Abstract WMP4: THRACE: Randomized Trial and Cost Effectiveness Evaluation on Thrombectomy in Acute Ischemic Stroke

THRACE is a controlled, multicenter (31 hospital centres in France) and randomized parallel group study, with a cost-effectiveness analysis. Objectives: The primary objective is to determine whether a combined approach intravenous (IV) thrombolysis and mechanical thrombectomy, is superior to the reference treatment with IV thrombolysis alone. The second objective is to determine the cost-effectiveness of this new procedure compared to the standard. Methods: All patients aged between 18 and 80 years with an acute ischemic stroke occurred within 4 hours are eligible for the study. Inclusion criteria are an occlusion of the intracranial carotid artery, the M1 portion of the middle cerebral artery or the upper third of the basilar and with a NIHSS score between 10 and 25. All the patients are treated with the reference IV treatment (0,9 mg/kg of rTpa). In the thrombectomy arm, thrombectomy is performed at the end of IV perfusion, with one of the thrombectomy device available. The modified Rankin Score at 3 month after treatment is the primary outcome. Secondary outcomes are the Barthel score at 3 month and the Quality of Life with Euroqol EQ-5D generic questionnaire at 3 and 12 months after treatment. The sample size was estimated at 480 patients. 200 are already included and the intermediate analysis is planned in the end of 2012. Grant: French Ministry of Health. STIC program 2009