Key result
LAAC reduces nonprocedural bleeding more in men than women post-AF ablation with similar efficacy.
Why the study?
Does left atrial appendage closure compared with oral anticoagulation after catheter ablation for atrial fibrillation improve efficacy and safety outcomes differently in men and women?
RCT (n=1,599)
1:1
Does left atrial appendage closure compared with oral anticoagulation after catheter ablation for atrial fibrillation improve efficacy and safety outcomes differently in men and women?
In the OPTION trial, LAAC and OAC following AF ablation had comparable efficacy for preventing death, stroke, or systemic embolism in both sexes, though LAAC provided a significantly greater magnitude of nonprocedural bleeding reduction in men than in women.
Answers are grounded in this paper and cite their sources.
LAAC yields similar efficacy to OAC post-AF ablation in both sexes but greater bleeding reduction in men; extends sex-specific safety data from RCTs.
Background Women sex is an established, nonmodifiable risk factor for adverse outcomes in patients with atrial fibrillation (AF). Left atrial appendage closure (LAAC) has been proposed as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with AF; however, there are limited data on sex-based outcomes of LAAC following catheter ablation. Objectives This study sought to compare outcomes of LAAC vs OAC after AF ablation in men and women. Methods Patients with AF and CHA2DS2-VASc ≥2 in men and ≥3 in women were randomized 1:1 to either ablation + LAAC or ablation + OAC. The primary safety endpoint was nonprocedural major or clinically relevant nonmajor bleeding at 36 months. The primary efficacy endpoint was a composite of all-cause death, stroke, or systemic embolism at 36 months. Results The study included 1,053 men and 546 women. LAAC and OAC demonstrated comparable primary efficacy events in men (HR: 0.96; 95% CI: 0.56-1.65; P = 0.88) and women (HR: 0.81; 95% CI: 0.41-1.62; P = 0.55), with no treatment-by-sex interaction (P interaction = 0.71). Procedural complication rates were similar at 2.3% in men and 3.7% in women with only 1 pericardial effusion in each group, not related to the index LAAC procedure. At 36 months, the primary safety endpoint was significantly lower in the device group among men (HR: 0.34; 95% CI: 0.23-0.50; P < 0.0001). In women, a similar but nonsignificant trend was observed (HR: 0.68; 95% CI: 0.42-1.09; P = 0.11), with a significant treatment-by-sex interaction (P interaction = 0.02). No significant difference was seen in the secondary safety endpoint across both treatment arms for either sex. Conclusions In this prespecified analysis of the OPTION (Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation [OPTION]) trial, stroke, systemic embolism, and mortality outcomes were not significantly different between LAAC and OAC following AF ablation in either men or women. Compared with OAC, LAAC demonstrated a greater magnitude of major and clinically relevant nonmajor bleeding reduction in men as compared with women. (Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation [OPTION]; NCT03795298).
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Mdaihly et al. (2026) conducted an RCT in Atrial fibrillation undergoing catheter ablation (n=1,599). Catheter ablation plus left atrial appendage closure (LAAC) vs. Catheter ablation plus oral anticoagulation (OAC) was evaluated on Composite of all-cause death, stroke, or systemic embolism at 36 months (HR 0.96 (men); HR 0.81 (women), 95% CI 0.56-1.65 (men); 0.41-1.62 (women), p=0.88 (men); 0.55 (women); P interaction = 0.71). LAAC vs OAC post-AF ablation yielded similar efficacy in men and women, but reduced nonprocedural bleeding more in men than women.
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