可生物降解铁支架在小型猪冠状动脉中的短期安全性和有效性。

Short-term safety and efficacy of the biodegradable iron stent in mini-swine coronary arteries.

机构信息

State Key Laboratory of Cardiovascular Disease, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.

Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.

出版信息

Chin Med J (Engl). 2013;126(24):4752-7.

PMID:24342324

Abstract

BACKGROUND

To overcome the drawbacks of permanent stents, biodegradable stents have been studied in recent years. The bioabsorbable polymer vascular scaffold (BVS) was the first bioabsorbable stent to undergo clinical trials, demonstrating safety and feasibility in the ABSORB studies. Iron can potentially serve as the biomaterial for biodegradable stents. This study aimed to assess the short-term safety and efficacy of a biodegradable iron stent in mini-swine coronary arteries.

METHODS

Eight iron stents and eight cobalt chromium alloy (VISION) control stents were randomly implanted into the LAD and RCA of eight healthy mini-swine, respectively. Two stents of the same metal base were implanted into one animal. At 28 days the animals were sacrificed after coronary angiography, and histopathological examinations were performed.

RESULTS

Histomorphometric measurements showed that mean neointimal thickness ((0.46 ± 0.17) mm vs. (0.45 ± 0.18) mm, P = 0.878), neointimal area ((2.55 ± 0.91) mm(2) vs. (3.04 ± 1.15) mm(2), P = 0.360) and percentage of area stenosis ((44.50 ± 11.40)% vs. (46.00 ± 17.95)%, P = 0.845) were not significantly different between the iron stents and VISION stents. There was no inflammation, thrombosis or necrosis in either group. The scanning electron microscopy (SEM) intimal injury scores (0.75 ± 1.04 vs. 0.88 ± 0.99, P = 0.809) and number of proliferating cell nuclear antigen (PCNA) positive staining cells were not significantly different between the two groups. The percentage of neointimal coverage by SEM examination was numerically higher in iron stents than in VISION stents ((84.38 ± 14.50)% vs. (65.00 ± 22.04)%, P = 0.057), but the difference was not statistically significant. Iron staining in the tissue surrounding the iron stents at 28 days was positive and the vascular wall adjacent to the iron stent had a brownish tinge, consistent with iron degradation. No abnormal histopathological changes were detected in coronary arteries or major organs.

CONCLUSIONS

The biodegradable iron stent has good biocompatibility and short-term safety and efficacy in the miniswine coronary artery. Corrosion of iron stents is observed at four weeks and no signs of organ toxicity related to iron degradation were noted.

摘要

背景

为了克服永久性支架的缺点，近年来研究了可生物降解支架。生物可吸收聚合物血管支架（BVS）是第一个经过临床试验的生物可吸收支架，在 ABSORB 研究中证明了其安全性和可行性。铁有可能成为可生物降解支架的生物材料。本研究旨在评估生物可降解铁支架在小型猪冠状动脉中的短期安全性和有效性。

方法

将 8 个铁支架和 8 个钴铬合金（VISION）对照支架分别随机植入 8 只健康小型猪的 LAD 和 RCA。同一金属基底的两个支架植入一只动物体内。在 28 天，进行冠状动脉造影后处死动物，并进行组织病理学检查。

结果

组织形态学测量显示，平均新生内膜厚度（（0.46 ± 0.17）mm 比（0.45 ± 0.18）mm，P = 0.878）、新生内膜面积（（2.55 ± 0.91）mm2 比（3.04 ± 1.15）mm2，P = 0.360）和面积狭窄率（（44.50 ± 11.40）%比（46.00 ± 17.95）%，P = 0.845）在铁支架和 VISION 支架之间无显著差异。两组均无炎症、血栓或坏死。扫描电子显微镜（SEM）内膜损伤评分（0.75 ± 1.04 比 0.88 ± 0.99，P = 0.809）和增殖细胞核抗原（PCNA）阳性染色细胞数无显著差异。SEM 检查显示，铁支架的新生内膜覆盖率数值高于 VISION 支架（（84.38 ± 14.50）%比（65.00 ± 22.04）%，P = 0.057），但差异无统计学意义。28 天时，铁支架周围组织的铁染色阳性，铁支架附近的血管壁呈褐色，与铁降解一致。在冠状动脉或主要器官中未发现异常的组织病理学变化。