Background and Purpose—The natural history of stroke is worse in women than in men. Controversial data have been published on the efficacy of thrombolysis with recombinant tissue plasminogen activator (rtPA) according to gender. We evaluated gender differences in the efficacy and safety outcomes of intravenous rtPA using a clinical registry and systematic review.

Methods—Since January 2002, we collected baseline characteristics and efficacy and safety outcomes for patients who received intravenous rtPA in our center. We performed a systematic PubMed literature search for previous observational studies that examined gender effects on outcomes after intravenous rtPA treatment.

Results—No gender difference in good outcome at 3 months (adjusted OR for women, 1.41; 95% CI, 0.76 to 2.60) and in 90-day mortality (adjusted OR, 1.38; 95% CI, 0.59 to 3.19) was found in our registry. We identified 16 studies that evaluated the gender effect among intravenous rtPA-treated patients. None of these studies supported a gender difference in favorable outcome, and one suggested an increased risk of mortality in men. In unadjusted partial meta-analysis in 4074 women and 5840 men including our registry data, we found a trend toward a lower risk of symptomatic intracranial hemorrhage in women (crude OR, 0.87; 95% CI, 0.68 to 1.10).

Conclusions—These results suggest no gender difference in outcome among patients treated with intravenous rtPA.