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ISAR-TRIPLE: Net clinical outcomes similar for 6-week vs. 6-month triple therapy
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Six weeks of triple therapy with oral anticoagulation, aspirin and clopidogrel was not superior to a 6-month regimen for the primary outcome of death, MI, definite stent thrombosis, stroke or TIMI major bleeding at 9 months, according to data from the ISAR-TRIPLE trial.
The results were first presented at TCT 2014 and are now published in the Journal of the American College of Cardiology.
The randomized, open-label trial included 614 patients who were receiving concomitant oral anticoagulation and aspirin therapy and underwent drug-eluting stent implantation for stable angina or ACS at centers in Denmark and Germany from September 2008 to December 2013. Patients were randomly assigned to a 6-week (n = 307) or 6-month (n = 307) regimen of clopidogrel therapy 75 mg on top of oral anticoagulation and aspirin. Patients were followed up by phone or at the physician’s office after 6 weeks, 6 months and 9 months.
The primary endpoint occurred in 9.8% of the 6-week therapy group vs. 8.8% of the 6-month therapy group (HR = 1.14; 95% CI, 0.68-1.91).
Researchers reported no significant difference in the secondary combined ischemic endpoint of cardiac death, MI, definite stent thrombosis and ischemic stroke between the two groups (6 weeks, 4%; 6 months, 4.3%; HR = 0.93; 95% CI, 0.43-2.05). Both durations also were associated with similar rates of TIMI major bleeding (6 weeks, 5.3%; 6 months, 4%; HR = 1.35; 95% CI, 0.64-2.84).
In a post-hoc landmark analysis, the 6-month therapy group experienced significantly more bleeding events, as defined by Bleeding Academic Research Consortium (BARC) classifications.
“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,” Katrin A. Fiedler, MD, from Deutsches Herzzentrum München, Technische Universität, Germany, and colleagues concluded.
In a related editorial, Cardiology Today’s Intervention Editorial Board member Deepak L. Bhatt, MD, MPH, noted that “patients with atrial fibrillation needing stents pose one of the greatest challenges in cardiovascular medicine.”
Deepak L. Bhatt
Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart and Vascular Center and professor of medicine at Harvard Medical School, said ongoing trials “should help define the optimal cocktail and duration of antithrombotic agent treatment in patients with atrial fibrillation and recent stents.” PIONEER AF-PCI will study two strategies of rivaroxaban (Xarelto, Janssen Pharmaceuticals) and one of oral vitamin K antagonist, and REDUAL-PCI will study dual therapy with dabigatran (Pradaxa, Boehringer Ingelheim) compared with triple therapy with warfarin in this patient population.
“Until such data become available and outside of clinical trials, it is very reasonable to adopt the general strategy supported by the ISAR-TRIPLE trial, and by the WOEST study, which is to abbreviate the duration of triple antithrombotic therapy,” Bhatt wrote. “On the basis of the ISAR-TRIPLE study, 6 weeks certainly seems like a reasonable starting point, titrating the duration and intensity of triple antithrombotic therapy upward or downward, depending on patient and lesion characteristics.” – by Jennifer Byrne
Disclosure: ISAR-TRIPLE was supported in part by an unrestricted research grant from Abbott, Deutsches Herzzentrum München and PCI research at Aarhus University Hospital. Bhatt reports serving on advisory boards for Cardax and Regado Biosciences; honoraria from Harvard Clinical Research Institute (clinical trial steering committee, including for REDUAL-PCI); and research funding from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi and The Medicines Company.
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