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

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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.

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Acknowledgements

The authors would like to thank Mr. Yu Linjun and Miss. Liu Lili for their help with PCI and OCT image blinding and data collection.

Funding

The study and rapid service fee was sponsored by Science and Technology Commission of Shanghai Municipality (ID 16DZ1930402), Shanghai Municipal Health and Family Planning Commission (ID 2013ZYJB1002), and Shanghai Jiao Tong University (ID YG2013MS31).

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authorship Contributions

Dr. Zhengbin Zhu, Dr. Jinwei Ni, Dr. Fenghua Ding, and Dr. Zhenkun Yang performed the angiography procedure and OCT study. Dr. Zhengbin Zhu and Dr. Haotian Zhang analyzed all clinical data and wrote the manuscript. Dr. Jinzhou Zhu and Dr. Weiwei Quan were responsible for patient follow-up and record all data. Dr. Run Du analyzed OCT images. Dr. Jian Hu and Prof. Ruiyan Zhang designed this study and observed the whole study process. Zhengbin Zhu, Jinzhou Zhu, and Run Du contributed equally.

Disclosures

Zhengbin Zhu, Jinzhou Zhu, Run Du, Haotian Zhang, Jinwei Ni, Weiwei Quan, Jian Hu, Fenghua Ding, Zhenkun Yang, and Ruiyan Zhang have nothing to disclose.

Compliance with Ethics Guidelines

The study protocol was approved by the Ethic Committee of Ruijin hospital, and each patient signed informed consent. This study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments.

Data Availability

All data and imaging material of this study is available. The datasets analyzed during the current study are available from the corresponding author on reasonable request.

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Authors and Affiliations

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

    Zhengbin Zhu, Jinzhou Zhu, Run Du, Haotian Zhang, Jinwei Ni, Weiwei Quan, Jian Hu, Fenghua Ding, Zhenkun Yang & Ruiyan Zhang

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

    Zhengbin Zhu, Jinzhou Zhu, Run Du, Fenghua Ding & Ruiyan Zhang

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  1. Zhengbin Zhu
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  2. Jinzhou Zhu
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Correspondence to Ruiyan Zhang.

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Zhu, Z., Zhu, J., Du, R. et al. Efficacy of Zotarolimus-Eluting Stents in Treating Diabetic Coronary Lesions: An Optical Coherence Tomography Study. Adv Ther 37, 1579–1590 (2020). https://doi.org/10.1007/s12325-020-01273-6

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