Long-term outcomes of hydrodynamic ultra-thin strut sirolimus-eluting stent with fluoropolymer containing triflusal: VELAZQUEZ-EPIC26 study.

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.