Registro prospectivo del stent liberador de sirolimus con polímero estable de fluoroacrilato AngioliteEstudio EPIC02 – RANGO
- Armando Pérez de Prado 1
- Raymundo Ocaranza 2
- Fernando Lozano Ruiz-Poveda 3
- José Moreu 4
- Raquel Álvarez Ramos 5
- Alberto Rodrigues 6
- Luis Fernández González 7
- Pablo Aguar Carrascosa 8
- Bruno García del Blanco 9
- Eduardo Pinar Bermúdez 10
- Vicente Peral Disdier 11
- Fermín Sainz Laso 12
- José R. Rumoroso Cuevas 13
- Alfonso Torres 14
- Manel Sabaté Tenas 15
- R. Trillo Nouche 16
- 1 Servicio de Cardiología, Hospital Universitario de León, León, España
- 2 Servicio de Cardiología, Hospital Lucus Augusti, Lugo, España
- 3 Servicio de Cardiología, Hospital General Universitario Ciudad Real, Ciudad Real, España
- 4 Servicio de Cardiología, Hospital Virgen de la Salud, Toledo, España
- 5 Servicio de Cardiología, Hospital Universitario de La Fe, Valencia, España
- 6 Servicio de Cardiología, Hospital de Vila Nova, Gaia, Portugal
- 7 Servicio de Cardiología, Hospital Cruces, Bilbao, España
- 8 Servicio de Cardiología, Hospital Dr. Peset, Valencia, España
- 9 Servicio de Cardiología, Hospital Vall D’Hebron, Barcelona, España
- 10 Servicio de Cardiología, Hospital Virgen de la Arrixaca, El Palmar, Murcia, España
- 11 Servicio de Cardiología, Hospital Son Espases, Palma de Mallorca, España
- 12 Servicio de Cardiología, Hospital Marqués de Valdecilla, Santander, España
- 13 Servicio de Cardiología, Hospital Galdakao-Usansolo, Bilbao, España
- 14 Servicio de Cardiología, Hospital Universitario de Araba, Vitoria, Álava, España
- 15 Servicio de Cardiología, Hospital Clínic, IDIBAPS, Barcelona, España
- 16 Servicio de Cardiología, Hospital Universitario de Santiago de Compostela, A Coruña, España
ISSN: 2604-7276, 2604-7306
Argitalpen urtea: 2021
Alea: 3
Zenbakia: 4
Orrialdeak: 258-266
Mota: Artikulua
Beste argitalpen batzuk: REC: Interventional Cardiology
Laburpena
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 ("64; 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
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