HealthDay News — Endovascular treatment (EVT) alone is neither superior nor noninferior to intravenous alteplase followed by EVT in a cohort of European patients with stroke, according to a study published in the Nov. 11 issue of the New England Journal of Medicine.
Natalie E. LeCouffe, M.D., from the University of Amsterdam, and colleagues performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT. Overall, 539 patients were randomly assigned to receive EVT alone or intravenous alteplase followed by EVT (standard of care) in a 1:1 ratio.
The researchers found that the median score on the modified Rankin scale at 90 days was 3 and 2 with EVT alone and alteplase plus EVT, respectively, for an adjusted common odds ratio of 0.84 (95 percent confidence interval [CI], 0.62 to 1.15; P = 0.28), which demonstrated neither superiority nor noninferiority of EVT alone. Mortality was 20.5 and 15.8 percent for EVT alone and alteplase plus EVT, respectively (adjusted odds ratio, 1.39; 95 percent CI, 0.84 to 2.30), and symptomatic intracerebral hemorrhage occurred in 5.9 and 5.3 percent, respectively (adjusted odds ratio, 1.30; 95 percent CI, 0.60 to 2.81).
“In contrast to some previous trials involving Asian patients with anterior-circulation stroke, we did not find that EVT alone was noninferior or superior to intravenous alteplase combined with EVT with regard to functional outcome at 90 days,” the authors write.
Several authors disclosed financial ties to pharmaceutical and medical device companies, including Stryker, Medtronic, and Cerenovus, which funded the study. The author of the editorial disclosed ties to Alexion Pharma.