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.

1-Year results from a prospective experience on CAS using the CGuard stent system: The IRONGUARD 2 study / Sirignano, Pasqualino; Stabile, Eugenio; Mansour, Wassim Ahmad; Capoccia, Laura; Faccenna, Federico; Intrieri, Francesco; Ferri, Michelangelo; Saccà, Salvatore; Sponza, Massimo; Mortola, Paolo; Ronchey, Sonia; Praquin, Barbara; Grillo, Placido; Chiappa, Roberto; Losa, Sergio; Setacci, Francesco; Pirrelli, Stefano; Taurino, Maurizio; Antonella Ruffino, Maria; Udini, Marco; Palombo, Domenico; Ippoliti, Arnaldo; Montelione, Nunzio; Setacci, Carlo; de Donato, Gianmarco; Ruggeri, Massimo; Speziale, Francesco. - In: JACC. CARDIOVASCULAR INTERVENTIONS. - ISSN 1876-7605. - (2021), pp. 1-7. [10.1016/j.jcin.2021.05.045]

1-Year results from a prospective experience on CAS using the CGuard stent system: The IRONGUARD 2 study

Pasqualino Sirignano
Primo
Writing – Original Draft Preparation
;
Wassim Mansour;Laura Capoccia;Federico Faccenna;Maurizio Taurino;Nunzio Montelione;Francesco Speziale
Ultimo
2021

Abstract

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.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1571235
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