Women who underwent radial PCI had a lower rate of bleeding and vascular complications compared with women treated femorally, according to results of a late-breaking clinical trial presented Oct. 29 at the Transcatheter Cardiovascular Therapeutics Conference in San Francisco. But the overall procedural failure rate was three times higher in the radial group.
SAFE-PCI for Women (Study of Access site for Enhancement of PCI for Women) was designed to compare bleeding and vascular complication rates in women who were randomized to either radial or femoral access during PCI or cardiac catheterization. Women have higher rates of post-PCI vascular bleeding and complications than men, and the radial approach has been shown to lower bleeding risk in the general population.
But women generally have smaller diameter arteries than men, which might increase their risk of spasm and prompt operators to switch to a femoral access.
The study, presented by principal investigator Sunil V. Rao, MD, of Duke University Medical Center in Durham, N.C., incorporated several innovations into its design. Researchers used the CathPCI Registry to identify centers with expertise in both approaches as possible participants and then to facilitate data collection. The study also applied the standardized Bleeding Academic Research Consortium (BARC) bleeding definitions, which the authors described as a first (Am Heart J 2013;166:421-428.e1).
The primary efficacy endpoint was BARC type 2, 3 or 5 bleeding or vascular complications that needed intervention within 72 hours after the procedure or at hospital discharge. The primary feasibility endpoint was procedural failure.
SAFE-PCI in Women was initially planned to enroll approximately 3,000 women, with about 1,800 expected to undergo PCI. The study’s Data and Monitoring Board recommended terminating the trial after it determined that the primary endpoint was much lower than expected.
Of the final cohort, 893 women were randomized to the radial group and 691 to the femoral group. The bleeding and complication rate was 0.6 percent in the radial group compared with 1.7 percent in the femoral group. In an analysis of PCI alone, 1.2 percent of the 345 women in the radial group experienced a bleeding or vascular complication vs. 2.9 percent in the femoral/PCI group.
Procedural failure totaled 6.7 percent in the radial group and 1.9 percent in the femoral group. Radial artery spasm accounted for 42.9 percent of the crossover to the femoral approach.
The benefit shown with the radial approach was higher than they expected for both the PCI and PCI and cardiac catheterization together, Rao said in a release. “[The] findings suggest 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.”
In recent years, bleeding and complication rates have declined for both sexes. In 2002, the bleeding and vascular complication rate for PCI was 6 percent in women and 2.1 percent in men (Cir Cardiovasc Interven 2009; 2:423-429). By 2007, the rates had dropped to 2.9 percent for women and 0.97 percent for men. This was in an era when radial PCI was rarely performed in the U.S.; nor did the study use BARC bleeding definitions.
SAFE-PCI in Women was funded by Abbott Vascular, ACIST Medical, Eli Lilly, Guerbet, Medtronic, Terumo Medical, The Medicines Company, the FDA Office of Women’s Health and the Duke Clinical Research Institute.