• Pedro Beraldo de Andrade, Luiz Alberto Piva E Mattos, Marden André Tebet, Fábio Salerno Rinaldi, Vinícius Cardozo Esteves, Ederlon Ferreira Nogueira, João Ítalo Dias França, Mônica Vieira Athanazio de Andrade, Robson Alves Barbosa, André Labrunie, Alexandre Antônio Cunha Abizaid, and Amanda Guerra de Moraes Rego Sousa.
• Invasive Cardiology, Santa Casa de Marília, Avenida Vicente Ferreira, 828 - Cascata, Marília, São Paulo 17515-900, Brazil. pedroberaldo@gmail.com.
• Trials. 2013 Jan 1;14:435.

BackgroundArterial access is a major site of bleeding complications after invasive coronary procedures. Among strategies to decrease vascular complications, the radial approach is an established one. Vascular closure devices provide more comfort to patients and decrease hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications, requiring evidence through adequately designed randomized trials. The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy.MethodsARISE is a national, multicenter, non-inferiority randomized clinical trial. Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device. The primary outcome is the occurrence of vascular complications at an arterial puncture site 30 days after the procedure, including major bleeding, retroperitoneal hematoma, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arterio-venous fistula, infection, limb ischemia, arterial occlusion, adjacent nerve injury or the need for vascular surgical repair.ResultsEnrollment was initiated in September 2012, and until October 2013 91 patients were included. The inclusion phase is expected to last until the second half of 2014.ConclusionsThe ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS.Trial RegistrationClinicalTrials.gov identifier: NCT01653587.

25 keywords...

hide…