Safety and efficacy of a novel iopromide-based paclitaxel-eluting balloon following bare metal stent implantation in rabbit aorta abdominalis

BACKGROUND: Drug-eluting balloons (DEB) may be promising technology for treating atherosclerotic arterial disease.In fact, several DEBs have been clinically available for the treatment of coronary in-stent restenosis (ISR), de novo coronary lesions, and peripheral artery disease.OBJECTIVE: We sought to elucidate the mechanism of action and in vivo safety and efficacy of a novel iopromide-based paclitaxel-eluting balloon.METHODS: In vitro cytotoxicity of a novel DEB on human umbilical vein endothelial cells (HUVECs) and in vivo pharmacokinetics of DEB in a rabbit aorta abdominalis were assessed.Then, bare metal stents (BMS) were implanted at both the proximal and distal sites of the rabbit aorta abdominalis.Stented vascular segments were immediately dilated with a bare balloon (control group) or the DEB (DEB group) randomly.Histological evaluation was performed in all treated segments at 28 days.Because paclitaxel is a tubulin-disrupting agent that binds preferentially to β-tubulin, we measured β-tubulin expression in aortal stent specimens via immunohistochemistry. RESULTS: We observed that DEB was compatible and could reduce neointimal hyperplasia compared with the bare balloon.Meanwhile, immunohistochemistry revealed that β-tubulin expression in the DEB group increased compared with the control group, indirectly suggesting successful uptake of paclitaxel by vessel walls after DEB dilation.CONCLUSIONS: The novel DEB is safe and has a favorable vascular healing response on neointimal hyperplasia.