Original title: Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent ImplantationThe ISAR-TRIPLE Trial. Reference: Katrin A. Fiedler et al. J Am Coll Cardiol. 2015;65(16):1619-1629.
Patients with oral anticoagulation indication after drug eluting stenting require aspirin and clopidogrel; however, the triple scheme has high bleeding risk and optimal duration is yet to be determined. The aim of this study was to assess whether a 6 week scheme of clopidogrel after DES could be associated to a superior net clinical benefit in patients receiving the usual aspirin and oral anticoagulation.
A total of 614 patients receiving DES treated with aspirin and anticoagulation were randomized to 6 weeks of clopidogrel (n=307) vs. 6 months of clopidogrel (n=307). Primary end point was a composite of death, infarction, definite stent thrombosis, stroke and TIMI major bleeding longer than 9 months
Primary end point happened in 30 patients (9.8%) of the 6 week clopidogrel group and in 27 patients (8.8%) of the 6 month group (HR: 1.14; CI 95% 0.68 to 1.91; p=0.63). Neither were there significant differences when considering ischemic end point (4% vs 4.3%; p=0.87) and TIMI major bleeding (5.3% vs 4%; p=0.44) separately.
Conclusion
Six weeks of triple scheme (aspirin, clopidogrel, oral anticoagulation) after DES implantation was not superior to the 6 month therapy as regards clinical net benefit. This suggests that choosing a short or long scheme should be case by case, according to bleeding/ischemic risk.
Editorial Comment
A study that also wanted to answer this question was one by Dewilde WJ, published at Lancet 2013; in this case, the study variable was not clopidogrel, but aspirin. With a similar number of patients, Dewilde showed a non-significant trend of major bleeding in favor of the clopidogrel/anticoagulation alone vs. the triple scheme. Although all of these studies have been recently opened and are relatively small, there seems to be enough information to use the triple scheme the least possible time and carefully assess the risk/benefit ratio.
SOLACI