Oral anticoagulation in patients with atrial fibrillation and heart valve prosthesis: a substudy from the LAAOS III Trial

OBJECTIVE: Societal guidelines recommend vitamin K antagonists (VKAs) for patients with atrial fibrillation with recent biological valve implantation, but the safety and efficacy of direct oral anticoagulants (DOACs) in this setting remain uncertain, especially in the early postoperative period. This substudy of the Left Atrial Appendage Occlusion Study (LAAOS) III trial aimed to compare thromboembolic and bleeding outcomes in patients discharged on VKAs versus DOACs after bioprosthesis implantation or mitral valve repair. METHODS: A total of 2645 patients were included, with 461 discharged on DOACs and 2184 on VKAs. Patients with mechanical valves or isolated coronary surgery were excluded. The primary end point was stroke or systemic thromboembolism. Major bleeding was a secondary end point. Cox proportional hazard models adjusted for time-dependent covariates and clinical factors (eg, age, previous stroke, left atrial appendage occlusion) were applied to assess outcomes. RESULTS: Patients discharged on DOACs were older, mostly male, and had lower rates of rheumatic heart disease than those on VKAs. During follow-up, no significant differences were observed in thromboembolic (hazard ratio, 0.754; 95% confidence interval, 0.496-1.145; P = .185) or major bleeding events (hazard ratio, 0.760; 95% confidence interval, 0.601-1.153; P = .197) between groups. A nonsignificant trend toward worse outcomes was noted for patients who discontinued or switched anticoagulation. CONCLUSIONS: In this large cohort of patients after mitral and/or aortic bioprosthesis implantation or mitral valve repair within the LAAOS III, DOACs showed similar thromboembolic and bleeding risks as VKAs, suggesting they may be a safe alternative.