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Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke.
Broderick, Joseph P. M.D.; Palesch, Yuko Y. Ph.D.; Demchuk, Andrew M. M.D.; Yeatts, Sharon D. Ph.D.; Khatri, Pooja M.D.; Hill, Michael D. M.D.; Jauch, Edward C. M.D.; Jovin, Tudor G. M.D.; Yan, Bernard M.D.; Silver, Frank L. M.D.; von Kummer, Rudiger M.D.; Molina, Carlos A. M.D.; Demaerschalk, Bart M. M.D.; Budzik, Ronald M.D.; Clark, Wayne M. M.D.; Zaidat, Osama O. M.D.; Malisch, Tim W. M.D.; Goyal, Mayank M.D.; Schonewille, Wouter J. M.D.; Mazighi, Mikael M.D., Ph.D.; Engelter, Stefan T. M.D.; Anderson, Craig M.D., Ph.D.; Spilker, Judith R.N., B.S.N.; Carrozzella, Janice R.N., B.A., R.T.(R.); Ryckborst, Karla J. R.N., B.N.; Janis, Scott L. Ph.D.; Martin, Renee H. Ph.D.; Foster, Lydia D. M.S.; Tomsick, Thomas A. M.D.; the Interventional Management of Stroke (IMS) III Investigators
[Article] New England Journal of Medicine. 368(10):893-903, March 7, 2013.

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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 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).

CONCLUSIONS: The 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.)