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

The aim of this study was to provide perioperative and mid-term evaluation, safety, and efficacy of CGuard (InspireMD) micromesh self-expanding stent with an embolic protection system during a carotid artery stenting (CAS) procedure.

All patients who underwent CAS with CGuard stent from January 2016 to June 2024 in a tertiary center were prospectively evaluated. The primary end points 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, myocardial infarction (major adverse event), occurring within 30 days and the rate of stroke, death, and restenosis during the follow-up.

A total of 218 consecutive patients underwent 226 CAS procedures with the CGuard stent during the study period. There were 142 male (63%) and mean age was 74.3 ± 8.0 years. Fifty-nine patients (26%) had a symptomatic stenosis. Technical success was 99.5%, because in 1 patient advancing the CGuard stent in a tight stenosis was impossible despite predilation. The mean procedural time was 33 minutes, the mean fluoroscopic time was 11 minutes, and the mean contrast media used was 41 mL. At 30 day, one patient had a transient ischemic attack (0.5%) and another patient experienced a minor stroke (0.5%). No patient died or developed myocardial infarction. The mean hospitalization duration after the procedure was 1.5 days. The 30-day rate of major adverse event was 0.5%. During a mean follow-up 35 months (range, 1-84 months), one patient had an asymptomatic stent occlusion and two patients experienced restenosis >70% successfully treated with a secondary stenting procedure in one case and stent explantation with Dacron patch closure in the other. The estimate of freedom from restenosis was 99.4% at 1 year, 97.5% at 3 years, and 97.5% at 5 years. Freedom from ipsilateral stroke was estimated 99.6% at 1 year, 98.7% at 3 years, and 98.7% at 5 years. The actuarial survival rate was 97.4% at 1 year, 92.4% at 3 years, and 78.7% at 5 years.

Preliminary data suggest that the CGuard stent with embolic protection system is an effective and safe device for the treatment of carotid artery stenosis with acceptably low perioperative and mid-term neurological event and durable patency rate. Larger, multicenter, randomized studies are advocated to confirm these findings.