Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation.

Left atrial appendage closure is considered for patients who are unsuitable candidates for long-term anticoagulation, but its role in patients who are eligible for anticoagulants has not been established.

对于不适合长期抗凝治疗的患者，考虑进行左心耳封堵术，但在适合抗凝治疗的患者中，其作用尚未确立。

Methods

In this ongoing, prospective, international, randomized trial involving patients with atrial fibrillation who were suitable candidates for anticoagulation, we randomly assigned patients in a 1:1 ratio to receive either device-based left atrial appendage closure (device group) or non-vitamin K antagonist oral anticoagulant (NOAC) therapy (anticoagulation group).

在这项持续进行的、前瞻性的、国际性的随机试验中，我们按照1:1的比例，随机分配了适合接受抗凝治疗的房颤患者，让他们接受左心耳封堵装置治疗（装置组）或非维生素K拮抗剂口服抗凝药（NOAC）治疗（抗凝组）。

The primary efficacy end point - a composite of death from cardiovascular causes, stroke, or systemic embolism - was tested for noninferiority (noninferiority margin, 4.8 percentage points) after 3 years of follow-up.

主要有效性终点——心血管原因死亡、中风或全身性栓塞的复合结果——在3年的随访后进行了非劣效性检验（非劣效性边界为4.8个百分点）。

The primary safety end point, non-procedure-related bleeding, was tested for superiority.

主要安全性终点，非程序相关出血，被测试以确定其优越性。

Results

Of the 3000 patients who underwent randomization, 1499 were assigned to the device group and 1501 to the anticoagulation group.

在随机化的3000名患者中，1499名被分配到器械组，1501名被分配到抗凝组。

The mean (±SD) age of the patients was 71.7±7.5 years, 31.9% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3.

患者的平均年龄（±标准差）为71.7±7.5岁，其中31.9%为女性，平均CHA2DS2-VASc评分为3.5±1.3。

At 3 years, a primary efficacy end-point event had occurred in 81 patients (Kaplan-Meier estimate, 5.7%) in the device group and in 65 patients (Kaplan-Meier estimate, 4.8%) in the anticoagulation group (difference, 0.9 percentage points; 95% confidence interval[CI], -0.8 to 2.6; P<0.001 for noninferiority).

在3年时，设备组有81名患者（Kaplan-Meier估计，5.7%）和抗凝组有65名患者（Kaplan-Meier估计，4.8%）发生了主要有效性终点事件（差异，0.9个百分点；95%置信区间[CI]，-0.8至2.6；P<0.001，显示非劣效性）。

Non-procedure-related bleeding occurred in 154 patients (Kaplan-Meier estimate, 10.9%) in the device group and in 260 patients (Kaplan-Meier estimate, 19.0%) in the anticoagulation group (hazard ratio, 0.55; 95% CI, 0.45 to 0.67; P<0.001 for superiority).

在器械组中，有154名患者发生了与操作无关的出血（Kaplan-Meier估计值，10.9%），而在抗凝组中，有260名患者发生了与操作无关的出血（Kaplan-Meier估计值，19.0%）（风险比，0.55；95%置信区间，0.45至0.67；P<0.001，显示优越性）。

Conclusions

Among patients with atrial fibrillation who were candidates for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy with respect to a composite of death from cardiovascular causes, stroke, or systemic embolism and was superior to NOAC therapy for non-procedure-related bleeding at 3 years.

在适合抗凝治疗的房颤患者中，基于器械的左心耳封堵在心血管原因死亡、中风或全身性栓塞的复合终点方面与NOAC治疗非劣效，并且在3年内对于非操作相关出血优于NOAC治疗。

(Funded by Boston Scientific; CHAMPION-AF ClinicalTrials.gov number, NCT04394546.).

(由波士顿科学公司资助; CHAMPION-AF 临床试验注册号, NCT04394546。)