My name is Nikolaus Sarafoff, from Munich, and I want to present the results of the ISAR-TRIPLE trial, which I had the honor to present on behalf of all coauthors at the TCT convention in Washington.
Patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention (PCI) require additional dual antiplatelet therapy with aspirin and clopidogrel. Such triple therapy substantially increases the risk of bleeding; however, the optimal duration of triple therapy after drug-eluting stent (DES) implantation has not been defined.
Two factors need to be considered in this regard. First, the risk for stent thrombosis is highest in the early phase after PCI and declines over time. Second, the risk of bleeding is dependent on length and intensity of oral anticoagulation therapy.
The objective of ISAR-TRIPLE was to evaluate clinical outcomes after six weeks versus six months of clopidogrel therapy in patients receiving DES who are on concomitant aspirin and oral anticoagulation. In total, 614 patients were randomized into the short (six-week) and the long (six-month) therapy groups. Patients were approximately 74 years old, and one third of patients presented with an acute coronary syndrome. Over 80% had atrial fibrillation, and the majority of patients received new-generation DES.
The primary endpoint of death, myocardial infarction, stent thrombosis, stroke, or TIMI major bleeding after nine months was not significantly different between the short- and the long-therapy groups. In addition, there were no significant differences regarding the secondary endpoints: the composite of ischemic complications, cardiac death, myocardial infarction, stent thrombosis or ischemic stroke, as well as major bleeding complications.
The incidence of all bleeding, according to Bleeding Academic Research Consortium (BARC) criteria, was as high as 40% and not significantly different between both groups.
In a post-hoc landmark analysis after six weeks, when treatment between both groups truly differed, there was a significantly lower incidence of bleeding with the shorter therapy.
In conclusion, the main finding was that a six-week triple therapy is not superior to six months of triple therapy in regard to net clinical outcomes. Shortening the duration of triple therapy neither reduced the incidence of major bleeding nor increased the incidence of ischemic events. The results of ISAR-TRIPLE suggest that physicians should weigh the tradeoff between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy.
I want to thank all of the ISAR-TRIPLE investigators for contributing to this study, and thank you for your attention.
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Cite this: ISAR-TRIPLE: Six-Week vs Six-Month Clopidogrel in DES and AF - Medscape - Oct 01, 2014.