• JAMA · Aug 2022

    Randomized Controlled Trial Multicenter Study Comparative Study

    Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial.

    • RESCUE BT Trial Investigators, Zhongming Qiu, Fengli Li, Hongfei Sang, Weidong Luo, Shuai Liu, Wenhua Liu, Zhangbao Guo, Huagang Li, Dong Sun, Wenguo Huang, Min Zhang, Weipeng Dai, Peiyang Zhou, Wei Deng, Zhiming Zhou, Xianjun Huang, Bo Lei, Jinglun Li, Zhengzhou Yuan, Bo Song, Jian Miao, Shudong Liu, Zhenglong Jin, Guoyong Zeng, Hongliang Zeng, Junjie Yuan, Changming Wen, Yang Yu, Guangxiong Yuan, Junxiong Wu, Chen Long, Jun Luo, Zhenxuan Tian, Chong Zheng, Zhizhou Hu, Shouchun Wang, Tao Wang, Li Qi, Rongzong Li, Yue Wan, Yingbing Ke, Youlin Wu, Xiurong Zhu, Weilin Kong, Jiacheng Huang, Daizhou Peng, Mingze Chang, Hanming Ge, Zhonghua Shi, Zhizhong Yan, Jie Du, Ying Jin, Dongsheng Ju, Chuming Huang, Yifan Hong, Tianzhu Liu, Wenlong Zhao, Jian Wang, Bo Zheng, Li Wang, Shugai Liu, Xiaojun Luo, Shiwei Luo, Xinwei Xu, Jinrong Hu, Jie Pu, Shengli Chen, Yaxuan Sun, Shunfu Jiang, Liping Wei, Xinmin Fu, Yongjie Bai, Shunyu Yang, Wei Hu, Guling Zhang, Chengde Pan, Shuai Zhang, Yan Wang, Wenfeng Cao, Shiquan Yang, Jun Zhang, Fuqiang Guo, Hongbin Wen, Jinhua Zhang, Jiaxing Song, Chengsong Yue, Linyu Li, Deping Wu, Yan Tian, Jie Yang, Mengjie Lu, Jeffrey L Saver, Raul G Nogueira, Wenjie Zi, and Qingwu Yang.
    • Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing 400037, China.
    • JAMA. 2022 Aug 9; 328 (6): 543553543-553.

    ImportanceTirofiban is a highly selective nonpeptide antagonist of glycoprotein IIb/IIIa receptor, which reversibly inhibits platelet aggregation. It remains uncertain whether intravenous tirofiban is effective to improve functional outcomes for patients with large vessel occlusion ischemic stroke undergoing endovascular thrombectomy.ObjectiveTo assess the efficacy and adverse events of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke secondary to large vessel occlusion.Design, Setting, And ParticipantsThis investigator-initiated, randomized, double-blind, placebo-controlled trial was implemented at 55 hospitals in China, enrolling 948 patients with stroke and proximal intracranial large vessel occlusion presenting within 24 hours of time last known well. Recruitment took place between October 10, 2018, and October 31, 2021, with final follow-up on January 15, 2022.InterventionsParticipants received intravenous tirofiban (n = 463) or placebo (n = 485) prior to endovascular thrombectomy.Main Outcomes And MeasuresThe primary outcome was disability level at 90 days as measured by overall distribution of the modified Rankin Scale scores from 0 (no symptoms) to 6 (death). The primary safety outcome was the incidence of symptomatic intracranial hemorrhage within 48 hours.ResultsAmong 948 patients randomized (mean age, 67 years; 391 [41.2%] women), 948 (100%) completed the trial. The median (IQR) 90-day modified Rankin Scale score in the tirofiban group vs placebo group was 3 (1-4) vs 3 (1-4). The adjusted common odds ratio for a lower level of disability with tirofiban vs placebo was 1.08 (95% CI, 0.86-1.36). Incidence of symptomatic intracranial hemorrhage was 9.7% in the tirofiban group vs 6.4% in the placebo group (difference, 3.3% [95% CI, -0.2% to 6.8%]).Conclusions And RelevanceAmong patients with large vessel occlusion acute ischemic stroke undergoing endovascular thrombectomy, treatment with intravenous tirofiban, compared with placebo, before endovascular therapy resulted in no significant difference in disability severity at 90 days. The findings do not support use of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke.Trial RegistrationChinese Clinical Trial Registry Identifier: ChiCTR-IOR-17014167.

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