动脉内替奈普酶用于急性基底动脉闭塞取栓后充分再通：INSIST-IT随机临床试验。
完整摘要 · 中文译文
急性基底动脉闭塞（BAO）患者成功再通后辅助性动脉内替奈普酶的临床效果仍不确定。在这项前瞻性、随机、适应性富集、开放标签、盲法终点、多中心试验中，估计症状发作24小时内的BAO患者在接受血管内治疗（EVT）后实现成功再灌注，被随机（1:1）分配至动脉内替奈普酶组（n = 75）或对照组（仅接受标准药物治疗，n = 69）。主要疗效结局为90天时独立行走（改良Rankin量表0-3分）；主要安全性结局为症状性颅内出血（sICH）。根据数据安全与监查委员会的建议，该试验因安全性担忧和缺乏疗效而提前终止。在144例随机患者中，143例（99.3%）完成了随访。在90天时，替奈普酶组40.0%的患者实现独立行走，而对照组为50.0%（OR 0.67；95% CI 0.34-1.29；P = 0.23）。sICH发生率分别为6.2%和4.8%（OR 1.31；95% CI 0.28-6.89；P = 0.73）。90天时全因死亡率分别为41.3%和26.5%（OR 1.96；95% CI 0.97-4.03；P = 0.063）。在这项提前终止的试验中，辅助性动脉内替奈普酶未能改善BAO患者的功能结局。
完整摘要 · 英文原文
The clinical effect of adjunctive intra-arterial tenecteplase after successful recanalization in acute basilar artery occlusion (BAO) remains uncertain. In this prospective, randomized, adaptive-enrichment, open label, blinded-end point, multi-center trial, patients with BAO within 24 h of estimated symptom onset who achieved successful reperfusion after endovascular treatment (EVT) were randomized (1:1) to intra-arterial tenecteplase (n = 75) or control (only received standard medical therapy, n = 69). The primary efficacy outcome was independent ambulation (modified Rankin Scale 0-3) at 90 days; the primary safety outcome was symptomatic intracranial hemorrhage (sICH). The trial was stopped early due to safety concerns and lack of efficacy per Data Safety and Monitoring Committee recommendation. Among 144 randomized patients, 143 (99.3%) completed follow-up. At 90 days, independent ambulation was achieved in 40.0% of the tenecteplase group versus 50.0% in the control group (OR 0.67; 95% CI 0.34-1.29; P = 0.23). sICH occurred in 6.2% versus 4.8% (OR 1.31; 95% CI 0.28-6.89; P = 0.73). All-cause mortality at 90 days was 41.3% versus 26.5% (OR 1.96; 95% CI 0.97-4.03; P = 0.063). In this prematurely terminated trial, adjunctive intra-arterial tenecteplase did not improve functional outcomes in patients with BAO.