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A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).
Tarantini, Giuseppe; Cardaioli, Francesco; De Iaco, Giuseppe; Tuccillo, Bernardino; De Angelis, Maria Carmen; Mauro, Ciro; Boccalatte, Marco; Trivisonno, Antonio; Ribichini, Flavio; Vadalà, Giuseppe; Caramanno, Giuseppe; Caruso, Marco; Lombardi, Mario; Fischetti, Dionigi; Danesi, Alessandro; Abbracciavento, Leonardo; Lorenzoni, Giulia; Gregori, Dario; Panza, Andrea; Nai Fovino, Luca; Esposito, Giovanni.
Afiliación
  • Tarantini G; Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padova, Italy.
  • Cardaioli F; Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padova, Italy.
  • De Iaco G; Department of Cardiology, Hospital "Cardinal G. Panico", Tricase, Italy.
  • Tuccillo B; U.O.C. Cardiologia, P.O. Ospedale del Mare, Napoli, Italy.
  • De Angelis MC; U.O.C. Cardiologia, P.O. Ospedale del Mare, Napoli, Italy.
  • Mauro C; Department of Cardiology, Hospital Cardarelli, Naples, Italy.
  • Boccalatte M; Interventional Cardiology Unit, Ospedale Santa Maria Delle Grazie Pozzuoli, Napoli, Italy.
  • Trivisonno A; Department of Cardiovascular Disease, "Antonio Cardarelli" Hospital, Campobasso, Italy.
  • Ribichini F; Division of Cardiology, AOUI Verona, Verona, Italy.
  • Vadalà G; Division of Cardiology, University Hospital Paolo Giaccone, Palermo, Italy.
  • Caramanno G; Interventional Cardiology, San Giovanni di Dio Hospital, Agrigento, Italy.
  • Caruso M; Interventional Cardiology Unit, ARNAS Civico, G. Di Cristina Benfratelli, Palermo, Italy.
  • Lombardi M; Interventional Cardiology Unit, A.O. Riuniti Villa Sofia-Cervello, Palermo, Italy.
  • Fischetti D; Division of Cardiology, "V. Fazzi" Hospital, Lecce, Italy.
  • Danesi A; Division of Cardiology, S. Spirito Hospital, Rome, Italy.
  • Abbracciavento L; Interventional Cardiology Unit, SS Annunziata Hospital, Taranto, Italy.
  • Lorenzoni G; Unit of Biostatistics, Epidemiology and Public Health, University of Padova, Padova, Italy.
  • Gregori D; Unit of Biostatistics, Epidemiology and Public Health, University of Padova, Padova, Italy.
  • Panza A; Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padova, Italy.
  • Nai Fovino L; Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padova, Italy.
  • Esposito G; Division of Cardiology, Università Degli Studi di Napoli Federico II, Napoli, Italy.
Front Cardiovasc Med ; 10: 1326091, 2023.
Article en En | MEDLINE | ID: mdl-38299080
ABSTRACT

Introduction:

The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population.

Methods:

The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year.

Results:

A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients.

Conclusion:

In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Observational_studies Idioma: En Revista: Front Cardiovasc Med Año: 2023 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Observational_studies Idioma: En Revista: Front Cardiovasc Med Año: 2023 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Suiza