needs coronary intervention, BMJ, 337, a840, 10.1136/bmj.39533.570602.BE Ruiz-Nodar, 2008, Anticoagulant and antiplatelet therapy use in 426 patients with atrial fibrillation undergoing percutaneous coronary intervention and stent implantation implications for bleeding risk and prognosis, J Am Coll Cardiol, 51, 818, 10.1016/j.jacc.2007.11.035 Leon, 1998, A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators, N Engl J Med, 339, 1665, 10.1056/NEJM199812033392303 Rubboli, 2005, Meta-analysis of trials comparing oral anticoagulation and aspirin versus dual antiplatelet therapy after coronary stenting. Clues for the management of patients with an indication for long-term anticoagulation undergoing coronary stenting, Cardiology, 104, 101, 10.1159/000086918 Urban, 1998, Randomized evaluation of anticoagulation versus antiplatelet therapy after coronary stent implantation in high-risk patients: the multicenter aspirin and ticlopidine trial after intracoronary stenting (MATTIS), Circulation, 98, 2126, 10.1161/01.CIR.98.20.2126 Van Es, 2002, Aspirin and coumadin after acute coronary syndromes (the ASPECT-2 study): a randomised controlled trial, Lancet, 360, 109, 10.1016/S0140-6736(02)09409-6 Hurlen, 2002, Warfarin, aspirin, or both after myocardial infarction, N Engl J Med, 347, 969, 10.1056/NEJMoa020496 Dewilde, 2009, Trial design: WOEST trial: design and rationale of the WOEST trial: what is the optimal antiplatelet and anticoagulant therapy in patients with oral anticoagulation and coronary stenting, Am Heart J, 158, 713, 10.1016/j.ahj.2009.09.001 Silber, 2005, Guidelines for percutaneous coronary interventions, Eur Heart J, 26, 804, 10.1093/eurheartj/ehi564 Patel, 2009, Circulation, 119, 1330, 10.1161/CIRCULATIONAHA.108.191768 Thygesen, 2007, Universal definition of myocardial infarction, Eur Heart J, 28, 2525, 10.1093/eurheartj/ehm355 Chesebro, 1987, Thrombolysis In Myocardial Infarction (TIMI) trial, phase I: a comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge, Circulation, 76, 142, 10.1161/01.CIR.76.1.142 1993, An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction, N Engl J Med, 329, 673, 10.1056/NEJM199309023291001 Mehran, 2011, Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium, Circulation, 123, 2736, 10.1161/CIRCULATIONAHA.110.009449 Cutlip, 2007, Clinical endpoints in coronary stent trials: a case for standardized definitions, Circulation, 115, 2344, 10.1161/CIRCULATIONAHA.106.685313 Steg, 2011, Bleeding in acute coronary syndromes and percutaneous coronary interventions: position paper by the Working Group on Thrombosis of the European Society of Cardiology, Eur Heart J, 32, 1854, 10.1093/eurheartj/ehr204 Roy, 2008, Impact of “nuisance” bleeding on clopidogrel compliance in patients undergoing intracoronary drug-eluting stent implantation, Am J Cardiol, 102, 1614, 10.1016/j.amjcard.2008.07.063 Lip, 2011, Bleeding risk assessment and management in atrial fibrillation patients. Executive summary of a position document from the European Heart Rhythm Association [EHRA], endorsed by the European Society of Cardiology [ESC] Working Group on Thrombosis, Thromb Haemost, 106, 997, 10.1160/TH11-10-0690 Kukreja, 2009, Three-year survival following multivessel percutaneous coronary intervention with bare-metal or drug-eluting stents in unselected patients, Am J Cardiol, 103, 203, 10.1016/j.amjcard.2008.08.068 Faxon, 2011, Consensus document: antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting. A North-American perspective, Thromb Haemost, 106, 572, 10.1160/TH11-04-0262 Wiviott, 2007, Prasugrel versus clopidogrel in patients with acute coronary syndromes, N Engl J Med, 357, 2001, 10.1056/NEJMoa0706482 Berger, 2010, Circulation, 121, 2575, 10.1161/CIRCULATIONAHA.109.895342 Park, 2010, Duration of dual antiplatelet therapy after implantation of drug-eluting stents, N Engl J Med, 362, 1374, 10.1056/NEJMoa1001266 Gwon, 2012, 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, 125, 505, 10.1161/CIRCULATIONAHA.111.059022 Valgimigli, 2012, Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial, Circulation, 125, 2015, 10.1161/CIRCULATIONAHA.111.071589 Miller, 2012, Meta-Analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation, Am J Cardiol, 110, 453, 10.1016/j.amjcard.2012.03.049 Wallentin, 2009, Ticagrelor versus clopidogrel in patients with acute coronary syndromes, N Engl J Med, 361, 1045, 10.1056/NEJMoa0904327 Wallentin, 2010, Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial, Lancet, 376, 975, 10.1016/S0140-6736(10)61194-4