Efficacy and safety of tirofiban after successful endovascular reperfusion in acute ischaemic stroke (ATTRACTION) in China: a multicentre, double-blind, randomised controlled trial.

We aimed to assess the efficacy and safety of tirofiban, a glycoprotein IIb/IIIa receptor antagonist, given to patients with acute ischaemic stroke who had had a successful endovascular reperfusion.

我们旨在评估给予急性缺血性中风患者成功血管内再灌注后使用替罗非班（一种糖蛋白IIb/IIIa受体拮抗剂）的有效性和安全性。

Methods

This multicentre, double-blind, randomised controlled trialat 82 hospitals in China included patients with acute ischaemic stroke due to anterior-circulation large-vessel occlusion who had had a successful reperfusion after thrombectomy.

这项在中国82家医院进行的多中心、双盲、随机对照试验，纳入了因前循环大血管闭塞导致的急性缺血性中风患者，这些患者在血栓切除术后的再灌注成功。

Eligible patients were randomly assigned (1:1) to receive either tirofiban (intra-arterial bolus 5 μg/kg followed by intravenous infusion 0·1 μg/kg per min for 24 h) or placebo (administered with the same volume and according to the same bolus and infusion procedures as tirofiban), using computer-generated randomisation with fixed blocks stratified by study site.

符合条件的患者被随机分配（1:1）接受替罗非班（动脉内推注5 μg/kg，随后静脉输注0.1 μg/kg/min，持续24小时）或安慰剂（以相同的体积和按照替罗非班相同的推注和输注程序进行），使用计算机生成的随机化方法，按研究地点进行固定分块分层。

Patients, treating clinicians, investigators, and outcome assessors were masked to group assignments.

患者、治疗医生、研究人员和结果评估者对分组分配情况均不知情。

The primary efficacy outcome was functional independence at 90 days (with a modified Rankin Scale score of 0-2), assessed in all randomly assigned participants (intention-to-treatpopulation).

主要疗效结果是在所有随机分配的参与者（意向治疗人群）中评估的90天功能独立（改良Rankin量表评分为0-2）。

Safety outcomes were symptomatic intracranial haemorrhage within 48 h, any evidence of intracranial haemorrhage on imaging within 48 h, and death within 90 days, and they were assessed in patients having received the study treatment with at least one safety evaluation.

安全性结果包括在48小时内出现症状性颅内出血、在48小时内影像学检查显示任何颅内出血证据，以及90天内的死亡情况，这些结果是在至少接受了一次安全性评估的患者中评估的。

The Adjunct Tirofiban Treatment after Successful Endovascular Thrombectomy Recanalisation in Acute Anterior Circulation Ischaemic Stroke (ATTRACTION) trial is registered with ClinicalTrials.gov, NCT06265051 and is now completed.

辅助替罗非班治疗在急性前循环缺血性卒中成功血管内血栓切除术后开通的试验（ATTRACTION）已在ClinicalTrials.gov上注册，注册号为NCT06265051，目前已完成。

Results

Of 1686 patients assessed, 1380 were randomly assigned to either the tirofiban group (689 patients) or the placebo group (691 patients) between April 9, 2024, and Sept 29, 2025.

在评估的1686名患者中，1380名被随机分配到替罗非班组（689名患者）或安慰剂组（691名患者），时间从2024年4月9日至2025年9月29日。

Median age was 71 years (IQR 62-77), 591 (43%) patients were female and 789 (57%) were male, and 1367 (99%) were of Han Chinese ethnicity.

中位年龄为71岁（四分位数间距62-77），591名（43%）患者为女性，789名（57%）为男性，1367名（99%）为汉族。

No patients were lost to follow-up at 90 days.

在90天的随访中，没有患者失访。

Functional independence at 90 days was recorded in 340 (49%) of 689 patients in the tirofiban group and 299 (43%) of 691 patients in the placebo group (unadjusted absolute risk difference 6·1 percentage points, 95% CI 0·8-11·3, p=0·023; adjusted risk ratio 1·15, 95% CI 1·03-1·27, p=0·0092).

在90天时，记录了689名患者中340名（49%）在替罗非班组和691名患者中299名（43%）在安慰剂组实现了功能独立（未调整的绝对风险差异为6.1个百分点，95%置信区间0.8-11.3，p=0.023；调整后的风险比为1.15，95%置信区间1.03-1.27，p=0.0092）。

There was no significant difference between study groups in the proportion of patients with symptomatic intracranial haemorrhage within 48 h (82 [12%] of 687 patients in the tirofiban group vs 65 [9%] of 691 patients in the placebo group), the proportion with any intracranial haemorrhage within 48 h (235 [34%] patients vs 219 [32%] patients), and 90-day mortality (126 [18%] patients vs 131 [19%] patients).

在48小时内，研究组之间在有症状的颅内出血患者比例上没有显著差异（687名患者中有82名[12%]使用替罗非班，691名患者中有65名[9%]使用安慰剂），在48小时内任何颅内出血患者比例上也没有显著差异（分别有235名[34%]患者和219名[32%]患者），以及90天的死亡率（分别有126名[18%]患者和131名[19%]患者）。

interpretation

In patients with acute ischaemic stroke due to anterior-circulation large-vessel occlusion achieving successful reperfusion, adjunctive tirofiban increased the likelihood of functional independence compared with placebo.

对于因前循环大血管闭塞导致的急性缺血性中风患者，在成功实现再灌注后，辅助使用替罗非班比使用安慰剂更有可能增加功能性独立的可能性。

Although symptomatic intracranial haemorrhage occurred numerically more often with tirofiban, the between-group difference was not significant, and this finding warrants caution when weighing potential benefit against bleeding risk.

尽管使用替罗非班时症状性颅内出血的发生率在数值上更高，但组间差异并不显著，这一发现需要在权衡潜在益处与出血风险时保持谨慎。

funding

Tongji Hospital Clinical Research Fund.

同济医院临床研究基金。