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Stroke. 2015 Aug;46(8):2325-7. doi: 10.1161/STROKEAHA.115.009951. Epub 2015 Jun 23.

Effect of Intravenous Recombinant Tissue-Type Plasminogen Activator in Patients With Mild Stroke in the Third International Stroke Trial-3: Post Hoc Analysis.

Author information

1
From the Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K., J.P.B.); Genentech, Inc, South San Francisco, CA (D.T.); Division of Clinical Neurosciences (G.C., P.S.), and Division of Neuroimaging Sciences (J.M.W.), University of Edinburgh, Edinburgh, Scotland; Neurological and Mental Health Division, The George Institute for Global Health, University of Sydney, Sydney, Australia (R.I.L.); and Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y.). pooja.khatri@uc.edu.
2
From the Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (P.K., J.P.B.); Genentech, Inc, South San Francisco, CA (D.T.); Division of Clinical Neurosciences (G.C., P.S.), and Division of Neuroimaging Sciences (J.M.W.), University of Edinburgh, Edinburgh, Scotland; Neurological and Mental Health Division, The George Institute for Global Health, University of Sydney, Sydney, Australia (R.I.L.); and Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y.).

Abstract

BACKGROUND AND PURPOSE:

Randomized trial evidence on the risk/benefit ratio of thrombolysis for mild stroke is limited. We sought to determine the efficacy of intravenous recombinant tissue-type plasminogen activator (IV r-tPA) in a subset of patients with mild deficit in the third International Stroke Trial (IST-3).

METHODS:

IST-3 compared IV r-tPA with control within 6 hours of onset in patients for whom IV r-tPA was considered promising but unproven. Analysis was restricted to subjects randomized within 3 hours of onset with a baseline National Institutes of Health Stroke Scale ≤5, pretreatment blood pressure <185/110, and no other r-tPA exclusion criteria. We compared r-tPA and control arms for primary (Oxfordshire Handicap Score [OHS] 0-2) and secondary (ordinal OHS and OHS 0-1) outcomes at 6 months.

RESULTS:

Among 3035 IST-3 subjects, 612 (20.2%) had an National Institutes of Health Stroke Scale ≤5; of these 106 (17.6%) met the restricted criteria. Allocation to r-tPA was associated with an increase in OHS 0 to 2 (84% r-tPA versus 65% control; adjusted odds ratio, 3.31; 95% confidence interval, 1.24-8.79) and a favorable shift in OHS distribution (adjusted odds ratio, 2.38; 95% confidence interval, 1.17-4.85). There was no significant effect of r-tPA on OHS 0 to 1 (60% versus 51%; adjusted odds ratio, 1.92; 95% confidence interval, 0.83-4.43).

CONCLUSIONS:

This post hoc analysis in a highly selected sample of IST-3 supports the rationale of A Study of the Efficacy and Safety of Activase (Alteplase) in Patients With Mild Stroke (PRISMS) trial-a randomized, phase IIIb study to evaluate IV r-tPA in mild ischemic stroke.

KEYWORDS:

clinical trials; stroke; thrombolytic therapy

PMID:
26106113
DOI:
10.1161/STROKEAHA.115.009951
[Indexed for MEDLINE]

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