Twelve months results from a prospective real-world multicenter clinical practice of CAS using the CGuard Embolic Prevention System (EPS): the IRONGUARD 2 study

Abstract

Abstract Objectives When compared to carotid endarterectomy, carotid artery stenting (CAS) has been associated to a higher rate of post procedural neurologic events, potentially related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual layered mesh covered carotid stent systems (DLS). However, recent reports demonstrated that these devices are also associated with a not-negligible restenosis rate among the studies. Aim of this registry was to evaluate 1-year safety and efficacy of DLS for CAS in the clinical practice. Methods From January 2017 to June 2019 a physician-initiated, prospective, multispecialty, registry enrolled 733 consecutive patients undergoing CAS using the CGuard Embolic Prevention System (EPS) in 20 centres. The primary endpoint was the occurrence of death and stroke at 1 year; secondary endpoints were transient ischemic attack (TIA), acute myocardial infarction (AMI), restenosis rate and in-stent thrombosis, ECA occlusion at 1 year. Results Among all enrolled subjects, late results were collected for 726 patients (99.04%). Dual antiplatelet therapy was maintained for at least 30 days post-procedurally in all patients, and for 3 months in 295 (40.63%), according with each center routine practice. After 30th post-operative day, new neurological adverse event was detected in 5 patients (0.68%), accounting for 1 minor stroke (0.13%), and 4 (0.55%) transient ischemic attacks. Eight patients (1.10%) died during the study period: 2 fatal acute myocardial infarctions (0.27%), 4 malignancies (0.55%), 1 suicide (0.13%), 1 undefined complication in Guillain-Barré Syndrome (0.13%). At duplex ultrasound examination, internal carotid artery was found patent in all but two patients (0.27%), and 2 asymptomatic in-stent restenosis (0.27%) were judged to be severe (>70%, peak systolic velocity >450cm/sec) and successfully treated by stent-in-stent. External carotid artery patency rate was 98.8% (718/726). At univariate analysis, post-dilatation (p=0.62; OR: 0.67; CI95%: 0.13–3.34), and dual antiplatelet therapy duration (p=0.97; OR: 0.96; CI95%: 0.11–8.31) were found to be not statistically related to occlusion and/or restenosis occurrence. Conclusion This real-world registry suggests that use of EPS in clinical practice is safe and associated to a minimal occurrence of adverse neurological events up to 12 months follow up. Funding Acknowledgement Type of funding sources: None.