Anticoagulation to prevent ischemic stroke and neurocognitive impairment in atrial fibrillation: the BRAIN-AF randomized clinical trial.

Observational studies suggest that anticoagulation may reduce the risk of cognitive decline in patients with AF and elevated thromboembolic risk, implicating subclinical cerebral emboli as a potential mechanistic link.

观察性研究表明，抗凝治疗可能降低房颤和高血栓栓塞风险患者的认知衰退风险，暗示亚临床脑栓塞可能是潜在的机制联系。

Whether anticoagulation prevents cognitive deterioration in patients with AF at low risk of stroke remains uncertain.

对于低卒中风险的房颤患者，抗凝治疗是否能预防认知功能恶化仍不确定。

Here we conducted a multicenter, double-blind, placebo-controlledtrial in which participants with AF and low thromboembolic risk (CHA2DS2-VASc scores of 0 or 1, excluding female sex) were randomized 1:1 to receive rivaroxaban 15 mg daily or placebo.

在这里，我们进行了一项多中心、双盲、安慰剂对照试验，将低血栓栓塞风险（CHA2DS2-VASc评分为0或1，排除女性）的房颤患者随机分为两组，一组每天接受15毫克利伐沙班，另一组接受安慰剂。

The primary outcome was a composite of cognitive decline (≥2-point drop in Montreal Cognitive Assessment), stroke or transient ischemic attack with a motor deficit or aphasia.

主要结果是认知下降（蒙特利尔认知评估得分下降≥2分）、中风或短暂性脑缺血发作伴有运动障碍或失语症的复合终点。

The trial was halted after meeting the predetermined futility criterion following a planned interim analysis, with 1,235 of the intended 1,424 participants (919 men; 316 women) enrolled.

在计划的中期分析后，由于达到了预先设定的无效标准，试验被停止，共有1,235名参与者（919名男性；316名女性）完成了预定的1,424名参与者的招募。

Over a median follow-up of 3.7 years, the primary outcome occurred in 256 (20.7%) participants, at an annual rate of 7.0% with rivaroxaban versus 6.4% with placebo, yielding a hazard ratioof 1.10 (95% confidence interval(0.86-1.40); P = 0.46).

在中位随访3.7年期间，主要结果发生在256名（20.7%）参与者中，利伐沙班组的年发生率为7.0%，而安慰剂组为6.4%，导致的风险比为1.10（95%置信区间（0.86-1.40）；P = 0.46）。

Conditional power analysis indicated a 1.2% probability of achieving a statistically significant treatment effect if the trial had been continued to its planned total of 410 events.

条件性功效分析表明，如果试验继续进行到计划的总事件数410个，实现统计学上显著的治疗效果的概率为1.2%。

Major bleeding occurred in two patients treated with rivaroxaban (0.09% per year) and five patients treated with placebo (0.21% per year).

在使用利伐沙班治疗的两名患者（每年0.09%）和使用安慰剂的五名患者（每年0.21%）中发生了主要出血事件。

In conclusion, despite the high incidenceof cognitive decline observed among patients with AF and low stroke risk, the BRAIN-AF trial, which tested a low dose of rivaroxaban to prevent stroke, transient ischemic attack and cognitive decline in patients with prior AF, was stopped early due to futility.

总之，尽管在低卒中风险的房颤患者中观察到认知能力下降的发生率较高，但旨在测试低剂量利伐沙班预防卒中、短暂性脑缺血发作和认知能力下降的BRAIN-AF试验，由于无效而提前终止。

ClinicalTrials.gov registration: NCT02387229 .

临床试验注册：NCT02387229 .