title: Design and rationale of the radial versus femoral access for coronary intervention (RIVAL) trial: a randomized comparison of radial versus femoral access for coronary angiography or intervention in patients with acute coronary syndromes.
abstract: BACKGROUND
  Major bleeding in acute coronary syndromes (ACS) is associated with an increased risk of subsequent mortality and recurrent ischemic events. Observational data and small randomized trials suggest that radial instead of femoral access for coronary angiography/intervention results in fewer bleeding complications, with preserved and possibly improved efficacy. Radial access versus femoral access has yet to be formally evaluated in a randomized trial adequately powered for the comparison of clinically important outcomes.
  
  
  OBJECTIVE
  The aim of this study is to evaluate the efficacy and safety of radial versus femoral access for coronary angiography/intervention in patients with ACS managed with an invasive strategy.
  
  
  METHODS
  This was a multicenter international randomized trial with blinded assessment of outcomes. 7021 patients with ACS (with or without ST elevation) have been randomized to either radial or femoral access for coronary angiography/intervention. The primary outcome is the composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft-related major bleeding up to day 30. The key secondary outcomes are (1) death, myocardial infarction, or stroke up to day 30 and (2) non-coronary artery bypass graft-related major bleeding up to day 30. Percutaneous coronary intervention (PCI) success rates will also be compared between the two access sites.
  
  
  CONCLUSIONS
  The RIVAL trial will help define the optimal access site for coronary angiography/intervention in patients with ACS.
authors.affiliation: McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. jollyss@mcmaster.ca
authors.forename: Sanjit S
authors.initials: SS
authors.lastname: Jolly
authors.forename: Kari
authors.initials: K
authors.lastname: Niemelä
authors.forename: Denis
authors.initials: D
authors.lastname: Xavier
authors.forename: Petr
authors.initials: P
authors.lastname: Widimsky
authors.forename: Andrzej
authors.initials: A
authors.lastname: Budaj
authors.forename: Vicent
authors.initials: V
authors.lastname: Valentin
authors.forename: Basil S
authors.initials: BS
authors.lastname: Lewis
authors.forename: Alvaro
authors.initials: A
authors.lastname: Avezum
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.forename: John
authors.initials: J
authors.lastname: Cairns
authors.forename: Susan
authors.initials: S
authors.lastname: Chrolavicius
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.forename: Shamir R
authors.initials: SR
authors.lastname: Mehta
mesh_terms: D054058:Acute Coronary Syndrome / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography / Q000379:methods; D005263:Femoral Artery; D006801:Humans; D017534:Radial Artery