中国RESCUE BT试验研究组比较了血管内取栓前静脉注射替罗非班与安慰剂对大血管闭塞性卒中功能预后的影响。2022年8月9日出版的《美国医学会杂志》发表了这项成果。

替罗非班是糖蛋白IIb/IIIa受体的高选择性非肽拮抗剂，能可逆抑制血小板聚集。静脉注射替罗非班是否能有效改善接受血管内血栓切除术的大血管闭塞缺血性卒中患者的功能预后仍不确定。

为了评估血管内血栓切除术前静脉注射替罗非班治疗大血管闭塞继发急性缺血性卒中的疗效和不良事件，研究组在中国55家医院进行了这项研究者发起、随机、双盲、安慰剂对照试验，纳入了948名最近24小时内出现近端颅内大血管闭塞的中风患者。2018年10月10日至2021年10月31日进行招募，最终随访时间为2022年1月15日。

将参与者随机分组，在血管内血栓切除术之前，463名接受静脉注射替罗非班，485名接受安慰剂治疗。主要结局是90天时的残疾水平，通过0（无症状）到6（死亡）的改良Rankin量表评分的总体分布来衡量。主要安全性结局是48小时内症状性颅内出血的发生率。

948名随机患者的平均年龄为67岁，391名为女性（41.2%），948名（100%）均完成了试验。替罗非班组与安慰剂组的90天改良Rankin评分中位数（IQR）分别均为3分。与安慰剂组相比，替罗非班组残疾程度较低的校正后共同优势比为1.08。替罗非班组症状性颅内出血的发生率为9.7%，安慰剂组为6.4%，差异为3.3%。

研究结果表明，对于接受血管内血栓切除术的大血管闭塞急性缺血性卒中患者，与安慰剂相比，血管内治疗前静脉注射替罗非班的患者在90天时残疾严重程度无显著差异。研究结果不支持在急性缺血性卒中血管内血栓切除术前静脉注射替罗非班。

附：英文原文

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

Author: 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, Bin Li, Ning Wang, Jun Sun, Yong Liang, Zongqin Li, Xuejie Xu, Kangjia Song, Zeyu Hao, Chuanqing Yu, Xiaofei Zhou, Jing Zuo, Wenbin Wu, Xiyang Chen, Yaoyu Tian, Xiaogang Hu, Liang Wei, Xiuhua Wu, De’an 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, Yupeng 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, Dong Yi

Issue&Volume: 2022/08/09

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.

DOI: 10.1001/jama.2022.12584

Source: https://jamanetwork.com/journals/jama/article-abstract/2795027