川芎嗪涂层支架生物相容性的实验研究

Biocompatibility of tetramethylpyrazine-eluting stents in normal porcine coronary arteries

目的 通过定量冠状动脉造影(QCA)及血管内超声(IVUS)检查观察支架置入后血管内膜增殖和血栓形成情况,评价川芎嗪涂层支架(TES)的生物相容性.方法 小型猪14只,分为两组,实验组于猪冠状动脉左前降支或右冠状动脉置入TES,对照组则置入金属裸支架(BMS),支架与血管直径比为1.1～1.2/1.0.支架置入前后均行QCA及IVUS检查.术后第28天行QCA及IVUS以观察支架内内膜增殖及血栓形成情况.实验终点处死动物,获取心、肾、肝、肺及支架置入段、支架前后5cm的血管行病理学检查.结果 14只动物均成功置入支架,其中4只动物因心脏压塞、麻醉意外及大出血死亡,5只于前降支或右冠状动脉近中段成功置入TES,5只置入BMS.术后第28天复查QCA及IVUS证实,两组局部血管壁完整,无溃疡、血管瘤及中层坏死;均无血管痉挛;未见血栓形成.组织病理学检查提示心、肾、肝、肺无明显损害.第28天QCA显示,对照组支架段血管直径与实验组相比明显减小(P＜0.01),IVUS显示实验组新生内膜面积比对照组小,差异有显著性.结论 TES能抑制内膜增殖,无致栓性,具有良好的生物相容性.

Objective To evaluate the biocompatibility of tetramethylpyrazine(TMP)-eluting stents(TES)in normal porcine coronary arteries.Methods Fourteen pigs were randomly divided into the experimental group(n=7)and the control group(n=7).The experimental group were underwent TES implantation and the control group were underwent bare-metal stents(BMS)implantation.The stents were deployed with a stent-to-artery ratio of 1.1~1.2/1.0 in order to induce vascular wall injury.Quantitative coronary angiography(QCA)and intravascular ultrasound(IVUS)were performed before and immediately after the implantations and at the end point time of 28 days.Stented-coronary,ventricular wall related to stented-coronary,lung,liver and kidney were collected to perform histopathology and histomorphometry by HE after euthanasia of animals on the endpoint.Results All the stents were implanted into porcine coronary arteries successfully,but 4 pigs were died of cardiac tamponade,anesthesia or bleeding.No thrombosis and damage caused by implantation in ventricular wall related to stented-coronary,lung,liver and kidney were found in the two groups.QCA showed that the diameter restenosis in the control group was significantly reduced compared with the experimental group.IVUS analysis showed that the neointimal area of stented-coronary was significantly reduced in the experimental group compared with the control group.Conclusions TES can inhibit the neointimal hyperplasia and there is no thrombosis,thus its biocompatibility seems good and acceptable in model of pigs.