Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence.Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362.
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.
Conclusions: Many factors that patients with symptomatic PAD consider important and terms that they use to communicate are absent from consensus treatment guidelines. Areas of mismatch between patientand clinician-defined decision approaches and terminology represent opportunities for development of more patient-centered approaches to care and communication.Objectives: This study retrospectively created a predictive score for primary patency (PP) in patients with critical limb ischemia (CLI) operated on with the use of a heparin-bonded expanded polytetrafluoroethylene (ePTFE) bypass graft (Hb-ePTFE) in a large multicenter registry.Methods: Over a 13-year period, ending in December 2014, a Hb-ePTFE graft was implanted in 683 patients undergoing below-knee revascularization for CLI in seven Italian vascular hospitals. Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Follow-up results were analyzed in terms of PP: univariate and multivariable analyses with Kaplan-Meier estimates were used to identify potential significant predictors of such end point at 3 years, and then a predictive risk score was constructed by dividing the
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