Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke

作者：Joseph P. Broderick, Yuko Y. Palesch, Andrew M. Demchuk, Sharon D. Yeatts, Pooja Khatri, Michael D. Hill, Edward C. Jauch, Tudor G. Jovin, Bernard Yan, Frank L. Silver, Rüdiger von Kummer, Carlos A. Molina, Bart M. Demaerschalk, Ronald F. Budzik, Wayne M. Clark, Osama O. Zaidat, Tim W. Malisch, Mayank Goyal, Wouter J. Schonewille, Mikaël Mazighi, Stefan T. Engelter, Craig S. Anderson, Judith Spilker, Janice Carrozzella, Karla J. Ryckborst, L. Scott Janis, Renée H. Martin, Lydia D. Foster, Thomas A. Tomsick · 发表于：New England Journal of Medicine · 年份：2013 · DOI：10.1056/nejmoa1214300 · 被引用次数：1819 · 研究领域：Acute Ischemic Stroke Management、Protease and Inhibitor Mechanisms、Blood Coagulation and Thrombosis Mechanisms

BACKGROUND: Endovascular therapy is increasingly used after the administration of intravenous tissue plasminogen activator (t-PA) for patients with moderate-to-severe acute ischemic stroke, but whether a combined approach is more effective than intravenous t-PA alone is uncertain. METHODS: We randomly assigned eligible patients who had received intravenous t-PA within 3 hours after symptom onset to receive additional endovascular therapy or intravenous t-PA alone, in a 2:1 ratio. The primary outcome measure was a modified Rankin scale score of 2 or less (indicating functional independence) at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). RESULTS: The study was stopped early because of futility after 656 participants had undergone randomization (434 patients to endovascular therapy and 222 to intravenous t-PA alone). The proportion of participants with a modified Rankin score of 2 or less at 90 days did not differ significantly according to treatment (40.8% with endovascular therapy and 38.7% with intravenous t-PA; absolute adjusted difference, 1.5 percentage points; 95% confidence interval [CI], -6.1 to 9.1, with adjustment for the National Institutes of Health Stroke Scale [NIHSS] score [8-19, indicating moderately severe stroke, or ≥20, indicating severe stroke]), nor were there significant differences for the predefined subgroups of patients with an NIHSS score of 20 or higher (6.8 percentage points; 95% CI, -4.4 to 18.1) and those w...