Impact of Sex on Outcomes With Femoral Artery Closure Devices Versus Manual Compression in Patients Undergoing Percutaneous Coronary Intervention

Abstract

Background and aims: Femoral artery access is widely used despite recent increase in radial access for percutaneous coronary interventions (PCI). Femoral artery closure devices are used to shorten vascular closure time and reduce bleeding. We sought to examine sex-based outcomes of femoral artery vascular closure devices (VCD) in patients undergoing PCI. Methods: We identified patients who had undergone PCI (n = 11,415) in the Indiana University Health Multicenter Cardiac Cath registry using femoral artery access. Clinical outcomes were compared between VCD and manual compression and analyzed according to sex. Patients with cardiogenic shock and left ventricular support devices were excluded. Results: The use of any vascular closure device as compared to femoral artery manual compression was associated with a reduction in 72-h bleeding events (adjusted odds ratio [OR]: 0.64; 95% confidence interval [CI]: 0.46-0.87). With manual compression, women had higher rates of 72-h bleeding as compared to men (4.5% vs. 1.6%, p < 0.001). Women demonstrated greater absolute risk reduction in 72-h bleeding events with use of VCD as compared to men (2.8% vs. 0.8%, p < 0.001). For women, VCD were associated with lower risk of access site bleeding (OR: 0.43; 95% CI: 0.24-0.8), hematoma (OR: 0.36; 95% CI: 0.2-0.63), and vascular complications (OR: 0.25, 95% CI: 0.09-0.72). Use of VCD was associated with lower risk of in-hospital death (adjusted OR: 0.4; 95% CI: 0.28-0.58; p < 0.001) in multivariable regression analysis. Conclusion: Women derive more benefit from use of femoral artery VCD during PCI than men with greater reduction in bleeding rates, access site hematoma, and vascular complications.