Sunil Rao (Duke Clinical Research Institute, Durham, USA) reported—according to the results of SAFE-PCI for Women trial—that an initial strategy of transradial access is reasonable in women undergoing cardiac catheterisation because it is associated with less bleeding or vascular complications than the transfemoral approach “with the recognition that a proportion of patients will require conversion to femoral access”.
Presenting the study at the 25th annual Transcatheter Cardiac Therapeutics meeting (TCT; 27 October–1 November, San Francisco, USA), Rao explained that the SAFE-PCI (Study of access enhancement of percutaneous coronary intervention) for Women trial was conducted because the role of transradial access in women undergoing PCI was “unclear”. He noted: “Women undergoing PCI present a unique challenge; while they are at higher risk of bleeding [therefore, may be more suited to the transradial approach because it is associated with a lower risk of bleeding than the transfemoral approach], they have smaller radial arteries and are more prone to radial spasm—which has been implicated as a cause of transradial procedure failure.” Rao added that women have been significantly under-represented in studies comparing the transfemoral approach with the transradial approach. “Accordingly, we conducted the SAFE-PCI for Women trial to determine the efficacy and feasibility of transradial PCI in women.”
In the study, women undergoing urgent or elective PCI, or diagnostic catheterisation with the possibility of PCI were randomised to the transfemoral or the transradial approach. The primary efficacy endpoint, at 72 hours after the procedure or hospital discharge (whichever came sooner), was the rate of bleeding or vascular complications and the primary feasibility endpoint was the rate of access site crossover (defined at the inability to complete the procedure at the assigned access site). There were two pre-specified analysis cohorts: the total randomised cohort and a subgroup of patients within the total cohort who underwent PCI (PCI cohort).
Initially, Rao explained, the investigators planned to enrol 3,000 patients (of which, an estimated 1,800 would undergo PCI). They assumed that the rate of bleeding or vascular complications with femoral access approach would be 8% and that the radial access approach would reduce this rate by 50%. However, he commented: “The rate of the primary efficacy endpoint was markedly lower than expected. Our data safety monitoring board recommended the termination of the trial because it was unlikely to show a difference in the planned sample size. As there were no safety issues, the steering committee voted to continue the study until enrolment in a quality of life substudy was complete. By the time of the substudy enrolment was complete (300 patients), we had randomised 1,787 women.”
Of these, 893 (of whom, 345 underwent PCI) were randomised to receive the radial approach and 894 (of whom, 345 underwent PCI) were randomised to receive the femoral approach. In the PCI cohort, the radial approach was associated with a 60% reduction (1.2% vs. 2.9% for the femoral approach) in the rate of bleeding or vascular complications but this did not reach statistical significance (p=0.12). Rao noted that there was a 70% reduction with the radial approach that did reach statistical significance in the total randomised cohort (0.6% vs. 1.7%, respectively; p=0.03) and added: “There was no significant interaction between PCI and diagnostic catheterisation for the primary efficacy endpoint, indicating that the benefit of radial access in reducing bleeding or vascular complications was consistent across both cohorts.”
In both the total and PCI cohorts, the radial approach was associated with a significantly increased rate of access site crossover and Rao said: “The most common reason for needing to convert to femoral from radial access to complete the procedure was radial artery spasm.”
“The SAFE-PCI for Women trial suggests that an initial strategy of radial access is reasonable and may be preferred [the majority of women in the study said they preferred the radial approach] in women, with the recognition that a proportion of patients will require conversion to femoral access,” he concluded, adding that the construct of the trial—which involved enrolling patients via the National Cardiovascular Data Infrastructure—was a promising approach for future clinical investigators as it produced higher quality data, reduced site workload, and reduced costs.