Revolutionizing anticoagulation: DOAC versus VKA in atrial fibrillation with early post-bioprosthetic valves replacement or valves repair

Background: Direct oral anticoagulants (DOACs) are extensively employed in patients with non-valvular atrial fibrillation and have recently been recommended for atrial fibrillation patients ≥3 months after bioprosthetic valve replacement. However, the efficacy and safety of DOACs in patients with atrial fibrillation within the first 3 months after biological valve replacement or repair remain unclear. This study systematically reviewed the literature to evaluate DOACs in this cohort. Methods: PubMed, Embase, Web of Science, and Cochrane Library were searched up to 15 August 2025, for randomized controlled trials (RCTs) comparing DOACs with vitamin K antagonists (VKAs) in atrial fibrillation patients within 3 months of biological valve surgery. Outcomes included all-cause death, stroke/thromboembolic events, bleeding events, and cardiovascular death. Results: Six RCTs with 2725 patients were included (1386 DOACs; 1339 VKAs). Primary analyses showed no significant differences between the groups in all-cause death relative risk (RR) = 0.930; 95% confidence interval (CI), 0.729–1.186; P = 0.560, stroke/thromboembolic events (RR = 0.724, 95% CI: 0.495–1.059 P = 0.096), or major bleeding (RR = 1.042; 95% CI, 0.563–1.930; P = 0.895). The secondary analysis also showed no significant difference in cardiovascular death (RR = 1.127, 95% CI: 0.814–1.559, P = 0.472). Conclusion: DOACs demonstrated comparable efficacy and safety to VKAs in the early postoperative period after biological valve replacement or repair, suggesting that they may serve as an alternative to VKAs.