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

Joseph Broderick, Yuko Palesch, Andrew Demchuk, Sharon Yeatts, Pooja Khatri, Michael Hill, Edward Jauch, Tudor Jovin, B Yan, Frank Silver, Rudiger Von Kummer, Carlos Molina, Bart Demaerschalk, Ronald Budzik, Wayne Clark, Osama Zaidat, Timothy Malisch, Mayank Goyal, Wouter Schonewille, Mikael MazighiStefan Engelter, Craig Anderson, Judith Spilker, Janice Carrozzella, Karla Ryckborst, L Janis, Renee Martin, Lydia Foster, Thomas Tomsick

    Research output: Contribution to journalArticlepeer-review

    1281 Citations (Scopus)

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

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