1-Month Results From a Prospective Experience on CAS Using CGuard Stent System

• Published in: JACC. Cardiovascular interventions 2020-09, Vol.13 (18), p.2170-2177
• Main Authors: Sirignano, Pasqualino, Stabile, Eugenio, Mansour, Wassim, Capoccia, Laura, Faccenna, Federico, Intrieri, Francesco, Ferri, Michelangelo, Saccà, Salvatore, Sponza, Massimo, Mortola, Paolo, Ronchey, Sonia, Grillo, Placido, Chiappa, Roberto, Losa, Sergio, Setacci, Francesco, Pirrelli, Stefano, Taurino, Maurizio, Ruffino, Maria Antonella, Udini, Marco, Palombo, Domenico, Ippoliti, Arnaldo, Montelione, Nunzio, Setacci, Carlo, de Donato, Gianmarco, Ruggeri, Massimo, Speziale, Francesco
• Format: Article
• Language: English
• Subjects: carotid artery disease; carotid artery stenting; stroke
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2020.05.026

This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice. When compared with carotid endarterectomy, CAS has been associated with a 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 dual-layer mesh-covered carotid stent systems. From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates. Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%. This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up. [Display omitted]