In women undergoing percutaneous coronary intervention (PCI), a radial approach does not significantly reduce bleeding or vascular complications, compared to a femoral approach, according to a study published Aug. 18 in JACC: Cardiovascular Interventions.

The study was led by Sunil V. Rao, MD, FACC, the Duke Clinical Research Institute, Durham, NC, and randomized 1,787 women undergoing cardiac catheterization or PCI to radial or femoral arterial access. Data from the ACC's CathPCI Registry and trial-specific data from the SAFE-PCI for Women trial were merged into a final study database.

While the SAFE-PCI for Women trial was stopped early for a lower than expected event rate, initial findings showed no significant difference in major bleeding or vascular complications requiring interventions between radial or femoral access among women undergoing PCI (radial 1.2 percent vs. 2.9 percent femoral). However, according to results from the larger sample size of women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding or vascular complications. The study also indicated access site crossover to be significantly higher among women assigned to radial access (6.1 percent vs. 1.7 percent). In addition, more women preferred radial access.

"The SAFE-PCI for Women trial represents several ‘firsts' for clinical trials," the study investigators note. "It is the first U.S.-based multicenter, prospective, randomized trial comparing radial and femoral approaches to cardiac catheterization or PCI and is the first randomized trial of PCI strategies performed solely in women. In addition, it is the first registry-based trial in the U.S. with patient-level randomization." They add that moving forward, their study "demonstrates a new paradigm for conducting efficient pragmatic clinical trials."

Keywords: Registries, Radial Artery, Cardiac Catheterization, Angioplasty, Balloon, Coronary, National Cardiovascular Data Registries, CathPCI Registry