摘要
目的:探索可吸收药物洗脱冠状动脉支架[IBS^TM支架,先健科技(深圳)有限公司]在小型猪冠状动脉模型中的短期有效性及安全性。方法:将28枚IBS^TM支架(IBS^TM组)和28枚钴铬合金依维莫司药物洗脱支架(Xience Prime^TM,Xience Prime^TM组)随机置入28头非动脉粥样硬化小型猪的两支主要冠状动脉。在支架置入7天、14天及28天后,应用光学相干断层扫描(OCT)、微型计算机断层扫描(Micro-CT)、扫面电镜(SEM)和组织病理学检查评估IBS^TM支架短期的安全性及有效性。结果:所有实验动物均未发生不良心血管事件。在支架置入28天后,两组间面积狭窄率、血管损伤积分和炎症积分差异均无统计学意义(P均>0.05)。IBS^TM组的纤维沉积积分比Xience Prime^TM组高([1.29±0.72)分vs(0.6±0.68)分,P=0.041],差异有统计学意义。Micro-CT显示在28天时IBS^TM支架并未出现任何腐蚀,仍然保持其结构的完整性。IBS^TM支架相比于Xience Prime^TM支架,在早期有更高的内皮覆盖率,但到28天时两组间差异并无统计学意义[7天:(77±15)%vs(30±30)%,P=0.032;14天:(87±8)%vs(64±17)%,P=0.017;28天:(96±3)%vs(97±2)%,P=0.861]。同时,免疫组化结果显示IBS^TM支架组内皮细胞生理功能有所恢复。结论:IBS^TM支架在小型猪冠状动脉模型中具有与Xience Prime^TM支架相似的短期安全性和有效性。IBS^TM支架在置入早期有更迅速且完整的内皮覆盖。
Objectives:To explore the short-term efficacy and safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffolds(IBS^TM scaffolds,Lifetech Scientific Co.Ltd.,Shenzhen,China)in porcine coronary arteries.Methods:28 IBS^TM scaffolds and 28 Xience Prime^TM stents were randomly implanted in two main coronary arteries of 28 nonatherosclerotic swines.Short-term safety and efficacy of the IBS^TM scaffolds compared with Xience Prime^TM stents were examined by optical coherence tomography(OCT),micro-computed tomography(Micro-CT),scanning electron microscopy(SEM)and histological observation at 7,14 and 28 days after implantation.Results:All mini-pigs implanted with IBS^TM scaffolds and Xience Prime^TM stents survived without any adverse cardiovascular events during the study.There was no significant difference between the IBS^TM scaffolds and Xience Prime^TM stents in area stenosis,vascular injury score and inflammatory score at 28 days post implantation.However,fibrin score of IBS^TM was higher than that of Xience Prime^TM stents at 28 days(1.29±0.72 vs 0.6±0.68,P=0.041).IBS^TM scaffolds kept its integral without corrosion after implantation for 28 days as assessed by the Micro-CT observation.The endothelialization percent of IBS^TM scaffolds was higher than Xience Prime^TM stents at early stage(7 and 14 days post implantation)and comparable at 28 days([77±15]%vs[30±30]%,P=0.032 at 7 days;[87±8]%vs[64±17]%,P=0.017 at 14 days;[96±3]%vs[97±2]%,P=0.861 at 28 days).Moreover,immunohistochemical analysis revealed the recovery of endothelial cell physiological functions to some extent in the IBS^TM scaffolds group.Conclusions:This study suggested that the IBS^TM scaffolds have comparable short-term safety and efficacy to that of Xience Prime^TM stents in porcine coronary arteries.Moreover,the IBS^TM scaffolds are linked with earlier and complete endothelialization.
作者
郑剑峰
田原
胡小莹
罗彤
吴超
田毅
唐跃
宋来凤
李莉
许亮
徐波
邱洪
高润霖
ZHENG Jianfeng;TIAN Yuan;HU Xiaoying;LUO Tong;WU Chao;TIAN Yi;TANG Yue;SONG Laifeng;LI Li;XU Liang;XU Bo;QIU Hong;GAO Runlin(Coronary Heart Disease Center,National Center for Cardiovascular Disease and Fuwai Hospital,CAMS and PUMC,Beijing(100037),China)
出处
《中国循环杂志》
CSCD
北大核心
2019年第7期713-719,共7页
Chinese Circulation Journal