新型可吸收药物洗脱冠状动脉支架在小型猪冠状动脉模型中的短期评估

Preclinical Short-term Evaluation of a Novel Sirolimus-eluting Iron Bioresorbable Coronary Scaffolds in Porcine Coronary Arteries

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.