SAFE-PCI: Radial Artery Access Beneficial in Women

San Francisco, CA—An initial strategy of radial artery access during cardiac catheterization or PCI is reasonable and may be preferred in women, according to results from the SAFE-PCI for Women trial.


sunil.tues.29 Investigators randomized 1,787 women at 60 US sites who were undergoing elective PCI, urgent PCI or diagnostic catheterization with possible PCI to a radial or femoral approach.


The primary efficacy endpoint was bleeding (BARC types 2, 3 or 5) or vascular complications requiring intervention within 72 hours of the procedure or at hospital discharge, whichever came first. The primary feasibility endpoint was procedural failure defined as the inability to complete PCI from the assigned access site.

In a subgroup of 691 women who underwent PCI, there was a nonsignificant reduction in bleeding or vascular complications with radial access. However, in the larger sample size of all women undergoing cardiac catheterization or PCI (n=1,787), there was a significant reduction in complications, Sunil V. Rao, MD, from Duke University Medical Center, reported at TCT 2013 (see Figure, page 37).

Procedure duration, total radiation dose and 30-day MACE were similar between the groups. There was, however, less contrast volume reported for radial access (–13 mL per PCI case).

In addition, radial access was the preferred approach by the majority of women undergoing PCI, Rao said.

The trial did not reach its planned enrollment due to early termination. After 1,120 patients were randomized, review by the Data and Safety Monitoring Board (DSMB) showed that the primary efficacy event rate was markedly lower than expected. The DSMB recommended termination of the trial; however, no harm was noted in either arm and the steering committee voted to continue the study until enrollment in a quality-of-life substudy was complete.


  Trial ‘firsts’

SAFE-PCI in Women is the first randomized trial comparing interventional strategies in women; the first multicenter, randomized trial comparing radial with femoral access in the United States; and the first registry-based randomized trial in the United States, Rao explained.

“This was a unique trial and I am thrilled to see an all-female study,” Roxana Mehran, MD, from Icahn School of Medicine at Mount Sinai, New York, N.Y., said during a pointed critique and critical appraisal of the trial. “The study provides evidence, albeit not conclusive, for greater efficacy with radial access in women. Given higher rates of [access site] crossover compared to bleeding, we need to consider that approximately three patients will require to crossover to prevent one primary endpoint when you use the radial access,” she said.

New paradigm for conducting trials

The trial represents a new paradigm for conducting efficient pragmatic clinical trials using the National Cardiovascular Data Registry, including high-quality data, adjudication when possible, faster enrollment and reduced costs, Rao said. The total budget for the trial was about $5 million.

“This trial construct is a promising approach for future clinical investigations,” he concluded.


Mehran reports receiving consultant fees/honoraria from, serving on the advisory board of, and receiving grant/research support from several device and pharmaceutical manufacturers; and serving on the executive committee of the SAFE-PCI in Women trial.

Rao reports receiving consultant fees from AstraZeneca and The Medicines Company.