HealthDay News — For patients with ischemic stroke with an unknown time of onset, intravenous alteplase is associated with better functional outcome than placebo, according to a study published online May 16 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the European Stroke Organisation, held from May 16 to 18 in Gothenburg, Sweden.
Götz Thomalla, MD, from the Universitätsklinikum Hamburg-Eppendorf in Germany, and colleagues randomized patients with an unknown time of stroke onset to receive intravenous alteplase (254 patients) or placebo (249 patients). Participants had an ischemic lesion visible on magnetic resonance imaging diffusion-weighted imaging, but no parenchymal hyperintensity on fluid-attenuated inversion recovery.
Due to cessation of funding after enrollment of 503 of an anticipated 800 patients, the trial was stopped early. The researchers found that 53.3 and 41.8% of the alteplase and placebo groups, respectively, had a favorable outcome at 90 days (adjusted odds ratio, 1.61). The median score on the modified Rankin scale at 90 days was 1 and 2 in the alteplase and placebo groups, respectively (adjusted common odds ratio, 1.62). Deaths occurred in 4.1 and 1.2% of the alteplase and placebo groups, respectively, which was not significantly different. The rate of symptomatic intracranial hemorrhage was 2.0 and 0.4% in the alteplase and placebo groups, respectively, which was not statistically significantly different.
“Intravenous thrombolysis with alteplase resulted in a better functional outcome than treatment with placebo,” the authors write.