Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study
Received 18 January 2020
Accepted for publication 15 May 2020
Published 8 July 2020 Volume 2020:16 Pages 271—284
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Takashi Kajiya
Stefanos Giannopoulos,1 Nicolas W Shammas,2 Ian Cawich,3 Cezar S Staniloae,4 George L Adams,5 Ehrin J Armstrong1
1Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of Colorado, Denver, CO, USA; 2Midwest Cardiovascular Research Foundation, Davenport, IA, USA; 3Arkansas Heart Hospital, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 4Leon H. Charney Division of Cardiology, New York University Langone Medical Center, New York, NY, USA; 5Department of Cardiology, North Carolina Heart and Vascular, Rex Hospital, UNC School of Medicine, Raleigh, NC, USA
Correspondence: Ehrin J Armstrong Email Ehrin.email@example.com
Introduction: Previous studies have suggested that women with chroniclimb-threatening ischemia (CLTI) may have worse outcomes than men. The aim of this study was to determine whether there are sex-related differences in outcomes of patients with CLTI undergoing endovascular treatment with current endovascular technologies.
Patients and Methods: Data were derived from the LIBERTY 360 study (NCT01855412). Hazard ratios and the respective 95% confidence intervals were synthesized to examine the association between sex and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE) and major amputation/death up to 3 years of follow-up.
Results: A total of 689 patients with CLTI (female: N=252 vs male: N=437) treated with any FDA approved or cleared device were included. The mean lesion length was 126.9± 117.3mm and 127.4± 113.3mm for the female and male patients, respectively. Although a slightly higher incidence of in-hospital mortality was observed in the female group (1.2% vs 0.0%, p=0.049), there was no difference in female vs male survival rates during follow-up. However, the risk of major amputation at 18 months was higher for the male group (male vs female: HR: 2.36; 95% CI: 1.09– 5.12; p=0.030). No difference between the two groups was detected in terms of TVR or MAE during follow-up.
Discussion: Data regarding sex-related disparity in outcomes after endovascular therapy of patients with CLTI are conflicting. Gender-related characteristics rather than biological sex characteristics might be the cause of these conflicting findings. Further studies are needed to evaluate the role of sex in revascularization outcomes among this high-risk population.
Keywords: endovascular repair, sex-specific, peripheral vascular disease, critical limb ischemia, chronic limb-threatening ischemia; revascularization
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