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.
Department of Cardiology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.|Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Zhengbin
Z
Zhu
Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Hui
H
Han
Department of Cardiology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.|Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Jinzhou
J
Zhu
Shanghai Pharmaceuticals Holding Co. Ltd, Central Research Institute, Shanghai, China.
Jing
J
Zhang
Department of Cardiology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Run
R
Du
Department of Cardiology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Jingwei
J
Ni
Department of Cardiology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Chen
C
Ying
Department of Cardiology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Xuanqi
X
An
Department of Cardiology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.|Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Ruiyan
R
Zhang
D000818:Animals; D001012:Aorta, Abdominal / Q000187:drug effects / Q000473:pathology* / Q000601:surgery; D054855:Drug-Eluting Stents; D006083:Graft Occlusion, Vascular / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology*; D006801:Humans; D007472:Iohexol / Q000031:analogs & derivatives / Q000737:chemistry; D017239:Paclitaxel / Q000008:administration & dosage*; D011817:Rabbits; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage; D062666:Vascular Access Devices
D050257:Tubulin Modulators; D007472:Iohexol; C038192:iopromide; D017239:Paclitaxel
Neointimal hyperplasia; paclitaxel-eluting balloon; pharmacokinetics