Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients

Abstract

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

Comparative test of radiological exposure between femoral and radial techniques, development of a protective device and clinical trial design

“…Thus, a randomised historical cohort between radial and femoral techniques, with identical inclusion and exclusion criteria, will be the subject of a comparative analysis (ARISE study—NCT01653587). 24…”

12-Month Clinical Follow-Up of Patients Undergoing Early Invasive Strategy by the Transradial or Transfemoral Approach with Vascular Closure Device

“…6 In summary, from July 2012 to March 2015, 240 patients with a diagnosis of NSTEMI who underwent invasive stratification were randomized to perform the procedure by radial access or femoral vein with VOD Angio-Seal (St. Jude Medical, St. Paul, Minnesota, US). The choice of Angio-Seal relied on the ease of handling, lower cost and greater casuistry published in the literature in its favor.…”

Comparison of a vascular closure device versus the radial approach to reduce access site complications in non‐ST‐segment elevation acute coronary syndrome patients: The angio‐seal versus the radial approach in acute coronary syndrome trial

“…The rationale and methodology of the hypothesis generating The Angio‐Seal versus the Radial Approach in Acute Coronary Syndrome (ARISE) trial has been previously described . Between July 2012 and March 2015, 240 NSTEMI patients undergoing early invasive strategy were randomized to radial or femoral approach with use of the Angio‐Seal VCD (St. Jude Medical, St. Paul, Minnesota, US).…”