Abstract
BACKGROUND: The thinnest strut platform is revolutionary improvement into the field of percutaneous coronary intervention. The aim of this study was to assess the safety and performance of world's thinnest (50 µm) strut biodegradable polymer coated Evermine 50™ everolimus-eluting coronary stent system (EES) in real-world patients with coronary artery disease. METHODS: This was a prospective, single-arm, single-center, post-marketing study in real-world patients. A total of 251 patients with de novo coronary artery lesion (lengths < 44 mm) and/or in-stent restenosis were enrolled and implanted with at least one Evermine 50 EES. The safety endpoint was major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction (MI) attributed to the target vessel and clinically-driven target lesion revascularization (CD-TLR), at 6-month follow-up. RESULTS: Out of 251 patients enrolled (mean age: 58.20 ± 9.92 years and 193 males), 48.6% and 45.4% patients were diabetic and hypertensive, respectively. A total of 343 lesions were intervened successfully with Evermine 50 out of 474 identified lesions (1.89 lesions per patients). Average stent length and diameter were 23.50 ± 12.21 mm and 2.83 ± 0.23 mm, respectively. At 6-month follow-up, the incidence of MACE was two (0.8%) in the form of one (0.4%) cardiac death and one (0.4%) CD-TLR. In addition, there was no definite or probable stent thrombosis reported up to 6-month follow-up. CONCLUSIONS: In the present study, lower rate of MACE was demonstrated, which reaffirms favourable clinical safety and performance of world's thinnest (50 µm) strut Evermine 50 EES in real-world patients with coronary artery disease.