Sex-Related Outcomes in Asymptomatic Patients Undergoing Carotid Artery Stenting

Abstract

Purpose: Aim of the study was to evaluate the influence of sex in asymptomatic patients undergoing carotid artery stenting (CAS). Materials and Methods: A retrospective observational study was conducted from January 2006 to December 2020. A total of 438 consecutive patients with asymptomatic carotid artery stenosis >70% underwent transfemoral CAS and were stratified in males (M) and females (F). Periprocedural 30-day outcomes were: stroke, death, and myocardial infarction (MI). Follow-up outcomes were: death and stroke rates (primary) and freedom from restenosis (FFR) and reintervention rates (secondary). Follow-up data were analyzed at 1, 5, and 10 years. Data were analyzed with χ2 test and Fisher’s exact test and follow-up outcomes with Kaplan-Meier curves. The log-rank test was used to determine differences between the groups and univariate analysis to identify the association between risk factors and intraoperative details with mortality and restenosis rates. Results: A total of 462 procedures were performed (M: n=321, 69.4%), in which 24 CAS were bilateral (5.5%). Mean age was 71.9±7.6 years (M: 72.1±7.8; F: 71.7±7.3). Periprocedural outcomes were: stroke rate 2.2% (n=10; M: n=5, 1.6%; F: n=5, 3.5%; p=0.176), mortality rate 0.6% (M: n=3, p=0.334), and stroke/death rate 2.8% (n=13; M: n=8, 2.5%; F: n=5, 3.5%; p=0.528); no cardiac events (MI) were recorded. A not-disabling (minor) stroke was detected in 3 males (0.9%), while a disabling (major) stroke was reported in 7 patients (1.7%) of whom 5 were ischemic events (M: n=2, 0.6%; F: n=3, 2.2%) and 2 were cerebral hemorrhages (F: 1.3%, p=0.046). Mean follow-up was 73.66±40.83 months (M: 72.66; F: 76.01; p=0.246). Overall survival rate was 96.1% (95% confidence interval [CI]: 93–98), 81.8% (95% CI: 77–86), and 45.5% (95% CI: 38–53) at 1, 5, and 10 years, respectively (p=0.236). The overall stroke rate was 0.3% (freedom from stroke [FFS]: 99.7%; 95% CI: 98–100), 0.9% (FFS: 99%; 95% CI: 98–100), and 4.3% (FFS: 95.7%; 95% CI: 89–98; M: n=6; F: n=2; p=0.774). Stroke-related mortality rate was 0.7% (FFS: 99.3%; 95% CI: 97–100) and 2.9% (FFS: 97.1%; 95% CI: 91–99) at 5 and 10 years, respectively, without differences between the groups (M: n=4; F: n=2; p=0.763). Overall FFR rate was 97.4% (95% CI: 95–99), 93.4% (95% CI: 90–96), and 89.5% (95% CI: 84–93; p=0.322). Two severe symptomatic restenosis (>70%, M) required a new endovascular revascularization. Conclusion: The sex variable does not influence outcomes of CAS in asymptomatic patients at short- and long-term follow-up, although females show a worst incidence of periprocedural major strokes. Carotid artery stenting may be safely proposed when a careful patient selection is applied. Clinical Impact The sex variable has been advocated as a considerable factor that could influence the outcomes of transfemoral carotid artery stenting (CAS). Literature data are contrasting, even if different papers mainly reported that CAS is associated to worst outcomes in female patients. Our study shows that the sex-variable does not influence outcomes of CAS in asymptomatic patients at short and long-term follow-up, although females had a worst incidence of periprocedural major strokes. CAS may be safely proposed when a careful patient selection is applied.