BACKGROUND Oral anticoagulation is recommended after ablation for atrial fibrillation among patients at high risk for stroke. Left atrial appendage closure is a mechanical alternative to anticoagulation, but data regarding its use after atrial fibrillation ablation are lacking. METHODS We conducted an international randomized trial involving 1600 patients with atrial fibrillation who had an elevated score (≥2 in men and ≥3 in women) on the CHA2DS2-VASc scale (range, 0 to 9, with higher scores indicating a greater risk of stroke) and who underwent catheter ablation. Patients were randomly assigned in a 1:1 ratio to undergo left atrial appendage closure or receive oral anticoagulation. The primary safety end point, tested for superiority, was non-procedure-related major bleeding or clinically relevant nonmajor bleeding. The primary efficacy end point, tested for noninferiority, was a composite of death from any cause, stroke, or systemic embolism at 36 months. The secondary end point, tested for noninferiority, was major bleeding, including procedure-related bleeding, through 36 months. RESULTS A total of 803 patients were assigned to undergo left atrial appendage closure, and 797 to receive anticoagulant therapy. The mean (±SD) age of the patients was 69.6±7.7 years, 34.1% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 36 months, a primary safety end-point event had occurred in 65 patients (8.5%) in the left atrial appendage closure group (device group) and in 137 patients (18.1%) in the anticoagulation group (P<0.001 for superiority); a primary efficacy end-point event had occurred in 41 patients (5.3%) and 44 patients (5.8%), respectively (P<0.001 for noninferiority); and a secondary end-point event had occurred in 3.9% and 5.0% (P<0.001 for noninferiority). Complications related to the appendage closure device or procedure occurred in 23 patients. CONCLUSIONS Among patients who underwent catheter-based atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of non-procedure-related major or clinically relevant nonmajor bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to a composite of death from any cause, stroke, or systemic embolism at 36 months. (Funded by Boston Scientific; OPTION ClinicalTrials.gov number, NCT03795298.).

中文翻译：

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心房颤动消融术后左心耳封堵术。


背景 对于中风高危患者，建议在消融后对心房颤动进行口服抗凝治疗。左心耳封堵术是抗凝治疗的机械替代方法，但缺乏关于心房颤动消融术后使用的数据。方法 我们进行了一项国际随机试验，涉及 1600 名心房颤动患者，这些患者在 CHA2DS2-VASc 量表上评分升高 （男性 ≥2 分，女性 ≥3 分） （范围，0 到 9，分数越高表示中风风险越高），并接受了导管消融术。患者以 1：1 的比例随机分配接受左心耳封堵术或接受口服抗凝治疗。优效性测试的主要安全终点是非手术相关的大出血或临床相关的非大出血。主要疗效终点（非劣效性测试）是 36 个月时全因死亡、卒中或全身性栓塞的复合终点。非劣效性测试的次要终点是 36 个月内的大出血，包括手术相关的出血。结果 共有 803 例患者被分配接受左心耳封堵术，797 例患者接受抗凝治疗。患者的平均 （±SD） 年龄为 69.6±7.7 岁，34.1% 的患者为女性，平均 CHA2DS2-VASc 评分为 3.5±1.3。在 36 个月时，左心耳封堵组 （装置组） 65 例患者 （8.5%） 和抗凝组 137 例患者 （18.1%） 发生了主要安全终点事件 （P<0.001 为优效）;主要疗效终点事件分别发生在 41 例患者 （5.3%） 和 44 例患者 （5.8%） （非劣效性 P<0.001）;3.9% 和 5.0% 发生了次要终点事件 （P<0.001 代表非劣效性）。23 例患者发生了与附件闭合装置或手术相关的并发症。结论 在接受基于导管的心房颤动消融术的患者中，左心耳封堵术与非手术相关严重或临床相关非严重出血的风险低于口服抗凝治疗相关，并且在 36 个月时因任何原因导致的死亡、卒中或全身性栓塞的复合风险方面不劣于口服抗凝治疗。（由波士顿科学公司资助;选项 ClinicalTrials.gov 编号 NCT03795298.）。