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Radial approach reduces complications in angiography, PCI
Women who undergo coronary angiography and PCI have a greater risk for major vascular complications compared with men, but use of radial access was associated with reduced complications in both sexes, according to new data from the RIVAL study.
Researchers conducted a prespecified subgroup analysis of 1,861 women and 5,160 men randomly assigned to radial or femoral access in the RIVAL study of patients with ACS planned for invasive therapy.
Radial access benefited both sexes
Overall, the risk for major vascular complications was 4.7% among women vs. 1.7% among men (P < .0001). However, major vascular complications were reduced with radial access in both women (3.1% vs. 6.1%; HR = 0.5; 95% CI, 0.32-0.78) and men (0.7% vs. 2.8%; HR = 0.27; 95% CI, 0.17-0.45). The number needed to treat with radial access to prevent one vascular complication was 33 in women and 49 in men, Shaheen Pandie, MBChB, MMed, from McMaster University and Population Health Research Institute, Hamilton, Ontario, Canada, and colleagues wrote.
The rate of crossover from radial to femoral or vice versa was higher in the group of patients assigned radial access compared with those assigned femoral access (women: 11.1% vs. 1.9%; HR = 5.88; P < .001; men: 6.3% vs. 1.9%; HR = 3.32; P < .0001; P for interaction = .054). The higher crossover rate from radial to femoral access among women was driven by a higher rate of radial artery spasm (women: 9.5%; men: 3.5%; P < .001).
PCI success rates were similar regardless of access site (women: HR = 1.05; P = .471; men: HR = 1; P = .888; P for interaction = .674), and no differences in PCI complications were observed.
When Pandie and colleagues conducted multivariable analyses, female sex was an independent predictor of major vascular complications (HR = 2.39; 95% CI, 1.76-3.25), along with increase in age per 10 years (HR = 1.41; 95% CI, 1.22-1.61), performance of PCI vs. no PCI (HR = 2.07; 95% CI, 1.41-3.04) and use of glycoprotein IIb/IIIa inhibitors (HR = 1.48; 95% CI, 1.07-2.03).
Significant predictors for radial-to-femoral access-site crossover included female sex (HR = 1.39; 95% CI, 1.04-1.85), increase in age per 10 years (HR = 1.14; 95% CI, 1.03-1.26) and previous CABG (HR = 2.95; 95% CI, 1.93-4.5).
There was no difference between the sexes for the RIVAL trial’s primary composite endpoint of death, MI, stroke and non-CABG bleeding (women: 3.9% vs. 5%; HR = 0.77; 95% CI, 0.5-1.19; men: 3.54% vs. 3.5%; HR = 1; 95% CI, 0.75-1.34; P for interaction = .325).
Study limitations
In a related editorial, Ellen C. Keeley, MD, MS, and Vertilio M. Cornielle-Caamano, MD, from the department of medicine, division of cardiology, University of Virginia, Charlottesville, noted several limitations of the study. The parent trial was not powered to assess differences between the sexes and not stratifying randomization according to sex, which could lead to selection bias; experience of the operator with the radial technique was not accounted for; and the study did not address the influence of choice of pharmacotherapy on vascular access site complications, according to Keely and Cornielle-Caamano.
The ongoing SAFARI-STEMI study “should help to tease out the relative effect of access site and choice of pharmacotherapy on bleeding complications in high-risk men and women undergoing PCI,” they wrote. – by Erik Swain
Disclosures: One researcher reports receiving grant support from Medtronic and speaker fees from AstraZeneca and St. Jude Medical. Another researcher reports consulting for and receiving an honorarium from Terumo Medical. Keeley and Cornielle-Caamano report no relevant financial disclosures.