“Even though ischemic heart disease is the No. 1 health risk for women, the proportion of women in heart studies is almost never more than 30 percent,” said lead author Sunil V. Rao, M.D., associate professor of medicine at Duke University School of Medicine. “It is important to understand if the outcomes are different between men and women, and whether the treatments may need to be different, because the disease process may be different.”
Rao and colleagues, led by the Duke Clinical Research Institute, launched the study after noting that the wrist access site, called the radial entry point, is much less commonly used in the United States than in other countries. Women especially are less likely to undergo an angioplasty, also known as percutaneous coronary intervention, or PCI, via the wrist.
The research team enrolled more than 1,700 patients in what was dubbed the Study of Access Site for Enhancement of Percutaneous Coronary Intervention (SAFE-PCI) for Women trial. The women were randomized to undergo PCI through the wrist or the groin, which is called the femoral site. Most of the women in both groups were taking a blood thinner to reduce the potential for clots.
The original goal was to include 3,000 women, but the trial ended early because the primary endpoints– bleeding or vascular complications rates – were lower than expected in both groups. Because of this low rate of bleeding, the Data Safety Monitoring Board, an independent group that monitored the trial, predicted that the trial wouldn’t show a difference in bleeding between the wrist artery and the leg artery.
However, the treatment benefit of accessing an artery at the wrist was better than expected, with just 1.2 percent of radial artery cases resulting in bleeding or other vascular issues, compared to 2.9 percent for femoral artery access – a 60 percent reduction in bleeding complications. Among all of the women who were enrolled in the study, about 40% of whom had angioplasty, the benefit was even larger – 70 percent reduction in bleeding and vascular complications.
Far more women who underwent the wrist access also said they would prefer to use that site again if a repeat procedure were needed.
The radial access site did not work for all women. In more than 6 percent of cases, doctors had to abandon the wrist access attempt and return to the traditional groin way of doing the procedure, typically because of spasms in the wrist artery or the blood vessel was too small.
“We have a lot of information comparing wrist-versus-leg approaches for PCI, but we haven’t had the data in women, and this is pretty consistent with what we’ve known for men,” Rao said. “The radial approach appears to be safer for women at high risk for bleeding. At the same time, we need to let our patients know that if we try this approach and there are issues such as spasms, we’ll have to switch and go to the leg.”
In addition to Rao, study authors include Connie N. Hess, Britt Barham, Laura H. Aberle, Kevin Anstrom, Tejan B. Patel, Jesse P. Jorgensen, Ernest L. Mazzaferri, Sanjit S. Jolly, Alice Jacobs, L. Kristin Newby, C. Michael Gibson, David F. Kong, Roxana Mehran, Ron Waksman, Ian C. Gilchrist, Brian J. McCourt, Eric D. Peterson, Robert A. Harrington and Mitchell W. Krucoff on behalf of the SAFE-PCI for Women investigators.
Funding for the study was provided by a consortium of industry, government and academic entities, including Medtronic, The Medicines Company, Abbott Vascular, Daiichi Sankyo Lilly, Terumo Medical, Guerbet, ACIST Medical, The FDA Office of Women’s Health, and The Duke Clinical Research Institute.
Women Benefit From Less-Used Wrist Access Site For Angioplasty
The finding, presented Tuesday, Oct. 29, 2013, at the annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco, resulted from a large clinical trial that was the first to exclusively study how a common heart intervention affects women. Most heart studies disproportionately enroll men, so new treatments and procedures may not accurately reflect how women might fare.