Real-world registry of the durable Angiolite fluoroacrylate polymer-based sirolimus-eluting stent: the EPIC02 – RANGO study

ABSTRACT Introduction and objectives: After the positive pre-clinical and clinical results with Angiolite, a cobalt-chromium sirolimus-eluting stent, we decided to analyze its performance in a non-selected, real-world population: the RANGO registry. Methods: We conducted an observational, prospectiv...

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Autores principales: Armando Pérez de Prado, Raymundo Ocaranza-Sánchez, Fernando Lozano Ruiz-Poveda, José Moreu Burgos, Raquel Álvarez Ramos, Alberto Rodrigues, Pablo Aguar, Eduardo Pinar, Vicente Peral, Fermín Sainz Laso, José Ramón Rumoroso, Alfonso Torres, Manel Sabaté, Ramiro Trillo Nouche
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spelling oai:doaj.org-article:2d2664193b654726b0c43d5f1ed79edc2021-11-16T10:22:38ZReal-world registry of the durable Angiolite fluoroacrylate polymer-based sirolimus-eluting stent: the EPIC02 – RANGO study10.24875/RECICE.M210002232604-7322https://doaj.org/article/2d2664193b654726b0c43d5f1ed79edc2021-11-01T00:00:00Zhttps://recintervcardiol.org/en/index.php?option=com_content&view=article&id=682https://doaj.org/toc/2604-7322ABSTRACT Introduction and objectives: After the positive pre-clinical and clinical results with Angiolite, a cobalt-chromium sirolimus-eluting stent, we decided to analyze its performance in a non-selected, real-world population: the RANGO registry. Methods: We conducted an observational, prospective, multicenter registry of patients with different clinical indications. All consecutive patients treated with percutaneous coronary intervention with, at least, 1 Angiolite stent and who gave their informed consent were included. The registry primary endpoint was the occurrence of target lesion failure (TLF) at 6, 12, and 24 months defined as cardiovascular death, myocardial infarction (MI) related to target vessel, and clinically driven target lesion revascularization. The secondary endpoints were the individual components of the primary endpoint, major adverse cardiovascular events (MACE: all-cause mortality, any MI, or any revascularization), and stent thrombosis. We describe the 2-year clinical results of the RANGO study in the entire population, in those who only received Angiolite stents, and in 2 predefined subgroups: diabetics and patients with small-vessels (≤ 2.5mm). Results: 646 patients (426 of them only received Angiolite stents) with a high-risk profile were recruited: prevalence of previous MI (18.4%), previous coronary revascularization (23.4%), clinical presentation as ST-segment elevation MI (23.1%), and multivessel disease (47.8%). At the 2-year follow-up, the rates of TLF, MACE, and stent thrombosis were 3.4%, 9.6%, and 0.9%, respectively. Similar results were observed among patients treated with Angiolite stents only: TLF, 3.1%; MACE, 8.0%; thrombosis, 0.7%. The rates were not significantly different for the diabetic (TLF, 3.0%; MACE, 14.1%; thrombosis, 1.0%), and small-vessel subgroups (TLF, 4.3%; MACE, 12.1%; thrombosis, 0%). Conclusions: In conclusion, the results of this observational registry on the use of Angiolite in a real-world population, including a high-risk population, corroborate the excellent results observed in previous studies, up to a 2-year follow-up. An extended 5-year follow-up is planned to discard the occurrence of late events.Armando Pérez de PradoRaymundo Ocaranza-SánchezFernando Lozano Ruiz-PovedaJosé Moreu BurgosRaquel Álvarez RamosAlberto RodriguesPablo AguarEduardo PinarVicente PeralFermín Sainz LasoJosé Ramón RumorosoAlfonso TorresManel SabatéRamiro Trillo NouchePermanyerarticleSirolimus-eluting-stent Durable fluoropolymer Observational study Efficacy Safety Stent thrombosisMedicineRENESREC: Interventional Cardiology (English Ed.), Vol 3, Iss 4, Pp 258-266 (2021)
institution DOAJ
collection DOAJ
language EN
ES
topic Sirolimus-eluting-stent
Durable fluoropolymer
Observational study
Efficacy
Safety
Stent thrombosis
Medicine
R
spellingShingle Sirolimus-eluting-stent
Durable fluoropolymer
Observational study
Efficacy
Safety
Stent thrombosis
