ISAR-TRIPLE Trial Findings Published

April 27, 2015—Findings from the ISAR-TRIPLE study of triple therapy using oral anticoagulation (OAC) plus dual-antiplatelet therapy (DAPT; aspirin and clopidogrel) in patients after drug-eluting stent (DES) implantation were published by Katrin A. Fiedler, MD, et al in the Journal of the American College of Cardiology (JACC. 2015;65:1619–1629). 

The study found that 6 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, concluded the ISAR-TRIPLE investigators.

The ISAR-TRIPLE findings were presented in September 2014 at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC. The ISAR-TRIPLE lead investigator is Nikolaus Sarafoff, MD, from Deutsches Herzzentrum, Munich and Klinikum der Universität Munich in Germany.

The study’s background is that patients receiving OAC who undergo (DES) implantation require additional DAPT and that this triple therapy confers an elevated bleeding risk. The optimal duration of this therapy is not known, noted the investigators. Therefore, this study was conducted with the goal of evaluating 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.

As summarized in JACC, this randomized, open-label trial enrolled patients receiving OAC who underwent DES implantation at three 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.

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. There were no significant differences for the secondary combined ischemic endpoint of cardiac death, MI, definite stent thrombosis, and ischemic stroke (12 [4%] vs 13 [4.3%]) or the secondary bleeding endpoint of TIMI major bleeding (16 [5.3%] vs 12 [4%]), reported the investigators in JACC.