One-year Clinical Outcomes of Biodegradable Polymer Coated Everolimus-eluting Coronary Stent: Results from a Prospective, Open-label, Non-randomized Study
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT Purpose Newer-generation biodegradable polymer coated drug-eluting stents have been developed to optimize the outcomes of percutaneous coronary intervention. Everoshine everolimus eluting coronary stent (EECS) is a newer-generation, ultrathin (65 µm) biodegradable polymer–coated drug-eluting stent designed on a cobalt– chromium stent platform. This study aimed to evaluate safety and efficacy of the newer generation polymercoated Everoshine EECS in patients with coronary artery disease (CAD) attributable to native coronary artery stenosis. Methods This was a single-center, single-arm, prospective study, which enrolled patients aged ≥ 18 years who had at least one native coronary artery lesions and were eligible for Everoshine EECS implantation. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization, assessed at the 30-day follow-up. Results A total of 193 patients were enrolled (mean age 57.8 ± 11.0 years; 142 (73.6%) male). Of these, 92 (47.7%) patients had ST-segment elevation MI (STEMI) and 39 (20.2%) had non-STEMI. A total of 267 stents were deployed, with a mean diameter of 2.9 ± 0.4 mm and a mean length of 27.0 ± 9.9 mm. At 30-day, 3 (1.6%) patients experienced MACE, and 2 (1.0%) patients experienced stent thrombosis. Cumulative MACE was observed in 5 (2.6%) patients at 1 year. Conclusion One-year clinical outcomes demonstrated satisfactory efficacy and safety of the novel biodegradable polymer-coated Everoshine EECS in patients with CAD attributable to native coronary artery stenosis. The trial is registered retrospectively ISRCTN13284341 dated 2 December 2024>.
Authors: Sridhar Kasturi, Shailender Singh, Vijay Kumar Reddy, Vikram Pratap, Abhishek Masalawala, Anil Kumar Mishra
Institutions: Sunshine Hospitals, Kamal Encon Industries Limited (India)
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4408147783