High nitrogen stainless steel drug-eluting stent - Assessment of pharmacokinetics and preclinical safety in vivo

doi:10.1016/j.bioactmat.2020.06.006

IMR OpenIR

	High nitrogen stainless steel drug-eluting stent - Assessment of pharmacokinetics and preclinical safety in vivo
	Chen, Shanshan 2; Yao, Zhifeng 3; Guan, Yongbiao 1; Yang, Hui 2; Shahzad, M. Babar 2; Wu, Yizhe 3; Zhang, Bingchun 2; Shen, Li 3; Yang, Ke 2
通讯作者	Guan, Yongbiao(guanyb@hotmail.com) ; Shen, Li(shen.li1@zs-hospital.sh.cn) ; Yang, Ke(kyang@imr.ac.cn)
	2020-12-01
发表期刊	BIOACTIVE MATERIALS
卷号	5 期号:4 页码:779-786
摘要	Pharmacokinetic analyses were performed using 20 pigs for 120-days implantation, while one sirolimus-eluting stent was implanted into one of their coronary artery. At different time points, the residual sirolimus on the stent, delivered locally (to artery wall), regionally (to adjacent and downstream muscle) and systemically (to plasma and visceral organs), was detected throughout 120 days. Preclinical safety evaluation was performed using 32 pigs for 180-days implantation to study the safety of metal platform material and the effectiveness of sirolimus eluting coating on the HNS stent. The neointima area, restenosis rate and inflammatory grade for HNS and control group stents were detected and analyzed. Approximately 80% sirolimus was eluted from the sirolimus-eluting stents after 30-days implantation in vivo. Additionally, there was sustained sirolimus in the artery wall, cardiac muscle and heart throughout 120-days implantation, and sirolimus accumulated to the peak at 90-days implantation. It was inferred that the sirolimus eluting stent in this study was covered by neointima before 90days implantation, indicating that the sirolimus eluting coating on the HNS stent was safe and effective. Very little sirolimus was distributed in visceral organs after 14-days implantation. HNS sirolimus-eluting stent exhibited lower restenosis rate and lower inflammatory grade than control group, which verified that the sirolimus-eluting coating design in this study was reasonable and practical. In addition, there were no significant difference in restenosis rate and inflammatory score between HNS bare-metal stent and drug-eluting stents, illustrating that HNS has good bio-compatibility and is suitable to use as coronary artery stent material.
关键词	Sirolimus-eluting stent Pharmacokinetics Preclinical safety Tissue response
资助者	National Key Research and Development Program of China ; Chinese Academy of Sciences President's International Fellowship Initiative ; National Natural Science Fund of China
DOI	10.1016/j.bioactmat.2020.06.006
收录类别	SCI
语种	英语
资助项目	National Key Research and Development Program of China[2016YFC1102404] ; National Key Research and Development Program of China[2016YFC1102405] ; Chinese Academy of Sciences President's International Fellowship Initiative[2018FYE0005] ; National Natural Science Fund of China[81670319] ; National Natural Science Fund of China[81521001]
WOS研究方向	Engineering ; Materials Science
WOS类目	Engineering, Biomedical ; Materials Science, Biomaterials
WOS记录号	WOS:000562478100004
出版者	KEAI PUBLISHING LTD
引用统计	被引频次：12[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	http://ir.imr.ac.cn/handle/321006/140326
专题	中国科学院金属研究所
通讯作者	Guan, Yongbiao; Shen, Li; Yang, Ke
作者单位	1.Acad Mil Med Sci, Natl Beijing Ctr Drug Safety Evaluat & Res, Beijing Inst Pharmacol & Toxicol, 27 Taiping Rd, Beijing 100850, Peoples R China 2.Chinese Acad Sci, Inst Met Res, 72 Wenhua Rd, Shenyang 110016, Peoples R China 3.Fudan Univ, Zhongshan Hosp, Shanghai Inst Cardiovasc Dis, Dept Cardiol, 180 Fenglin Rd, Shanghai 200032, Peoples R China
推荐引用方式 GB/T 7714	Chen, Shanshan,Yao, Zhifeng,Guan, Yongbiao,et al. High nitrogen stainless steel drug-eluting stent - Assessment of pharmacokinetics and preclinical safety in vivo[J]. BIOACTIVE MATERIALS,2020,5(4):779-786.
APA	Chen, Shanshan.,Yao, Zhifeng.,Guan, Yongbiao.,Yang, Hui.,Shahzad, M. Babar.,...&Yang, Ke.(2020).High nitrogen stainless steel drug-eluting stent - Assessment of pharmacokinetics and preclinical safety in vivo.BIOACTIVE MATERIALS,5(4),779-786.
MLA	Chen, Shanshan,et al."High nitrogen stainless steel drug-eluting stent - Assessment of pharmacokinetics and preclinical safety in vivo".BIOACTIVE MATERIALS 5.4(2020):779-786.