Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent Implantation

Abstract

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. (Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation [ISAR-TRIPLE]; NCT00776633).

Anti-thromboembolic strategies in atrial fibrillation

“…In the ISAR-TRIPLE trial [52,53], a 6-week TT was not inferior to a 6-month-TT with respect to net clinical outcomes. Most trials [40-49, 58, 59] …”

“…• The randomized, open-label trial ISAR-TRIPLE trial [52,53] was performed in 3 European centers and involved 614 patients. Anticoagulated patients who underwent PCI-SI (with DES) received a TT, i.e.…”

“…It is still unproven, but it might be, that third-generation 'olimus'-eluting-stents require a shorter duration of TT. In a large clinical trial, in patients receiving new generation DES-zotarolimus [40,49,[52][53][54][55][56][57][58][59], no differences were observed between a 3-month DAPT vs. a 12-month DAPT. To answer at least some of the missing information, the MUSICA interventional trial [38] is currently enrolling more than 2,300 patients who will be assigned to receive TT or DAPT: the primary endpoint is the occurrence of ischemia, and the secondary endpoint consists of bleeding complications.…”

Design and Rationale of the RE‐DUAL PCI Trial: A Prospective, Randomized, Phase 3b Study Comparing the Safety and Efficacy of Dual Antithrombotic Therapy With Dabigatran Etexilate Versus Warfarin Triple Therapy in Patients With Nonvalvular Atrial Fibrillation Who Have Undergone Percutaneous Coronary Intervention With Stenting

“…Data from registries support the WOEST findings 19, 20. More recently, the findings from the open‐label ISAR‐TRIPLE trial,21 which involved 614 patients with an indication for OAC who were undergoing drug‐eluting stent (DES) implantation, support a limited duration (6 weeks vs 6 months) of triple antithrombotic therapy 22…”

“…However, this study was not powered to assess efficacy and can therefore only be considered hypothesis‐generating. In the ISAR‐TRIPLE study,21 in which patients were randomized to 6 weeks or 6 months of clopidogrel on top of aspirin and OAC after DES implantation, no difference was apparent between groups in the primary endpoint of death, MI, ST, stroke, or Thrombolysis In Myocardial Infarction major bleeding (HR: 1.14, 95% CI: 0.68, 1.91, p  = 0.63) at 9‐month follow‐up. Furthermore, there were no differences in the combined secondary endpoint (cardiac death, MI, ST, or ischemic stroke; HR: 0.93, 95% CI: 0.43, 2.05, p  = 0.44) or in Thrombolysis In Myocardial Infarction major bleeding (HR: 1.35, 95% CI: 0.64, 2.84, p  = 0.87).…”