Healing and stent coverage with the new ultrathin sirolimus-eluting stent with abluminal biodegradable polymer

Catheter Cardiovasc Interv. 2023 Nov;102(6):1040-1047. doi: 10.1002/ccd.30871. Epub 2023 Oct 19.

Abstract

Background: Genoss drug-eluting stent (DES) (Genoss Company Limited) is a new ultrathin sirolimus-eluting stent with an abluminal biodegradable polymer and a cobalt-chromium platform.

Aims: The aim of this study was to evaluate vascular healing and neointimal coverage after implantation of the Genoss DES using optical coherence tomography (OCT) 6 months postimplantation.

Methods: From August 22, 2019 to June 17, 2020, this multicenter, observational, investigator-initiated study enrolled 20 patients who underwent OCT examination 6 months after Genoss DES implantation and provided informed consent. An analyst, blinded to the patients' and procedural information analyzed OCT images at an independent core laboratory.

Results: Of the 20 patients, 19 with 27 stents in 21 lesions from 21 vessels were included in the analysis, while one patient withdrew consent and was unwilling to undergo follow-up OCT. OCT analysis was performed 204.4 ± 31.9 days after Genoss DES implantation. A total of 4285 stent struts from 661 cross-sections were analyzed. Strut tissue coverage was observed in 98.7 ± 4.3% of struts, with 0.1 ± 1.2% malapposed struts per lesion. The mean thickness of neointimal hyperplasia (NIH) on the covered struts was 0.12 ± 0.04 mm.

Conclusions: Six months after stent implantation, most Genoss DES struts were covered with a thin layer of NIH that was evenly distributed along the stent length. This pilot study evaluated the outcomes of 6 months dual antiplatelet therapy in the context of ultrathin strut stents, providing insight into developing ethical standards and a scientific foundation for conducting an adequately designed clinical trial.

Keywords: drug-eluting stent; optical coherence tomography; percutaneous coronary intervention; sirolimus-eluting stent; ultrathin strut stent.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Coronary Artery Disease* / diagnostic imaging
  • Coronary Artery Disease* / therapy
  • Coronary Vessels / diagnostic imaging
  • Coronary Vessels / pathology
  • Drug-Eluting Stents*
  • Humans
  • Neointima / pathology
  • Percutaneous Coronary Intervention* / adverse effects
  • Pilot Projects
  • Polymers
  • Prosthesis Design
  • Sirolimus
  • Stents
  • Time Factors
  • Tomography, Optical Coherence
  • Treatment Outcome

Substances

  • Sirolimus
  • Polymers