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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 efficacy of four different biodegradable or non-degradable polymer-coated rapamycin-eluting stents (SESs) into healthy miniature pig coronary arteries. Methods: The experimental data of four different coated SESs completed in this research group from 2007-09 to 2009-07 were analyzed and divided into biodegradable polylactide polyglycolic acid copolymer (PLGA) coated SES group PLGA group), degradable PLLA coated SES group (PLLA group), non-degraded SBS coated SES group (SBS group) and non-degraded polyethylene Vinyl acetate (EVAC) coated SES group (EVAC group). The PLGA group included 5 pigs at the 4 week end point of observation and the other 3 pigs each including 4 at the 4 week end point. Each pig in the left anterior descending branch and the right coronary artery into the same stent 1. Coronary angiography was performed at the end of observation and sacrificed. Morphology was used to observe the vascular wall inflammation and intimal hyperplasia. Results: At 4 weeks, there were 3 cases of infiltration of lymphocytes and eosinophils in the vascular wall of EVAC group, forming inflammatory granuloma, but there was no obvious inflammatory reaction in PLGA, PLLA and SBS groups. The average inflammatory cell density, residual luminal diameter, residual luminal area, the area around the internal elastic plate and the area around the external elastic plate in the PLGA, PLLA and SBS groups were significantly lower than those in the EVAC group (all P <0.05) ), But there was no significant difference between PLGA group, PLLA group and SBS group (all P> 0.05). There were no significant differences among the groups in the indicators of intimal hyperplasia (mean intima thickness, neointimal area, stenosis percentage) (all P> 0.05). No stent stenosis (stenosis ≥ 50%) occurred in all groups. CONCLUSIONS: These four SES scaffolds with different coatings all significantly inhibited intimal hyperplasia at 4 weeks after implantation of healthy miniature pig coronary stents. SES with degradable PLGA and PLLA coatings had good histocompatibility, whereas non-degraded EVAC coating SES had a heavier inflammatory response.