Additional outcomes and subgroup analyses of NXY-059 for acute ischemic stroke in the SAINT I trial

Kennedy R. Lees, Antonio Davalos, Stephen M. Davis, Hans Christoph Diener, James Grotta, Patrick Lyden, Ashfaq Shuaib, Tim Ashwood, Hans Goran Hardemark, Warren Wasiewski, Ugochi Emeribe, Justin A. Zivin

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    46 Citations (Scopus)

    Abstract

    BACKGROUND AND PURPOSE - NXY-059 is a free radical-trapping neuroprotectant demonstrated to reduce disability from ischemic stroke. We conducted analyses on additional end points and sensitivity analyses to confirm our findings. METHODS - We randomized 1722 patients with acute ischemic stroke to a 72-hour infusion of placebo or intravenous NXY-059 within 6 hours of stroke onset. The primary outcome was disability at 90 days, as measured by the modified Rankin Scale (mRS), a 6-point scale ranging from 0 (no residual symptoms) to 5 (bed-bound, requiring constant care). Additional and exploratory analyses included mRS at 7 and 30 days; subgroup interactions with final mRS; assessments of activities of daily living by Barthel index; and National Institutes of Health Stroke Scale (NIHSS) neurological scores at 7 and 90 days. RESULTS - NXY-059 significantly improved the distribution of the mRS disability score compared with placebo at 7, 30, and 90 days (Cochran-Mantel-Haenszel test P=0.002, 0.004, 0.038, respectively; 90-day common odds ratio 1.20; 95% CI, 1.01 to 1.42). The benefit was not attributable to any specific baseline characteristic, stratification variable or subgroup interaction. Neurological scores were improved at 7 days (odds ratio [OR], 1.46; 95% CI, 1.13, 1.89; P=0.003) and the Barthel index was improved at 7 and 30 days (OR, 1.55; 95% CI, 1.22, 1.98; P<0.0001; OR, 1.27; 95% CI, 1.01, 1.59; P=0.02). CONCLUSIONS - NXY-059 within 6 hours of acute ischemic stroke significantly reduced disability. Benefit on neurological scores and activities of daily living was detectable early but not significant at 90 days; however, our trial was underpowered to measure effects on the neurological examination. The benefit on disability is not confounded by interactions and is supported by other outcome measures. © 2006 American Heart Association, Inc.
    Original languageEnglish
    Pages (from-to)2970-2978
    JournalStroke
    Volume37
    Issue number12
    DOIs
    Publication statusPublished - 1 Jan 2006

    Keywords

    • Acute care
    • Drug trials
    • Free radicals
    • Ischemia
    • Neuroprotection
    • NXY-059

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