1-Month Results From a Prospective Experience on CAS Using CGuard Stent System: The IRONGUARD 2 Study: JACC: Cardiovascular Interventions

P. Sirignano, E. Stabile, W. Mansour, L. Capoccia, F. Faccenna, F. Intrieri, M. Ferri, S. Saccà, M. Sponza, P. Mortola, S. Ronchey, P. Grillo, R. Chiappa, S. Losa, F. Setacci, S. Pirrelli, M. Taurino, M.A. Ruffino, M. Udini, D. PalomboA. Ippoliti, N. Montelione, C. Setacci, G. de Donato, M. Ruggeri, F. Speziale

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: 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. Background: 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. 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 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. Results: 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%. Conclusions: 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. © 2020 American College of Cardiology Foundation
Original languageEnglish
Pages (from-to)2170-2177
Number of pages8
JournalJACC Cardiovasc. Interventions
Volume13
Issue number18
DOIs
Publication statusPublished - 2020

Keywords

  • carotid artery disease
  • carotid artery stenting
  • stroke
  • acute heart infarction
  • aged
  • Article
  • cardiovascular mortality
  • carotid artery obstruction
  • cerebrovascular accident
  • clinical outcome
  • clinical practice
  • device safety
  • dual antiplatelet therapy
  • embolism prevention
  • external carotid artery
  • female
  • femoral artery
  • follow up
  • hemostasis
  • hospital discharge
  • hospital mortality
  • hospitalization
  • human
  • major clinical study
  • male
  • peroperative complication
  • postoperative complication
  • priority journal
  • prospective study
  • transient ischemic attack

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