Intra-Arterial Tenecteplase Following Endovascular Reperfusion for Large Vessel Occlusion Acute Ischemic Stroke
Authors: 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 ,   POST-TNK Investigators, Li Shaofa , Huang Chuming , Ni Yang , Duan Zuowei , Guo Junqing , Ni Huafu , Zheng Bo , Li Fengli , Yu Nizhen Yu , Peng Zhouzhou , Kong Weilin , Liu Xiang , Fan Shitao , Yue Chengsong , Song Min , Gong Chen , Huang Liping 
Published: January 2025

Importance

The impact of adjunctive intra-arterial tenecteplase administration following near-complete to complete reperfusion by endovascular thrombectomy (EVT) for acute ischemic stroke is unknown.

Objective

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.

Interventions

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).

Main Outcomes and Measures

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.

Results

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.

Conclusions and Relevance

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.

Trial Registration

ChiCTR.org.cn Identifier: ChiCTR2200064809