Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study.
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.
['Giannopoulos|Stefanos|S|0000-0002-1942-911X', 'Shammas|Nicolas W|NW|0000-0001-8279-0111', 'Cawich|Ian|I|', 'Staniloae|Cezar S|CS|', 'Adams|George L|GL|0000-0002-9820-943X', 'Armstrong|Ehrin J|EJ|']
D000368:Aged D000369:Aged, 80 and over D000671:Amputation D000800:Angioplasty, Balloon D002423:Cause of Death D002908:Chronic Disease D005260:Female D017052:Hospital Mortality D006801:Humans D007511:Ischemia D023821:Limb Salvage D008297:Male D008875:Middle Aged D058729:Peripheral Arterial Disease D011446:Prospective Studies D018570:Risk Assessment D012307:Risk Factors D012737:Sex Factors D013997:Time Factors D016896:Treatment Outcome
chronic limb-threatening ischemia revascularization critical limb ischemia endovascular repair peripheral vascular disease sex-specific