@article{6fb2552286fa4678916f353deabf417f,
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 = "Objectives 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)",
keywords = "PCI, radial approach, women and heart disease",
author = "Rao, {Sunil V.} and Hess, {Connie N.} and Britt Barham and Aberle, {Laura H.} and Anstrom, {Kevin J.} and Patel, {Tejan B.} and Jorgensen, {Jesse P.} and Mazzaferri, {Ernest L.} and Jolly, {Sanjit S.} and Alice Jacobs and Newby, {L. Kristin} and Gibson, {C. Michael} and Kong, {David F.} and Roxana Mehran and Ron Waksman and Gilchrist, {Ian C.} and McCourt, {Brian J.} and Messenger, {John C.} and Peterson, {Eric D.} and Harrington, {Robert A.} and Krucoff, {Mitchell W.}",
note = "Funding Information: The NCRI is an investigator network created through collaboration between the Duke Clinical Research Institute and the American College of Cardiology and funded by the National Heart, Lung, and Blood Institute (grant 1RC2HL101512-01). The network includes sites participating in the National Cardiovascular Data Registry{\textquoteright}s CathPCI Registry, an ongoing PCI registry co-sponsored red by the American College of Cardiology and the Society for Cardiovascular Angiography and Intervention. Under the construct of the NCRI, the data stream of registry-participating sites is accessed electronically to populate a clinical trial database for patients consented and enrolled in the SAFE-PCI for Women trial. Patient demographics, medical history, concomitant medications, procedure details, and in-hospital clinical outcomes routinely entered in the registry's data collection system using standardized data elements are transferred to an electronic trial case report form. Additional trial-specific information including procedure information related to vascular access site and outcomes of interest not obtained as part of the registry are collected using additional electronic case report form pages per usual clinical trial standards. The NCRI computer systems, including randomization components, are formally validated, and the integrated registry and trial-specific data conform to the same quality requirements. Because radial access accounts for a minority of procedures in the United States (9) , initial study sites were identified through the CathPCI Registry on the basis of their actual transradial PCI volume as described previously (12) . Participating sites and principal investigators are listed in the Online Appendix . ",
year = "2014",
month = aug,
doi = "10.1016/j.jcin.2014.04.007",
language = "English (US)",
volume = "7",
pages = "857--867",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "8",
}