Key result
Dabigatran dual therapy reduces bleeding compared with warfarin triple therapy in Japanese NVAF post-PCI patients.
Why the study?
To investigate 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 the overall trial population.
Does dabigatran dual therapy reduce bleeding events compared to warfarin triple therapy in East-Asian patients with NVAF undergoing PCI?
RCT (n=240)
randomized
Yes
Does dabigatran dual therapy reduce bleeding events compared to warfarin triple therapy in East-Asian patients with NVAF undergoing PCI?
Absolute Event Rate: 26% vs 29.2%
Supports dabigatran dual therapy to lower bleeding in East Asian NVAF patients post-PCI; extends RE-DUAL PCI findings to this population.
BACKGROUND: In the RE-DUAL PCI trial, dual anti-thrombotic therapy with dabigatran and a P2Y 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.
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Ako et al. (2019) conducted an RCT in Non-valvular atrial fibrillation (NVAF) receiving percutaneous coronary intervention (PCI) (n=240). Dabigatran dual therapy vs. Warfarin triple therapy was evaluated on time to first International Society on Thrombosis and Hemostasis major or clinically relevant non-major bleeding events. Dabigatran dual therapy (110 mg or 150 mg) in Japanese NVAF patients undergoing PCI resulted in primary bleeding rates of 26.0% and 23.1%, versus 29.2% and 30.8% with warfarin triple therapy.
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