Abstract
BACKGROUND: We investigated the sex-specific variations in distal radial access (DRA)-associated outcomes, as well as the factors influencing these outcomes, by utilizing a comprehensive real-world registry. METHODS: In this post-hoc analysis of the KODRA (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach) trial, we selected 4608 patients who underwent successful coronary procedures, including percutaneous coronary intervention or coronary angiography, via DRA. Primary end points were overall DRA site outcomes including bleeding, radial artery occlusion, tenderness, hand edema, numbness, perforation, and dissection. We performed both propensity score matching and multivariable logistic regression to evaluate sex-specific differences in DRA-associated outcomes. Moreover, a multivariable analysis using logistic regression was also performed to evaluate the independent associated factors of DRA site outcomes. RESULTS: The mean age was 66.5±11.8 years, and 67.8% (3125 men and 1483 women) were male among 4608 enrolled patients. The incidence of overall DRA site outcomes was significantly higher in women than in men (7.5% versus 4.1%, P<0.001). However, there was no major bleeding in both groups. In the multivariable analysis, female sex was a significant risk factor of overall DRA site outcomes, along with body mass index, chronic kidney disease, percutaneous coronary intervention procedure, use of potent P2Y(12) inhibitor, and unfractionated heparin dose. CONCLUSIONS: This subgroup analysis of the KODRA trial by sex showed that overall DRA site outcomes following coronary procedures via DRA were more common in women than in men. However, no major bleeding was observed in either men or women. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04080700.