可降解聚乳酸涂层西罗莫司洗脱支架在小型猪冠状动脉模型中的实验研究

目的评价新型L605钴铬合金平台可降解聚乳酸共聚物载体西罗莫司药物洗脱支架（bioabsorbable polymeric sirolimus-eluting stent,BPSES）在小型猪冠状动脉抑制新生内膜增殖的有效性和安全性。方法金属裸支架（bare mental stent,BMS）18枚、单纯可降解聚乳酸共聚物涂层支架（bioabsorbable polymer-only stent,BPOS）18枚以及BPSES 18枚被分别随机置入18头小型猪的前降支（18枚）、回旋支（18枚）以及右冠状动脉（18枚）。置入28天和90天,复查冠状动脉造影评价管腔丢失。置入7天、28天以及90天处死部分动物行塑料包埋硬组织切片染色组织形态学分析。结果置入28天及90天,BPSES与BMS相比,显著降低管腔丢失（28天0.54±0.45 mm比1.11±0.45mm,P=0.048;90天0.42±0.34 mm比0.96±0.41 mm,P=0.024）。在损伤积分相似的情况下,置入28天时BPSES较BMS新生内膜面积明显减少（0.90±0.40 mm2比1.88±0.71 mm2,P=0.015）,而在90天时亦叮见此趋势，7天、28天和90天BPSES和BPOS炎症反应及内皮化程度与BMS相似。结论BPSES在置入小型猪冠状动脉28天后，可以安全有效地抑制新生内膜增殖，90天时亦可见此趋势。

A novel bioabsorbable polymeric sirolimus-eluting stent: evaluation in a porcine model

Objective To evaluate the efficacy and safty of bioabsorbable polylactic acid sirolimus eluting-stents（BPSES） in inhibiting neointimal hyperplasia in porcine coronary model.Methods Bare metal stents（BMS）（n=18）,mere bioabsorbable polylactic acid polymer coated stents（BPOS）（n=18） and BPSES（n=18） were implanted in left anterior descending（n=18）,left circumflex coronary（n=18） and right coronary artery（n=18） of 18 swines in random.Coronary angiography was performed 28 days and 90 days after the stenting procedure and histomorphologic analysis was done m a certain nunmer ot ammals after 7 days （n=4）, 18 days （n=6） and 90 days （n =6）, respectively. Results The 28-day （n =6） amt 90-day （n = 6） outcome by quantitative coronary angiography （QCA） showed significant reduction in luminal loss （LL） in BPSFS （28-day-LL： 0. 54 ±0.45 mm vs 1. 11 ±0. 45mm,P =0. 048 ;90-day-LL：0. 42 ± 0.34 mm vs 0.96 ± 0.41 ram, P = 0.024） compared with BMS. With similar injury scores, histomorphologic analysis on day 28 showed there was a significant reduction in neointimal tissue proliferation with BPSES compared with BMS control（ average neointimal area： 0. 90 ±0. 40 mm^2 vs 1.88 ±0. 71 toni2 ,P = 0. 015 ）. High magnification histomorphologic examination revealed similar inflammation score and endothelialization score between BPSES and BMS. Conclusion Bioabsorbable polymeric sirolimus-eluting stents showed reduction in neointimal hyperplasia with good biocompatibility in porcine coronary model.