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Background and Purpose— Women are more likely to have a worse outcome after an acute stroke than men. Some studies have suggested that women also benefit less from intravenous thrombolysis after an acute ischemic stroke, but others found no sex differences in safety and efficacy. We aimed to evaluate differences in 3-month outcome between sexes in intravenous tissue-type plasminogen activator–treated patients registered in the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register. Methods— A total of 45 079 patients treated with intravenous alteplase were recorded from 2002 to 2011. Main outcome measures were symptomatic intracerebral hemorrhage, functional independence (modified Rankin Scale score, 0–2), and mortality at 3 months. Results— Among 25 777 (57.2%) men and 19 302 (42.8%) women, we found no difference in the rate of symptomatic intracerebral hemorrhage ( P =0.13), a significantly higher likelihood of functional independence at 3 months in men ( P P P =0.39), whereas male sex was related to a higher risk of mortality (odds ratio, 1.19; 95% confidence interval, 1.10–1.29; P =0.00003) and symptomatic intracerebral hemorrhage (odds ratio, 1.25, 95% confidence interval, 1.04 – 1.51; P =0.02). Conclusions— Data from Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register suggest that intravenous thrombolysis may modify the observed survival and recovery advantage for men expected in the natural course of an ischemic stroke, with a possible larger beneficial treatment effect in women when compared with men.

A meta-analysis of published randomized trials performed by Kitsios et al1 failed to resolve current uncertainties regarding the optimum secondary prevention strategy against cryptogenic stroke in patients with a patent foramen ovale. The results of their analysis are enticing. All 3 individual randomized studies in their analysis exhibited major limitations that rendered their interpretation problematic. First, despite broad definitions of composite primary end points, all 3 studies were underpowered because the a priori risk estimate was far from the actual outcome incidence observed in each study. Therefore, both positive and negative results could have been because of chance. Second, the enrollment of patients with transient ischemic attacks—a diagnosis that is difficult to confirm—and the inclusion of transient …