Author(s): Hemmen TM, Rapp KS, Emond JA, Raman R, Lyden PD
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Abstract BACKGROUND: In 1995 two studies by the National Institute of Neurological Disorders and Stroke (NINDS) proved that intravenous tissue plasminogen activator (t-PA) was superior to placebo in patients with stroke of less than 3 hours' duration. The recently published European Cooperative Acute Stroke Study (ECASS) III introduced new patient selection criteria and treatment between 3 and 4.5 hours. Using these criteria, t-PA was shown effective at the later time window. Both analyses used the 3-month modified Rankin scale (mRS) score as main primary outcome. We sought to study the effect of applying the ECASS III selection criteria to the original NINDS cohort. METHODS: We analyzed the subgroup of patients from NINDS sample who matched the ECASSS III criteria. We examined 3-month outcomes adjusted and unadjusted for confounding factors. RESULTS: The NINDS t-PA study included 624 patients. A total of 200 in the t-PA-treated group and 199 in the placebo group were selected after applying ECASS III criteria. Of these selected patients, 52\% in the t-PA group versus 31\% had mRS score of 0 or 1 at 3 months (P < .001). The unadjusted odds ratio for t-PA treatment versus placebo on day-90 mRS score 0 to 1 versus 2 to 6 was 2.45 (95\% confidence interval: 1.63-3.69). When adjusted for baseline National Institutes of Health Stroke Scale score, smoking status, time to treatment, and history of hypertension, the odds ratio was 2.14 (95\% confidence interval: 1.34-3.41) (P < .001). CONCLUSION: Using the ECASS III criteria in patients treated in less than 3 hours, 52\% of t-PA-treated patients had a favorable outcome at 3 months. Copyright (c) 2010 National Stroke Association. Published by Elsevier Inc. All rights reserved.
This article was published in J Stroke Cerebrovasc Dis
and referenced in Journal of Addiction Research & Therapy