AIM: To evaluate the net clinical benefit following direct oral anticoagulants (DOACs) vs warfarin by diabetes status in patients with non-valvular atrial fibrillation.
METHODS: 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 bleedings defined net clinical benefit. 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, 0.81-0.89] and 0.87 [95% CI, 0.79-0.96]; absolute risk reduction per 1000 patients treated, -33 [95% CI, -45, -21]) and -24 [95% CI, -43, -5]), but interaction test was not significant by relative and absolute numbers (P = 0.68 and P = 0.44, respectively).
CONCLUSION: Net clinical benefit following DOACs was not different between patients with and without DM over a period of 2.2 years.