Wild Léa, Beele Alicia, Seguchi Masaru, Lenz Tobias, Nicol Philipp, Sabic-Halilcevic Emina, Klosterman Grace R, Kastrati Adnan, Joner Michael
Department of Cardiovascular Diseases, German Heart Center Munich, Technical University Munich University Hospital, Lazarettstraße 36, 80636, Munich, Germany.
DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Berlin, Germany.
J Cardiovasc Transl Res. 2025 Aug 15. doi: 10.1007/s12265-025-10680-5.
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.
我们旨在在幼年猪冠状动脉支架置入模型中，评估一种新型无聚合物混合药物洗脱支架（DES）相对于基准器械以及针对测试器械单一组件的特定对照物的性能。将80个支架植入28只幼年猪体内，并在第28天和第90天使用定量冠状动脉造影和组织病理学进行评估（每组n = 10）。在第14天使用扫描电子显微镜评估早期再内皮化情况（每组n = 3）。测试器械的特点是具有钴铬（CoCr）骨架以及释放依维莫司的无聚合物普罗布考基质。与聚合物涂层对照物相比，无聚合物测试支架在第28天显示出更好的支架覆盖，在第90天新生内膜生长显著更低，在第14天接近完全内皮化。这项临床前研究支持了无聚合物混合DES良好的血管愈合情况，值得进一步进行临床研究。
