期刊
STROKE
卷 46, 期 8, 页码 2325-2327出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1161/STROKEAHA.115.009951
关键词
clinical trials; stroke; thrombolytic therapy
资金
- Medical Research Council, Stroke Association
- Health Foundation
- Research Council of Norway
- Arbetsmarknadens forsakringsbolag Insurances (Sweden)
- Swedish Heart Lung Fund
- Chest Heart Stroke Scotland
- UK Medical Research Council
- UK Age UK
- UK Row Fogo Charitable Trust
- Scottish Funding Council
- Foundation of Marianne and Marcus Wallenberg
- Karolinska Institute
- Government of Poland
- Australian Heart Foundation
- Australian National Health and Medical Research Council (NHMRC)
- Swiss National Research Foundation
- Swiss Heart Foundation
- Foundation for health and cardio-/neurovascular research, Basel, Switzerland
- Assessorato alla Sanita
- Regione dell'Umbria
- Genentech, Inc.
- MRC [G0400069] Funding Source: UKRI
- Medical Research Council [G0400069] Funding Source: researchfish
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.
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