ORIGINAL ARTICLE   

Minerva Medica 2020 August;111(4):315-23

DOI: 10.23736/S0026-4806.20.06205-9

Copyright © 2020 EDIZIONI MINERVA MEDICA

lingua: Inglese

Safety and performance of everolimus-eluting stents comprising of biodegradable polymers with ultrathin stent platforms

Sudheer V. BOLINERA ¹, Vemuri R. THARAKNATH ¹, Sanivarapu S. REDDY ¹, Raghava S. POLAVARAPU ¹ ✉, Anurag POLAVARAPU ¹, Naren POLAVARAPU ¹, Sravanthi BYRAPANENI ¹, Sirichandana GANGASANI ¹, Meghana CHILUKURI ², Vijaya PAMIDIMUKKALA ¹

¹ Heart and Brain Center, Lalitha Super Specialties Hospital, Kothapet, Guntur, India; ² Mahatma Gandhi Memorial Hospital, Warangal, India

BACKGROUND: The registry investigated clinical outcomes after 12 months of implantation of ultra-thin strut (60 µm) biodegradable polymer-coated Tetrilimus everolimus-eluting stents (EES; Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in patients with atherosclerotic coronary lesions. Additionally, sub-group analysis was performed to evaluate outcomes of ultra-long (44/48 mm) Tetrilimus EES in patients with long lesions.
METHODS: This was an observational, single-center, single-arm and investigator-initiated retrospective registry. In this all-comers registry, patients who underwent implantation of Tetrilimus EES for treatment of coronary artery disease during routine clinical practice between February-2016 and August-2016 at tertiary care center of India were included. Primary endpoint was occurrence of any major adverse cardiac event (MACE) up to 12 months’ follow-up. MACE was a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Similar endpoints were observed in sub-group patients.
RESULTS: Total 766 stents were implanted to treat 695 lesions in 558 patients. Of treated lesions, 11.4% lesions were type B2 and 78.3% were type C lesions. In sub-group analysis of 143 patients, a total of 155 long coronary lesions were intervened successfully with only one stent been implanted per lesion. At 12 months’ follow-up, four (0.7%) cases of cardiac death, eight (1.4%) of MI, and two (0.4%) of TLR were reported, resulting in a 2.5% rate of MACE. The MACE rate was 2.8% in sub-group patients.
CONCLUSIONS: Twelve months’ clinical data demonstrated favorable safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice and also in patients with ultra-long lesions.

KEY WORDS: Biopolymers; Everolimus; Drug-eluting stents; Percutaneous coronary intervention