One-month results from a prospective experience on CAS using C-GUARD stent system: the IRONGUARD-2 study

Abstract

Abstract Objectives To evaluate 30-day safety and efficacy of dual layered mesh covered carotid stent systems (DLS) for carotid artery stenting (CAS) in the clinical practice. Background When compared to carotid endarterectomy CAS has been associated to an higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of DLS. 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. Primary endpoint was the stroke up to 30 days; secondary endpoints were the technical and procedural success; external carotid artery (ECA) occlusion; in-hospital and 30 days transient ischemic attack (TIA), acute myocardial infarction (AMI) and death rates. Results Symptoms were present in 131 patients (17.87%). An embolic protection device (EPD) was used in 731 patients (99.72%). Procedural success was 100%, technical success was obtained in all but one patient (99.86%), who died in-hospital due to a haemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, ECA occlusion was evident in 8 patients (1.09%). Between hospital discharge and 30-day, 2 TIAs, 1 minor stroke and 3 AMIs occurred. Therefore, the stroke rate at 30 days was 0.13. Conclusion This real-world registry suggests that use of CGuard EPS in clinical practice is safe and associated to a minimal occurrence of adverse neurological events up to 30 days follow up. Funding Acknowledgement Type of funding source: None