The first-ever randomized trial to compare interventional access strategies in women found distinct advantages with radial access over the more traditional femoral route, with a trend toward a reduction of bleeding and vascular complications by about 60 percent through radial access, according to results from the SAFE-PCI trial presented Oct. 29 as part of Transcatheter Cardiovascular Therapeutics (TCT) 2013 in San Francisco.

The Study of Access site For Enhancement of PCI for Women (SAFE-PCI for Women) trial prospectively compared radial access and femoral access in 1,787 women undergoing elective percutaneous coronary intervention (PCI), urgent PCI or diagnostic catheterization with possible PCI. Results showed no difference between the radial and femoral groups in 30-day death, vascular complications or unplanned revascularizations.

Radial access also reduced bleeding and vascular complications by 60 percent in a smaller group who underwent PCI only. In the PCI group, bleeding and complication rates were 1.2 percent in the radial group compared to 2.9 percent in the femoral group (p=0.12). When assessing the overall cohort of randomized patients, bleeding and complication rates were 0.6 percent vs. 1.7 percent (p=0.03). Further, about six percent of women had to convert to femoral access, primarily because of radial artery spasm. Women generally preferred radial access, with 71.9 percent saying they preferred radial access for the next procedure versus 23.5 percent who preferred femoral access.

The trial is also the first registry-based randomized trial to be conducted in the U.S. and used the National Cardiovascular Research Infrastructure platform, a collaboration between the National Heart, Lung, and Blood Institute, the ACC and the Duke Clinical Research Institute, which embeds randomization into the CathPCI Registry, identifies appropriate trial sites and automatically exports relevant data into an electronic case report form. The authors note that moving forward, "this first-of-a-kind clinical trial structure demonstrates a promising approach for conducting clinical trials."

"The treatment benefit of radial access over femoral access was larger than expected (~60 percent) in both the PCI group and total randomized cohorts," said lead author Sunil Rao, MD, FACC, associate professor of medicine, Duke University School of Medicine. "The SAFE-PCI for Women Trial suggests that an initial strategy of radial access is reasonable and may be preferred in women, with the recognition that a proportion of patients will require bailout to femoral access," he adds.

"This trial is an important achievement," said NCDR Senior Medical Officer Frederick A. Masoudi, MD, MSPH, FACC. "It focuses entirely on women, who are known to have significantly higher risks for bleeding during interventional cardiovascular procedures than men. Further, as it was embedded in the CathPCI Registry, it was able to take advantage of the robust data collection process used in many U.S. hospitals for quality improvement. Multiple uses of detailed clinical data like that in the registry is a model for future efforts to identify optimal strategies to improve patient outcomes," he adds.

Keywords: Cooperative Behavior, Quality Improvement, Registries, Spasm, National Heart, Lung, and Blood Institute (U.S.), Radial Artery, San Francisco, Catheterization, Hemorrhage, Percutaneous Coronary Intervention