中国科技大学 与医学部刘新峰团队，研究了急性后循环动脉闭塞患者血管内再通成功后动脉内注射替萘普酶对患者预后的影响。这一研究成果于2025年1月14日发表在《英国医学杂志》上。

为了评估血管内再通成功后动脉内注射替萘普酶是否能改善急性后循环动脉闭塞患者的预后，2023年1月24日至2023年8月24日，研究组在中国31家医院进行了一项多中心随机对照试验。

研究组共招募了208名成功再通椎动脉V4段（脑梗死扩展溶栓评分2b50-3级）；基底动脉的近端、中段或远端；或大脑后动脉P1段闭塞的患者，其中104人随机分配接受替萘普酶治疗，104人接受标准护理。动脉内替萘普酶（0.0625mg/kg，最大剂量6.25mg）在残余血栓（如果仍然存在）近端或桥脑穿支主干远端给药，持续15秒以上，或仅进行血管内治疗（对照组）。

主要结局是随机分组后90天无残疾（改良Rankin量表评分0或1）。主要安全性结局包括36小时内出现症状性颅内出血和90天内的全因死亡率。所有疗效和安全性分析均通过意向治疗进行，并根据年龄、卒中前改良的Rankin量表评分、从中度至重度卒中发作（美国国立卫生研究院卒中量表评分≥6）到随机分组的时间、高血压和基线卒中严重程度进行校正。

在90天时，替萘普酶组有36名患者（34.6%）和对照组有27名患者（26.0%）的改良Rankin量表评分为0或1（校正后的风险比为1.36，95%置信区间为0.92至2.02；P=0.12）。替萘普酶组和对照组在90天时的死亡率相似：29名（27.9%）对28名（26.9%）患者，校正后的风险比为1.13，0.73至1.74。替萘普酶组有8名患者（8.3%）和对照组有3名患者（3.1%）在36小时内出现症状性颅内出血（调整后的风险比为3.09，0.78至12.20）。

研究结果表明，在因急性后大血管或近端血管闭塞导致的急性缺血性卒中患者中，成功再通后动脉内注射替萘普酶与90天时综合残疾和死亡率的统计学显著降低无关。

附：英文原文

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

Author: Wei Hu, Chunrong Tao, Li Wang, Zhongjun Chen, Di Li, Wenhuo Chen, Tingyu Yi, Lihua Xu, Chuanqing Yu, Tao Wang, Xiaoxi Yao, Tao Cui, Guangxiong Yuan, Junfeng Su, Li Chen, Zhiming Zhou, Zhengfei Ma, Junjun Wang, Benxiao Wang, Hongxing Han, Hao Wang, Jie Chen, Peiyang Zhou, Zhihua Cao, Youquan Ren, Xueli Cai, Huaizhang Shi, Guang Zhang, Liping Yu, Xingyun Yuan, Jinglun Li, Guoyong Zeng, Chuyuan Ni, Tong Li, Yingchun Wu, Yuwen Li, Kai Li, Yong Liu, Yao Wang, Yu Jin, Hanwen Liu, Jianshang Wen, Jun Sun, Yuyou Zhu, Rui Li, Chao Zhang, Tianlong Liu, Jianlong Song, Li Wang, Juan Cheng, Adnan I Qureshi, Thanh N Nguyen, Jeffrey L Saver, Raul G Nogueira, Xinfeng Liu

Issue&Volume: 2025/01/14

Abstract:

Objective To assess whether intra-arterial tenecteplase administered after successful endovascular recanalisation improves outcomes in patients with acute arterial occlusion of the posterior circulation.

Design Multicentre randomised controlled trial.

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

Participants 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.

Interventions 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).

Main outcome measures The primary outcome was freedom from disability (modified Rankin scale score 0 or 1) at 90 days after randomisation. Primary safety outcomes included symptomatic intracranial haemorrhage within 36 hours and all cause mortality at 90 days. 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.

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 interval 0.92 to 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. 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).

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.

DOI: 10.1136/bmj-2024-080489

Source: https://www.bmj.com/content/388/bmj-2024-080489