Abstract
Background: 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. Methods: 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 ex vivo 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. Results: 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, p = 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. Conclusions: The ability to enhance drug delivery and retention in targeted arterial segments can ultimately improve clinical peripheral endovascular outcomes.
Highlights
Drug-coated balloons (DCBs) represent a new therapeutic approach to treat peripheral arterial disease (PAD) [1,2,3,4,5]
To determine the impact of vascular deformation on DCB retention, both the KOS–paclitaxel DCB and the commercially available DCB were tested under only physiological pulsatile conditions and physiological pulsatile conditions with vascular deformation conditions
There was a reduction in arterial paclitaxel levels from 1 h to 3 days post-treatment for both the KOS–paclitaxel and the commercially available DCB under physiological pulsatile conditions
Summary
Drug-coated balloons (DCBs) represent a new therapeutic approach to treat peripheral arterial disease (PAD) [1,2,3,4,5]. 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. The retention of the KOS-paclitaxel coating, in comparison to a commercially available DCB, was evaluated using a novel vascular-motion simulating ex vivo flow model at 1 h and 3 days. Results: 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, p = 0.018). Conclusions: The ability to enhance drug delivery and retention in targeted arterial segments can improve clinical peripheral endovascular outcomes
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