Net clinical benefit of direct oral anticoagulants in atrial fibrillation patients with or without diabetes mellitus: a meta-analysis of outcome trials

Objective: To evaluate the net clinical benefit following direct oral anticoagulants (DOACs) vs. warfarin by diabetes status in patients with non-valvular atrial fibrillation. Design and method: We searched 3 electronic databases through end-February 2021 to identify relevant outcome trials in patients with and without diabetes mellitus (DM). All-cause death, non-fatal stroke/systemic embolism, and major bleeding events defined net clinical benefit. In addition, outcome risk ratios and 95% confidence interval (CI), and absolute risk outcome reduction per 1000 treated patients were assessed. Results: Four trials of DOACs vs. warfarin compared 22,087 patients with DM to 49,592 patients without DM. CHADS2 and 10-year fatal cardiovascular risk were higher in patients with vs. those without DM (3.7 vs. 2.5 and 28.4% vs. 23.4%, respectively). DOACs were associated with more favorable net clinical benefit compared to warfarin in patients with and without DM (relative risk reduction, 0.85 [95% CI] and 0.87 [95% CI]; absolute risk reduction per 1000 patients treated, 33 [95% CI] and 24 [95% CI}. However, the interaction test was not significant by relative and absolute numbers (P = 0.68 and P = 0.44, respectively). Conclusions: The net clinical benefit following DOACs was not different between patients with and without DM over 2.2 years.