DOACs demonstrated comparable efficacy to VKAs for all-cause death (RR 0.930; 95% CI 0.729-1.186; P=0.560) in atrial fibrillation patients early after biological valve surgery.
Meta-Analysis (n=2,725)
Do DOACs prevent all-cause death, stroke/thromboembolic events, and bleeding events compared to VKAs in atrial fibrillation patients within 3 months of biological valve surgery?
DOACs demonstrate comparable efficacy and safety to VKAs in patients with atrial fibrillation during the early postoperative period (within 3 months) after biological valve replacement or repair.
Effect estimate: RR 0.930 (95% CI 0.729-1.186)
p-value: p=0.560
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.
Han et al. (2026) conducted a meta-analysis in Atrial fibrillation within 3 months of biological valve surgery (n=2,725). Direct oral anticoagulants (DOACs) vs. Vitamin K antagonists (VKAs) was evaluated on All-cause death (RR 0.930, 95% CI 0.729-1.186, p=0.560). DOACs demonstrated comparable efficacy to VKAs for all-cause death (RR 0.930; 95% CI 0.729-1.186; P=0.560) in atrial fibrillation patients early after biological valve surgery.