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Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial.
JAMA ( IF 63.1 ) Pub Date : 2022-08-09 , DOI: 10.1001/jama.2022.12584
, Zhongming Qiu 1, 2 , Fengli Li 1 , Hongfei Sang 3 , Weidong Luo 1, 4 , Shuai Liu 1 , Wenhua Liu 5 , Zhangbao Guo 5 , Huagang Li 6 , Dong Sun 6 , Wenguo Huang 7 , Min Zhang 7 , Min Zhang 8 , Weipeng Dai 8 , Peiyang Zhou 9 , Wei Deng 9 , Zhiming Zhou 10 , Xianjun Huang 10 , Bo Lei 11 , Jinglun Li 12 , Zhengzhou Yuan 12 , Bo Song 13 , Jian Miao 14 , Shudong Liu 15 , Zhenglong Jin 16 , Guoyong Zeng 17 , Hongliang Zeng 17 , Junjie Yuan 1 , Changming Wen 18 , Yang Yu 18 , Guangxiong Yuan 19 , Junxiong Wu 19 , Chen Long 19 , Jun Luo 20 , Zhenxuan Tian 20 , Chong Zheng 21 , Zhizhou Hu 21 , Shouchun Wang 22 , Tao Wang 23 , Li Qi 24 , Rongzong Li 24 , Yue Wan 25 , Yingbing Ke 25 , Youlin Wu 26 , Xiurong Zhu 26 , Weilin Kong 1 , Jiacheng Huang 1 , Daizhou Peng 27 , Mingze Chang 28 , Hanming Ge 28 , Zhonghua Shi 29 , Zhizhong Yan 29 , Jie Du 30 , Ying Jin 31 , Dongsheng Ju 31 , Chuming Huang 32 , Yifan Hong 32 , Tianzhu Liu 33 , Wenlong Zhao 34 , Jian Wang 35 , Bo Zheng 35 , Li Wang 36 , Shugai Liu 37 , Xiaojun Luo 37 , Shiwei Luo 38 , Xinwei Xu 38 , Jinrong Hu 1 , Jie Pu 39, 40 , Shengli Chen 41 , Yaxuan Sun 42 , Shunfu Jiang 43 , Liping Wei 44 , Xinmin Fu 45 , Yongjie Bai 46 , Shunyu Yang 47 , Wei Hu 48 , Guling Zhang 49 , Chengde Pan 50 , Shuai Zhang 51 , Yan Wang 52 , Wenfeng Cao 53 , Shiquan Yang 54 , Jun Zhang 55 , Fuqiang Guo 56 , Hongbin Wen 57 , Jinhua Zhang 58 , Jiaxing Song 1 , Chengsong Yue 1 , Linyu Li 1 , Deping Wu 1 , Yan Tian 1 , Jie Yang 1 , Mengjie Lu 59 , Jeffrey L Saver 60 , Raul G Nogueira 61 , Wenjie Zi 1 , Qingwu Yang 1, 62
Affiliation  

Importance Tirofiban 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. Objective To assess the efficacy and adverse events of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke secondary to large vessel occlusion. Design, Setting, and Participants This 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. Interventions Participants received intravenous tirofiban (n = 463) or placebo (n = 485) prior to endovascular thrombectomy. Main Outcomes and Measures The 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. Results Among 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 Relevance Among 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 Registration Chinese Clinical Trial Registry Identifier: ChiCTR-IOR-17014167.
更新日期:2022-08-09
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