Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke The RESCUE BT Randomized Clinical Trial
Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke The RESCUE BT Randomized Clinical Trial
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血管内血栓切除术前静脉注射替罗非班与安慰剂对大血管闭塞性中风功能结果的影响：RESCUE BT 随机临床试验
DOI：
10.1001/jama.2022.12584
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发表时间：
2022-08-09
影响因子：
120.7
通讯作者：
Yang, Qingwu
中科院分区：
文献类型：
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作者：
Qiu, Zhongming;Li, Fengli;Yang, Qingwu
重要性 替罗非班是一种高度选择性的糖蛋白 IIb/IIIa 受体非肽拮抗剂，可逆性抑制血小板聚集。目前尚不确定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性缺血性卒中患者的功能结果。 目的 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的急性缺血性卒中的疗效和不良事件。 这项双盲、安慰剂对照试验在中国 55 家医院进行，入组了 948 名在最后已知时间 24 小时内出现卒中和近端颅内大血管闭塞的患者。招募于2018年10月10日至2021年10月31日期间进行，最终随访于2022年1月15日进行。 干预措施 参与者在血管内血栓切除术之前接受静脉注射替罗非班（n = 463）或安慰剂（n = 485）。 主要结果和措施 主要结果是通过修改后的总体分布来衡量的90天残疾水平Rankin 量表分数从 0（无症状）到 6（死亡）。主要安全性结果是 48 小时内有症状的颅内出血的发生率。 结果 在随机分配的 948 名患者中（平均年龄 67 岁；391 名女性 [41.2%]），948 名患者（100%）完成了试验。替罗非班组与安慰剂组的 90 天改良 Rankin 量表评分中位数 (IQR) 分别为 3 (1-4) 和 3 (1-4)。与安慰剂相比，替罗非班组残疾程度较低的调整后常见优势比为 1.08（95% CI，0.86-1.36）。替罗非班组的症状性颅内出血发生率为 9.7%，而安慰剂组为 6.4%（差异为 3.3% [95% CI，02% 至 6,8%]）。 结论和相关性 在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中，与血管内治疗前的安慰剂相比，接受静脉替罗非班治疗 90 天时残疾严重程度没有显着差异。研究结果不支持在血管内血栓切除术之前使用静脉注射替罗非班治疗急性缺血性卒中。
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, 02% 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.