Use of Dual-Layered Stents for Carotid Artery Angioplasty: 1-Year Results of a Patient-Based Meta-Analysis.


Journal

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

Informations de publication

Date de publication:
27 07 2020
Historique:
received: 19 11 2019
revised: 11 03 2020
accepted: 31 03 2020
entrez: 25 7 2020
pubmed: 25 7 2020
medline: 20 1 2021
Statut: ppublish

Résumé

This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS). Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published. The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year. Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis. This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate.

Sections du résumé

OBJECTIVES
This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS).
BACKGROUND
Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published.
METHODS
The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year.
RESULTS
Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis.
CONCLUSIONS
This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate.

Identifiants

pubmed: 32703595
pii: S1936-8798(20)30872-4
doi: 10.1016/j.jcin.2020.03.048
pii:
doi:

Types de publication

Journal Article Meta-Analysis

Langues

eng

Sous-ensembles de citation

IM

Pagination

1709-1715

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Auteurs

Eugenio Stabile (E)

Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples "Federico II", Naples, Italy. Electronic address: geko50@hotmail.com.

Gianmarco de Donato (G)

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

Piotr Musialek (P)

Department of Cardiac and Vascular Diseases, Jagiellonian University, John Paul II Hospital, Krakow, Poland.

Koen Deloose (K)

Department of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.

Roberto Nerla (R)

Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.

Pasqualino Sirignano (P)

Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

Adam Mazurek (A)

Department of Cardiac and Vascular Diseases, Jagiellonian University, John Paul II Hospital, Krakow, Poland.

Wassim Mansour (W)

Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

Vincenzo Fioretti (V)

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

Fabrizio Esposito (F)

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

Salvatore Chianese (S)

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

Marc Bosiers (M)

Department of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.

Carlo Setacci (C)

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

Francesco Speziale (F)

Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

Antonio Micari (A)

Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.

Giovanni Esposito (G)

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

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Classifications MeSH