Medicine
R
Armando Pérez de Prado
Raymundo Ocaranza-Sánchez
Fernando Lozano Ruiz-Poveda
José Moreu Burgos
Raquel Álvarez Ramos
Alberto Rodrigues
Pablo Aguar
Eduardo Pinar
Vicente Peral
Fermín Sainz Laso
José Ramón Rumoroso
Alfonso Torres
Manel Sabaté
Ramiro Trillo Nouche
Real-world registry of the durable Angiolite fluoroacrylate polymer-based sirolimus-eluting stent: the EPIC02 – RANGO study
description ABSTRACT Introduction and objectives: After the positive pre-clinical and clinical results with Angiolite, a cobalt-chromium sirolimus-eluting stent, we decided to analyze its performance in a non-selected, real-world population: the RANGO registry. Methods: We conducted an observational, prospective, multicenter registry of patients with different clinical indications. All consecutive patients treated with percutaneous coronary intervention with, at least, 1 Angiolite stent and who gave their informed consent were included. The registry primary endpoint was the occurrence of target lesion failure (TLF) at 6, 12, and 24 months defined as cardiovascular death, myocardial infarction (MI) related to target vessel, and clinically driven target lesion revascularization. The secondary endpoints were the individual components of the primary endpoint, major adverse cardiovascular events (MACE: all-cause mortality, any MI, or any revascularization), and stent thrombosis. We describe the 2-year clinical results of the RANGO study in the entire population, in those who only received Angiolite stents, and in 2 predefined subgroups: diabetics and patients with small-vessels (≤ 2.5mm). Results: 646 patients (426 of them only received Angiolite stents) with a high-risk profile were recruited: prevalence of previous MI (18.4%), previous coronary revascularization (23.4%), clinical presentation as ST-segment elevation MI (23.1%), and multivessel disease (47.8%). At the 2-year follow-up, the rates of TLF, MACE, and stent thrombosis were 3.4%, 9.6%, and 0.9%, respectively. Similar results were observed among patients treated with Angiolite stents only: TLF, 3.1%; MACE, 8.0%; thrombosis, 0.7%. The rates were not significantly different for the diabetic (TLF, 3.0%; MACE, 14.1%; thrombosis, 1.0%), and small-vessel subgroups (TLF, 4.3%; MACE, 12.1%; thrombosis, 0%). Conclusions: In conclusion, the results of this observational registry on the use of Angiolite in a real-world population, including a high-risk population, corroborate the excellent results observed in previous studies, up to a 2-year follow-up. An extended 5-year follow-up is planned to discard the occurrence of late events.
format article
author Armando Pérez de Prado
Raymundo Ocaranza-Sánchez
Fernando Lozano Ruiz-Poveda
José Moreu Burgos
Raquel Álvarez Ramos
Alberto Rodrigues
Pablo Aguar
Eduardo Pinar
Vicente Peral
Fermín Sainz Laso
José Ramón Rumoroso
Alfonso Torres
Manel Sabaté
Ramiro Trillo Nouche
author_facet Armando Pérez de Prado
Raymundo Ocaranza-Sánchez
Fernando Lozano Ruiz-Poveda
José Moreu Burgos
Raquel Álvarez Ramos
Alberto Rodrigues
Pablo Aguar
Eduardo Pinar
Vicente Peral
Fermín Sainz Laso
José Ramón Rumoroso
Alfonso Torres
Manel Sabaté
Ramiro Trillo Nouche
author_sort Armando Pérez de Prado
title Real-world registry of the durable Angiolite fluoroacrylate polymer-based sirolimus-eluting stent: the EPIC02 – RANGO study
title_short Real-world registry of the durable Angiolite fluoroacrylate polymer-based sirolimus-eluting stent: the EPIC02 – RANGO study
title_full Real-world registry of the durable Angiolite fluoroacrylate polymer-based sirolimus-eluting stent: the EPIC02 – RANGO study
title_fullStr Real-world registry of the durable Angiolite fluoroacrylate polymer-based sirolimus-eluting stent: the EPIC02 – RANGO study
title_full_unstemmed Real-world registry of the durable Angiolite fluoroacrylate polymer-based sirolimus-eluting stent: the EPIC02 – RANGO study
title_sort real-world registry of the durable angiolite fluoroacrylate polymer-based sirolimus-eluting stent: the epic02 – rango study
publisher Permanyer
publishDate 2021
url https://doaj.org/article/2d2664193b654726b0c43d5f1ed79edc
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