无载体西罗莫司洗脱支架在小型猪冠状动脉模型中预防冠状动脉支架再狭窄的实验研究

Evaluation of a novel polymer-free sirolimus-eluting stent in a porcine model

目的评价新型无载体西罗莫司药物洗脱支架(polymer-free sirolimus-eluting stent,PFSES)在小型猪冠状动脉模型中抑制新生内膜增殖的有效性和安全性。方法金属裸支架(baremental stent,BMS,n=13)、无载体纳米微孔裸支架(polymer-free bare mental stent,PFBMS,n=13)、聚合物载体西罗莫司洗脱支架(polymeribased sirolimus-eluting stent,PSES,n=13)以及PFSES(n=13)被分别随机置入26头小型猪的前降支(n=26)和回旋支(n=26)。支架置入28天和90天后,复查冠状动脉造影评价管腔丢失。90天后处死部分动物(n=12)行塑料包埋硬组织切片染色组织形态学分析。结果置入28天(n=24)及90天(n=12),PFSES与BMS相比,显著降低管腔丢失(0.69±0.49 mm比1.27±0.36 mm,P=0.041;0.77±0.44 mm比1.33±0.29 mm,P<0.01)。在90天组织形态学分析中,损伤积分相似的情况下,PFSES较BMS明显减少新生内膜面积(2.412±1.149 mm2比4.475±1.345 mm2,P<0.05)。PFSES炎症反应与BMS相似,且明显低于PSES。结论PFSES在置入小型猪冠状动脉28及90天后,可以安全有效地抑制内膜增殖和预防支架内再狭窄。

Objective To evaluate the efficacy and safty of Polymer-free sirolimus eluting-stents（PFSES） in preventing restenosis in porcine coronary model.Methods Bare metal stents（BMS）（n=13）,polymer-free bare metal stents（PFBMS）（n=13）,polymeric sirolimus-eluting stents（PSES）（n=13） and PFSES（n=13） were implanted in left anterior descending coronary arteries（n=26） and left circumflex coronary（n=26） of 27 swines randomly.Coronary angiography was performed 28 days and 90 days after the procedure.Twelve animals were sacrificed for histomorphologic analysis after 90 days.Results The 28-day（n=24） and 90-day（n=12） outcome by quantitative coronary angiography（QCA） showed significant reduction in luminal loss（LL） in PFSES（LL：0.69±0.49 mm vs 1.27±0.36 mm,P=0.041;0.77±0.44 mm vs 1.33±0.29 mm,P〈0.01）compared with BMS.By histomorphomeric analysis,with the similar injury sores,there was also a corresponding significant reduction in neointimal tissue proliferation in PFSES compared with BMS control（average neointimal area： 2.412±1.149 mm2 vs 4.475±1.345 mm2,P〈0.05）.High magnification histomorlogic examination revealed similar inflammation score between PFSES and BMS,both of which were lower than PSES.Conclusion Polymer-free sirolimus-eluting stents can reduce neointimal hyperplasia with good biocompatibility in porcine coronary model.