Journal article
Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke
The New England journal of medicine, Vol.368(10), pp.893-903
2013
DOI: 10.1056/NEJMoa1214300
PMCID: PMC3651875
PMID: 23390923
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. opens in new tab.)
Details
- Title: Subtitle
- Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke
- Creators
- Joseph P BRODERICK - Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, United StatesYuko Y PALESCH - Department of Public Health Sciences, Medical University of South Carolina, Charleston, United StatesRüdiger von Kummer - Department of Neuroradiology, Dresden University Stroke Center, University Hospital, Dresden, GermanyCarlos A MOLINA - Neurovascular Unit, Department of Neurology, Hospital Universitari Vail d'Hebron, Barcelona, SpainBart M DEMAERSCHALK - Department of Neurology, Mayo Clinic, Phoenix, AZ, United StatesRonald BUDZIK - OhioHealth Neuroscience Institute, Riverside Methodist Hospital, Columbus, OH, United StatesWayne M CLARK - Oregon Stroke Center, Oregon Health and Science University, Portland, United StatesOsama O ZAIDAT - Department of Radiology, Medical College of Wisconsin, Milwaukee, United StatesTim W MALISCH - Alexian Brothers Medical Center, Elk Grove Village, IL, United StatesMayank GOYAL - Seaman Family Magnetic Resonance Research Centre, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, CanadaWouter J SCHONEWILLE - Department of Neurology, University Medical Center Utrecht and the Rudolph Magnus Institute of Neurosciences, Utrecht, NetherlandsMikael MAZIGHI - Department of Neurology and Stroke Center, Bichat University Hospital, Paris, FranceAndrew M DEMCHUK - Seaman Family Magnetic Resonance Research Centre, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, CanadaStefan T ENGELTER - Department of Neurology, Basel University Hospital, Basel, SwitzerlandCraig ANDERSON - George Institute for Global Health, Royal Prince Alfred Hospital, University of Sydney, Sydney, CanadaJudith SPILKER - Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, United StatesJanice CARROZZELLA - Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, United StatesKarla J RYCKBORST - Seaman Family Magnetic Resonance Research Centre, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, CanadaL. Scott JANIS - National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, United StatesRenée H MARTIN - Department of Public Health Sciences, Medical University of South Carolina, Charleston, United StatesLydia D FOSTER - Department of Public Health Sciences, Medical University of South Carolina, Charleston, United StatesThomas A TOMSICK - Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, United StatesSharon D YEATTS - Department of Public Health Sciences, Medical University of South Carolina, Charleston, United StatesPooja KHATRI - Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, United StatesMichael D HILL - Seaman Family Magnetic Resonance Research Centre, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, CanadaEdward C JAUCH - Division of Emergency Medicine, Medical University of South Carolina, Charleston, United StatesTudor G JOVIN - Stroke Institute, University of Pittsburgh Medical Center, Pittsburgh, United StatesBernard YAN - Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, AustraliaFrank L SILVER - University of Toronto, Department of Medicine, Division of Neurology and the University Health Network, Toronto, CanadaInterventional Management of Stroke (IMS) III Investigators
- Contributors
- Colin P Derdeyn (Contributor) - University of Iowa, Radiology
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.368(10), pp.893-903
- Publisher
- Massachusetts Medical Society; Waltham, MA
- DOI
- 10.1056/NEJMoa1214300
- PMID
- 23390923
- PMCID
- PMC3651875
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Language
- English
- Date published
- 2013
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984020756202771
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