TY - JOUR
KW - Female
KW - Humans
KW - Aged
KW - Male
KW - Treatment Outcome
KW - Aged, 80 and over
KW - Administration, Intravenous
KW - Fibrinolytic Agents/ administration & dosage
KW - Tissue Plasminogen Activator/ administration & dosage
KW - Internationality
KW - Stroke/ diagnosis/ drug therapy/epidemiology
AU - Sandercock P.
AU - Cohen G.
AU - Lindley R.
AU - Wardlaw J.
AU - Broderick J.
AU - Yeatts S.
AU - Khatri P.
AU - Tayama D.
AB - <p>
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.-->
</p>

AD - 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.<br/>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.).
AN - 26106113
BT - Stroke
DP - NLM
ET - 2015/06/25
LA - eng
LB - AUS<br/>PDO<br/>FY16
M1 - 8
N1 - Khatri, Pooja<br/>Tayama, Darren<br/>Cohen, Geoff<br/>Lindley, Richard I<br/>Wardlaw, Joanna M<br/>Yeatts, Sharon D<br/>Broderick, Joseph P<br/>Sandercock, Peter<br/>PRISMS and IST-3 Collaborative Groups<br/>Medical Research Council/United Kingdom<br/>Clinical Trial, Phase III<br/>Multicenter Study<br/>Randomized Controlled Trial<br/>Research Support, Non-U.S. Gov't<br/>United States<br/>Stroke. 2015 Aug;46(8):2325-7. doi: 10.1161/STROKEAHA.115.009951. Epub 2015 Jun 23.
N2 - <p>
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.-->
</p>

PY - 2015
SN - 1524-4628 (Electronic)<br/>0039-2499 (Linking)
SP - 2325
EP - 7
T2 - Stroke
TI - Effect of Intravenous Recombinant Tissue-Type Plasminogen Activator in Patients With Mild Stroke in the Third International Stroke Trial-3: Post Hoc Analysis
VL - 46
Y2 - FY16
ER -