Huang Jiacheng, Yang Jie, Liu Chang, Li Linyu, Yang Dahong, Guo Changwei, Zeng Guoyong, Song Jiaxing, Ma Jinfu, Xu Xu, Shi Xiaolei, Yang Shihai, Sun Wenzhe, Wang Zhixi, Tang Yufeng, Jiang Maojun, Wang Li, Cheng Xiangping, Luo Jun, Zhou Peiyang, Fang Xing, Cheng Guangsen, Ruan Zhongfan, Li Jinglun, Liu Jincheng, Lei Bo, Tian Yaoyu, Tan Xiaolin, Yuan Guangxiong, Wang Jian, Huang Xinyuan, Deng Shengling, Jin Zhenglong, Zou Xin, Zhang Jie, Cheng Daoyou, Luo Xiaojun, Liao Jiasheng, Miao Jian, Li Zhenqiang, Sun Yaxuan, Jiang Guohui, Kong Deyan, Jiang Shuyu, Wang Zhiyuan, Wang Duolao, Kaesmacher Johannes, Nguyen Thanh N, Nogueira Raul G, Saver Jeffrey L, Chen Yangmei, Zi Wenjie
Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.
JAMA. 2025 Feb 18;333(7):579-588. doi: 10.1001/jama.2024.23466.
The impact of adjunctive intra-arterial tenecteplase administration following near-complete to complete reperfusion by endovascular thrombectomy (EVT) for acute ischemic stroke is unknown.
To assess the efficacy and adverse events of adjunctive intra-arterial tenecteplase in patients with large vessel occlusion stroke who had achieved near-complete to complete reperfusion (defined as a score on the expanded Thrombolysis in Cerebral Infarction [eTICI] scale of 2c to 3) after EVT.
DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, randomized, open-label, blinded outcome assessment trial implemented at 34 hospitals in China among 540 patients with stroke due to proximal intracranial large vessel occlusion within 24 hours of the time they were last known to be well, with an eTICI score of 2c to 3 after EVT, and without prior intravenous thrombolysis. Recruitment took place between October 26, 2022, and March 1, 2024, with final follow-up on June 3, 2024.
Eligible patients were randomly assigned to receive intra-arterial tenecteplase (n = 269) at 0.0625 mg/kg or no intra-arterial thrombolysis (control group; n = 271).
The primary efficacy outcome was freedom from disability, defined as a score of 0 or 1 on the modified Rankin Scale (range, 0 [no symptoms] to 6 [death]) at 90 days. The primary safety outcomes were death at 90 days and symptomatic intracranial hemorrhage within 48 hours.
A total of 539 participants (99.8%) completed the trial (median age, 69 years; 221 female [40.9%]). The proportion with a modified Rankin Scale score of 0 or 1 at 90 days was 49.1% (132/269) in the intra-arterial tenecteplase group and 44.1% (119/270) in the control group (adjusted risk ratio, 1.15 [95% CI, 0.97-1.36]; P = .11). Ninety-day mortality was 16.0% and 19.3% (adjusted hazard ratio, 0.75 [95% CI, 0.50-1.13]; P = .16), respectively. The proportions of symptomatic intracranial hemorrhage were 6.3% and 4.4% (adjusted risk ratio, 1.43 [95% CI, 0.68-2.99]; P = .35), respectively.
In patients with acute ischemic stroke due to large vessel occlusion presenting within 24 hours of time last known to be well and who had achieved near-complete to complete reperfusion after EVT, adjunctive intra-arterial tenecteplase did not significantly increase the likelihood of freedom from disability at 90 days.
ChiCTR.org.cn Identifier: ChiCTR2200064809.
对于急性缺血性卒中患者，在通过血管内血栓切除术（EVT）实现近乎完全至完全再灌注后，辅助动脉内注射替奈普酶的影响尚不清楚。
评估在接受EVT后已实现近乎完全至完全再灌注（定义为脑梗死溶栓扩展量表[eTICI]评分为2c至3）的大血管闭塞性卒中患者中，辅助动脉内注射替奈普酶的疗效和不良事件。
设计、设置和参与者：由研究者发起的随机、开放标签、盲法结局评估试验，在中国34家医院对540例颅内近端大血管闭塞导致的卒中患者进行，这些患者在最后一次已知状态良好后的24小时内发病，EVT后eTICI评分为2c至3，且未接受过静脉溶栓治疗。招募时间为2022年10月26日至2024年3月1日，最终随访时间为2024年6月3日。
符合条件的患者被随机分配接受0.0625mg/kg动脉内注射替奈普酶（n = 269）或不进行动脉内溶栓治疗（对照组；n = 271）。
主要疗效结局为无残疾，定义为90天时改良Rankin量表评分为0或1（范围为0[无症状]至6[死亡]）。主要安全结局为90天时的死亡和48小时内的症状性颅内出血。
共有539名参与者（99.8%）完成了试验（中位年龄69岁；221名女性[40.9%]）。动脉内注射替奈普酶组90天时改良Rankin量表评分为0或1的比例为49.1%（132/269），对照组为44.1%（119/270）（调整风险比，1.15[95%CI，0.97 - 1.36]；P = 0.11）。90天死亡率分别为16.0%和19.3%（调整风险比，0.75[95%CI，0.50 - 1.13]；P = 0.16）。症状性颅内出血的比例分别为6.3%和4.4%（调整风险比，1.43[95%CI，0.68 - 2.99]；P = 0.35）。
对于在最后一次已知状态良好后的24小时内出现、因大血管闭塞导致的急性缺血性卒中患者，且在EVT后已实现近乎完全至完全再灌注，辅助动脉内注射替奈普酶在90天时并未显著增加无残疾的可能性。
中国临床试验注册中心标识符：ChiCTR2200064809。
