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

• Published in: JACC. Cardiovascular interventions 2020-07, Vol.13 (14), p.1709-1715
• Main Authors: Stabile, Eugenio, de Donato, Gianmarco, Musialek, Piotr, Deloose, Koen, Nerla, Roberto, Sirignano, Pasqualino, Mazurek, Adam, Mansour, Wassim, Fioretti, Vincenzo, Esposito, Fabrizio, Chianese, Salvatore, Bosiers, Marc, Setacci, Carlo, Speziale, Francesco, Micari, Antonio, Esposito, Giovanni
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Angioplasty - adverse effects; Angioplasty - instrumentation; Angioplasty - mortality; Carotid Stenosis - complications; Carotid Stenosis - diagnostic imaging; Carotid Stenosis - mortality; Carotid Stenosis - therapy; Databases, Factual; Female; Humans; Male; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Stents; Stroke - etiology; Thrombosis - etiology; Time Factors; Treatment Outcome
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2020.03.048

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.