Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke

作者：Bruce Campbell, Peter Mitchell, Leonid Churilov, Nawaf Yassi, Timothy Kleinig, Richard Dowling, Bernard Yan, Steven Bush, Helen M. Dewey, Vincent Thijs, Rebecca Scroop, Marion Simpson, Mark Brooks, Hamed Asadi, Teddy Y. Wu, Darshan Shah, Tissa Wijeratne, Timothy Ang, Ferdinand Miteff, Christopher Levi, Edrich Rodrigues, Henry Zhao, Patrick Salvaris, Carlos García-Esperón, Peter Bailey, Henry E. Rice, Laetitia de Villiers, Helen Brown, Kendal Redmond, David Leggett, John Fink, Wayne Collecutt, Andrew Wong, Claire Muller, Alan Coulthard, Ken Mitchell, John Clouston, Kate Mahady, Deborah Field, Henry Ma, Thanh G. Phan, Winston Chong, Ronil V. Chandra, Lee‐Anne Slater, Martín Krause, Timothy Harrington, Kenneth Faulder, Brendan Steinfort, Christopher F. Bladin, Gagan Sharma, Patricia Desmond, Mark Parsons, Geoffrey A. Donnan, Stephen M. Davis · 发表于：New England Journal of Medicine · 年份：2018 · DOI：10.1056/nejmoa1716405 · 被引用次数：896 · 研究领域：Acute Ischemic Stroke Management、Intracerebral and Subarachnoid Hemorrhage Research、Cerebrovascular and Carotid Artery Diseases

BACKGROUND: Intravenous infusion of alteplase is used for thrombolysis before endovascular thrombectomy for ischemic stroke. Tenecteplase, which is more fibrin-specific and has longer activity than alteplase, is given as a bolus and may increase the incidence of vascular reperfusion. METHODS: We randomly assigned patients with ischemic stroke who had occlusion of the internal carotid, basilar, or middle cerebral artery and who were eligible to undergo thrombectomy to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or alteplase (at a dose of 0.9 mg per kilogram; maximum dose, 90 mg) within 4.5 hours after symptom onset. The primary outcome was reperfusion of greater than 50% of the involved ischemic territory or an absence of retrievable thrombus at the time of the initial angiographic assessment. Noninferiority of tenecteplase was tested, followed by superiority. Secondary outcomes included the modified Rankin scale score (on a scale from 0 [no neurologic deficit] to 6 [death]) at 90 days. Safety outcomes were death and symptomatic intracerebral hemorrhage. RESULTS: Of 202 patients enrolled, 101 were assigned to receive tenecteplase and 101 to receive alteplase. The primary outcome occurred in 22% of the patients treated with tenecteplase versus 10% of those treated with alteplase (incidence difference, 12 percentage points; 95% confidence interval [CI], 2 to 21; incidence ratio, 2.2; 95% CI, 1.1 to 4.4; P=0.002 for noninferiority;...