Preclinical evaluation of the functionality of a polymer-coated sirolimuseluting stent in pigs.

Acta cirurgica brasileira Pub Date : 2024-09-09 eCollection Date: 2024-01-01 DOI:10.1590/acb397324
Sílvio César Perini, Jeanne Louise Fernandes Jesus, Alessandro Batista Soares, Rosane Angélica Ligabue, Luiz Carlos Bodanese
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Abstract

Purpose: To compare the endothelial coverage of different stents in porcine carotid arteries. Research problem: How effective are polyurethane stents (PU) and PU + rapamycin (PU + RAPA) compared to bare-metal stents on endothelial coverage by neointima in pigs after 28 days?

Methods: The methodology had two phases for an interventional, experimental, prospective study, with three Moura pigs, 12 weeks old and weighing between 19 and 22.5 kg. In phase I, eight stents were implanted in carotid arteries; three stents coated with PU, three coated with PU + RAPA, and two without coating. After 28 days, phase II was carried out, consisting of euthanasia, removal of the stents, to evaluate the exposed area of the stent struts, and the percentage of endothelialization through optical microscopy and scanning electron microscopy.

Results: The eight stents implanted with ultrasound sizing and post-dilation with a larger diameter balloon were analyzed by Doppler ultrasound, intravascular ultrasound, and angiography after 28 days.

Conclusions: This study showed complete endothelial coverage by the endoluminal neointima of the stent struts, good integration and coverage with the arterial wall, with no exposed struts showing the presence of intimal hyperplasia (whitish tissue).

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在猪体内对聚合物涂层西罗莫司洗脱支架的功能进行临床前评估。
目的:比较不同支架在猪颈动脉中的内皮覆盖率。研究问题:28 天后,聚氨酯支架(PU)和聚氨酯+雷帕霉素(PU+RAPA)与裸金属支架相比,对猪新生内膜的内皮覆盖效果如何?该方法分两个阶段进行介入性、实验性和前瞻性研究,研究对象为三头 12 周大、体重在 19 至 22.5 千克之间的莫拉猪。在第一阶段,8 个支架被植入颈动脉;其中 3 个支架涂有聚氨酯,3 个涂有聚氨酯 + RAPA,2 个未涂。28 天后,进行第二阶段,包括安乐死、移除支架、通过光学显微镜和扫描电子显微镜评估支架支柱的暴露面积和内皮化百分比:28天后,通过多普勒超声、血管内超声和血管造影对植入的8个支架进行了分析:这项研究表明,支架支管的腔内新生内膜完全覆盖内皮,与动脉壁的结合和覆盖良好,没有暴露的支管出现内膜增生(白色组织)。
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