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

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.

• Authors: 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, 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, Qingwu Yang
• Journal: JAMA (JAMA) Vol. 328 Issue 6 Pg. 543-553 (08 09 2022) ISSN: 1538-3598 [Electronic] United States
• PMID: 35943471 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Platelet Aggregation Inhibitors
• Tirofiban

Topics

• Administration, Intravenous
• Aged
• Arterial Occlusive Diseases (complications, drug therapy, surgery)
• Brain Ischemia (drug therapy, etiology, surgery)
• Double-Blind Method
• Endovascular Procedures (methods)
• Female
• Humans
• Intracranial Hemorrhages (chemically induced)
• Ischemic Stroke (drug therapy, etiology, surgery)
• Male
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Stroke (drug therapy, etiology, surgery)
• Thrombectomy (methods)
• Tirofiban (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome