Anticoagulation for Atrial Fibrillation with Intermediate Stroke Risk.

Methods

We conducted a multicenter, open-label, adjudicator-masked superiority trial in South Korea involving patients with atrial fibrillation and an intermediate risk of stroke (a score of 1 in men and 2 in women on the CHA2DS2-VASc scale; range, 0 to 9, with higher scores indicating a greater risk of stroke).

我们在韩国进行了一项多中心、开放标签、评估者盲法的优越性试验，涉及房颤和中风风险中等的患者（CHA2DS2-VASc评分男性为1分，女性为2分；范围为0至9分，分数越高表示中风风险越大）。

Patients were randomly assigned in a 1:1 ratio to receive either direct oral anticoagulant (DOAC) therapy or no anticoagulation.

患者以1:1的比例随机分配接受直接口服抗凝药物（DOAC）治疗或不接受抗凝治疗。

The primary end point was a composite of stroke, systemic embolism, major bleeding, or death from cardiovascular causes at 24 months.

主要终点是24个月时的中风、全身性栓塞、主要出血或心血管原因死亡的复合终点。

Results

Of 1803 patients who underwent randomization, 902 were assigned to receive DOAC therapy and 901 were assigned to receive no anticoagulant therapy.

共有1803名患者进行了随机分组，其中902名被分配接受DOAC治疗，901名被分配不接受抗凝治疗。

The mean age of the patients was 60.4 years, and 23.7% were women.

患者的平均年龄为60.4岁，女性占23.7%。

At 24 months, a primary end-point event had occurred in 4 patients (cumulative incidence, 0.5%) in the DOAC group and in 13 (cumulative incidence, 1.5%) in the no-anticoagulant group (difference, -1.0 percentage points; 95% confidence interval[CI], -2.0 to -0.1; P = 0.03; hazard ratio, 0.31; 95% CI, 0.10 to 0.94).

在24个月时，DOAC组有4名患者发生了主要终点事件（累积发生率为0.5%），而无抗凝组有13名患者发生了主要终点事件（累积发生率为1.5%）（差异，-1.0个百分点；95%置信区间[CI]，-2.0至-0.1；P = 0.03；风险比，0.31；95% CI，0.10至0.94）。

Stroke occurred in 3 patients (cumulative incidence, 0.3%) in the DOAC group and in 10 (cumulative incidence, 1.1%) in the no-anticoagulant group.

DOAC组有3名患者发生了中风（累积发生率为0.3%），而无抗凝组有10名患者发生了中风（累积发生率为1.1%）。

The incidenceof systemic embolism and major bleeding appeared to be similar in the two trial groups, and no deaths from cardiovascular causes occurred in either group.

在两个试验组中，全身性栓塞和主要出血的发生率似乎相似，且两组中均未发生心血管原因的死亡。

Serious adverse events occurred in 80 patients (8.9%) in the DOAC group and in 84 (9.3%) in the no-anticoagulant group.

在DOAC组中有80名患者（8.9％）和在无抗凝组中有84名患者（9.3％）发生了严重不良事件。

Conclusions

Among patients with atrial fibrillation at intermediate risk for stroke, DOAC therapy led to a lower risk of stroke, systemic embolism, major bleeding, or death from cardiovascular causes at 24 months than no anticoagulation.

在中风风险中等的房颤患者中，DOAC治疗在24个月内导致的中风、全身性栓塞、主要出血或心血管原因死亡的风险低于不进行抗凝治疗。

(Funded by the Ministry of Health and Welfare, South Korea, and others; SINGLE-AF ClinicalTrials.gov number, NCT04437654.).

该项目由韩国卫生福利部和其他机构资助；SINGLE-AF的ClinicalTrials.gov编号为NCT04437654。