Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent Implantation The ISAR-TRIPLE Trial

被引：349

作者：

Fiedler, Katrin A. ^{[1
]}

Maeng, Michael ^{[2
]}

Mehilli, Julinda ^{[3
,4
]}

Schulz-Schuepke, Stefanie ^{[1
]}

Byrne, Robert A. ^{[1
,4
]}

Sibbing, Dirk ^{[3
,4
]}

Hoppmann, Petra ^{[5
]}

Schneider, Simon ^{[5
]}

Fusaro, Massimiliano ^{[1
]}

Ott, Ilka ^{[1
]}

Kristensen, Steen D.

Ibrahim, Tareq ^{[5
]}

Massberg, Steffen ^{[2
,3
,4
]}

Schunkert, Heribert ^{[1
,4
]}

Laugwitz, Karl-Ludwig ^{[4
,5
]}

Kastrati, Adnan ^{[1
,4
]}

Sarafoff, Nikolaus ^{[3
]}

机构：

[1] Tech Univ, Deutsch Herzzentrum Munchen, Klin Herz & Kreislauferkrankungen, Munich, Germany

[2] Aarhus Univ Hosp, Dept Cardiol, DK-8000 Aarhus, Denmark

[3] Univ Munich, Klinikum Univ Munchen, Med Klin & Poliklin 1, D-81377 Munich, Germany

[4] Partner Site Munich Heart Alliance, Deutsch Zentrum Herz Kreislaufforsch, Munich, Germany

[5] Tech Univ, Klinikum Rechts Isar, Med Klin & Poliklin 1, Munich, Germany

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2015年 / 65卷 / 16期

关键词：

aspirin; atrial fibrillation; clopidogrel; percutaneous coronary intervention; vitamin K antagonist; DUAL ANTIPLATELET THERAPY; PERCUTANEOUS CORONARY INTERVENTIONS; ATRIAL-FIBRILLATION; ANTITHROMBOTIC THERAPY; CONSENSUS DOCUMENT; CLOPIDOGREL; ASPIRIN; THROMBOSIS; EFFICACY; DISCONTINUATION;

D O I：

10.1016/j.jacc.2015.02.050

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND Patients receiving oral anticoagulation (OAC) who undergo drug-eluting stent (DES) implantation require additional dual antiplatelet therapy with aspirin and clopidogrel. Such triple therapy confers an elevated bleeding risk, and its optimal duration is not known. OBJECTIVES The goal of this study was to evaluate whether shortening the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation was associated with a superior net clinical outcome in patients receiving concomitant aspirin and OAC. METHODS In this randomized, open-label trial, we enrolled patients receiving OAC who underwent DES implantation at 3 European centers between September 2008 and December 2013. A total of 614 patients receiving concomitant aspirin and OAC were randomized to either 6-week clopidogrel therapy (n = 307) or 6-month clopidogrel therapy (n = 307). The primary endpoint was a composite of death, myocardial infarction (MI), definite stent thrombosis, stroke, or Thrombolysis In Myocardial Infarction (TIMI) major bleeding at 9 months. RESULTS The primary endpoint occurred in 30 patients (9.8%) in the 6-week group compared with 27 patients (8.8%) in the 6-month group (hazard ratio [HR]: 1.14; 95% CI: 0.68 to 1.91; p = 0.63). There were no significant differences for the secondary combined ischemic endpoint of cardiac death, MI, definite stent thrombosis, and ischemic stroke (12 [4.0%] vs. 13 [4.3%]; HR: 0.93; 95% CI: 0.43 to 2.05; p = 0.87) or the secondary bleeding endpoint of TIMI major bleeding (16 [5.3%] vs. 12 [4.0%]; HR: 1.35; 95% CI: 0.64 to 2.84; p = 0.44). CONCLUSIONS Six weeks of triple therapy was not superior to 6 months with respect to net clinical outcomes. These results suggest that physicians should weigh the trade-off between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy. (C) 2015 by the American College of Cardiology Foundation.

引用

页码：1619 / 1629

页数：11

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