目的：评价L-605钴铬合金支架平台、聚丙交酯-乙交酯（PLGA）共聚物载体西罗莫司药物洗脱支架在小型猪冠状动脉过度扩张模型中的安全性和有效性。方法裸金属支架（BMS，15枚）、已上市可降解涂层西罗莫司药物洗脱支架（EXCEL，21枚）和钴铬合金PLGA共聚物载体西罗莫司药物洗脱支架（Co-P-SES，21枚）分组随机置入30头小型猪的前降支（LAD）28枚，回旋支（LCX）13枚，右冠状动脉（RCA）16枚。术后28 d、91 d及182 d复查冠状动脉造影，评价管腔丢失（LL）等指标后处死动物，进行组织形态学及组织病理学分析。结果术后28 d及91 d，各实验组的管腔丢失、新生内膜面积、炎症积分及内皮化积分差异均无统计学意义，但术后28 d Co-P-SES组在扫描电镜下观察内皮化程度优于EXCEL组；术后182 d，Co-P-SES组与EXCEL组在管腔丢失、炎症积分及内皮化积分中差异均无统计学意义，但在内弹力板环绕面积相似的情况下， Co-P-SES组的管腔面积大于EXCEL组[（4.31±0.94）mm2比（2.62±1.17）mm2，P=0.020）]，新生内膜面积小于EXCEL组[（1.87±0.53）mm2比（0.84±0.41）mm2，P=0.004）]，差异均有统计学意义。结论在小型猪冠状动脉过度扩张模型中，Co-P-SES的安全性与EXCEL类似，在内皮化及减少新生内膜形成方面可能存在一定优势，有必要进一步临床研究以更好地评价其安全性及有效性。%Objective To assess the safety and efifcacy of a novel biodegradable polymer-coated Cobalt-Chromium alloy sirolimus-eluting stent in a porcine model. Methods Bare metal stents (BMS) (n=15), commercial available EXcellstents (n=21), and Cobalt-Chromium alloy PLAG-coated sirolimus-eluting stents (Co-P-SES) (n=21) were implanted in left anterior descending coronary (LAD, n=28)and left circumflex coronary (LCX, n=13), and right coronary artery (RCA, n=16) of 30 mini-pigs randomly. Coronary angiography was performed 28 days, 90 days and 180 days after the stenting procedure to evaluate luminal loss (LL), and then, histomorphology analysis was performed. Results 28 days and 91 days after the implantation, there were no significant differences in LL, neointimal area, Inflammation score and endothelialization score among the three groups. 28 days after the implantation, better endothelialization was observed in Co-P-SES group compared with EXcellgroup under scanning electron microscope. 182 days after the implantation, there were larger lumen area and less neointimal area in Co-P-SES group compared with EXcellgroup under similar internal elastic lamina area[(4.31±0.94) mm2 vs. (2.62±1.17) mm2, P=0.020];[(1.87±0.53) mm2 vs. (0.84±0.41) mm2, P=0.004]with statistical significance. Conclusions The novel biodegradable polymer-coated Cobalt-Chromium alloy sirolimus-eluting stents showed similar safety compared with commercial available EXcellstents. There would be a better potential of the novel stent on inhibiting the neointimal proliferation and endothelialization. However, further preclinical study including long term endpoints and clinical study should be conducted in order to evaluate the safety and effectiveness of the novel Co-P-SES.
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