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Randomized Controlled Trial
. 2014 Aug;7(8):857-67.
doi: 10.1016/j.jcin.2014.04.007.

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

Sunil V Rao  1 , Connie N Hess  2 , Britt Barham  2 , Laura H Aberle  2 , Kevin J Anstrom  2 , Tejan B Patel  3 , Jesse P Jorgensen  4 , Ernest L Mazzaferri Jr  5 , Sanjit S Jolly  6 , Alice Jacobs  7 , L Kristin Newby  2 , C Michael Gibson  8 , David F Kong  2 , Roxana Mehran  9 , Ron Waksman  10 , Ian C Gilchrist  11 , Brian J McCourt  2 , John C Messenger  12 , Eric D Peterson  2 , Robert A Harrington  13 , Mitchell W Krucoff  2
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Free article
Randomized Controlled Trial

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

Sunil V Rao et al. JACC Cardiovasc Interv. 2014 Aug.
Free article

Abstract

Objectives: This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial.

Background: Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear.

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 to 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 to 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 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access.

Conclusions: In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236).

Keywords: PCI; radial approach; women and heart disease.

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