新型生物全降解药物洗脱支架置入小型猪冠状动脉后冠状动脉造影及连续血管内超声评价

目的评价聚左旋乳酸/无定形磷酸钙（PLLA/ACP）新型生物全降解药物支架置入猪冠状动脉6个月内支架弹性回缩及有效性。方法将16枚新型生物支架随机置入小型猪冠状动脉内,行冠状动脉造影检查（术后即刻、随访终点）和血管内超声（IVUS）检查（术后即刻、1个月、6个月）,并且,在术后1个月和6个月分别处死12、4只动物,取支架置入部位血管固定行苏木素-伊红（HE）染色,观察内膜增生情况和支架贴壁情况。结果各小型猪随访终点造影复查可见支架置入段血管血流通畅,无狭窄及血栓形成等现象。IVUS检查提示,平均支架面积和平均支架直径在置入术后1个月和术后6个月时分别与术后即刻比较,差异均无统计学意义平均支架面积：（6.08±1.30）mm2、（6.00±0.60）mm2比（5.97±0.53）mm2,P〉0.05;平均支架直径：（2.76±0.30）mm、（2.76±0.14）mm比（2.75±0.12）mm,P〉0.05],提示支架未发生显著弹性回缩;病理形态学分析提示,支架置入段血管轻度狭窄,未见支架贴壁不良。结论新型生物全降解支架置入小型猪冠状动脉6个月后,未发现显著支架弹性回缩,具有足够的支撑性能;内膜增生程度较轻,能够保证管腔通畅。

Angiography and consecutive intravascular unltrasound assessment of anovel fully bioabsorbable drug-eluting scaffold within 6 months in porcine model

Objective To evaluate the acute recoil and effectiveness of a novel fully bioabsorbable PLLA / ACP drug-eluting scaffold within 6 months in porcine model. Methods A total of 16 novel fully bioabsorbable scaffold were randomly implanted into the coronary arteries of 16 porcines. Angiography analysis performed immediately（ 0 hour）,end of follow-up and intravascular ultrasound（ IVUS） were performed immediately（ 0 hour）,1 month and 6 months after implantation. 12 and 4 porcines were euthanatized at 1 month and 6 months after operation respectively. The stent-segment coronary arteries were examined by HE staining. Results No in-stent restenosis and thrombosis were detected at the end of followup of each porcines. By IVUS,compare to stenting immediately,the mean area of stent and the mean diameter of stent had no statistically significant differences at 1 month and 6 months,mean area of stent was（ 5. 97 ± 0. 53） mm2 vs.（ 6. 08 ± 1. 30） mm2and（ 6. 00 ± 0. 60） mm2,respectively,P 〉 0. 05] and mean diameter of stent was （ 2. 75 ± 0. 12） mm vs.（ 2. 76 ± 0. 30） mm and（ 2. 76 ± 0. 14） mm,respectively,P 〉0. 05]. By Path morphological analysis,the stented segment of the vessel associated with mild restenosis,and stents were well positioned. Conclusions No elastic recoil of the novel fully bio absorbable scaffold was detected in porcine model within 6 months. The novel stent performed excellent physical properties,caused low levels of thehyperplasia of neointimal,and successfully keep the vascular patency.