Comparison of outcomes between males and females treated with left atrial appendage closure or oral anticoagulation after catheter ablation for atrial fibrillation: an OPTION subanalysis

Abstract Background/Introduction Female sex is an established, non-modifiable risk factor for adverse outcomes in atrial fibrillation (AF) patients. Left atrial appendage closure (LAAC) has been shown to be a generally safe and effective alternative to oral anticoagulation (OAC) for stroke prevention in patients with AF. However, there is limited data on sex-based outcomes with LAAC associated with catheter ablation. Purpose The OPTION trial compared the strategy of LAAC to oral anticoagulation for reducing the risk of thromboembolism in patients who had a catheter ablation for atrial fibrillation. Evaluation of outcome in women vs men was prespecified. Methods OPTION was a randomized controlled trial enrolling catheter ablation patients. The ablation procedure could have occurred 90 to 180 days prior to or within 10 days of randomization. Groups were randomized 1:1 to either ablation+LAAC or ablation+OAC (~95% DOAC). The primary safety endpoint was 36-month non-procedural bleeding defined as International Society on Thrombosis and Haemostasis [ISTH] major bleeding or clinically relevant non-major bleeding. The primary efficacy endpoint was 36-month all-cause death, stroke, or systemic embolism. The secondary endpoint was 36-month ISTH major bleeding, including procedural bleeding. Additional endpoints included ablation and LAAC procedural characteristics, medication adherence, and arrythmia recurrence. Results A total of 1600 patients were randomized in OPTION (803 patients to catheter ablation+LAAC and 797 to ablation+OAC); one-third were women. The rate of the primary efficacy endpoint was similar in ablation+LAAC and ablation+OAC-treated men and women (Table). The primary safety endpoint was significantly lower in the ablation+LAAC treated men compared to ablation+OAC-treated men. The difference in ablation+LAAC vs ablation+OAC-treated women was directionally similar. At 3 years, no differences in rates of mortality, ischemic stroke, and systemic embolism were found between treatment arms in women or in men. The reduction in post-operative bleeding was higher in men as compared to women. Conclusion(s) OPTION demonstrated that LAAC reduced non-procedural bleeding compared to OAC without increasing the risk of thromboembolic events. Women exhibited higher rates of major bleeding compared to men; however, a beneficial reduction in bleeding was still observed with LAAC although conclusions may be impacted by the smaller sample size.