With Some Caveats, SAFE-PCI Shows Positive Signs for Radial Access in Women

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An initial strategy of radial over femoral access in women undergoing elective percutaneous coronary intervention (PCI) failed to reduce bleeding or vascular complications in a randomized trial published in the August 2014 issue of JACC: Cardiovascular Interventions. However, since the study was stopped early due to a lower-than-expected event rate, the researchers still support the use of radial, citing reduced risk in the overall catheterization cohort and patient preference.

Methods
Results from the SAFE-PCI for Women trial were originally presented in October 2013 at the Transcatheter Cardiovascular Therapeutics scientific symposium.
Leveraging data from the registry-based National Cardiovascular Infrastructure network, investigators led by Sunil V. Rao, MD, of the Duke Clinical Research Institute (Durham, NC), randomized 1,787 women undergoing either diagnostic cardiac cath or elective PCI at 60 US sites to radial (n = 893) or femoral (n = 894) access from September 2011 to July 2013. By the time of its termination, the trial had included 691 PCI cases (345 via radial and 346 femoral access), mostly for NSTE-ACS.


Overall, radial access reduced the combined risk of BARC type 2, 3, or 5 bleeding or vascular complications requiring intervention before discharge (primary endpoint) compared with femoral access. Among PCI-treated patients, radial access was associated with a nonsignificant 60% reduction in the primary endpoint. Conversion from radial to femoral access was more than 3-fold more common than the reverse in both the overall and PCI cohorts (table 1). 

Table 1. Efficacy and Feasibility

 

Radial

Femoral

OR (95% CI)

P Value

Bleeding or Vascular Complications

    PCI

    Overall

 

1.2%

0.6%

 

2.9%

1.7%

 

0.39 (0.12-1.27)

0.32 (0.12-0.90)

 

.12

 .03

Access-Site Crossover

    PCI

    Overall

 

6.1%

6.7%

 

1.7%

1.9%

 

3.65 (1.45-9.17)

3.70 (2.14-6.40)

 

< .01

< .01

 

The main reason for crossover from radial to femoral was radial artery spasm, affecting 42.9% of the PCI cohort and 43.6% of the overall study population. Procedure duration and total radiation dose did not differ between the 2 access routes. 

In addition, with regard to bleeding or vascular complications, there was no interaction with the volume of radial procedures performed at participating sites. 

Thirty-day follow-up in 84.2% of the PCI group showed similar rates of death, vascular complications, or unplanned revascularization between femoral and radial procedures. Additionally, 71.9% of patients assigned to radial preferred it for their next procedure, while only 23.5% of those assigned to femoral preferred to repeat the same access.

A New Approach to Trial Design  

Dr. Rao and colleagues write that this trial “demonstrates a new paradigm for conducting efficient pragmatic clinical trials.” It is the first randomized trial to compare radial and femoral approaches in cardiac catheterization or PCI and also the first to be performed solely in women, they note.

In an email with TCTMD, Dr. Rao highlighted the underrepresentation of women in interventional cardiology trials. This is especially true, he said, given that women “have worse outcomes from ischemic heart disease and more complications from guidelines-based therapies.” The cause of these differences in outcome remain unknown, he continued, adding, “We won’t know the best treatments for women unless we study them specifically.”

Robert W. Yeh, MD, MSc, of Massachusetts General Hospital (Boston, MA), agreed that sex differences are important to recognize.

“We know that women have more femoral bleeding complications than men, perhaps due to having smaller arteries that present greater challenges for obtaining access,” he told TCTMD in an email. “Women tend to be overdosed on anticoagulants more frequently, which likely contributes to bleeding. At the same time, transradial catheterization in women also may be more technically challenging due to smaller radial arteries and more difficulty engaging coronaries due to shorter stature.”

 

However, he said, it is unlikely that many future large randomized trials will focus exclusively on women. “In order for that type of design to make sense, there needs to be a strong belief that the biological response to the treatment being studied would differ between sexes,” Dr. Yeh commented, adding that he does expect to see a greater proportion of women being included in clinical trials overall.

The current study “is among the first to have utilized a pragmatic design, embedding itself within a large national registry to facilitate site selection and data acquisition,” Dr. Yeh observed. “There is much enthusiasm for this type of design to increase the feasibility and decrease costs associated with randomized trials. 

‘Radial-First’ Upheld

Given the results of SAFE-PCI, both Drs. Rao and Yeh support a radial-first approach in women undergoing cardiac cath—whether diagnostic or interventional.

“Although the study was technically a negative trial for the primary endpoint,… radial access reduced bleeding in the overall population of patients randomized in the study,” Dr. Yeh said. “Even in the nonsignificant primary result for the PCI subgroup, the point estimate strongly suggested reduced bleeding for radial access. There was no ‘cost’ in terms of fluoro time or contrast, and importantly, the patients themselves preferred radial access.”

Note: Coauthor Roxana Mehran, MD, is a faculty member of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 


Source: 
Rao SV, Hess CN, Barham B, et al. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the study of access site for enhancement of PCI for women (SAFE-PCI for Women) trial. J Am Coll Cardiol Intrv. 2014;7:857-867.

Disclosures:

 

 

  • The study was funded by Abbott Vascular, ACIST Medical, Daiichi Sankyo/Eli Lilly, Duke Clinical Research Institute, FDA Office of Women’s Health, Guerbet, Medtronic Vascular, Terumo Medical, and The Medicines Company.
  • Dr. Rao reports receiving consulting honoraria from Medtronic, Terumo Medical, and The Medicines Company.
  • Dr. Yeh reports no relevant conflicts of interest.

 

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