SAFE-PCI Examines Radial Artery Access in Women
October 29, 2013—The Cardiovascular Research Foundation (CRF) announced that findings from the SAFE-PCI for Women clinical trial suggest that an initial strategy of using radial artery access for cardiac catheterization or percutaneous coronary intervention (PCI) in women has potential for reducing bleeding complications. The study’s primary findings were presented at CRF’s TCT 2013: Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, California.
CRF noted that women are at particular risk for bleeding and vascular complications after PCI and, although a transradial approach can potentially reduce these complications, this technique has never been prospectively studied in women. Women also have smaller radial arteries than men, making radial PCI potentially more challenging.
According to CRF, SAFE-PCI for Women was designed with a novel approach to minimize trial costs. The trial used prospectively gathered data collection instruments based upon the existing National Cardiovascular Research Infrastructure (NCRI), a clinical trial infrastructure created through collaboration between the National Heart, Lung, and Blood Institute (NHLBI), the American College of Cardiology, and the Duke Clinical Research Institute. It was also built on the NCDR CathPCI Registry, the largest ongoing PCI registry in the world.
As summarized by CRF, SAFE-PCI for Women is a registry-based multicenter, randomized trial in the United States comparing radial with femoral access. The trial was composed of 1,787 women undergoing elective PCI, urgent PCI, or diagnostic catheterization with possible PCI. The patients were randomized to either a radial or femoral approach.
The primary efficacy endpoint was bleeding (Bleeding Academic Research Consortium types 2, 3 or 5) or vascular complications requiring intervention within 72 hours postprocedure or at hospital discharge, whichever came first. The primary feasibility endpoint was procedural failure, defined as the inability to complete the PCI from the assigned access site.
CRF advised that after 1,120 patients had been randomized, 446 of whom had undergone PCI, review of data 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 because the trial was unlikely to show a difference at the planned sample size. No harm was noted in either arm; therefore, the trial’s steering committee voted to continue the study until enrollment in a quality-of-life substudy was complete.
Of the 1,787 women who were randomized (893 to radial access, 894 to femoral access), 691 patients underwent PCI (345 radial access and 346 femoral access). In the PCI group, bleeding and complication rates were 1.2% in the radial group compared to 2.9% in the femoral group (P = .12). When assessing the overall cohort of randomized patients (those receiving both diagnostic procedures alone as well as those receiving PCI), bleeding and complication rates were 0.6% versus 1.7% (P = .03). The overall procedural failure rate was 6.7% in the radial group and 1.9% in the femoral group (P < .001). Within the radial group, conversion to femoral access was often due to radial artery spasm (42.9% among the patients who converted).
In the CRF’s press release, the trial’s lead investigator Sunil V. Rao, MD, commented, “The SAFE-PCI for Women trial represents several ‘firsts.’ It is the first randomized trial of 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. The treatment benefit of radial access over femoral access was larger than expected (approximately 60%) in both the PCI group and total randomized cohorts.”
Dr. Rao, who is Associate Professor of Medicine at Duke University Medical Center in Durham, North Carolina, continued, “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. As the first registry-based randomized trial in the United States, the SAFE-PCI for Women trial demonstrates a new paradigm shift for conducting efficient practical clinical trials using the National Cardiovascular Research Infrastructure. This trial construct is a promising approach for future clinical investigations.”