title: A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial.
abstract: OBJECTIVE
  This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial.
  
  
  BACKGROUND
  Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear.
  
  
  METHODS
  Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population.
  
  
  RESULTS
  The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access.
  
  
  CONCLUSIONS
  In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236).
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina. Electronic address: sunil.rao@duke.edu.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Connie N
authors.initials: CN
authors.lastname: Hess
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Britt
authors.initials: B
authors.lastname: Barham
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Laura H
authors.initials: LH
authors.lastname: Aberle
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Anstrom
authors.affiliation: Unity Health System, Rochester, New York.
authors.forename: Tejan B
authors.initials: TB
authors.lastname: Patel
authors.affiliation: University of South Carolina School of Medicine-Greenville, Greenville, South Carolina.
authors.forename: Jesse P
authors.initials: JP
authors.lastname: Jorgensen
authors.affiliation: The Ohio State University Medical Center, Columbus, Ohio.
authors.forename: Ernest L
authors.initials: EL
authors.lastname: Mazzaferri
authors.affiliation: McMaster University, Hamilton, Ontario, Canada.
authors.forename: Sanjit S
authors.initials: SS
authors.lastname: Jolly
authors.affiliation: Boston University School of Medicine, Boston, Massachusetts.
authors.forename: Alice
authors.initials: A
authors.lastname: Jacobs
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: L Kristin
authors.initials: LK
authors.lastname: Newby
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: David F
authors.initials: DF
authors.lastname: Kong
authors.affiliation: Mount Sinai Hospital, New York, New York.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: Washington Hospital Center, Washington, DC.
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.affiliation: Penn State Hershey Medical Center, Hershey, Pennsylvania.
authors.forename: Ian C
authors.initials: IC
authors.lastname: Gilchrist
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Brian J
authors.initials: BJ
authors.lastname: McCourt
authors.affiliation: The American College of Cardiology, Washington, DC.
authors.forename: John C
authors.initials: JC
authors.lastname: Messenger
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.affiliation: Stanford University Medical Center, Palo Alto, California.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.affiliation: The Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D000368:Aged; D002170:Canada; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D057239:Early Termination of Clinical Trials; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D016014:Linear Models; D008875:Middle Aged; D016017:Odds Ratio; D057240:Patient Preference; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D017534:Radial Artery; D012042:Registries; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
keywords: PCI; radial approach; women and heart disease