title: 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: BACKGROUND
  Arterial 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.
  
  
  METHODS
  ARISE 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.
  
  
  RESULTS
  Enrollment 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.
  
  
  CONCLUSIONS
  The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01653587.
authors.affiliation: Invasive Cardiology, Santa Casa de Marília, Avenida Vicente Ferreira, 828 - Cascata, Marília, São Paulo 17515-900, Brazil. pedroberaldo@gmail.com.
authors.forename: Pedro Beraldo
authors.initials: PB
authors.lastname: de Andrade
authors.forename: Luiz Alberto Piva
authors.initials: LA
authors.lastname: E Mattos
authors.forename: Marden André
authors.initials: MA
authors.lastname: Tebet
authors.forename: Fábio Salerno
authors.initials: FS
authors.lastname: Rinaldi
authors.forename: Vinícius Cardozo
authors.initials: VC
authors.lastname: Esteves
authors.forename: Ederlon Ferreira
authors.initials: EF
authors.lastname: Nogueira
authors.forename: João Ítalo Dias
authors.initials: JÍ
authors.lastname: França
authors.forename: Mônica Vieira Athanazio
authors.initials: MV
authors.lastname: de Andrade
authors.forename: Robson Alves
authors.initials: RA
authors.lastname: Barbosa
authors.forename: André
authors.initials: A
authors.lastname: Labrunie
authors.forename: Alexandre Antônio Cunha
authors.initials: AA
authors.lastname: Abizaid
authors.forename: Amanda Guerra de Moraes Rego
authors.initials: AG
authors.lastname: Sousa
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000628:therapy*; D001938:Brazil; D002985:Clinical Protocols; D004867:Equipment Design; D005263:Femoral Artery; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D009203:Myocardial Infarction / Q000175:diagnosis / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods*; D011677:Punctures; D017534:Radial Artery; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome