Factor XIa Inhibitors for Secondary Prevention After Noncardioembolic Stroke: A Systematic Review and Meta-Analysis.

Factor XIa (FXIa) inhibitors may reduce thrombotic risk while preserving hemostasis.

FXIa（因子XIa）抑制剂可能在保持止血功能的同时降低血栓风险。

Methods

We systematically searched MEDLINE and Scopus for randomized-controlled clinical trials (RCTs) comparing FXIa inhibitors with placebo in patients with acute noncardioembolic ischemic stroke or TIA.

我们系统地检索了MEDLINE和Scopus，以寻找比较FXIa抑制剂与安慰剂在急性非心源性缺血性中风或TIA患者中的随机对照临床试验（RCTs）。

Primary efficacy outcome was first stroke (ischemic, hemorrhagic, or undefined), and primary safety outcome was first major bleeding event during follow-up.

主要疗效结果是首次中风（缺血性、出血性或未定义），主要安全性结果是随访期间首次重大出血事件。

Risk ratios (RRs) with 95% CIs were pooled using random-effects models.

使用随机效应模型汇总了风险比（RRs）和95%置信区间（CIs）。

Results

Three RCTs recruiting 14,239 participants (6,927 assigned to FXIa inhibitors and 7,312 to placebo) were included.

纳入了三项招募了14,239名参与者（6,927名被分配到FXIa抑制剂组，7,312名被分配到安慰剂组）的RCTs。

Effect estimates were largely driven by a single phase 3 trial, recruiting 12,327 participants.

效果估计主要由一项招募了12,327名参与者的第三阶段试验驱动。

FXIa inhibitors reduced the risks for any stroke (RR = 0.75; 95% CI 0.66-0.84), ischemic stroke (RR = 0.74; 95% CI 0.66-0.84), and composite cardiovascular events (RR = 0.83; 95% CI 0.75-0.92), when compared with placebo.

与安慰剂相比，FXIa抑制剂降低了任何中风（RR = 0.75; 95% CI 0.66-0.84）、缺血性中风（RR = 0.74; 95% CI 0.66-0.84）和复合心血管事件（RR = 0.83; 95% CI 0.75-0.92）的风险。

FXIa inhibitors did not increase the risks for major bleeding (RR = 1.12; 95% CI 0.87-1.44), hemorrhagic stroke, intracranial hemorrhage, any bleeding, or all-cause mortality.

FXIa抑制剂并未增加主要出血风险（RR = 1.12; 95% CI 0.87-1.44）、出血性中风、颅内出血、任何出血或全因死亡率。

Discussion

The addition of a FXIa inhibitor to standard antiplatelet therapy after an acute noncardioembolic ischemic stroke or TIA reduces the risk of stroke recurrence without evidence of an increased bleeding risk.

在急性非心源性缺血性中风或短暂性脑缺血发作后，将FXIa抑制剂添加到标准抗血小板治疗中，可以降低中风复发的风险，且没有证据表明出血风险增加。