在猪冠状动脉中植入支架前，用染料木黄酮包被的新型药物洗脱球囊的效果。

Effect of a novel drug-eluted balloon coated with genistein before stent implantation in porcine coronary arteries.

作者信息

Sheiban Imad, Anselmino Matteo, Moretti Claudio, Biondi-Zoccai Giuseppe, Galloni Marco, Vignolini Cristina, Mattoni Mario, Sciuto Filippo, Omedè Pierluigi, Trevi Gian Paolo

机构信息

Interventional Cardiology, Division of Cardiology, University of Turin, San Giovanni Battista Hospital, Turin, Italy.

出版信息

Clin Res Cardiol. 2008 Dec;97(12):891-8. doi: 10.1007/s00392-008-0705-2. Epub 2008 Sep 5.

DOI:10.1007/s00392-008-0705-2

PMID:18777002

Abstract

BACKGROUND

The major drawback of stent implantation in native human coronary vessels is the occurrence of restenosis. Drug-eluting stents significantly reduce restenosis after percutaneous coronary intervention (PCI), but may be associated with persistent local inflammation involved in the restenosis mechanisms. In this setting coating coronary devices with anti-inflammatory agents represents an intriguing alternative to stent-based local drug delivery. The aim of the present study was to test in a porcine model the safety and efficacy of a novel Genistein-eluting balloon preceding coronary stenting.

DESIGN

Female piglets underwent PCI in a randomized fashion with either a Genistein-eluting or a standard balloon angioplasty, followed in all vessels by bare-metal stent implantation. Pigs were sacrificed at different time points to appraise safety (i.e. endothelialization) and efficacy (i.e. anti-inflammatory and anti-proliferative effects): 1, 4, and 6-8 weeks following PCI.

RESULTS

Overall analysis was conducted on 14 piglets. Twenty-five bare-metal stents were implanted preceded by angioplasty with a conventional balloon in 13 vessels and by the Genistein-eluted balloon in 12. No untoward effects were reported in either group. Healing and endothelialization appeared universal within 4 weeks. The Genistein-eluted balloon group disclosed a significant reduction, at four weeks from implantation, of the peri-stent inflammatory cells count (mononucleocytes 39 +/- 32 Vs. 96 +/- 29 per square millimetre, P = 0.019). This effect did not clearly translate into a trend towards a reduced neointimal hyperplasia at 6-8 weeks (0.13 +/- 0.11 Vs. 0.14 +/- 0.09, P = 0.835).

CONCLUSION

This study provides the first in vivo demonstration of the anti-inflammatory effects of a Genistein-eluting balloon in PCI, warranting further research including the combination of a Genistein-eluting balloon with standard drug-eluting stent.

摘要

背景

在人体天然冠状动脉血管中植入支架的主要缺点是再狭窄的发生。药物洗脱支架显著降低了经皮冠状动脉介入治疗（PCI）后的再狭窄，但可能与再狭窄机制中持续存在的局部炎症有关。在这种情况下，用抗炎剂包被冠状动脉装置是基于支架的局部药物递送的一种有趣替代方法。本研究的目的是在猪模型中测试一种新型的在冠状动脉支架置入前使用的染料木黄酮洗脱球囊的安全性和有效性。

设计

雌性仔猪以随机方式接受PCI，分别使用染料木黄酮洗脱球囊或标准球囊血管成形术，随后在所有血管中植入裸金属支架。在PCI后的不同时间点（1周、4周以及6 - 8周）处死猪，以评估安全性（即内皮化）和有效性（即抗炎和抗增殖作用）。

结果

对14只仔猪进行了全面分析。共植入25个裸金属支架，其中13个血管先进行了传统球囊血管成形术，12个血管先使用了染料木黄酮洗脱球囊。两组均未报告不良影响。4周内愈合和内皮化普遍出现。染料木黄酮洗脱球囊组在植入后四周时，支架周围炎症细胞计数显著减少（每平方毫米单核细胞39±32个对96±29个，P = 0.019）。但这种效果在6 - 8周时并未明显转化为内膜增生减少的趋势（0.13±0.11对0.14±0.09，P = 0.835）。