陆军军医大学(第三军医大学)第二附属医院资文杰团队,研究了血管内再灌注后动脉内替尼普酶,治疗大血管闭塞性急性缺血性卒中,对患者预后的影响。这一研究成果发表在2025年1月13日出版的《美国医学会杂志》上。
急性缺血性卒中血管内血栓切除术(EVT)接近完全再灌注后,辅助动脉内注射替萘普酶的影响尚不清楚。
为了评估辅助动脉内注射替萘普酶对大血管闭塞性卒中患者的疗效和不良事件,这些患者在EVT后实现了接近完全再灌注(定义为脑梗塞溶栓[eTICI]量表2c至3的评分),研究组在中国34家医院,对540名因近端颅内大血管闭塞导致的卒中患者进行了由研究者发起的、随机、开放标签、盲法的结果评估试验,这些患者在最后一次知道病情好转后24小时内发生卒中,EVT后eTICI评分为2c至3,且之前没有静脉溶栓。招募工作于2022年10月26日至2024年3月1日进行,最后一次后续随访于2024年6月3日进行。
符合条件的患者被随机分配接受0.0625 mg/kg的动脉内替萘普酶治疗(n=269)或不接受动脉内溶栓治疗(对照组;n = 271)。主要疗效结局是无残疾,定义为90天时改良Rankin量表为0或1分(范围为0[无症状]至6[死亡])。主要安全性结局为90天内死亡和48小时内出现症状性颅内出血。
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%])。动脉内替萘普酶组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)(校正后的风险比为1.15[95%CI,0.97-1.36];P = 0.11)。两组90天死亡率分别为16.0%和19.3%(校正后的危险比为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%(校正后的风险比为1.43[95%CI,0.68-2.99];P=0 .35)。
研究结果表明,在最后知道病情好转后24小时内出现因大血管闭塞导致的急性缺血性卒中的患者,在EVT后几乎完全再灌注,辅助动脉内替萘普酶在90天内没有显著增加免于残疾的可能性。
附:英文原文
Title: Intra-Arterial Tenecteplase Following Endovascular Reperfusion for Large Vessel Occlusion Acute Ischemic Stroke: The POST-TNK Randomized Clinical Trial
Author: 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, POST-TNK Investigators, Shaofa Li, Chuming Huang, Yang Ni, Zuowei Duan, Junqing Guo, Huafu Ni, Bo Zheng, Fengli Li, Nizhen Yu Yu, Zhouzhou Peng, Weilin Kong, Xiang Liu, Shitao Fan, Chengsong Yue, Min Song, Chen Gong, Liping Huang
Issue&Volume: 2025-01-13
Abstract:
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.
DOI: 10.1001/jama.2024.23466
Source: https://jamanetwork.com/journals/jama/fullarticle/2829205
JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:157.335
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex