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Stroke. 2015 May;46(5):1321-7. doi: 10.1161/STROKEAHA.115.009180. Epub 2015 Apr 9.

Twelve-Month Clinical and Quality-of-Life Outcomes in the Interventional Management of Stroke III Trial.

Author information

1
From the Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati (J.P.B., P.K., J.S., J.C., T.A.T.); Department of Public Health Sciences (Y.Y.P., S.D.Y., L.D.F., A.S., K.N.S.) and Division of Emergency Medicine (E.C.J.), Medical University of South Carolina, Charleston; Calgary Stroke Program, Seaman Family MR Research Centre, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada (A.M.D., M.D.H., M.G., K.J.R.); Stroke Institute, University of Pittsburgh Medical Center, Pittsburgh (T.G.J.); Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia (B.Y.); Department of Neuroradiology, Dresden University Stroke Center, University Hospital, Dresden, Germany (R.v.K.); Neurovascular Unit, Department of Neurology, Hospital Universitari Vall d'Hebron, Barcelona (C.A.M.); Department of Neurology, University Medical Center Utrecht and the Rudolph Magnus Institute of Neurosciences, Utrecht, the Netherlands, and the St. Antonius Hospital, Nieuwegein, the Netherlands (W.J.S.); Department of Neurology and Stroke Center, Lariboisière Hospital, Paris (M.M.); Department of Neurology, Basel University Hospital, Basel, Switzerland (S.T.E.); George Institute for Global Health, Royal Prince Alfred Hospital, University of Sydney, Sydney (C.A.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.).
2
From the Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati (J.P.B., P.K., J.S., J.C., T.A.T.); Department of Public Health Sciences (Y.Y.P., S.D.Y., L.D.F., A.S., K.N.S.) and Division of Emergency Medicine (E.C.J.), Medical University of South Carolina, Charleston; Calgary Stroke Program, Seaman Family MR Research Centre, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada (A.M.D., M.D.H., M.G., K.J.R.); Stroke Institute, University of Pittsburgh Medical Center, Pittsburgh (T.G.J.); Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia (B.Y.); Department of Neuroradiology, Dresden University Stroke Center, University Hospital, Dresden, Germany (R.v.K.); Neurovascular Unit, Department of Neurology, Hospital Universitari Vall d'Hebron, Barcelona (C.A.M.); Department of Neurology, University Medical Center Utrecht and the Rudolph Magnus Institute of Neurosciences, Utrecht, the Netherlands, and the St. Antonius Hospital, Nieuwegein, the Netherlands (W.J.S.); Department of Neurology and Stroke Center, Lariboisière Hospital, Paris (M.M.); Department of Neurology, Basel University Hospital, Basel, Switzerland (S.T.E.); George Institute for Global Health, Royal Prince Alfred Hospital, University of Sydney, Sydney (C.A.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.). joseph.broderick@uc.edu.

Abstract

BACKGROUND AND PURPOSE:

Randomized trials have indicated a benefit for endovascular therapy in appropriately selected stroke patients at 3 months, but data regarding outcomes at 12 months are currently lacking.

METHODS:

We compared functional and quality-of-life outcomes at 12 months overall and by stroke severity in stroke patients treated with intravenous tissue-type plasminogen activator followed by endovascular treatment as compared with intravenous tissue-type plasminogen activator alone in the Interventional Management of Stroke III Trial. The key outcome measures were a modified Rankin Scale score ≤2 (functional independence) and the Euro-QoL EQ-5D, a health-related quality-of-life measure.

RESULTS:

656 subjects with moderate-to-severe stroke (National Institutes of Health Stroke Scale ≥8) were enrolled at 58 centers in the United States (41 sites), Canada (7), Australia (4), and Europe (6). There was an interaction between treatment group and stroke severity in the repeated measures analysis of modified Rankin Scale ≤2 outcome (P=0.039). In the 204 participants with severe stroke (National Institutes of Health Stroke Scale ≥20), a greater proportion of the endovascular group had a modified Rankin Scale ≤2 (32.5%) at 12 months as compared with the intravenous tissue-type plasminogen activator group (18.6%, P=0.037); no difference was seen for the 452 participants with moderately severe strokes (55.6% versus 57.7%). In participants with severe stroke, the endovascular group had 35.2 (95% confidence interval: 2.1, 73.3) more quality-adjusted-days over 12 months as compared with intravenous tissue-type plasminogen activator alone.

CONCLUSIONS:

Endovascular therapy improves functional outcome and health-related quality-of-life at 12 months after severe ischemic stroke.

CLINICAL TRIAL REGISTRATION:

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359424.

KEYWORDS:

acute stroke; endovascular procedures; randomized trial; tPA

PMID:
25858239
PMCID:
PMC4414900
DOI:
10.1161/STROKEAHA.115.009180
[Indexed for MEDLINE]
Free PMC Article

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