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大球囊后扩张对当代耐用型聚合物药物洗脱支架涂层的影响:扫描电子显微镜研究。

Effect of oversized partial postdilatation on coatings of contemporary durable polymer-based drug-eluting stents: a scanning electron microscopy study.

机构信息

Department of Cardiology, Thoraxcentrum Twente, Enschede, the Netherlands.

出版信息

J Interv Cardiol. 2011 Apr;24(2):149-61. doi: 10.1111/j.1540-8183.2010.00617.x. Epub 2010 Dec 28.

Abstract

BACKGROUND

Oversized postdilation of drug-eluting stents (DES) is often performed to avoid stent malapposition. In stents implanted in long lesion or major bifurcations, extremely oversized partial postdilation may be required, which exposes DES coating to extreme forces. This study aims to assess shape and incidence of coating irregularities on durable polymer-based DES following extremely oversized partial postdilatation.

METHODS

Fifteen DES samples (3 3.5 mm stents of Cypher Select plus [Cordis Europa, Roden, the Netherlands], Taxus Liberté[Boston Scientific Corp., Natick, MA, USA], Endeavor Sprint [Medtronic Vascular, Santa Rosa, CA, USA], Endeavor Resolute [Medtronic Vascular, Santa Rosa, CA, USA], and Xience V [Abbott Vascular, Santa Clara, CA, USA]) were deployed in sterile water (37 °C) at 14 atm, followed by a proximal postdilation with noncompliant 5.0-mm balloons at 18 atm. Stents were then examined with scanning electron microscopy.

RESULTS

Thorough examination of a total of 660 scanning electron microscopic images demonstrated that shape and incidence of coating irregularities in the postdilated and/or transitional DES regions differed only mildly from the nonpostdilated regions. Cypher Select plus showed more peeling without bare metal aspect in the postdilated and transitional regions, and cracks were wider (P < 0.001) in the postdilated and transitional regions; in Taxus Liberté one additional irregularity (torn webbing) and more wrinkles were observed (P < 0.05 for both); in Endeavor Resolute wider cracks were found in the extremely postdilated region only (P < 0.001). Endeavor Sprint and Xience V showed no differences in shape or incidence of coating irregularities between oversized and nonoversized stent regions.

CONCLUSIONS

Bench side assessment of five contemporary durable polymer-based DES with scanning electron microscopy suggests that even very aggressive stent postdilatation results in no more than mild differences in coating irregularities between postdilated and nonpostdilated stent regions.

摘要

背景

为避免支架贴壁不良,常对药物洗脱支架(DES)进行过大尺寸后扩张。在长病变或主要分叉处植入支架时,可能需要进行非常大的局部后扩张,这会使 DES 涂层承受极大的力。本研究旨在评估在非常大的局部后扩张后,持久聚合物基 DES 的涂层不规则情况及形状。

方法

15 个 DES 样本(Cordis Europa 的 3.3.5mm Cypher Select plus 支架、Boston Scientific 的 Taxus Liberté 支架、Medtronic Vascular 的 Endeavor Sprint 支架、Medtronic Vascular 的 Endeavor Resolute 支架和 Abbott Vascular 的 Xience V 支架)在无菌水(37°C)中以 14 个大气压进行扩张,随后在 18 个大气压下使用非顺应性 5.0mm 球囊进行近段后扩张。之后使用扫描电子显微镜对支架进行检查。

结果

对总共 660 张扫描电子显微镜图像进行彻底检查后发现,扩张后的和/或过渡区的 DES 涂层不规则情况和发生率与未扩张区仅略有不同。Cypher Select plus 在扩张后和过渡区显示出更多的剥落,且无裸露金属外观,且裂缝更宽(P<0.001);在 Taxus Liberté 支架中,还观察到一个额外的不规则性(撕裂的织带)和更多的褶皱(两者均为 P<0.05);在 Endeavor Resolute 支架中,仅在极度扩张区发现更宽的裂缝(P<0.001)。 Endeavor Sprint 和 Xience V 支架在超大尺寸和非超大尺寸支架区域之间的涂层不规则形状或发生率没有差异。

结论

使用扫描电子显微镜对 5 种现代持久聚合物基 DES 进行的台边评估表明,即使进行非常激进的支架后扩张,扩张后的和未扩张的支架区域之间的涂层不规则性也仅存在轻微差异。

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