Despite No Measurable Gain in QoL, Women Still Prefer Radial for Cardiac Cath
Quality of life (QoL) after cardiac catheterization is similar for women whether the procedure is done via radial or femoral access, according to a substudy of the SAFE-PCI for Women trial published online May 4, 2015, ahead of print in the American Heart Journal. Yet when asked what they would prefer for a repeat procedure, most women who had radial stood by that strategy, whereas those receiving femoral were more likely to consider the alternate route.
The findings “suggest that in contemporary practice, patient preference for the radial approach among women undergoing cardiac catheterization appears to be based on factors other than those captured by established QoL instruments,” said Connie N. Hess, MD, MHS, of the Duke Clinical Research Institute (Durham, NC), and colleagues.
The SAFE-PCI for Women trial randomized 1,787 women undergoing either diagnostic cardiac cath or elective PCI at 60 US sites to radial or femoral access from September 2011 to July 2013. Of this group, the prespecified QoL substudy enrolled 304 patients, including 103 who underwent PCI.
The European Quality of Life-5 Dimensions (EQ-5D) and EQ visual analogue scale (EQ VAS) were used to assess QoL at baseline, discharge, and—by protocol, among PCI patients only—at 30 days.
Measures of QoL Similar Across the Board
After adjustment for baseline score, patients randomized to radial vs femoral access had similar results on all aspects of both the EQ-5D and EQ VAS at discharge and at 30-day follow-up. The QoL measurements also were equivalent between access routes when analyzed by the actual treatment received, the center’s radial procedure volume, and patient age.
In addition, the 2 approaches resulted in similar proportions of patients who were free from access site pain. Yet at 30 days, patients assigned to radial access were much more likely to report that they would prefer a repeat procedure via the same route than were those assigned to femoral access (table 1).
Although the study did not find any measurable differences in QoL, “other potential advantages of radial over femoral artery access exist and should motivate operators to consider this strategy for cardiac catheterization,” the researchers write. These include reductions in access site–related bleeding and complications, as well as potentially lower cost, they say, adding that “maintaining a ‘radial first’ mentality” can help overcome the learning curve and improve operator proficiency.
Quicker Recovery, Less Bruising
Ajay J. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY), told TCTMD in an email that, while it is hard to know for sure why no QoL disparities were picked up, “I suspect that the instruments to measure the differences are not very fine-tuned, particularly for the low-risk population that was enrolled.”
Radial operators need to balance the “fact that women have smaller arteries and can experience a greater incidence of spasm and pain… against the [knowledge that] bleeding reductions can be greater on an absolute scale, given that women are generally higher risk for bleeding following PCI (particularly when fully anticoagulated),” he advised.
As to why patients might in general prefer radial access, Dr. Kirtane suggested the “ability to ambulate very soon after the procedure and the absence of significant bruising and/or bleeding are both very beneficial.”
Both access routes have “pluses and minuses,” Ellen C. Keeley, MD, MS, of the University of Virginia Health System (Charlottesville, VA), added in an email with TCTMD. “But in general the radial approach just seems ‘less invasive’ and is associated with less bedrest/activity restriction. This may be why it was preferred. Having a sore wrist or a bruise in that area tends to be more tolerated and less scary than the same thing located in the femoral artery area.”
That being said, she added, with radial, “[i]t may be more of the perception that the procedure was minimal, whereas this is really not the case.”
Dr. Keeley expressed doubt that women would have unique reasons for preferring radial, “other than it being easier to ambulate and perhaps get back into doing what they want to do sooner.”
While both approaches are important, she noted, neither “is fail-safe or perfect.” Operator experience is particularly important in radial access, though it “may be associated with less bleeding,” Dr. Keeley said. “However, more data is needed in order to sort out the effect of anticoagulation choice (as is being studied in the SAFARI-STEMI trial).”
Hess CN, Krucoff MW, Sheng S, et al. Comparison of quality-of-life measures after radial versus femoral artery access for cardiac catheterization in women: results of the SAFE-PCI for Women quality-of-life substudy. Am Heart J. 2015;Epub ahead of print.
- The SAFE-PCI for Women trial was funded by Abbott Cardiovascular Systems, ACIST Medical Systems, the Duke Clinical Research Institute, Guerbet, Lilly USA, Medtronic Vascular, Terumo Medical, and The Medicines Company. The FDA Office of Women’s Health provided funding for the QoL substudy.
- Drs. Hess and Keeley report no relevant conflicts of interest.
- Dr. Kirtane reports receiving institutional research grants from Abbott Vascular, Abiomed, Boston Scientific, Eli Lilly, Medtronic, St. Jude Medical, and Vascular Dynamics.