• 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 Budzik, Wayne M Clark, Osama O Zaidat, Tim W Malisch, Mayank Goyal, Wouter J Schonewille, Mikael Mazighi, Stefan T Engelter, Craig Anderson, Judith Spilker, Janice Carrozzella, Karla J Ryckborst, L Scott Janis, Renée H Martin, Lydia D Foster, Thomas A Tomsick, and Interventional Management of Stroke (IMS) III Investigators.
• Department of Neurology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, OH 45267-0525, USA. joseph.broderick@uc.edu.
• N. Engl. J. Med.. 2013 Mar 7;368(10):893-903.

BackgroundEndovascular 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.MethodsWe 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).ResultsThe 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 with a score of 19 or lower (-1.0 percentage point; 95% CI, -10.8 to 8.8). Findings in the endovascular-therapy and intravenous t-PA groups were similar for mortality at 90 days (19.1% and 21.6%, respectively; P=0.52) and the proportion of patients with symptomatic intracerebral hemorrhage within 30 hours after initiation of t-PA (6.2% and 5.9%, respectively; P=0.83).ConclusionsThe trial showed similar safety outcomes and no significant difference in functional independence with endovascular therapy after intravenous t-PA, as compared with intravenous t-PA alone. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00359424.).

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