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From the Department of Neurology, College of Physicians and Surgeons, Columbia University, and the Columbia-Presbyterian Medical Center of New York Presbyterian Hospital, New York, NY (M.S.V.E., S.P.); New York State Psychiatric Institute, New York, NY (J.P.); Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA (W.K.); Department of Neurology, Des Moines University Medical School, Des Moines, IA (M.J.); and Department of Neurology and Public Health Sciences, University of Virginia Health System, Charlottesville, VA (K.C.J.).
Address correspondence and reprint requests to Dr. Mitchell S. Elkind, Columbia University, 710 West 168 St., New York, NY 10032; e-mail: mse13{at}columbia.edu
Objective: To determine the association between sex and functional outcomes after thrombolytic treatment for acute ischemic stroke in the context of a clinical trial.
Methods: We analyzed predictors of outcome among patients treated with recombinant tissue plasminogen activator (rtPA) in the Glycine Antagonist in Neuroprotection for Patients with Acute Stroke Americas trial, a multicenter, randomized, double-blind, placebo-controlled study of a putative neuroprotectant.
Results: Among 1,367 trial patients, 333 (24%) were treated with rtPA within 3 hours. The proportion of patients achieving good functional outcomes at 3 months differed by sex (47.5% of men vs 30.3% of women had Barthel Index [BI] 
95; 32.2% of men vs 23.4% of women had modified Rankin Score [mRS] 
1). NIH Stroke Score was similar by sex. Men were more likely to have good functional outcomes after adjusting for relevant covariates: for BI 95, adjusted odds ratio (OR) 3.28 (1.74 to 6.17); for mRS 1, adjusted OR 2.12 (1.11 to 4.03). Survival was worse among men: adjusted OR 0.45 (0.20 to 1.01). Other predictors of functional outcomes included age, stroke side, severity, complications, and infections.
Conclusions: Among tissue plasminogen activator-treated patients in this clinical trial population, men were approximately three times as likely to have good functional outcomes, despite elevated mortality. Thrombolysis for stroke may not reverse the tendency for women to have worse functional outcomes after stroke.
*A complete list of the GAIN Investigators can be found at the end of the article cited in reference 12.
Deceased.
GlaxoSmithKline provided funding for the GAIN Americas Trial.
Disclosure: The first author had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The sponsor of the trial reviewed and approved this manuscript. The sponsor neither provided funding for this analysis nor participated in the design or conduct of this analysis or in the preparation of the manuscript. Dr. Elkind reports receiving honoraria for speaking about stroke therapy from Boehringer-Ingelheim, Inc. and BMS-Sanofi Partnership (both in excess of $10,000), and from diaDexus Inc.; and for serving as a consultant to BMS-Sanofi Partnership. Dr. Elkind also receives research support from BMS-Sanofi Partnership and diaDexus Inc. Dr. Jacoby reports receiving honoraria for speaking about stroke therapy from Genentech. Dr. Johnston reports receiving honoraria for speaking about stroke therapy from Boehringer-Ingelheim, Inc. and BMS-Sanofi Partnership, and serving as a consultant to Ono Pharma USA, Inc. and AstraZeneca.
Received May 12, 2006. Accepted in final form November 13, 2006.
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