Abstract 44: DEVT: Endovascular Treatment Alone versus Intravenous Alteplase Plus Endovascular Treatment in Stroke

Abstract

Background: In large vessel occlusion strokes, it is unknown whether the potential risks and added costs associated with intravenous alteplase before mechanical thrombectomy remain justifiable. Methods: In 33 stroke centers in China, patients presenting with proximal anterior circulation intracranial occlusion strokes within 4.5 hours from onset and eligible for intravenous thrombolysis underwent 1:1 randomization mechanical thrombectomy alone (primary-thrombectomy group) or standard dose of intravenous alteplase followed by mechanical thrombectomy (bridging-therapy group). The primary endpoint was non-inferiority of functional independence at 90 days (defined as score 0-2 on the modified Rankin scale). Non-inferiority was established with a margin of -0.1. Safety outcomes included the incidence of symptomatic intracerebral hemorrhage within 48 hours and 90-day mortality. Results: The trial was stopped early because of efficacy when 234 of a planned 970 patients had undergone randomization (116 to the primary-thrombectomy and 118 to the bridging-therapy group). The primary endpoint of functional independence at 90 days was achieved by 63(54.3%) patients in the primary-thrombectomy versus 55(46.6%) in the bridging-therapy group (incidence difference, 7.7%; 95% confidence interval, -5.1% to 20.5%), indicating that primary-thrombectomy was non-inferior to bridging-therapy (Z=2.7157, P non-inferiority =0.00330). No significant between-group differences were detected in symptomatic intracerebral hemorrhage (6.1% versus 6.8%) and 90-day mortality (17.2% versus 17.8%). Conclusions: In stroke patients with proximal anterior circulation occlusions within 4.5 hours from onset, mechanical thrombectomy alone was non-inferior to intravenous alteplase followed by mechanical thrombectomy in terms of 90-day functional independence. (Funded by the Natural Science Foundation of China and others; DEVT chictr.org.cn number, ChiCTR-IOR-17013568.)