Among patients with valvular heart disease (VHD) and atrial fibrillation (AF), dabigatran was equally effective anticoagulant as warfarin, according to study findings published in The American Journal of Cardiology.
Researchers sought to investigate the efficacy and safety of dabigatran in patients with AF and left-sided VHD. To accomplish this, they conducted the Effectiveness of Dabigatran vs Conventional Treatment for Prevention of Silent Cerebral Infarct in Aortic and Mitral Valvular Atrial Fibrillation Patients (DECISIVE) trial, a prospective, single-center, open-label, randomized controlled trial.
The study took place between March 2017 and October 2019 and included 59 patients (aged 61.2±9.0 years; 31% women) treated with dabigatran. Of these patients, 52 were switched from warfarin, 5 from antiplatelet therapy alone, and 2 from no therapy. Of the control group of 60 patients with similar demographics, 53 used warfarin and 7 used antiplatelets. Follow-up was after 1 year. The primary endpoint was new brain lesions (silent brain infarct and microbleed) or stroke determined by brain magnetic resonance imaging.
Neither group experienced stroke or death events in the follow-up period. The dabigatran cohort had 20 patients with silent brain infarct and 2 with microbleed, and the control cohort saw almost identical results. Dabigatran vs control occurrence of the primary endpoint was similar (34% vs 40%; relative risk 0.87; 95% CI, 0.59-1.29; P =.491). Among patients with mitral stenosis (dabigatran 40, control 42), primary endpoint occurrence was also similar (32% vs 34%; relative risk 0.93; 95% CI, 0.57-1.50; P =.759).
Study limitations included being underpowered, the inability under current guidelines to interpret the primary endpoints as clinical events, and the short follow-up period.
Researchers noted that, “primary endpoint rates after treatment with dabigatran were similar to conventional treatment in patients with significant VHD and AF.” They added that larger prospective studies are necessary to validate nonvitamin K antagonist oral anticoagulants as an alternative to warfarin in patients with AF and VHD.
Cho MS, Kim M, Lee SA, et al. Comparison of dabigatran versus warfarin treatment for prevention of new cerebral lesions in valvular atrial fibrillation. Am J Cardiol. Published online May 9, 2022. doi:10.1016/j.amjcard.2022.03.050
This article originally appeared on The Cardiology Advisor