Clinical Outcomes of World's Thinnest (50 µmr) Strut Biodegradable Polymer Coated Everolimus-Eluting Coronary Stent System in Real-World Patients.

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.

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions.

BACKGROUND: When coronary lesions involve segments > 48 mm, the only treatment possibility is stent overlapping which is associated with higher neointimal proliferation that lead to more restenosis. Furthermore, tapering of coronary arteries is a major challenge observed with long diffuse coronary lesions. This study attempted to assess the safety and performance of world's first commercialised long-tapered (60 mm) sirolimus-eluting coronary stent (SES) system for the treatment of long diffused de novo coronary lesions in real world scenario. METHODS: This was a retrospective, non-randomised, multicentre study which included 362 consecutive patients implanted with long-tapered BioMime™ Morph SES system for the treatment of long diffused de novo coronary lesions. Safety endpoint was major adverse cardiac events (MACE), which was defined as composite of cardiac death, myocardial infarction (MI) and ischemic-driven target lesion revascularization (ID-TLR), at 12-month follow-up. RESULTS: Out of 362 patients included, 170 (47.0%) were diabetic and 159 (43.9%) were hypertensive. The mean age of all patients was 61.09 ± 9.04 years. A total of 625 lesions were identified; out of which 402 lesions were intervened successfully using BioMime Morph. The cumulative incidence of MACE was 7 (2.0%) at 12-month follow-up which included four (1.1%) cardiac deaths, one (0.3%) case of MI and two (0.6%) ID-TLR. Acute stent thrombosis was reported in one (0.3%) patient. CONCLUSIONS: The present study confirms the safety and performance of BioMime Morph, and hence, can be considered as a treatment of choice for long diffused tapered de novo coronary lesions in routine clinical practice.