Randomized comparison of left atrial appendage closure and oral anticoagulation after catheter ablation for atrial fibrillation: subanalysis of AF type

Abstract Background/Introduction Cardiac ablation is effective at reducing the symptoms associated with arrhythmia. If anticoagulation is ceased postablation, contrary to clinical guidelines, patients are at increased risk of stroke due to the potential for asymptomatic atrial fibrillation (AF). Although left atrial appendage closure (LAAC) is an approved treatment to decrease the risk of thromboembolism from the left atrial appendage, it has not been well-studied following AF ablation. Purpose OPTION compared the safety and efficacy of LAAC in a contemporary postablation clinical AF patient population at risk of stroke to contemporary oral anticoagulation (OAC). In this prespecified subanalysis, treatment characteristics and outcomes by AF type (paroxysmal and persistent) will be evaluated. Methods OPTION is a multinational, multicenter, randomized, controlled trial. Catheter ablation patients were eligible if the procedure occurred 90 to 180 days prior to or was scheduled within 10 days of randomization. Patients were randomized 1:1 to ablation+LAAC versus ablation+OAC (95% DOAC) stratified by study site and ablation cohort (sequential or concomitant). The primary safety endpoint was non-procedural bleeding through 36 months based on International Society on Thrombosis and Haemostasis [ISTH] major bleeding or clinically relevant non-major bleeding definitions. The primary efficacy endpoint was the composite of all-cause death, stroke, or systemic embolism at 36 months. The secondary endpoint was ISTH major bleeding through 36 months. Additional endpoints include ablation and LAAC procedural characteristics, arrythmia recurrence, and quality of life. Results A total of 803 patients were randomized to catheter ablation+LAAC and 797 to ablation+OAC. Overall, patients were 70±8 years old, one-third were women, mean CHA2DS2-VASc score was 3.5±1.3, and mean HAS-BLED was 1.2±0.8. Approximately 60% of patients had paroxysmal AF and 40% had persistent AF in each treatment arm. OPTION met its primary and secondary endpoints. In the subgroup of patients with paroxysmal AF, the primary efficacy endpoint occurred in 3.5% of LAAC and 4.0% OAC patients at 3 years. In patients with persistent AF, the rate was 8.0% in the LAAC and 9.0% in the OAC cohort. The primary safety endpoint occurred at a rate of 8.1% in LAAC and 18.1% in OAC-treated patients with paroxysmal AF. The rates were 8.9% in LAAC and 16.9% in OAC-treated patients with persistent AF. The rate of the secondary endpoint was 2.8% in the LAAC and 4.6% in OAC patients with paroxysmal AF. In patients with persistent AF, this rate was 5.5% in the LAAC and 5.8% in the OAC cohorts. Conclusion(s) In OPTION, among patients undergoing AF ablation, LAAC resulted in significantly less non-procedural bleeding than oral anticoagulation, while preserving similarly low rates of stroke, systemic embolism or death. Outcomes were consistent among patients with paroxysmal and persistent AF.