{"title":"血管内再灌注后动脉内Tenecteplase治疗大血管闭塞急性缺血性卒中：tnk后随机临床试验","authors":"Jiacheng Huang, Jie Yang, Chang Liu, Linyu Li, Dahong Yang, Changwei Guo, Guoyong Zeng, Jiaxing Song, Jinfu Ma, Xu Xu, Xiaolei Shi, Shihai Yang, Wenzhe Sun, Zhixi Wang, Yufeng Tang, Maojun Jiang, Li Wang, Xiangping Cheng, Jun Luo, Peiyang Zhou, Xing Fang, Guangsen Cheng, Zhongfan Ruan, Jinglun Li, Jincheng Liu, Bo Lei, Yaoyu Tian, Xiaolin Tan, Guangxiong Yuan, Jian Wang, Xinyuan Huang, Shengling Deng, Zhenglong Jin, Xin Zou, Jie Zhang, Daoyou Cheng, Xiaojun Luo, Jiasheng Liao, Jian Miao, Zhenqiang Li, Yaxuan Sun, Guohui Jiang, Deyan Kong, Shuyu Jiang, Zhiyuan Wang, Duolao Wang, Johannes Kaesmacher, Thanh N Nguyen, Raul G Nogueira, Jeffrey L Saver, Yangmei Chen, Wenjie Zi","doi":"10.1001/jama.2024.23466","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>The impact of adjunctive intra-arterial tenecteplase administration following near-complete to complete reperfusion by endovascular thrombectomy (EVT) for acute ischemic stroke is unknown.</p><p><strong>Objective: </strong>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.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Interventions: </strong>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).</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>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.</p><p><strong>Trial registration: </strong>ChiCTR.org.cn Identifier: ChiCTR2200064809.</p>","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1000,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Intra-Arterial Tenecteplase Following Endovascular Reperfusion for Large Vessel Occlusion Acute Ischemic Stroke: The POST-TNK Randomized Clinical Trial.\",\"authors\":\"Jiacheng Huang, Jie Yang, Chang Liu, Linyu Li, Dahong Yang, Changwei Guo, Guoyong Zeng, Jiaxing Song, Jinfu Ma, Xu Xu, Xiaolei Shi, Shihai Yang, Wenzhe Sun, Zhixi Wang, Yufeng Tang, Maojun Jiang, Li Wang, Xiangping Cheng, Jun Luo, Peiyang Zhou, Xing Fang, Guangsen Cheng, Zhongfan Ruan, Jinglun Li, Jincheng Liu, Bo Lei, Yaoyu Tian, Xiaolin Tan, Guangxiong Yuan, Jian Wang, Xinyuan Huang, Shengling Deng, Zhenglong Jin, Xin Zou, Jie Zhang, Daoyou Cheng, Xiaojun Luo, Jiasheng Liao, Jian Miao, Zhenqiang Li, Yaxuan Sun, Guohui Jiang, Deyan Kong, Shuyu Jiang, Zhiyuan Wang, Duolao Wang, Johannes Kaesmacher, Thanh N Nguyen, Raul G Nogueira, Jeffrey L Saver, Yangmei Chen, Wenjie Zi\",\"doi\":\"10.1001/jama.2024.23466\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>The impact of adjunctive intra-arterial tenecteplase administration following near-complete to complete reperfusion by endovascular thrombectomy (EVT) for acute ischemic stroke is unknown.</p><p><strong>Objective: </strong>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.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Interventions: </strong>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).</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>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.</p><p><strong>Trial registration: </strong>ChiCTR.org.cn Identifier: ChiCTR2200064809.</p>\",\"PeriodicalId\":54909,\"journal\":{\"name\":\"Jama-Journal of the American Medical Association\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":63.1000,\"publicationDate\":\"2025-01-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Jama-Journal of the American Medical Association\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jama.2024.23466\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Jama-Journal of the American Medical Association","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jama.2024.23466","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Intra-Arterial Tenecteplase Following Endovascular Reperfusion for Large Vessel Occlusion Acute Ischemic Stroke: The POST-TNK Randomized Clinical Trial.
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.
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JAMA (Journal of the American Medical Association) is an international peer-reviewed general medical journal. It has been published continuously since 1883. JAMA is a member of the JAMA Network, which is a consortium of peer-reviewed general medical and specialty publications.
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