Abstract
PURPOSE: This study aims to evaluate the safety and efficacy of the CGuard dual-layer stent with its mesh embolic protection system (EPS) in elective cases for treatment of internal carotid artery stenosis and compares it to the Carotid Wallstent as benchmark. METHODS: In this retrospective, multicenter study, we analyzed data from consecutive patients who underwent carotid artery stenting with CGuard at two high-volume neurointerventional centers and compared them with prior consecutive patients treated with Carotid Wallstent (CWS), with and without a balloon guiding catheter (BGC) as protection, at the same institutions. Patient demographics, procedural details, clinical complications, early in-stent thrombosis and occlusion rates, and late follow-up restenosis rates were assessed. RESULTS: A total of 428 patients were treated, 144 with the CGuard stent, 203 with CWS + BGC and 83 with CWS-BGC, the majority of patients for symptomatic stenoses. Technical success was achieved in 98.6% of CGuard patients. No clinical complications were observed in CGuard patients, however the clinical complication rate was 2.96% (6/203) for CWS + BGC and 4.94% (4/83) for CWS-BGC patients (p = 0.052). The in-hospital stent occlusion rate was 0.69% (1/144) for CGuard and 2.1% (6/286) in CWS ± BGC patients (p = 0.49). On long-term follow-up (mean 9.9 months) the CGuard demonstrated a comparatively low rate of restenosis (6.25%) and retreatment (2.1%). CONCLUSION: The CGuard dual-layer stent was safe and effective for carotid artery stenting in our series. Its design appears to contribute to a low risk of periprocedural complications, high technical success rate, while maintaining restenosis rates comparable to the Carotid Wallstent.