Abstract 60: Synthesis Expansion: Randomized Trial On Primary Endovascular Treatment Vs. Standard Intravenous Recombinant Tissue Plasminogen Activator For Acute Ischemic Stroke

Background: As compared with systemic i.v. thrombolytic therapy, primary endovascular treatment results in a higher rate of patency of the ischemic stroke-related cerebral artery. However, the comparative clinical efficacy of the two approaches has not been carefully studied. Methods: We randomly assigned a total of 362 patients with acute ischemic stroke seen within 4.5 h from symptoms onset to endovascular treatment (i.e., intra-arterial thrombolysis with recombinant tissue plasminogen activator - t-PA - if necessary, associated to or substituted by mechanical clot disruption and/or retrieval) or i.v. t-PA administered according to EU labeling. The purpose of the study was to determine the proportion of independent survivors at three months. Safety endpoints included symptomatic intracranial hemorrhage, death and other serious adverse events. Results: A total of 181 patients were assigned to undergo endovascular treatment, and 181 to receive i.v. t-PA. Median time from stroke onset to start to treatment was 3 h 45 min for endovascular treatment (range: 1 h 30 min to 5 h 55 min) and 2 h 45 min (range: 55 min to 4 h 30 min) for i.v. t-PA (p=0.002). All the randomized patients were assessed at 3 months and analyzed. We will present analyses comparing the effect of endovascular treatment with i.v. t-PA on a) the primary outcome (proportion of patients alive and independent at 3 months as assessed by the modified Rankin scale) adjusted for key covariates, b) death from any cause within 3 months, c) events within 7 days: fatal and non fatal symptomatic intracranial hemorrhages, fatal and non fatal neurological deterioration attributed to brain swelling from the initial ischemic stroke, fatal and non fatal neurological deterioration not attributed to swelling or intracranial hemorrhage, fatal and non fatal recurrent ischemic stroke, death from any cause. Conclusions: Data from the trial will provide new evidence on the balance of risk and benefit of endovascular treatment, as compared to systemic thrombolysis, among patients with acute ischemic stroke.