Author + information
- Received November 19, 2019
- Revision received March 11, 2020
- Accepted March 31, 2020
- Published online July 20, 2020.
- Eugenio Stabile, MD, PhDa,∗∗ (, )@eugenio_stabile,
- Gianmarco de Donato, MD, PhDb,∗,
- Piotr Musialek, MD, PhDc,
- Koen Deloose, MDd,
- Roberto Nerla, MDe,
- Pasqualino Sirignano, MDf,
- Adam Mazurek, MDc,
- Wassim Mansour, MDf,
- Vincenzo Fioretti, MDa,
- Fabrizio Esposito, MDa,
- Salvatore Chianese, MDa,
- Marc Bosiers, MDd,
- Carlo Setacci, MDb,
- Francesco Speziale, MDf,
- Antonio Micari, MDe and
- Giovanni Esposito, MD, PhDa
- aDivision of Cardiology, Department of Advanced Biomedical Sciences, University of Naples “Federico II”, Naples, Italy
- bDivision of Vascular surgery, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy
- cDepartment of Cardiac and Vascular Diseases, Jagiellonian University, John Paul II Hospital, Krakow, Poland
- dDepartment of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium
- eInterventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy
- fVascular and Endovascular Surgery Division, Department of Surgery “Paride Stefanini”, Policlinico Umberto I, “Sapienza” University of Rome, Rome, Italy
- ↵∗Address for correspondence:
Prof. Eugenio Stabile, Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples “Federico II,” Via Sergio Pansini 5, Naples, Italy.
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.
↵∗ Drs. Stabile and de Donato contributed equally to this work.
Dr. Musialek has received fees for serving on advisory boards, consulting, and proctoring for Abbott, InspireMD, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received November 19, 2019.
- Revision received March 11, 2020.
- Accepted March 31, 2020.
- 2020 American College of Cardiology Foundation
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