Endovascular therapy after intravenous t-PA versus t-PA alone for stroke

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 Clark, Osama O. Zaidat, Tim W. Malisch, Mayank Goyal, Wouter J. Schonewille, Mikael MazighiStefan T. Engelter, Craig Anderson, Judith Spilker, Janice Carrozzella, Karla J. Ryckborst, L. Scott Janis, Renée H. Martin, Lydia D. Foster, Thomas A. Tomsick

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1224 Scopus citations

Abstract

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.)

Original languageEnglish (US)
Pages (from-to)893-903
Number of pages11
JournalNew England Journal of Medicine
Volume368
Issue number10
DOIs
Publication statusPublished - Mar 7 2013

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ASJC Scopus subject areas

  • Medicine(all)

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Broderick, J. P., Palesch, Y. Y., Demchuk, A. M., Yeatts, S. D., Khatri, P., Hill, M. D., ... Tomsick, T. A. (2013). Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. New England Journal of Medicine, 368(10), 893-903. https://doi.org/10.1056/NEJMoa1214300