Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke
RESCUE BT Trial Investigators, Jie Shuai, Zili Gong, Li Huang, Juan Liu, Kun Tang, Zhenhui Duan, Houjie Ni, Yumin Liu, Fei Xie, Dongrun Yan, Songsheng Ye, Zhiquan Zhang, Zhihua Cao, Xianjin Shang, Xianhui Ding, Xiangjun Xu, Li Chen, Jiachuan Wu, Renliang Meng, Li Jiang, Yang Xie, Lei Lei, Libo Zhao, Tao Yu, Zhengjin Luo, Бин Ли, Ning Wang, Jun Sun, Yong Liang, Zongqin Li, XU Xue-jie, Kangjia Song, Zeyu Hao, Chuanqing Yu, Xiaofei Zhou, Jing Zuo, Wenbin Wu, Xiyang Chen, Yaoyu Tian, Xiaogang Hu, Wei Liang, Xiuhua Wu, Dezheng Fu, Ce Han, Chunying Li, Yachun Liu, Chukai Xu, Shiyu Deng, Ling Fang, Gangfeng Gu, Rong Su, Jing Guo, Jing Wang, Minghua Cao, Mingchao Wu, Xuxu Wu, Yu‐Peng Wu, Jisheng Qi, Da Liu, Wenkai Long, Yuxian Zhang, Mingshan Tang, Fei Zeng, Changya Liu, Tieyu Tang, Ying Yang, Yongliang Zhou, Dongzhang Xue, Ju Han, Jianhong Wang, Xuan Liu, Xu Zheng, Anding Xu, Guilian Zhang, Yi Dong, Yonggang Hao, Dan Liu, Min Lin, Fajin Lv, Chao Qin, Hua Yang, Zhongming Qiu, Fengli Li, Hongfei Sang, Weidong Luo, Shuai Liu, Wenhua Liu, Zhangbao Guo, Huagang Li, Dong Sun, Wenguo Huang, Min Zhang, Min Zhang, Weipeng Dai, Peiyang Zhou, Wei Deng, Zhiming Zhou, Xianjun Huang, Bo Lei
Abstract
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.