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生物可吸收依维莫司和诺伐莫司洗脱支架植入后的后扩张:急性机械效应的光学相干断层扫描观察性研究

Post-dilatation after implantation of bioresorbable everolimus- and novolimus-eluting scaffolds: an observational optical coherence tomography study of acute mechanical effects.

作者信息

Blachutzik Florian, Boeder Niklas, Wiebe Jens, Mattesini Alessio, Dörr Oliver, Most Astrid, Bauer Timm, Röther Jens, Tröbs Monique, Schlundt Christian, Achenbach Stephan, Hamm Christian W, Nef Holger M

机构信息

Department of Cardiology, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.

Department of Cardiology and Angiology, University of Giessen, Giessen, Germany.

出版信息

Clin Res Cardiol. 2017 Apr;106(4):271-279. doi: 10.1007/s00392-016-1048-z. Epub 2016 Oct 18.

Abstract

OBJECTIVES

The objective was to investigate the acute mechanical effects of post-dilatation on bioresorbable scaffolds (BRS) as determined by optical coherence tomography (OCT).

BACKGROUND

Post-dilatation with high-pressure balloons is regarded as a key component of BRS implantation for treatment of coronary artery stenoses. However, the impact of post-dilatation on BRS in vivo has not been thoroughly investigated.

METHODS

OCT was performed after the implantation procedure of 51 everolimus-eluting or novolimus-eluting polylactic acid-based BRS with (n = 27) or without non-compliant balloon post-dilatation (n = 24). The number of malapposed struts, strut fractures, edge dissections, residual in-scaffold area stenosis, and incomplete scaffold apposition area was analyzed over the complete length of each BRS with a spacing of 1 mm.

RESULTS

OCT revealed a significantly lower incomplete scaffold apposition area if post-dilatation was performed (0.16 ± 0.49 mm with post-dilatation vs. 2.65 ± 2.78 mm without post-dilatation, p < 0.001), as well as a significantly lower absolute number of malapposed struts (1 ± 2 with post-dilatation vs. 13 ± 13 without post-dilatation, p < 0.001). No significant differences regarding residual in-scaffold area stenosis, strut fracture, edge dissection, symmetry index, or eccentricity index were observed in patients with vs. without post-dilatation.

CONCLUSION

Post-dilatation of BRS with non-compliant balloons significantly reduces the number of malapposed struts and incomplete scaffold apposition area without inducing higher rates of edge dissection or strut fracture.

摘要

目的

本研究旨在通过光学相干断层扫描(OCT)来探究后扩张对生物可吸收支架(BRS)的急性机械效应。

背景

使用高压球囊进行后扩张被认为是植入BRS治疗冠状动脉狭窄的关键步骤。然而,后扩张对体内BRS的影响尚未得到充分研究。

方法

对51个依维莫司洗脱或诺维莫司洗脱的聚乳酸基BRS进行植入手术,其中27个使用非顺应性球囊进行后扩张,24个未进行后扩张。术后采用OCT进行检查。以1毫米的间距对每个BRS的全长分析贴壁不良支架的数量、支架骨折、边缘夹层、支架内残余面积狭窄以及支架贴壁不全面积。

结果

OCT显示,进行后扩张时,支架贴壁不全面积显著降低(后扩张组为0.16±0.49毫米,未后扩张组为2.65±2.78毫米,p<0.001),贴壁不良支架的绝对数量也显著减少(后扩张组为1±2个,未后扩张组为13±13个,p<0.001)。后扩张组与未后扩张组在支架内残余面积狭窄、支架骨折、边缘夹层、对称指数或偏心指数方面未观察到显著差异。

结论

使用非顺应性球囊对BRS进行后扩张可显著减少贴壁不良支架的数量和支架贴壁不全面积,且不会导致更高的边缘夹层或支架骨折发生率。

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