Long-term outcomes of hydrodynamic ultra-thin strut sirolimus-eluting stent with fluoropolymer containing triflusal: VELAZQUEZ-EPIC26 study.
Por:
Linares Vicente JA, Sainz Laso F, Casanova Sandoval JM, Rumoroso Cueva JR, Gómez Menchero A, Gómez Hospital JA, Pérez Guerrero A, Santos Martinez S, Fernández Portalés J, Romani S, García Del Blanco B, Ocaranza Sánchez R, Urbano Carrillo C, García San Roman K, Vinhas H, Cid Álvarez B, Sanchís Fores J, Tellería Arrieta M, Torres Bosco A, Pinar Bermúdez E, Méndez Castro JJ, Lozano Ruiz de Poveda F, Pérez de Prado A, De la Torre Hernández JM
Ahead of Print:
17 jul 2025
Resumen:
BACKGROUND: A new-generation coronary sirolimus eluting-stent(SES), whose novel characteristics are summarized in ultra-thin oval-shaped hydrodynamic struts (68 µm) and abluminal drug release with permanent fluoropolymer containing the platelet aggregation inhibitor triflusal, showed low target lesion failure(TLF) and absence of stent thrombosis(ST) at 1 year in a first-in-human study. Long-term clinical efficacy is unknown. We aim to investigate long-term clinical efficacy of this new SES in a real-world population undergoing PCI for native coronary artery. METHODS: VELAZQUEZ-EPIC26 is a prospective, observational and multicentre study of a large cohort undergoing PCI with the new SES (ihtDEStiny™). Primary endpoint was TLF at 2 years (composite of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization). Secondary clinical safety and efficacy endpoints included definitive or probable ST, target vessel failure (TVF), major adverse cardiac events (MACE), and BARC 3-5 bleeding. RESULTS: Between 2021 and 2023, 406 patients (mean age 65 ± 11 years, 75 % males, 26 % diabetes) were included. 519 SES were implanted over 482 target lesions. Mean stent diameter and length were 3.03 ± 0.49 mm and 22 ± 7,6 mm respectively. Procedural success rate was 97.3 %. TLF at 2 years was 2,2 % (n = 9). There were 3 cardiovascular deaths (0,7 %), none related to SES complications. 1 very late definite stent thrombosis was reported (0,2 %, n = 1). TVF, MACE and BARC 3-5 bleeding rates at years were 3 % (n = 12), 3,2 % (n = 13) and 3,5 % (n = 14) respectively. CONCLUSIONS: In a large real-world population undergoing PCI for native coronary artery, a new hydrodynamic ultra-thin strut SES with abluminal permanent fluoropolymer containing triflusal shows low TLF and very low ST rates at 2 years.
Filiaciones:
Linares Vicente JA:
Department of Cardiology, Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria Aragon (IISA), Zaragoza, Spain
Sainz Laso F:
Department of Cardiology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain
Casanova Sandoval JM:
Department of Cardiology, Hospital Universitario Arnau de Vilanova, Lleida, Spain
Rumoroso Cueva JR:
Department of Cardiology, Hospital Universitario Galdakao-Usansolo, Bizkaia, Spain
Gómez Menchero A:
Department of Cardiology, Hospital Universitario Juan Ramón Jimenez, Huelva, Spain
Gómez Hospital JA:
Department of Cardiology, Hospital Universitario de Bellvitge - IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain
Pérez Guerrero A:
Department of Cardiology, Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria Aragon (IISA), Zaragoza, Spain
Santos Martinez S:
Department of Cardiology, Hospital General Universitario de Elche, Alicante, Spain
Fernández Portalés J:
Department of Cardiology, Hospital Universitario de Cáceres, Cáceres, Spain
Romani S:
Department of Cardiology, Hospital Universitario de Cáceres, Cáceres, Spain
García Del Blanco B:
Department of Cardiology, Hospital Universitario Vall d'Hebron, Barcelona, Spain
Ocaranza Sánchez R:
Department of Cardiology, Hospital Universitario Lucus Augusti, Lugo, Spain
Urbano Carrillo C:
Department of Cardiology, Hospital Regional Universitario de Málaga, Malaga, Spain
García San Roman K:
Department of Cardiology, Hospital Universitario de Cruces, Bizkaia, Spain
Vinhas H:
Interventional Cardiology Unit, Centro Hospitalar e Universitario do Algarve, Portugal
Cid Álvarez B:
Department of Cardiology, Hospital Universitario de Santiago Compostela, A Coruña, Spain
Sanchís Fores J:
Department of Cardiology, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain
Tellería Arrieta M:
Department of Cardiology, Hospital Universitario Donostia, San Sebastian, Spain
Torres Bosco A:
Department of Cardiology, Hospital Universitario de Álava - Txagorritxu, Alava, Spain
Pinar Bermúdez E:
Department of Cardiology, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain
Méndez Castro JJ:
Department of Cardiology, Hospital Universitario de Bellvitge - IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain
Lozano Ruiz de Poveda F:
Department of Cardiology, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain
Pérez de Prado A:
EPIC Foundation, Department of Cardiology, Hospital Universitario de León, León, Spain
De la Torre Hernández JM:
Department of Cardiology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain
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