A Registry-Based Randomized Trial Comparing Radial and Femoral Approaches in Women Undergoing Percutaneous Coronary Intervention: The SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) Trial

Study Questions:

What is the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial (SAFE-PCI for Women)?

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], 0.12-1.27); 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, 0.12-0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR, 3.65; 95% CI, 1.45-9.17); total randomized cohort: (6.7% vs. 1.9%; OR, 3.70; 95% CI, 2.14-6.40). More women preferred radial access.

Conclusions:

The authors concluded that the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI.

Perspective:

In the SAFE-PCI for Women trial that was terminated early, radial access did not significantly lower the incidence of bleeding or vascular complications in women undergoing PCI; however, in the larger sample size of women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding or vascular complications. There was a need to convert from radial access to femoral access in 6.7% of patients. Thus, this lack of a significant difference may be due to the limited sample size of women undergoing PCI. On the basis of the site activity and experience in the SAFE-PCI for Women trial and the demonstrated efficiency of the National Cardiovascular Research Infrastructure (NCRI) model, a randomized trial comparing both clinical outcomes and door-to-balloon time metrics between radial and femoral access in ST-segment elevation myocardial infarction patients appears warranted and feasible.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Odds Ratio, Myocardial Infarction, Cardiac Catheterization, Confidence Intervals, Hemorrhage, Percutaneous Coronary Intervention


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