急性缺血性卒中取栓术中动脉内使用替奈普酶：BRETIS-TNK2试验。
完整摘要 · 中文译文
血管内治疗（EVT）期间动脉内给予替奈普酶可能提高首过再通率并溶解微循环血栓，但其疗效和安全性尚不确定。我们假设该策略较单纯EVT能改善功能结局。本项3期、随机、适应性富集、开放标签、盲法终点的多中心研究旨在评估动脉内替奈普酶是否能改善急性缺血性卒中患者的临床结局。症状发作24小时内适合EVT的大血管闭塞患者被随机（1:1）分配至在EVT期间接受动脉内替奈普酶的替奈普酶组或仅接受EVT的对照组。主要终点为良好功能结局。在380例随机患者中（替奈普酶组192例，对照组188例），分别有190例和186例患者可获得主要结局数据。替奈普酶组40.0%的患者 versus 对照组46.8%的患者出现90天良好功能结局（改良Rankin量表0-2分）（未校正比值比0.76，[95% CI 0.50-1.14]，P = 0.19）。本研究表明，在该人群中，血栓切除术期间动脉内给予替奈普酶并未改善90天功能结局。（由国家科技重大专项和医院发起基金资助；ClinicalTrials.gov注册号：NCT05657444）。
完整摘要 · 英文原文
Intra-arterial tenecteplase during endovascular treatment (EVT) may increase first-pass recanalization and dissolve microcirculatory thrombi, but its efficacy and safety are uncertain. We hypothesised that this strategy would improve functional outcomes versus EVT alone. This phase 3, randomised, adaptive-enrichment, open-label, blinded-endpoint multicentre study aims to evaluate whether intra‑arterial tenecteplase improves clinical outcomes for patients with acute ischemic stroke. Patients with large‑vessel occlusion eligible for EVT within 24 hours of symptom onset were randomly assigned (1:1) to the tenecteplase group receiving intra‑arterial tenecteplase during EVT or the control group receiving EVT alone. The primary endpoint was favorable functional outcome. Of 380 randomised patients (192 in the tenecteplase group and 188 in the control group), primary outcome data were available for 190 and 186 patients, respectively. Favorable 90-day functional outcomes (modified Rankin Scale 0-2) occurred in 40.0% of the tenecteplase group versus 46.8% of the control group (unadjusted odds ratio 0.76, [95% CI 0.50-1.14], P = 0.19). This work suggests intra-arterial tenecteplase during thrombectomy did not improve 90-day functional outcomes in this population. (Funded by National Science and Technology Major Project and hospital-initiated grants; ClinicalTrials.gov registration: NCT05657444).