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

TL;DR

A new polymer-free drug-eluting stent showed better healing and less tissue growth in pigs compared to traditional stents, suggesting it could be a safer option for heart patients.

Contribution

The study introduces a polymer-free hybrid drug-eluting stent with a novel coating strategy that improves vascular healing.

Findings

The polymer-free stent showed improved strut coverage at 28 days compared to polymer-coated controls.

It had significantly lower neointimal growth at 90 days and near-complete endothelialization at 14 days.

The device demonstrated a favorable vascular healing profile in preclinical testing.

Abstract

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.

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

The online version contains supplementary material available at 10.1007/s12265-025-10680-5.

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