Background: In the RE-DUAL PCI trial, dual anti-thrombotic therapy with dabigatran and a P2Y12inhibitor had a lower risk of bleeding and similar risk reduction of thromboembolic events, compared with warfarin triple therapy, in patients with NVAF undergoing PCI. This subanalysis investigated whether the efficacy and safety of dabigatran dual therapy in Japanese and East-Asian patients enrolled in the RE-DUAL PCI trial were similar to those of the overall patient population of the trial. Methods and Results: RE-DUAL PCI was a multicenter, randomized trial. The primary endpoint was the time to first International Society on Thrombosis and Hemostasis major or clinically relevant non-major bleeding events. Of the East-Asian patients (n=240) enrolled in the RE-DUAL PCI trial, 111 were Japanese and received dabigatran 110 mg (n=50) or 150 mg (n=13) dual therapy, or warfarin triple therapy (n=48). The incidence of the primary endpoint in Japanese patients was 26.0% and 29.2% with dabigatran 110-mg dual therapy and the corresponding warfarin triple therapy, and 23.1% and 30.8% with dabigatran 150-mg dual therapy and the corresponding warfarin triple therapy, respectively. Similar results were observed in the East-Asian population.
Conclusions: This subanalysis of the RE-DUAL PCI trial demonstrated that, like in the overall patient population, dabigatran dual therapy may offer physicians additional options for managing Japanese and East-Asian patients with NVAF receiving PCI.
Keywords: Atrial fibrillation; Dabigatran; East Asia; Japan; Percutaneous coronary intervention.