管形冠状动脉支架V-Flex~(TM)在猪冠状动脉和髂动脉支架模型上的实验评价

在猪的冠状动脉和周围血管支架模型上 ,通过血管造影和组织病理学检查评价一种新型的 316L不锈钢管型冠状动脉支架V -FlexTM的安全有效性。将 16个支架置入 16只猪的右冠状动脉 ,8只猪观察 6周 ,另 8只猪观察 12周。血管造影显示所有右冠状动脉通畅 ,6周时 16只猪的右冠状动脉造影定量分析显示直径狭窄平均为9% ;6周时 8只猪的组织病理学分析显示右冠状动脉内膜增生为 1.15± 0 .38mm2 ,12周时 8只猪的组织病理学分析显示内膜增生为 1.2 2± 0 .34mm2 。同Palmaz -Schatz冠状动脉支架在周围动脉上比较 ,V -FlexTM引起的内膜增生较轻 (6周 :1.11± 0 .37mm2 比 2 .40± 0 .36mm2 ;12周 :1.5 3± 0 .42mm2 比 2 .47± 0 .6 3mm2 ,P均 <0 .0 5 ) ,血管损伤、炎症反应及血栓反应亦较轻。研究结果表明 ,V -FlexTM冠状动脉支架在猪的冠状动脉和周围动脉上引起的新生内膜增生轻 ,血管损伤小 ,且炎症反应、血栓反应亦较轻 ,有较好的生物相容性

Experimental Evaluation of a New Tubular Coronary Stent (V-Flex~(TM) )in Porcine Coronary and Iliac Artery Model

Aim To evaluate the safety, efficacy, angiographic and histopathological effects of a new 316L stainless steel tubular stent (V-Flex TM ) in a porcine coronary and peripheral artery model. Methods Stent implantation in the right coronary artery was successful in all 16 pigs. 8 pigs with V-Flex TM stent were angiophically treated after 6 weeks and then sacrificed, the remaining 8 pigs with V-Flex TM stent were angiophically controlled and sacrificed at 12 weeks. Then all vascular samples and angiographic films were analyzed morphologically. Results 6 week treated group showed only a mild fibromusclar neointimal hyperplasia of 1.15±0.38 mm 2. The neointimal hyperplasia was 1.22±0.34 mm 2 at 12 week controlled group, comparison with the Palmaz-Schatz coronary stent in a porcine peripheral artery model demonstrated significantly less neointimal hyperplasia at 6 weeks (1.11±0.73 mm 2 vs 2.40±0.36 mm 2,P<0.05)and at 12 weeks (1.53±0.42 mm 2 vs 2.47±0.63 mm 2,P<0.05), and also less in injury, inflammation and thrombus reaction at 6 and 12 weeks. Conclusion V-Flex TM coronary stent implantation in a porcine coronary and peripheral arteries results in a high procedural success and 12 weeks histopathological and morphologic evaluation demonstrated only a mild fibromuscular showed significantly less neointimal hyperplasia in the V-Flex TM stent.