Evaluation of the Safety and Efficacy of an Edoxaban-based Antithrombotic Regimen in Patients with Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) with Stent Placement: Rationale and Design of the ENTRUST-AF PCI Trial

Publication date: Available online 23 October 2017 Source:American Heart Journal Author(s): Pascal Vranckx, Thorsten Lewalter, Marco Valgimigli, Jan G. Tijssen, Paul-Egbert Reimitz, Lars Eckardt, Hans-Joachim Lanz, Wolfgang Zierhut, Rüdiger Smolnik, Andreas Goette Background The optimal antithrombotic treatment after percutaneous coronary intervention (PCI) with stenting in patients with atrial fibrillation (AF) is unknown. In the ENGAGE AF-TIMI 48 trial, edoxaban was non-inferior to a vitamin-K antagonist (VKA) with respect to the prevention of stroke or systemic embolism and was associated with significantly lower rates of bleeding and cardiovascular death (CVD) in patients with non-valvular AF. The effects of edoxaban in combination with single or dual antiplatelet therapy in the setting of PCI are unexplored. Design The ENTRUST-AF PCI trial is a multinational, multicenter, randomized, open-label phase 3b trial with blinded endpoint evaluation involving 1500 patients on oral anticoagulation for AF. Patients are randomized between 4hours and 5days after successful PCI to either an edoxaban-based strategy (experimental arm; 60mg [or 30mg according to dose reduction criteria] once-daily plus a P2Y12-antagonist [default clopidogrel, 75mg once-daily] for 12months) or a VKA-based strategy (control arm; VKA plus a P2Y12-antagonist [as above] plus acetylsalicylic acid [100mg once-daily] for 30days to 12months). The primary safety endpoint is the incidence of Internat...
Source: American Heart Journal - Category: Cardiology Source Type: research