Abstract 18024: The Efficacy and Safety of Rivaroxaban vs Warfarin in Patients Undergoing Atrial Fibrillation Ablation: A Meta-Analysis
Introduction: Rivaroxaban, an oral direct factor Xa inhibitor, is an alternative to warfarin for stroke prophylaxis in patients with atrial fibrillation (AF). Patients are increasingly undergoing AF ablation while taking rivaroxaban, but little is known regarding the safety of this approach.
Methods: We performed a meta-analysis of studies which compared the use of peri-procedural rivaroxaban with warfarin in patients undergoing AF ablation. We identified 1 published randomized controlled trial and 5 abstracts; 3 observational studies with control groups, and 2 observational studies without control groups. Embolic complications were defined as stroke/TIA or pulmonary embolism, and bleeding complications as all major events requiring transfusion and minor events including pericardial effusion, femoral hematoma, and GI bleeding. Studies were stratified according to controlled vs. uncontrolled study design, and analyzed using the Mantel-Haenszel fixed effect model.
Results: There were a total of 634 patients on rivaroxaban, and 479 patients on warfarin undergoing AF ablation. Mean age was 63, and CHADS2 score ranged from 0.9-3. Rivaroxaban was held 12-48 hours pre-procedure, resumed 6-24 hours post-procedure, and in 224 (35%) was uninterrupted. The composite embolic rate was 1.7% in the rivaroxaban group, and 1.5% in the warfarin group (p=NS). The composite bleeding rate was 11.5% the rivaroxaban group, and 10.5% in the warfarin group (p=NS). Meta-analysis using controlled studies (410 rivaroxaban vs. 479 warfarin patients) showed no difference in embolic complications (OR, 0.791; 95% CI, 0.246-2.541) and bleeding complications (OR, 1.214; 95% CI, 0.790-1.867) between the two groups (Figure).
Conclusion: Rivaroxaban may be a safe alternative to warfarin anticoagulation in patients undergoing AF ablation. Further randomized controlled trials are needed to determine its relative safety and efficacy compared to warfarin peri-ablation.
- © 2013 by American Heart Association, Inc.