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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

background:The radial approach has demonstrated superior benefits to the femoral approach in reducing vascular complications and bleeding events associated to percutaneous coronary interventions. However, because this is a more complex procedure, it requires a learning curve to get all of the advantages of the technique. The aim of this study was to present the characteristics of the procedures of a center that prioritizes the use of radial approach. Methods: Prospective registry of patients undergoing percutaneous coronary intervention (PCI) using the radial or ulnar access where angiographic success, technical failure, ischemic adverse events and severe bleeding rates were assessed. A pre-specified analysis of the group undergoing PCI for the right coronary artery was performed, comparing patients using Judkins right catheter (JR) or Amplatz catheters. Results: Between April 2010 and May 2012, 1,117 patients underwent PCI, 1,040 (93.1%) by the radial approach and 50 (4.5%) by the ulnar approach. Sedation was performed in 58.5% of the patients, the crossover rate was 1.2%, and angiographic success was 96.2%. Extra backup catheters were used in 99.1% of PCIs for the left coronary artery, JR in 69.4% and Amplatz in 27.1% of the PCIs for the right coronary artery. When the JR and Amplatz were compared, longer procedure duration, longer fluoroscopy time, larger number of catheters, more frequent lesion predilation and higher number of implanted stents were observed in the group using Amplatz catheters as well as lower angiographic success rates. Conclusions: The use of radial access in PCI showed a high success rate and a low rate of major cardiac