Kachel Mateusz, Melo Pedro H C, Cheng Yanping, Conditt Gerard B, Gram Danielle, Anderson Jeffrey, Rousselle Serge D, Parikh Sahil A, Granada Juan F, Kaluza Grzegorz L
Skirball Center for Innovation, Cardiovascular Research Foundation, Orangeburg, NY, USA.
AHP Center for Cardiovascular Research and Development, Katowice, Poland.
Sci Rep. 2025 Mar 27;15(1):10624. doi: 10.1038/s41598-025-91759-6.
Drug-eluting resorbable scaffolds (DRS) are conceptually attractive for treatment of peripheral arterial disease, particularly below-the-knee. MOTIV is a peripheral variant of REVA Medical's well-established, radiopaque tyrosine-polycarbonate (Tyrocore) sirolimus-eluting DRS. The purpose of this study was to provide imaging and histopathologic data on vascular response to MOTIV in porcine peripheral arteries. MOTIV scaffolds (3.0 or 3.5 × 12/24/36/48/60 mm) were implanted in 20 internal iliac arteries of 9 Yorkshire swine. At 30 and 90 days, vascular stenosis, strut coverage, and strut apposition were characterized using optical coherence tomography. Scaffold structure and vascular healing were assessed by histopathology and scanning electron microscopy. At termination, all vessels remained patent. The average neointimal thickness was 0.22 ± 0.05 mm in Group 1 (30 days) and 0.18 ± 0.10 mm in Group 2 (90 days); the percent area stenosis was 28 ± 6% and 24 ± 11%, respectively. All struts were fully covered by neointima. No malapposition, stent fracture or late strut discontinuity was observed. Adequate vessel wall healing at both time points was characterized by a typically fully mature neointima and complete reendothelialization at all sites. No unresorbed luminal thrombus was observed. The inflammation scores were low for all vessels on both time points, except for one animal. The average inflammation (excluding multinucleated giant cells [MNGCs]) was 0.6 (MNGCs score was 0.9) for the stented vessel segments at 30 days and 0.8 (MNGCs score of 1.0) at 90 days. Implantation of the MOTIV up to 60 mm long in small-caliber peripheral arteries of swine resulted in 100% patency rate and adequate vascular healing at 30-day and 90-day timepoints. The Tyrocore-based DRS retained the necessary structural integrity throughout the course of the study and confirmed their favorable biocompatibility in small-caliber porcine peripheral arteries.
药物洗脱可吸收支架（DRS）在概念上对外周动脉疾病的治疗具有吸引力，尤其是膝下动脉疾病。MOTIV是REVA Medical公司成熟的、不透射线的酪氨酸-聚碳酸酯（Tyrocore）西罗莫司洗脱DRS的外周型产品。本研究的目的是提供猪外周动脉对MOTIV血管反应的影像学和组织病理学数据。将MOTIV支架（3.0或3.5×12/24/36/48/60mm）植入9只约克夏猪的20条髂内动脉。在30天和90天时，使用光学相干断层扫描对血管狭窄、支架覆盖和支架贴壁情况进行评估。通过组织病理学和扫描电子显微镜评估支架结构和血管愈合情况。实验结束时，所有血管均保持通畅。第1组（30天）平均新生内膜厚度为0.22±0.05mm，第2组（90天）为0.18±0.10mm；面积狭窄百分比分别为28±6%和24±11%。所有支架均被新生内膜完全覆盖。未观察到贴壁不良、支架断裂或晚期支架连续性中断。在两个时间点，血管壁愈合良好，其特征为典型的完全成熟新生内膜和所有部位的完全内皮化。未观察到未吸收的腔内血栓。除一只动物外，两个时间点所有血管的炎症评分均较低。支架植入血管段在30天时平均炎症（不包括多核巨细胞[MNGC]）评分为0.6（MNGC评分为0.9），90天时为0.8（MNGC评分为1.0）。在猪小口径外周动脉中植入长达60mm的MOTIV，在30天和90天时通畅率达100%，血管愈合良好。基于Tyrocore的DRS在整个研究过程中保持了必要的结构完整性，并证实了它们在猪小口径外周动脉中具有良好的生物相容性。
