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新型载药支架在动物模型中的血管造影和组织学结果。

Angiographic and histological results following implantation of a novel stent-on-a-wire in the animal model.

机构信息

Thoraxcenter, Erasmus MC, 'sGravendijkwal 230, Rotterdam, The Netherlands.

出版信息

EuroIntervention. 2012 Jul 20;8(3):390-9. doi: 10.4244/EIJV8I3A59.

DOI:10.4244/EIJV8I3A59
PMID:22377624
Abstract

AIMS

The Svelte Stent-On-A-Wire (SOAW) is a thin strut novel device consisting of a balloon-expandable cobalt-chromium stent premounted onto a single lumen fixed-wire delivery catheter platform. We evaluated the performance of the novel Svelte SOAW in comparison with the MultiLink Vision (ML Vision) balloon-expandable stent, in porcine coronary arteries.

METHODS AND RESULTS

Eight Yorkshire swine (30-day follow-up cohort) and eight Yucatan mini-swine (90-day follow-up cohort) were implanted with either Svelte or control ML Vision. Acute performance characteristics were graded by interventionalists during implantation. Angiographic assessments were performed at the index procedure and at 30 or at 90 days post implantation. Scanning electron microscopy (SEM), histological and histomorphometric analysis of stented segments were performed after angiographic follow-up. Acute implantation performance was similar between the two stents; however, deflation time was significantly lower in the Svelte stent group (Svelte 4.70±0.93 s vs. ML Vision 9.56±0.96 s, p <0.05). Angiographic late loss was similar for both stents at 30 (Svelte 0.83±0.59 mm vs. ML Vision 0.88±0.71 mm, p=0.969) and at 90 days (Svelte 0.76±0.35 mm vs. ML Vision 0.83±0.35 mm, p=0.679). SEM analysis showed complete endothelialisation at 30 days in both stent types. Histopathological assessment demonstrated minimal injury and inflammation at 30 and 90 days with Svelte and ML Vision stents as well as similar endothelialisation, neointimal maturation, adventitial fibrosis and neointimal fibrin. No evidence of in-stent thrombus was reported in either stent group. Histomorphometric analysis showed no differences between the two groups in lumen, stent, media or neointimal areas at either 30 or 90 days post implantation.

CONCLUSIONS

At 30 and 90 days after implantation in porcine coronary arteries, the Svelte Stent-On- A-Wire showed vascular healing and tissue response equivalent to that observed with ML Vision stent.

摘要

目的

Svelte 支架-on-a-wire(SOAW)是一种由气球可扩张钴铬支架预先安装在单腔固定线输送导管平台上组成的薄支架新型装置。我们评估了新型 Svelte SOAW 与多链接 Vision(ML Vision)气球可扩张支架在猪冠状动脉中的性能。

方法和结果

8 头约克夏猪(30 天随访队列)和 8 头尤卡坦迷你猪(90 天随访队列)植入 Svelte 或对照 ML Vision。在植入过程中,介入医师对急性性能特征进行分级。在指数程序和植入后 30 或 90 天进行血管造影评估。在血管造影随访后进行支架段的扫描电子显微镜(SEM)、组织学和组织形态学分析。两种支架的急性植入性能相似;然而,Svelte 支架组的放气时间明显缩短(Svelte 4.70±0.93 s 比 ML Vision 9.56±0.96 s,p<0.05)。两种支架在 30 天时的晚期造影丢失相似(Svelte 0.83±0.59 mm 比 ML Vision 0.88±0.71 mm,p=0.969),90 天时相似(Svelte 0.76±0.35 mm 比 ML Vision 0.83±0.35 mm,p=0.679)。SEM 分析显示两种支架类型在 30 天时均完全内皮化。组织病理学评估显示 Svelte 和 ML Vision 支架在 30 和 90 天时仅有最小的损伤和炎症,并且具有相似的内皮化、新生内膜成熟、外膜纤维化和新生内膜纤维蛋白。在两个支架组中均未报告支架内血栓形成的证据。组织形态学分析显示,在植入后 30 或 90 天,两组在管腔、支架、中膜或新生内膜面积方面无差异。

结论

在猪冠状动脉植入后 30 和 90 天,Svelte 支架-on-a-wire 显示血管愈合和组织反应与 ML Vision 支架观察到的相当。

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