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载唑雷莫司洗脱支架治疗糖尿病冠状动脉病变的疗效:光学相干断层成像研究。

Efficacy of Zotarolimus-Eluting Stents in Treating Diabetic Coronary Lesions: An Optical Coherence Tomography Study.

机构信息

Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Cardiovascular Research Institution, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

出版信息

Adv Ther. 2020 Apr;37(4):1579-1590. doi: 10.1007/s12325-020-01273-6. Epub 2020 Mar 7.

DOI:10.1007/s12325-020-01273-6
PMID:32146703
Abstract

BACKGROUND

Diabetes mellitus (DM) plays an important role in restenosis and late in-stent thrombosis (ST). The current study using optical coherence tomography (OCT) aims to compare target lesion neointima in patients with or without diabetes after zotarolimus-eluting stent (ZES) treatment.

METHODS

OCT images of 90,212 struts and quantitative coronary angiography (QCA) in 62 patients (32 with DM and 30 without DM) with 69 de novo coronary lesions (34 DM and 35 non-DM) both after ZES implantation and 12 ± 1 month angiographic follow-up were recorded. Patient characteristics, lesion characteristics, clinical outcomes, and OCT findings including neointimal thickness, coverage, malapposition, and intimal morphology were analyzed.

RESULTS

Baseline patient characteristics and lesion characteristics data were similar between the two groups. Higher neointimal thickness (0.14 ± 0.09 mm vs. 0.09 ± 0.04 mm, p = 0.021), more neovascularization (3.03 ± 6.24 vs. 0.52 ± 1.87, p = 0.017) and higher incidence of layered signal pattern (12.19 ± 19.91% vs. 4.28 ± 9.02%, p = 0.049) were observed in diabetic lesions comparing with non-diabetic lesions. No differences were found in malapposition, uncovered percentage, and thrombus between the two groups (all p > 0.05). Occurrence of clinical adverse events was also similar during the follow-up period (p > 0.05).

CONCLUSION

Although more neointimal proliferation and more neovascularization were found in diabetic coronary lesions when compared with non-diabetic lesions, treatment with ZES showed similar stent malapposition rate at 1-year follow-up. The data indicated that ZES treatment could possibly be effective in treating diabetic coronary lesions.

TRIAL REGISTRATION

ClinicalTrials.gov identifier, NCT01747356.

摘要

背景

糖尿病(DM)在再狭窄和支架内晚期血栓形成(ST)中起着重要作用。本研究使用光学相干断层扫描(OCT)比较了接受佐他莫司洗脱支架(ZES)治疗后有或无糖尿病患者的靶病变新生内膜。

方法

记录了 62 例患者(32 例合并 DM,30 例无 DM)69 处新发冠状动脉病变(34 例 DM,35 例非 DM)的 90212 个支架 OCT 图像和定量冠状动脉造影(QCA),并在 ZES 植入后 12±1 个月进行了血管造影随访。分析患者特征、病变特征、临床结果以及包括新生内膜厚度、覆盖率、贴壁不良和内膜形态在内的 OCT 发现。

结果

两组患者的基线特征和病变特征数据相似。糖尿病病变的新生内膜厚度较高(0.14±0.09mm vs. 0.09±0.04mm,p=0.021),新生血管化程度较高(3.03±6.24 vs. 0.52±1.87,p=0.017),分层信号模式的发生率较高(12.19±19.91% vs. 4.28±9.02%,p=0.049)。两组间贴壁不良、未覆盖百分比和血栓形成无差异(均 p>0.05)。随访期间临床不良事件的发生也相似(p>0.05)。

结论

尽管与非糖尿病病变相比,糖尿病冠状动脉病变中发现更多的新生内膜增殖和更多的新生血管化,但 ZES 治疗在 1 年随访时显示出相似的支架贴壁不良率。数据表明,ZES 治疗可能对治疗糖尿病冠状动脉病变有效。

试验注册

ClinicalTrials.gov 标识符,NCT01747356。

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