Intra-Arterial Tenecteplase Following Endovascular Reperfusion for Large Vessel Occlusion Acute Ischemic Stroke The POST-TNK Randomized Clinical Trial

被引：20

作者：

Huang, Jiacheng ^{[1
,2
,3
]}

Yang, Jie ^{[2
]}

Liu, Chang ^{[1
,2
,3
]}

Li, Linyu ^{[1
,2
,3
]}

Yang, Dahong ^{[2
,3
]}

Guo, Changwei ^{[2
,3
]}

Zeng, Guoyong ^{[4
]}

Song, Jiaxing ^{[1
,2
,3
]}

Ma, Jinfu ^{[2
,3
]}

Xu, Xu ^{[2
,3
]}

Shi, Xiaolei ^{[2
,3
]}

Yang, Shihai ^{[2
,3
]}

Sun, Wenzhe ^{[2
,3
]}

Wang, Zhixi ^{[2
,3
]}

Tang, Yufeng ^{[5
]}

Jiang, Maojun ^{[6
]}

Wang, Li ^{[7
]}

Cheng, Xiangping ^{[8
]}

Luo, Jun ^{[9
]}

Zhou, Peiyang ^{[10
]}

Fang, Xing ^{[11
]}

Cheng, Guangsen ^{[12
]}

Ruan, Zhongfan ^{[13
]}

Li, Jinglun ^{[14
]}

Liu, Jincheng ^{[15
]}

Lei, Bo ^{[16
]}

Tian, Yaoyu ^{[17
]}

Tan, Xiaolin ^{[18
]}

Yuan, Guangxiong ^{[19
]}

Wang, Jian ^{[20
]}

Huang, Xinyuan ^{[21
]}

Deng, Shengling ^{[22
]}

Jin, Zhenglong ^{[23
]}

Zou, Xin ^{[24
]}

Zhang, Jie ^{[1
]}

Cheng, Daoyou ^{[25
]}

Luo, Xiaojun ^{[26
]}

Liao, Jiasheng ^{[27
]}

Miao, Jian ^{[28
]}

Li, Zhenqiang ^{[29
]}

Sun, Yaxuan ^{[30
]}

Jiang, Guohui ^{[31
]}

Kong, Deyan ^{[32
]}

Jiang, Shuyu ^{[1
]}

Wang, Zhiyuan ^{[1
]}

Wang, Duolao ^{[33
]}

Kaesmacher, Johannes ^{[34
,35
,36
]}

Nguyen, Thanh N. ^{[37
]}

Nogueira, Raul G. ^{[38
]}

Saver, Jeffrey L. ^{[39
]}

机构：

[1] Chongqing Med Univ, Dept Neurol, Affiliated Hosp 2, 74 Linjiang Rd, Chongqing 400010, Peoples R China

[2] Third Mil Med Univ, Army Med Univ, Xinqiao Hosp, Dept Neurol, 183 Xinqiao Main St, Chongqing 400037, Peoples R China

[3] Third Mil Med Univ, Army Med Univ, Affiliated Hosp 2, 183 Xinqiao Main St, Chongqing 400037, Peoples R China

[4] Nanchang Univ, Affiliated Ganzhou Hosp, Dept Neurol, Ganzhou, Peoples R China

[5] Mianyang Cent Hosp, Dept Neurol, Mianyang, Sichuan, Peoples R China

[6] Peoples Hosp QianNan Buyi & Miao Autonomous Prefe, Dept Neurol, Duyun, Peoples R China

[7] Zigong Third Peoples Hosp, Dept Neurol, Zigong, Peoples R China

[8] Luzhou Peoples Hosp, Dept Neurol, Luzhou, Peoples R China

[9] Sichuan Mianyang 404 Hosp, Dept Cerebrovasc Dis, Mianyang, Sichuan, Peoples R China

[10] Xiangyang 1 Peoples Hosp, Dept Neurol, Xiangyang, Hubei, Peoples R China

[11] Beilun Peoples Hosp, Dept Gastroenterol, Ningbo, Peoples R China

[12] Zhuhai Peoples Hosp Med Grp, Dept Cerebrovasc Dis, Zhuhai, Peoples R China

[13] Univ South China, Affiliated Hosp 1, Dept Surg, Hengyang, Peoples R China

[14] Southwest Med Univ, Dept Neurol, Affiliated Hosp, Luzhou, Peoples R China

[15] XiangYang Hosp Tradit Chinese Med, Dept Neurol, Xiangyang, Peoples R China

[16] Peoples Hosp Leshan, Dept Cerebrovasc Dis, Leshan, Peoples R China

[17] Qian Xi Nan Peoples Hosp, Dept Neurol, Xingyi, Peoples R China

[18] Meishan Second Peoples Hosp, Dept Neurol, Meishan, Sichuan, Peoples R China

[19] Xiangtan Cent Hosp, Dept Emergency, Xiangtan, Peoples R China

[20] Yaan Peoples Hosp, Dept Neurol, Yaan, Peoples R China

[21] Guizhou Med Univ, Affiliated Baiyun Hosp, Dept Neurosurg, Guiyang, Peoples R China

[22] Guangan Peoples Hosp, Dept Neurol, Guangan, Peoples R China

[23] Jiangmen Wuyi Hosp Tradit Chinese Med, Dept Neurol, Jiangmen, Peoples R China

[24] Third Hosp Mianyang, Dept Neurol, Mianyang, Sichuan, Peoples R China

[25] Xingyi Peoples Hosp, Dept Neurol, Xingyi, Peoples R China

[26] Guangyuan Cent Hosp, Dept Cerebrovasc Dis, Guangyuan, Peoples R China

[27] Suining First Peoples Hosp, Dept Neurol, Suining, Peoples R China

[28] Yanan Univ, Xianyang Hosp, Dept Neurol, Xianyang, Peoples R China

[29] Ningbo Med Cent Lihuili Hosp, Dept Neurosurg, Ningbo, Zhejiang, Peoples R China

[30] Shanxi Prov Peoples Hosp, Dept Neurol, Taiyuan, Peoples R China

[31] North Sichuan Med Coll, Affiliated Hosp, Dept Neurol, Nanchong, Peoples R China

[32] Guangxi Med Univ, Dept Gastroenterol, Affiliated Hosp 2, Nanning, Guangxi, Peoples R China

[33] Univ Liverpool Liverpool Sch Trop Med, Global Hlth Trials Unit, Liverpool, Merseyside, England

[34] Univ Bern, Univ Hosp Bern, Inselspital, Dept Diagnost & Intervent Neuroradiol, Bern, Switzerland

[35] CHRU Tours, Diagnost & Intervent Neuroradiol, CIC IT 1415, Tours, France

[36] Le Studium Loire Valley Inst Adv Studies, Orleans, France

[37] Boston Univ, Boston Med Ctr, Chobanian & Avedisian Sch Med, Dept Neurol & Radiol, Boston, MA USA

[38] Univ Pittsburgh, UPMC Stroke Inst, Dept Neurol, Pittsburgh, PA USA

[39] Univ Calif Los Angeles, David Geffen Sch Med, Dept Neurol, Los Angeles, CA USA

来源：

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2025年 / 333卷 / 07期

基金：

中国国家自然科学基金; 中国博士后科学基金;

关键词：

THROMBECTOMY;

D O I：

10.1001/jama.2024.23466

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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

引用

页码：579 / 588

页数：10

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