title: A novel polymer-free paclitaxel-eluting stent with a nanoporous surface for rapid endothelialization and inhibition of intimal hyperplasia: Comparison with a polymer-based sirolimus-eluting stent and bare metal stent in a porcine model.
abstract: Hypersensitivity and inflammatory responses to polymers may be responsible for late stent thrombosis after implantation of a drug-eluting stent (DES). Polymer-free DES may reduce the prevalence of these adverse reactions in vessels. We evaluated a polymer-free paclitaxel-eluting-stent with a nanoporous surface (nano-PES) for endothelialization and inhibition of neointimal hyperplasia by optical coherence tomography (OCT) and pathology in a porcine model. Nano-PES with high-dose (HD) and low-dose (LD) paclitaxel (1.0 μg/mm(2) and 0.4 μg/mm(2), respectively) was compared with a sirolimus-eluting stent (SES) and bare-metal stent (BMS) in a porcine model. Fifty-three stents (14 HD, 14 LD, 14 SES, 11 BMS) were implanted in 18 minipigs. At 14 days, nano-PES with HD and LD showed more complete endothelialization compared with SES. BMS had 100% endothelial coverage. At 28 days, a significant reduction in neointimal hyperplasia was detected by OCT in the nano-PES HD group compared with BMS. No benefit in prevention of the neointimal hyperplasia was observed in the nano-PES LD group. Nano-PES stents showed decreased deposition of fibrin and inflammation compared with SES. Pharmacokinetic studies revealed that nano-PES could effectively deliver the drug to the local coronary artery and it released the drug more rapidly than SES. Such a release profile was favorable for rapid endothelialization of nano-PES. The present study showed the nano-PES to be a new drug-delivery technology; that it used a nanoporous stent surface; that it offered desirable drug-elution properties without the use of polymers; that it may translate into an improved safety profile for next-generation DES.
authors: Department of Cardiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China.
authors: Haibo
authors: H
authors: Jia
authors: Haixia
authors: H
authors: Liu
authors: Junying
authors: J
authors: Kong
authors: Jingbo
authors: J
authors: Hou
authors: Jian
authors: J
authors: Wu
authors: Maomao
authors: M
authors: Zhang
authors: Jinwei
authors: J
authors: Tian
authors: Huimin
authors: H
authors: Liu
authors: Lijia
authors: L
authors: Ma
authors: Sining
authors: S
authors: Hu
authors: Xingtao
authors: X
authors: Huang
authors: Shaosong
authors: S
authors: Zhang
authors: Shuo
authors: S
authors: Zhang
authors: Bo
authors: B
authors: Yu
authors: Ik-Kyung
authors: IK
authors: Jang
mesh_terms: D000818:Animals; D000972:Antineoplastic Agents, Phytogenic / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use*; D017023:Coronary Angiography; D004337:Drug Carriers / Q000737:chemistry; D054855:Drug-Eluting Stents; D006965:Hyperplasia / Q000188:drug therapy* / Q000473:pathology; D008422:Materials Testing; D008670:Metals / Q000737:chemistry; D049329:Nanostructures / Q000737:chemistry; D017239:Paclitaxel / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use*; D011108:Polymers / Q000737:chemistry; D016062:Porosity; D015607:Stents; D013499:Surface Properties; D013552:Swine; D013556:Swine, Miniature; D041623:Tomography, Optical Coherence; D017539:Tunica Intima / Q000187:drug effects* / Q000473:pathology
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D004337:Drug Carriers; D008670:Metals; D011108:Polymers; D017239:Paclitaxel