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光学相干断层扫描评估重叠裸金属支架和药物洗脱支架植入后体内血管反应。

Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents.

机构信息

Division of Cardiology, Cardiovascular Department, Ospedali Riuniti di Bergamo, Bergamo, Italy.

出版信息

JACC Cardiovasc Interv. 2010 May;3(5):531-9. doi: 10.1016/j.jcin.2010.02.008.

Abstract

OBJECTIVES

We designed a randomized trial exploiting optical coherence tomography (OCT) to assess coverage and apposition of overlapping bare-metal stents (BMS) and drug-eluting stents (DES) in human coronary arteries.

BACKGROUND

Overlapping DES impair healing in animals. Optical coherence tomography allows accurate in vivo assessment of stent strut coverage and apposition.

METHODS

Seventy-seven patients with long coronary stenoses were randomized to overlapping sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), or BMS. The primary goal of the study was to determine the rate of uncovered/malapposed struts in overlap versus nonoverlap segments, according to stent type, at 6-month follow-up with OCT.

RESULTS

A total of 53,047 struts were analyzed. The rate of uncovered/malapposed struts was 1.5 +/- 3.4% and 0.6 +/- 2.7% in overlap versus nonoverlap BMS (p = NS), respectively, and 4.3 +/- 11% and 3.6 +/- 8% in overlap versus nonoverlap DES (p = NS), respectively. There were no differences in the rates of uncovered/malapposed struts between overlapping BMS and DES, likely due to low frequency of uncovered/malapposed struts in ZES (0.1 +/- 0.4%), which offset the higher rates observed in SES (6.7 +/- 9.6%) and PES (6.7 +/- 16.5%, p < 0.05). Overlap segments showed greater neointimal volume obstruction versus nonoverlap segments in all DES (p < 0.05 for all DES types). Strut-level neointimal thickness at overlap and nonoverlap segments were lowest in SES (0.16 +/- 0.1 mm and 0.12 +/- 0.1 mm, respectively) compared with PES (0.27 +/- 0.1 mm and 0.20 +/- 0.1 mm, respectively), ZES (0.40 +/- 0.16 mm and 0.33 +/- 0.13 mm, respectively), and BMS (0.55 +/- 0.31 mm and 0.53 +/- 0.25 mm, respectively, p < 0.05).

CONCLUSIONS

As assessed by OCT the impact of DES on vascular healing was similar at overlapping and nonoverlapping sites. However, strut malapposition, coverage pattern, and neointimal hyperplasia differ significantly according to DES type. (Optical Coherence Tomography for Drug Eluting Stent Safety [ODESSA]; NCT00693030).

摘要

目的

我们设计了一项随机试验,利用光学相干断层扫描(OCT)评估重叠的裸金属支架(BMS)和药物洗脱支架(DES)在人体冠状动脉中的覆盖和贴壁情况。

背景

重叠的 DES 会损害动物的愈合。光学相干断层扫描可准确评估支架梁的覆盖和贴壁情况。

方法

77 例患有长段冠状动脉狭窄的患者被随机分为重叠的西罗莫司洗脱支架(SES)、紫杉醇洗脱支架(PES)、佐他莫司洗脱支架(ZES)或 BMS 组。该研究的主要目的是在 6 个月的 OCT 随访时,根据支架类型确定重叠与非重叠段的无覆盖/贴壁支架梁的发生率。

结果

共分析了 53047 个支架梁。无覆盖/贴壁支架梁的发生率在重叠 BMS 与非重叠 BMS 分别为 1.5%±3.4%和 0.6%±2.7%(p=NS),在重叠 DES 与非重叠 DES 分别为 4.3%±11%和 3.6%±8%(p=NS)。重叠的 BMS 和 DES 之间无覆盖/贴壁支架梁的发生率无差异,这可能是由于 ZES 的无覆盖/贴壁支架梁发生率较低(0.1%±0.4%),抵消了 SES(6.7%±9.6%)和 PES(6.7%±16.5%)中较高的发生率(p<0.05)。在所有 DES 中,重叠段的新生内膜体积阻塞均大于非重叠段(所有 DES 类型均为 p<0.05)。SES 在重叠和非重叠段的支架梁内新生内膜厚度最低(分别为 0.16±0.1mm 和 0.12±0.1mm),与 PES(分别为 0.27±0.1mm 和 0.20±0.1mm)、ZES(分别为 0.40±0.16mm 和 0.33±0.13mm)和 BMS(分别为 0.55±0.31mm 和 0.53±0.25mm)相比,差异均有统计学意义(p<0.05)。

结论

根据 OCT 评估,DES 在重叠和非重叠部位对血管愈合的影响相似。然而,支架梁贴壁不良、覆盖模式和新生内膜增生根据 DES 类型而显著不同。(光学相干断层扫描评估药物洗脱支架安全性研究[ODESSA];NCT00693030)。

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