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 polymer-coated 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 <trial registration number: ISRCTN13284341 dated 2 December 2024>.

Sridhar Kasturi, Shailender Singh, and Vijay Kumar Reddy declare no conflict of interest. Vikram Pratap, Abhishek Masalawala, Anil Kumar Mishra are employees of Kamal Encon Industries Limited, Faridabad, India.

ISRCTN13284341

The study was funded by Kamal Encon Industries Limited, Faridabad, India.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Institutional Ethics Committee of Sunshine Hospital gave approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

The data that support the findings of this study are available from the corresponding author upon reasonable request.