Department of Mechanical Engineering, University of South Alabama, Mobile, AL 36688, USA.
iC42 Clinical Research and Development, Department of Anesthesiology, University of Colorado; Aurora, CO 80045, USA.
Molecules. 2020 Mar 31;25(7):1596. doi: 10.3390/molecules25071596.
Drug-coated balloons (DCBs), which deliver anti-proliferative drugs with the aid of excipients, have emerged as a new endovascular therapy for the treatment of peripheral arterial disease. In this study, we evaluated the use of keratose (KOS) as a novel DCB-coating excipient to deliver and retain paclitaxel.
A custom coating method was developed to deposit KOS and paclitaxel on uncoated angioplasty balloons. The retention of the KOS-paclitaxel coating, in comparison to a commercially available DCB, was evaluated using a novel vascular-motion simulating flow model at 1 h and 3 days. Additionally, the locoregional biological response of the KOS-paclitaxel coating was evaluated in a rabbit ilio-femoral injury model at 14 days.
The KOS coating exhibited greater retention of the paclitaxel at 3 days under pulsatile conditions with vascular motion as compared to the commercially available DCB (14.89 ± 4.12 ng/mg vs. 0.60 ± 0.26 ng/mg, = 0.018). Histological analysis of the KOS-paclitaxel-treated arteries demonstrated a significant reduction in neointimal thickness as compared to the uncoated balloons, KOS-only balloon and paclitaxel-only balloon.
The ability to enhance drug delivery and retention in targeted arterial segments can ultimately improve clinical peripheral endovascular outcomes.
载药球囊（DCB）利用赋形剂输送抗增殖药物，已成为治疗外周动脉疾病的一种新的血管内治疗方法。本研究旨在评估角蛋白（KOS）作为一种新型 DCB 涂层赋形剂用于递送和保留紫杉醇的效果。
开发了一种定制的涂层方法，将 KOS 和紫杉醇沉积在未涂层的血管成形术球囊上。使用新型血管运动模拟流动模型在 1 小时和 3 天评估 KOS-紫杉醇涂层的保留情况，并与市售 DCB 进行比较。此外，在 14 天的兔髂股损伤模型中评估 KOS-紫杉醇涂层的局部生物反应。
与市售 DCB 相比，KOS 涂层在具有血管运动的脉动条件下，在 3 天内保留更多的紫杉醇（14.89 ± 4.12 ng/mg 比 0.60 ± 0.26 ng/mg， = 0.018）。用 KOS-紫杉醇处理的动脉的组织学分析表明，与未涂层球囊、仅 KOS 球囊和仅紫杉醇球囊相比，新生内膜厚度显著减少。
能够增强靶向动脉段的药物输送和保留能力，最终可以改善外周血管腔内治疗的临床结局。
