RS05 - Eight year single center experience with double layer carotid stent

Objectives: The aim of this study was to provide perioperative and mid term evaluation, safety, and efficacy of CGuard (InspireMD, Tel Aviv, Israel) micromesh self-expanding stent with embolic protection system (EPS) during carotid artery stenting (CAS) procedure

Methods: All patients who underwent CAS with CGuard stent from January 2016 to Dicember 2023 in a tertiary center were prospectively evaluated. Primary end point were technical success, combined risk of any stroke or death within 30 days (perioperative) and any ipsilateral stroke after the procedure. Secondary end points were stroke, death, transient ischemic attack (TIA), myocardial infarction (major adverse event or MAE), occurring within 30 days and the rate of stroke, death, and restenosis during the follow-up

Results: A total of 207 patients underwent CAS with C guard stent during the study period. There were 133 male (64%) and mean age was 72.6 (+ 8,1) years. Fifty six patients (27%) had a symptomatic stenosis. Technical success was 99,5%, as in one patient advancing the C guard stent in a tight stenosis resulted impossible despite the predilation . Mean procedural time was 37 minutes, mean fluoro time was 12 min, mean contrast media used was 39 ml. At 30 day, 1 patients had transient ischemic attack (0.5%) and another one patient experienced minor stroke (0.5%). No patient died or developed myocardial infarction. Mean hospitalization lenght after procedure was 1.5 days. The 30-day rate of MAE was 0.5%. During a mean follow-up 35 months (range 1-84) 1 patient had asymptomatic stent occlusion and 1 patient experienced restenosis > 70% successfully treated with a secondary stenting procedure. Estimate of freedom from restenosis was 100% at 30 days, 99,1% at 1 year, 98.3% at 3 years and 98,3% at 5 years (Figure 1). Estimate freedom from ipsilateral stroke was 99.5% at 30 days, 99,5% at 1 year, 97,2 at 3 years and 97,2 at 5 years (Figure 2) . Actuarial survival rate was 100% at 30 days, 94.9% at 1 year, 84,3% at 3 years and 74,9% at 5 years

Conclusions: Preliminary date suggests that CGuard stent with EPS is an effective and safe device for the treatment of carotid artery stenosis with acceptable low perioperative and mid term neurological events and durable patency rate.
Larger multicenter and randomized studies are advocated to confirm these findigs.