ORIGINAL ARTICLE   

Minerva Medica 2020 December;111(6):529-35

DOI: 10.23736/S0026-4806.20.06333-8

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Impact of ultra-long sirolimus-eluting stents on coronary artery lesions: one-year results of real-world FLEX-LONG Study

Vijaya PAMIDIMUKKALA ¹, Anurag R. POLAVARAPU ², Naren R. POLAVARAPU ², Sirichandana GANGASANI ², Deepthi GALI ², Sudheer V. BOLINERA ², Sravanthi BYRAPANENI ², Raghava S. POLAVARAPU ³ ✉

¹ Department of Neurology, Lalitha Super Specialities Hospital Pvt. Ltd., Heart and Brain Center, Kothapet, India; ² Department of Medicine, Lalitha Super Specialities Hospital Pvt. Ltd., Heart and Brain Center, Kothapet, India; ³ Department of Cardiology, Lalitha Super Specialities Hospital Pvt. Ltd., Heart and Brain Center, Kothapet, India

BACKGROUND: The FLEX-LONG study assessed the safety and clinical outcomes of ultra-long (44 mm/48 mm) biodegradable polymer-coated Supraflex (Sahajanand Medical Technology Pvt. Ltd., Surat, India) sirolimus-eluting stents (SES) in real-world patients with complex, long coronary artery lesions.
METHODS: It was an investigator-initiated, retrospective, non-randomized, observational and single-center study, which evaluated one-year results of 141 patients who had undergone implantation of at least one ultra-long (44 mm/48 mm) Supraflex SES. The incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), at one-year follow-up was considered as primary outcome. Stent thrombosis was analyzed as a safety outcome.
RESULTS: The mean age of the study population was 56.2±9.6 years and 78.0% (110/141) patients were male. The study analyzed high risk patients, including 62 (44.0%) hypertensive and 60 (42.6%) diabetic patients. Total 147 target lesions were treated, including 25 (17.0%) total occlusions. Total 51 (34.7%) and 96 (65.3%) Supraflex SES of 44 mm and 48 mm were implanted, respectively. Average stent length and diameter were 46.6±1.9 mm and 3.4±0.2 mm, respectively. One-year follow-up was obtained in 100% of patients. There was one probable stent thrombosis after three weeks. At one-year follow-up, 99.3% of patients remained event free.
CONCLUSIONS: The results of the FLEX-LONG study support the use of ultra-long (44 mm/48 mm) Supraflex SES, in the treatment of high-risk real-world patients. The stent appeared to be safe and effective at one-year with low clinical events in complex, long coronary artery lesions.

KEY WORDS: Drug-eluting stents; Sirolimus; Coronary vessels