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CYPHER-Select、TAXUS-Express和Polyzene-F纳米涂层钴铬合金支架在小型猪冠状动脉模型中的再狭窄情况。

Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F nanocoated cobalt-chromium stents in the minipig coronary artery model.

作者信息

Radeleff Boris, Thierjung Heidi, Stampfl Ulrike, Stampfl Sibylle, Lopez-Benitez Ruben, Sommer Christof, Berger Irina, Richter Goetz M

机构信息

Department of Radiology, University Heidelberg, INF 110, 69120, Heidelberg, Germany.

出版信息

Cardiovasc Intervent Radiol. 2008 Sep-Oct;31(5):971-80. doi: 10.1007/s00270-007-9243-y. Epub 2007 Dec 19.

DOI:10.1007/s00270-007-9243-y
PMID:18095019
Abstract

PURPOSE

To date no direct experimental comparison between the CYPHER-Select and TAXUS-Express stents is available. Therefore, we investigated late in-stent stenosis, thrombogenicity, and inflammation, comparing the CYPHER-Select, TAXUS-Express, and custom-made cobalt chromium Polyzene-F nanocoated stents (CCPS) in the minipig coronary artery model.

METHODS

The three stent types were implanted in the right coronary artery of 30 minipigs. The primary endpoint was in-stent stenosis assessed by quantitative angiography and microscopy. Secondary endpoints were inflammation and thrombogenicity evaluated by scores for inflammation and immunoreactivity (C-reactive protein and transforming growth factor beta). Follow-up was at 4 and 12 weeks.

RESULTS

Stent placement was successful in all animals; no thrombus deposition occurred. Quantitative angiography did not depict statistically significant differences between the three stent types after 4 and 12 weeks. Quantitative microscopy at 4 weeks showed a statistically significant thicker neointima (p = 0.0431) for the CYPHER (105.034 +/- 62.52 microm) versus the TAXUS (74.864 +/- 66.03 microm) and versus the CCPS (63.542 +/- 39.57 microm). At 12 weeks there were no statistically significant differences. Inflammation scores at 4 weeks were significantly lower for the CCPS and CYPHER compared with the TAXUS stent (p = 0.0431). After 12 weeks statistical significance was only found for the CYPHER versus the TAXUS stent (p = 0.0431). The semiquantitative immunoreactivity scores for C-reactive protein and transforming growth factor beta showed no statistically significant differences between the three stent types after 4 and 12 weeks.

CONCLUSIONS

The CCPS provided effective control of late in-stent stenosis and thrombogenicity in this porcine model compared with the two drug-eluting stents. Its low inflammation score underscores its noninflammatory potential and might explain its equivalence to the two DES.

摘要

目的

迄今为止,尚无关于CYPHER-Select支架与TAXUS-Express支架的直接实验比较。因此,我们在小型猪冠状动脉模型中,比较了CYPHER-Select支架、TAXUS-Express支架和定制的钴铬聚烯-F纳米涂层支架(CCPS),研究了晚期支架内狭窄、血栓形成和炎症情况。

方法

将三种类型的支架植入30只小型猪的右冠状动脉。主要终点是通过定量血管造影和显微镜评估支架内狭窄。次要终点是通过炎症和免疫反应评分(C反应蛋白和转化生长因子β)评估炎症和血栓形成。随访时间为4周和12周。

结果

所有动物的支架置入均成功;未发生血栓沉积。定量血管造影显示,4周和12周后,三种支架类型之间无统计学显著差异。4周时的定量显微镜检查显示,与TAXUS支架(74.864±66.03微米)和CCPS支架(63.542±39.57微米)相比,CYPHER支架(105.034±62.52微米)的新生内膜在统计学上显著更厚(p = 0.0431)。12周时无统计学显著差异。与TAXUS支架相比,4周时CCPS和CYPHER支架的炎症评分显著更低(p = 0.0431)。12周后,仅CYPHER支架与TAXUS支架之间存在统计学显著差异(p = 0.0431)。4周和12周后,三种支架类型之间C反应蛋白和转化生长因子β的半定量免疫反应评分无统计学显著差异。

结论

与两种药物洗脱支架相比,在该猪模型中,CCPS能有效控制晚期支架内狭窄和血栓形成。其低炎症评分突出了其非炎性潜力,这可能解释了它与两种药物洗脱支架等效的原因。

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