摘要
目的:对比4种不同的生物可降解或非降解聚合物涂层的雷帕霉素洗脱支架(SES)置入健康小型猪冠状动脉后的安全性及有效性。方法:对2007-09至2009-07期间本研究组完成的采用4种不同涂层SES的动物实验资料进行分析,分为可降解的聚乳酸聚羟基乙酸共聚物(PLGA)涂层SES组(PLGA组)、可降解的聚左旋乳酸(PLLA)涂层SES组(PLLA组)、非降解的苯乙烯丁烯嵌段共聚物(SBS)涂层SES组(SBS组)和非降解的聚乙烯醋酸乙烯酯(EVAC)涂层SES组(EVAC组)。PLGA组包括4周观察终点的猪5只,另外3组包括4周观察终点的猪各4只。每只猪于左前降支和右冠状动脉各置入同种支架1枚。至观察终点时复查冠状动脉造影并处死取材,通过形态学方法观察血管壁炎症及内膜增生情况。结果:4周时EVAC组有3例标本血管壁大量淋巴细胞和嗜酸细胞浸润,形成炎症肉芽肿,而PLGA组、PLLA组和SBS组无明显炎症反应。PLGA组、PLLA组和SBS组平均炎症细胞密度,残余管腔直径,残余管腔面积,内弹力板围绕面积,外弹力板围绕面积均显著小于EVAC组,差异有统计学意义(P均<0.05),而PLGA组、PLLA组和SBS组之间差异无统计学意义(P均>0.05)。各组间在反映内膜增生的指标(平均内膜厚度、新生内膜面积、面积狭窄百分比)上差异均无统计学意义(P均>0.05)。各组均无支架内狭窄(面积狭窄百分比≥50%)发生。结论:这4种采用不同涂层的SES支架均可以显著抑制健康小型猪冠状动脉支架置入术后4周时的内膜增生。采用可降解的PLGA和PLLA涂层的SES有良好的组织相容性,而非降解的EVAC涂层SES有较重的炎症反应。
Objective： To compare the safety and efficiency in 4 kinds of sirolimus-eluting stem （SES） coated with different biodegradable or permanent polymers in healthy porcine coronary artery model. Methods ： We performed a preclinical study in 4 kinds of SES coated with different polymers in healthy porcine coronary artery from September 2007 to July 2009 in our hospital. SES were coated with biodegradable polylactic acid-co-polyglycolic acid polymer （PLGA group） and poly-L-lactic acid polymer （PLLA group） ; with permanent styrene-butylene-styrene polymer （SBS group） and ethylene-vinyl acetate copolymer （EVAC group）. In PLGA group,n = 5, and in the other three groups,n =4,respectively. Two same stents were implanted into the same animal, one in left anterior descending artery, the other in right coronary artery for 4 weeks. Coronary angiography was performed at the end point of the treatment, and the neointimal proliferation and inflammation were examined by histomorphometric measurements in each animal. Results： At 4-week time point,extensive inflammation with granulomatous reaction including eosinophils and lymphocytes infiltration was developed in 3 animals in EVAC group,while no obvious inflammatory reaction was observed in the other 3 groups. The average inflammatory cell density in stented artery wall was significantly higher in EVAC group than that in the other 3 groups,P 〈 0.05 respectively, and no statistical differences were found among the other 3 groups, P 〉 0. 05. The similar level of
neointimal proliferation parameters as the average of neointimal thickness, neointimal area and the percentage area stenosis were found in all 4 experimental groups. No in-stent stenosis occurred in the experimental animals. Conclusion： Our study presented that 4 kinds of SES could significantly inhibit the neointimal proliferation in 4 weeks of stent implantation in healthy porcine coronary artery model. SES coated with biodegradable PLGA and PLLA polymers had the better biocompatibility; while with permanent EVAC polymers might cause severe inflammatory response in some cases.
出处
《中国循环杂志》
CSCD
北大核心
2010年第5期387-390,共4页
Chinese Circulation Journal
