Author + information
- Received April 3, 2014
- Accepted April 7, 2014
- Published online August 1, 2014.
- Sunil V. Rao, MD∗∗ (, )
- Connie N. Hess, MD, MHS∗,
- Britt Barham, BA∗,
- Laura H. Aberle, BSPH∗,
- Kevin J. Anstrom, PhD∗,
- Tejan B. Patel, MD†,
- Jesse P. Jorgensen, MD‡,
- Ernest L. Mazzaferri Jr., MD§,
- Sanjit S. Jolly, MD‖,
- Alice Jacobs, MD¶,
- L. Kristin Newby, MD∗,
- C. Michael Gibson, MD#,
- David F. Kong, MD∗,
- Roxana Mehran, MD∗∗,
- Ron Waksman, MD††,
- Ian C. Gilchrist, MD‡‡,
- Brian J. McCourt∗,
- John C. Messenger, MD§§,
- Eric D. Peterson, MD, MPH∗,
- Robert A. Harrington, MD‖‖ and
- Mitchell W. Krucoff, MD∗
- ∗The Duke Clinical Research Institute, Durham, North Carolina
- †Unity Health System, Rochester, New York
- ‡University of South Carolina School of Medicine-Greenville, Greenville, South Carolina
- §The Ohio State University Medical Center, Columbus, Ohio
- ‖McMaster University, Hamilton, Ontario, Canada
- ¶Boston University School of Medicine, Boston, Massachusetts
- #Beth Israel Deaconess Medical Center, Boston, Massachusetts
- ∗∗Mount Sinai Hospital, New York, New York
- ††Washington Hospital Center, Washington, DC
- ‡‡Penn State Hershey Medical Center, Hershey, Pennsylvania
- §§The American College of Cardiology, Washington, DC
- ‖‖Stanford University Medical Center, Palo Alto, California
- ↵∗Reprint requests and correspondence:
Dr. Sunil V. Rao, 508 Fulton Street (111A), Durham, North Carolina 27705.
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)
Abbott Vascular, Medtronic Vascular (grant no. A 1054367), Terumo Medical, The Medicines Company, Daiichi Sankyo/Eli Lilly and Company (grant no. H7T-US-X014), ACIST Medical, Guerbet, FDA Office of Women’s Health (grant no. HHSF223201111381P), and The Duke Clinical Research Institute funded this study. None of the funding sources had a role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation or approval of the manuscript; and decision to submit the manuscript for publication. Some funding sources reviewed the manuscript before submission. Dr. Rao is a consultant for The Medicines Company and Terumo Medical. Dr. Jolly has received research funding from Medtronichttp://dx.doi.org/10.13039/100004374. Dr. Waksman has received consulting fees and honoraria from Biotronik, Medtronic, Boston Scientific, Abbott Vascular, and AstraZeneca; is on Speakers' Bureau of AstraZeneca; and is a shareholder in Endothelix, Inc. Dr. Mehran has received research grant support from The Medicines Company, Bristol-Myers Squibbhttp://dx.doi.org/10.13039/100002491, Sanofi-Aventis, Eli Lilly & Co./Daiichi Sankyo, Regado Biosciences, and STENTYS and consulting fees from Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, CSL Behring, Janssen (JNJ), Maya Medical, and Merck and is on the Advisory Board of Covidien, Janssen Pharmaceuticals, and Sanofi-Aventis. Dr. Harrington has received research grants from Merck, The Medicines Company, Sanofi-Aventis, Bristol-Myers Squibbhttp://dx.doi.org/10.13039/100002491, and Portola Pharma and consulting fees from Merck, Bristol-Myers Squibb, AstraZeneca, Gilead, Jansen/J&J, Merck, WebMD, CSL Behring, MyoKardia, The Medicines Company, and Amgen. Dr. Krucoff has received consulting fees and research support from Medtronic, Abbott Vascular, Terumo, and Acist. Dr. Anstrom has received research support from AstraZeneca, Lilly, Medtronichttp://dx.doi.org/10.13039/100004374 and consulting fees from Abbott Vascular, AstraZeneca, BMS, Pfizer, GSK, and Ikaria. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 3, 2014.
- Accepted April 7, 2014.
- American College of Cardiology Foundation