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Radial access may be reasonable option for women undergoing PCI
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SAN FRANCISCO — Radial access may be preferable in women undergoing PCI or diagnostic catheterization, but clinicians should be aware that a proportion of patients will require conversion to femoral access, according to late-breaking data presented at TCT 2013.
In the multicenter SAFE-PCI for Women trial, researchers randomly assigned 1,787 women undergoing elective or urgent PCI or diagnostic catheterization with possible PCI across 60 US sites to a radial (n=893) or femoral (n=894) artery access approach. The primary efficacy endpoint was bleeding, (BARC types 2, 3 or 5) or vascular complications requiring intervention within 72 hours of index PCI or at hospital discharge. The primary feasibility endpoint was access site crossover, defined as the inability to complete the procedure from the assigned access site.
Among the patients who underwent PCI, those in the radial access group experienced a nonsignificant reduction in risk for bleeding or vascular complications (1.2% vs. 2.9%; OR=0.4, 95% CI, 0.1-1.3) compared with those in the femoral access group. However, access site crossover was significantly more common in the radial access group (6.1% vs. 1.7%; OR=3.6; 95% CI, 1.5-9.2).
Across the entire randomized cohort, including those who underwent diagnostic catheterization, risk for bleeding or vascular complications was significantly reduced in the radial access group, as compared with the femoral access group (0.6% vs. 1.7%; OR=0.3; 95% CI, 0.1-0.9), but the need for access site crossover was also significantly higher among these patients (6.7% vs. 1.9%; OR=3.7; 95% CI, 2.1-6.4). Radial artery spasm was the most frequent cause of conversion from radial to femoral access (43.6% of the crossover patients).
Sunil V. Rao
“Radial access did not significantly reduce bleeding or vascular complications in the subgroup of women undergoing PCI, but it did significantly reduce bleeding or vascular complications in the larger sample size of women undergoing cardiac catheterization or PCI,” Sunil V. Rao, MD, FSCAI, associate professor of medicine at Duke University, said. “Given the consistency of these data with prior trials comparing radial with femoral access in lower-risk groups, the … trial suggests 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 conversion to femoral access.”
For more information:
Rao SV. Plenary session IV. Late breaking clinical trials I. Presented at: TCT 2013; Oct. 27–Nov. 1, 2013; San Francisco.
Disclosure: The trial was funded by a consortium of academic, industry and government entities, including: Abbott Vascular, ACIST Medical, Eli Lilly, Guerbet, Medtronic, Terum Medical, The Medicines Company, the FDA Office of Women’s Health and the Duke Clinical Research Institute. Rao reported serving as a consultant for AstraZeneca and The Medicines Company.