Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 368, Issue 10, Pages 893-903Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1214300
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Funding
- National Institutes of Health
- National Institute of Neurological Disorders and Stroke [UC U01NS052220, MUSC U01NS054630, U01NS077304]
- Genentech
- EKOS
- Concentric Medical
- Cordis Neurovascular
- Boehringer Ingelheim
- Oakstone Publishing
- BrainsGate
- Edge Therapeutics
- Covidien
- Penumbra
- Janssen Pharmaceuticals
- Medical Dialogues
- Vernalis Group
- Hoffmann-La Roche Canada
- Servier Canada
- Bristol-Myers Squibb Canada
- Heart and Stroke Foundation of Alberta, Northwest Territories, and Nunavut
- Alberta Innovates-Health Solutions
- Silk Road Medical
- Boehringer Ingelheim Canada
- Lundbeck
- GE Healthcare
- Photo-Thera
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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.)
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