Intra-arterial tenecteplase after successful endovascular recanalisation in patients with acute posterior circulation arterial occlusion (ATTENTION-IA): multicentre randomised controlled trial.

Methods

Multicentre randomised controlled trial.

多中心随机对照试验。

31 hospitals in China, 24 January 2023 to 24 August 2023.

31家中国医院，2023年1月24日至2023年8月24日。

208 patients with successful recanalisation (grade 2b50-3 on the extended thrombolysis in cerebral infarction scale) of an occlusion in the V4 segment of the vertebral artery; proximal, middle, or distal segment of the basilar artery; or P1 segment of the posterior cerebral artery: 104 were randomly allocated to receive tenecteplase and 104 to receive standard care.

208名患者成功再通（扩展型脑梗死溶栓治疗量表2b50-3级）椎动脉V4段、基底动脉近端、中段或远端段或后脑动脉P1段的闭塞；104名被随机分配接受替奈普酶治疗，104名接受标准护理。

Intra-arterial tenecteplase (0.0625 mg/kg, maximum dose 6.25 mg) administered proximal to the residual thrombus (if still present) or distal to the origin of the main pontine perforator branches over 15 seconds, or endovascular treatment only (control group).

在残余血栓近端（如果仍然存在）或主要脑桥穿通支起始部远端，通过动脉内给予0.0625 mg/kg的替奈普酶（最大剂量6.25 mg），持续15秒，或者仅进行血管内治疗（对照组）。

The primary outcome was freedom from disability (modified Rankin scale score 0 or 1) at 90 days after randomisation.

主要结果是在随机分组后90天内无残疾（改良Rankin量表评分为0或1）的状态。

Primary safety outcomes included symptomatic intracranial haemorrhage within 36 hours and all cause mortality at 90 days.

主要安全性结果包括36小时内出现的症状性颅内出血和90天内的全因死亡率。

All efficacy and safety analyses were conducted by intention to treat and adjusted for age, pre-stroke modified Rankin scale score, time from onset of moderate to severe stroke (National Institutes of Health stroke scale score ≥6) to randomisation, hypertension, and baseline stroke severity.

所有疗效和安全性分析均按意向治疗原则进行，并根据年龄、中风前改良Rankin量表评分、从中度到重度中风（美国国立卫生研究院中风量表评分≥6）到随机分组的时间、高血压和基线中风严重程度进行了调整。

Results

At 90 days, 36 patients (34.6%) in the tenecteplase group and 27 (26.0%) in the control group had a modified Rankin scale score of 0 or 1 (adjusted risk ratio 1.36, 95% confidence interval0.92 to 2.02; P=0.12).

在90天时，接受替奈普酶治疗的组别中有36名患者（34.6%）和对照组中有27名患者（26.0%）的改良Rankin量表评分为0或1（调整后的风险比为1.36，95%置信区间为0.92至2.02；P=0.12）。

Mortality at 90 days was similar between the tenecteplase and control groups: 29 (27.9%) v 28 (26.9%), adjusted risk ratio 1.13, 0.73 to 1.74.

在90天时，替奈普酶组和对照组的死亡率相似：替奈普酶组29人（27.9%），对照组28人（26.9%），调整后的风险比为1.13，95%置信区间为0.73至1.74。

Symptomatic intracranial haemorrhage within 36 hours occurred in eight patients (8.3%) in the tenecteplase group and three (3.1%) in the control group (adjusted risk ratio 3.09, 0.78 to 12.20).

在36小时内，接受替奈普酶治疗的患者中有8名（8.3%）出现了症状性颅内出血，而对照组中有3名（3.1%）（调整后的风险比为3.09，95%置信区间为0.78至12.20）。

Conclusions

In patients with acute ischaemic stroke due to acute posterior large or proximal vessel occlusion, intra-arterial tenecteplase administered after successful recanalisation was not associated with a statistically significant reduction in combined disability and mortality at 90 days.

对于因急性后部大血管或近端血管闭塞导致的急性缺血性中风患者，在成功再通后经动脉给予替奈普酶，并未与90天时联合残疾和死亡率的统计学显著降低相关。

trial_registration

ClinicalTrials.gov NCT05684172.

临床试验注册号：NCT05684172。