Department of Neurology, 105785Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.
Department of Neurology, The 903th Hospital of The People's Liberation Army, Hangzhou, China.
Int J Stroke. 2021 Feb;16(2):229-235. doi: 10.1177/1747493020925349. Epub 2020 May 23.
Eight randomized controlled trials have consistently shown that endovascular treatment plus best medical treatment improves outcome after acute anterior proximal intracranial large vessel occlusion strokes. Whether intravenous thrombolysis prior to endovascular treatment in patients with anterior circulation, large vessel occlusion is of any additional benefits remains unclear.
This study compares the safety and efficacy of direct endovascular treatment versus intravenous recombinant tissue-type plasminogen activator bridging with endovascular treatment (bridging therapy) in acute stroke patients with intracranial internal carotid artery or middle cerebral artery-M1 occlusion within 4.5 h of symptom onset.
The DEVT study is a randomized, controlled, multicenter trial with blinded outcome assessment. This trial uses a five-look group-sequential non-inferiority design. Up to 194 patients in each interim analysis will be consecutively randomized to direct endovascular treatment or bridging therapy group in 1:1 ratio over three years from about 30 hospitals in China.
The primary end-point is the proportion of independent neurological function defined as modified Rankin scale score of 0 to 2 at 90 days. The primary safety measure is symptomatic intracerebral hemorrhage at 48 h and mortality at 90 days.
ChiCTR-IOR-17013568 (www.chictr.org.cn).
八项随机对照试验一致表明，血管内治疗联合最佳药物治疗可改善急性前近端颅内大血管闭塞性卒中患者的预后。在血管内治疗前对前循环、大血管闭塞患者进行静脉溶栓治疗是否有额外获益尚不清楚。
本研究比较了在症状发作 4.5 小时内颅内颈内动脉或大脑中动脉-M1 闭塞的急性卒中患者中直接血管内治疗与静脉重组组织型纤溶酶原激活物桥接血管内治疗（桥接治疗）的安全性和疗效。
DEVT 研究是一项随机、对照、多中心试验，采用盲法结局评估。该试验采用五组序贯非劣效性设计。在三年内，将来自中国约 30 家医院的连续患者按 1:1 的比例随机分为直接血管内治疗组或桥接治疗组。
主要终点为 90 天时独立神经功能的比例，定义为改良Rankin 量表评分 0-2 分。主要安全性指标为 48 小时内症状性脑出血和 90 天死亡率。
ChiCTR-IOR-17013568（www.chictr.org.cn）。
