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血管造影、血管内超声和 OCT 评估重叠药物洗脱支架和裸金属支架部位冠状动脉疾病严重程度的长期影响:ODESSA 试验的子研究。

Angiographic, IVUS and OCT evaluation of the long-term impact of coronary disease severity at the site of overlapping drug-eluting and bare metal stents: a substudy of the ODESSA trial.

机构信息

Harrington McLaughlin Heart and Vascular Institute, University Hospitals Case Medical Centre, Cleveland, OH 44106-5038, USA.

出版信息

Heart. 2010 Oct;96(19):1574-8. doi: 10.1136/hrt.2009.188037. Epub 2010 Aug 23.

Abstract

BACKGROUND

A potentially adverse vascular response to overlapping drug eluting stents (DES) has been suggested in current research.

OBJECTIVE

To evaluate the impact of baseline disease severity at the site of stent overlap.

METHODS AND RESULTS

This is a substudy of ODESSA, a prospective, randomised controlled trial designed to evaluate healing of overlapping stents. 71/77 patients with a total of 86 overlapping stents were studied: 25 sirolimus, 24 paclitaxel, 26 zotarolimus-eluting stents; and 11 bare metal stents (BMS). Patients were categorised into high-grade stenosis (HGS, ≥ 70% diameter stenosis) and low-grade stenosis (LGS, <70%) at the site of stent overlap. Angiography and intravascular ultrasound were performed after stent deployment and repeated at 6 months, together with additional optical coherence tomography. Images were analysed by an independent core laboratory. End points were binary restenosis, percentage neointimal hyperplasia (%NIH), mean lumen and stent areas and degree of strut coverage/apposition at overlapping stents at 6 months. Stent overlaps occurred in 49 HGS and 37 LGS. Restenosis was found in 5/6 HGS versus 0/5 LGS treated with overlapping BMS (p=0.01) and 4/43 HGS versus 0/32 LGS treated with overlapping DES. There was a trend towards higher %NIH at BMS overlap in HGS versus LGS (p=0.07). DES overlaps had lower lumen and stent areas and similar %NIH in HGS versus LGS. Any uncovered or malapposed struts occurred more often in overlapping DES at LGS than at HGS (59.4% vs 32.6%, p=0.03).

CONCLUSIONS

Overlapping DES in normal-appearing coronary segments showed a higher incidence of uncovered or malapposed struts, while restenosis occurred exclusively in overlapping stents at HGS. These findings should be considered when deploying overlapping stents.

摘要

背景

目前的研究表明,重叠药物洗脱支架(DES)可能会引起血管不良反应。

目的

评估支架重叠部位基础疾病严重程度的影响。

方法和结果

这是 ODESSA 的一项子研究,该前瞻性、随机对照试验旨在评估重叠支架的愈合情况。共有 71/77 例患者(共 86 个重叠支架)参与研究:25 个为西罗莫司支架,24 个为紫杉醇支架,26 个为佐他莫司洗脱支架,11 个为裸金属支架(BMS)。将支架重叠部位的狭窄程度分为重度狭窄(HGS,≥70%直径狭窄)和轻度狭窄(LGS,<70%)。支架置入后进行血管造影和血管内超声检查,并在 6 个月时重复检查,同时进行额外的光学相干断层扫描。图像由独立的核心实验室进行分析。终点为 6 个月时的二元再狭窄、新生内膜增生百分比(%NIH)、平均管腔和支架面积以及重叠支架处支架覆盖率/贴壁程度。49 个 HGS 和 37 个 LGS 发生支架重叠。在重叠 BMS 治疗中,5/6 的 HGS 出现再狭窄,而 0/5 的 LGS 出现再狭窄(p=0.01);在重叠 DES 治疗中,4/43 的 HGS 出现再狭窄,而 0/32 的 LGS 出现再狭窄。BMS 重叠的 HGS 与 LGS 相比,%NIH 更高(p=0.07)。HGS 和 LGS 的 DES 重叠处的管腔和支架面积较低,%NIH 相似。在 LGS 时,DES 重叠处未覆盖或贴壁不良的支架比 HGS 时更常见(59.4% vs 32.6%,p=0.03)。

结论

在外观正常的冠状动脉节段中,重叠的 DES 支架更易出现未覆盖或贴壁不良的支架,而仅在 HGS 支架中发生再狭窄。在部署重叠支架时应考虑这些发现。

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