1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System: The IRONGUARD 2 Study.

Carotid Artery, Internal Carotid Stenosis / diagnostic imaging Humans Prospective Studies Stents Treatment Outcome
carotid artery disease carotid artery stenting stroke

Journal

JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004

Informations de publication

Date de publication:
13 09 2021
Historique:
received: 01 03 2021
revised: 10 05 2021
accepted: 18 05 2021
pubmed: 16 8 2021
medline: 3 11 2021
entrez: 15 8 2021
Statut: ppublish

Résumé

The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry. DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year. From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion. At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence. This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.

Sections du résumé

OBJECTIVES
The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry.
BACKGROUND
DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year.
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 at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion.
RESULTS
At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence.
CONCLUSIONS
This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.

Identifiants

DOI: 10.1016/j.jcin.2021.05.045 PMID: 34391704
pubmed: 34391704
pii: S1936-8798(21)01136-5
doi: 10.1016/j.jcin.2021.05.045
pii:
doi:

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

1917-1923

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Auteurs

Pasqualino Sirignano (P)

Vascular and Endovascular Surgery Unit, Department of Surgery, "Sapienza" University of Rome, Rome, Italy. Electronic address: pasqualino.sirignano@uniroma1.it.

Eugenio Stabile (E)

Division of Cardiology, Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy.

Wassim Mansour (W)

Vascular and Endovascular Surgery Unit, Department of Surgery, "Sapienza" University of Rome, Rome, Italy.

Laura Capoccia (L)

Vascular and Endovascular Surgery Unit, Department of Surgery, "Sapienza" University of Rome, Rome, Italy.

Federico Faccenna (F)

Vascular and Endovascular Surgery Unit, Department of Surgery, "Sapienza" University of Rome, Rome, Italy.

Francesco Intrieri (F)

Unit of Vascular and Endovascular Surgery, Annunziata Hospital, Cosenza, Italy.

Michelangelo Ferri (M)

Vascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy.

Salvatore Saccà (S)

Division of Cardiology, Mirano Public Hospital, Mirano, Italy.

Massimo Sponza (M)

Division of Vascular and Interventional Radiology, Udine University Hospital, Udine, Italy.

Paolo Mortola (P)

Department of Vascular and Endovascular Surgery, Galliera Hospital, Genoa, Italy.

Sonia Ronchey (S)

Unit of Vascular Surgery, Surgical Specialty Department, S. Filippo Neri Hospital, Rome, Italy.

Barbara Praquin (B)

Unit of Vascular Surgery, Surgical Specialty Department, S. Filippo Neri Hospital, Rome, Italy.

Placido Grillo (P)

Division of Cardiology, Sant. Anna Hospital, Catanzaro, Italy.

Roberto Chiappa (R)

Department of Vascular and Endovascular Surgery, Sandro Pertini Hospital, Rome, Italy.

Sergio Losa (S)

Cardiovascular Department, MultiMedica IRCCS Scientific Institute, Milan, Italy.

Francesco Setacci (F)

Cardiovascular Department, MultiMedica IRCCS Scientific Institute, Milan, Italy.

Stefano Pirrelli (S)

Division of Vascular Surgery, Carlo Poma Hospital, Mantova, Italy.

Maurizio Taurino (M)

Unit of Vascular Surgery, Department of Clinical and Molecular Medicine, "Sapienza" University of Rome, Sant'Andrea Hospital, Rome, Italy.

Maria Antonella Ruffino (MA)

Department of Diagnostic Imaging and Radiotherapy - Vascular Radiology, Città della Salute e della Scienza di Torino, Turin, Italy.

Marco Udini (M)

Vascular Surgery, Moriggia Pelascini Hospital, Gravedona, Como, Italy.

Domenico Palombo (D)

Vascular and Endovascular Surgery Unit, IRCCS Ospedale Policlinico San Martino, University of Genoa, Genoa, Italy.

Arnaldo Ippoliti (A)

Vascular Surgery Unit, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.

Nunzio Montelione (N)

Vascular Surgery, University of Campus Biomedico of Rome, Rome, Italy.

Carlo Setacci (C)

Department of Medicine, Surgery and Neuroscience, Vascular and Endovascular Surgery, University of Siena, Siena, Italy.

Gianmarco de Donato (G)

Department of Medicine, Surgery and Neuroscience, Vascular and Endovascular Surgery, University of Siena, Siena, Italy.

Massimo Ruggeri (M)

Vascular Surgery, San Camillo de Lellis Hopital, Rieti, Italy.

Francesco Speziale (F)

Vascular and Endovascular Surgery Unit, Department of Surgery, "Sapienza" University of Rome, Rome, Italy.

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Classifications MeSH

questionsmedicales.fr › Système cardiovasculaire › Vaisseaux sanguins › Artères › Artères carotides › Artère carotide commune › Artère carotide interne › 1-Year Results From a Prospective Experience...
questionsmedicales.fr › Maladies cardiovasculaires › Maladies vasculaires › Angiopathies intracrâniennes › Artériopathies carotidiennes › Sténose carotidienne › 1-Year Results From a Prospective Experience...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › 1-Year Results From a Prospective Experience...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › 1-Year Results From a Prospective Experience...
questionsmedicales.fr › Équipement et fournitures › Prothèses et implants › Endoprothèses › 1-Year Results From a Prospective Experience...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › 1-Year Results From a Prospective Experience...