<p>We aimed to evaluate a novel polymer-free hybrid drug eluting stent&#xa0;(DES) relative to benchmark devices and specific controls addressing singular components of the test device in a juvenile pig model of coronary stenting. 80 stents were implanted in 28 juvenile pigs and evaluated at 28 and 90&#xa0;days using quantitative coronary angiography and histopathology (<i>n</i> = 10 per group). Scanning electron microscopy was used at 14&#xa0;days to assess early re-endothelialization (<i>n</i> = 3 per group). The test device featured a cobalt-chromium (CoCr) backbone with a polymer-free probucol matrix releasing everolimus. The polymer-free test stent showed improved strut coverage at 28&#xa0;days compared to the polymer-coated control, with significantly lower neointimal growth at 90&#xa0;days and near complete endothelialization at 14&#xa0;days. This preclinical study supports the favorable vascular healing profile of a polymer-free hybrid DES, warranting further clinical investigation.</p> Graphical Abstract <p>Preclinical assessment of a novel polymer-free DES. The polymer-free coating strategy demonstrated a favorable healing profile in both short- and mid-term evaluation compared to polymer-based benchmark devices</p> <p></p>

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Preclinical Assessment of a Novel Polymer-Free Hybrid Drug Eluting Stent

  • Léa Wild,
  • Alicia Beele,
  • Masaru Seguchi,
  • Tobias Lenz,
  • Philipp Nicol,
  • Emina Sabic-Halilcevic,
  • Grace R. Klosterman,
  • Adnan Kastrati,
  • Michael Joner

摘要

We aimed to evaluate a novel polymer-free hybrid drug eluting stent (DES) relative to benchmark devices and specific controls addressing singular components of the test device in a juvenile pig model of coronary stenting. 80 stents were implanted in 28 juvenile pigs and evaluated at 28 and 90 days using quantitative coronary angiography and histopathology (n = 10 per group). Scanning electron microscopy was used at 14 days to assess early re-endothelialization (n = 3 per group). The test device featured a cobalt-chromium (CoCr) backbone with a polymer-free probucol matrix releasing everolimus. The polymer-free test stent showed improved strut coverage at 28 days compared to the polymer-coated control, with significantly lower neointimal growth at 90 days and near complete endothelialization at 14 days. This preclinical study supports the favorable vascular healing profile of a polymer-free hybrid DES, warranting further clinical investigation.

Graphical Abstract

Preclinical assessment of a novel polymer-free DES. The polymer-free coating strategy demonstrated a favorable healing profile in both short- and mid-term evaluation compared to polymer-based benchmark devices