Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial.

Methods

Multicentre, double blind, randomised, placebo controlled trial.

多中心、双盲、随机、安慰剂对照试验。

106 hospitals in China between March 2022 and May 2023.

2022年3月至2023年5月期间，中国有106家医院参与。

1362 patients with clinically diagnosed acute ischaemic stroke within 24 hours of symptom onset, aged 18-80 years, with a National Institutes of Health Stroke Scale (NIHSS) score of 6-25 and an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of 6-10, confirmed large vessel occlusion in the anterior circulation, and planned endovascular thrombectomy.

1362名患者在症状发作后24小时内被临床诊断为急性缺血性中风，年龄在18-80岁之间，美国国立卫生研究院卒中量表（NIHSS）评分为6-25分，阿尔伯塔卒中项目早期计算机断层扫描评分（ASPECTS）为6-10分，前循环大血管闭塞得到确认，并计划进行血管内血栓切除术。

Patients were randomly allocated in a 1:1 ratio to receive edaravone dexborneol 37.5 mg (edaravone, 30 mg; (+)-dexborneol, 7.5 mg; 690 patients) or placebo (672 patients) before endovascular thrombectomy and continued the regimen twice daily for a consecutive period of 10-14 days.

患者以1:1的比例随机分配接受37.5毫克的依达拉奉右旋龙脑（依达拉奉30毫克；(+)-右旋龙脑7.5毫克；690名患者）或安慰剂（672名患者），在血管内血栓切除术前使用，并持续每天两次，连续使用10-14天。

Functional independence at 90 days, defined as a modified Rankin Scale score (range 0 (no symptoms) to 6 (death)) of 0-2, and serious adverse events.

90天时的功能独立性，定义为改良Rankin量表评分（范围从0（无症状）到6（死亡））为0-2，以及严重不良事件。

Results

One patient from each group was lost to follow-up at 90 days.

在90天随访时，每组各有1名患者失访。

Of the 1360 patients included in the intention-to-treatanalysis, 379 (55.0%) of 689 patients in the edaravone dexborneol group and 333 (49.6%) of 671 patients in the placebo group achieved functional independence on day 90 (risk ratio 1.11, 95% confidence interval(CI) 1.00 to 1.23; P=0.05; risk difference 5.4%, 95% CI 0.1% to 10.7%).

在纳入意向性治疗分析的1360名患者中，90天时，依达拉奉右旋糖酐组的689名患者中有379名（55.0%），安慰剂组的671名患者中有333名（49.6%）实现了功能独立（风险比1.11，95%置信区间（CI）1.00至1.23；P=0.05；风险差异5.4%，95% CI 0.1%至10.7%）。

Patients with mismatch at admission (defined as NIHSS score ≥10 and ASPECTS ≥9 or NIHSS score ≥20 and ≥7) were more likely to achieve functional independence in the subgroup analysis (55.5% (178/321) versus 42.9% (134/312); risk ratio 1.29, 1.10 to 1.52; risk difference 13.0%, 5.6% to 20.3%; P for interaction=0.003).

入院时存在不匹配的患者（定义为NIHSS评分≥10且ASPECTS评分≥9或NIHSS评分≥20且ASPECTS评分≥7）在亚组分析中更有可能实现功能独立（55.5%（178/321）对比42.9%（134/312）；风险比1.29，95%置信区间1.10至1.52；风险差异13.0%，95%置信区间5.6%至20.3%；交互作用P值=0.003）。

The rates of serious adverse events were similar in the two groups (27.2% (188/690) versus 25.7% (173/672); risk ratio 1.06, 0.89 to 1.26; risk difference 1.5%, -3.2% to 6.2%: P=0.53).

两组中严重不良事件的发生率相似（27.2%（188/690）对比25.7%（173/672）；风险比1.06，95%置信区间0.89至1.26；风险差异1.5%，95%置信区间-3.2%至6.2%；P=0.53）。

Conclusions

Among patients with acute ischaemic stroke within 24 hours of symptom onset who underwent endovascular thrombectomy, those treated with edaravone dexborneol, compared with placebo, were more likely to achieve functional independence at 90 days without increased safety concerns.

在症状发作后24小时内接受血管内血栓切除术的急性缺血性中风患者中，与安慰剂相比，接受依达拉奉右旋糖酐治疗的患者在90天时更有可能实现功能独立，且未增加安全问题。

This effect seemed to be primarily driven by the subgroup with mismatch present at admission, suggesting that dedicated trials in this population may be warranted.

这种效果似乎主要由入院时存在不匹配的亚组所驱动，这表明在这一人群中进行专门的试验可能是合理的。

trial_registration

ClinicalTrials.gov NCT05249920.

ClinicalTrials.gov NCT05249920。