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Comparison of Efficacy and Safety Between Drug-Coated Balloons Versus Drug-Eluting Stents in the Treatment of De Novo Coronary Lesions in Large Vessels: A Study-Level Meta-Analysis of Randomized Control Trials

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Abstract

Background

Drug-coated balloons (DCB) can be used as an alternative to drug-eluting stents (DES) in patients with de novo small vessel coronary artery disease. This study aims to assess the efficacy and safety of solely using DCB versus DES in percutaneous coronary intervention (PCI) for de novo coronary lesions in large vessels.

Method

A database search was conducted using PubMed, EMBASE, Cochrane Library, and http://Clinicaltrials.gov for trials comparing DCB only with DES in treating de novo coronary lesions in large vessels. Efficacy outcomes included coronary angiography (CAG), follow-up minimal lumen diameter (MLD), and late luminal loss (LLL). Safety outcomes included target lesion failure [TLF: cardiac death, myocardial infarction (MI), target lesion revascularization (TLR)] and their individual components.

Results

We included seven randomized control trials (RCTs) with 816 patients, of which 422 and 394 patients were in the DCB and DES groups, respectively. MLD measured during the 6-12 months follow-up in the DCB group was statistically significantly smaller than in the DES group (MD –0.21, 95% CI –0.34 to –0.07, P = 0.003, I2 = 52%). LLL measured at 6–12 months follow-up was statistically significantly lower in the DCB group than in the DES group (MD –0.13, 95% CI –0.22 to –0.05, P = 0.003, I2 = 60%). TLF, cardiac death, MI, and TLR, were not statistically significantly different between the two groups.

Conclusion

Use of DCB was associated with less LLL at 6–12 months than DES and was not associated with any increase in adverse clinical events. This data suggests DCB are as effective in treating de novo coronary lesions in large vessels as DES.

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Data Availability

The original contributions presented in the study are included in the article/Supporting Information Material, further inquiries can be directed to the corresponding authors.

Code Availability

Not applicable.

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Funding

The analysis was financed by the Tang Du Yin Feng program (2021YFJH007).

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Authors and Affiliations

  1. Department of Cardiology, Xi Jing Hospital, Air Force Medical University, Shaanxi, China

    Bing Sun & Xu Tong Zhang

  2. Department of Cardiology, Tang Du Hospital, Air Force Medical University, Shaanxi, China

    Rui Rui Chen

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  1. Bing Sun
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  2. Xu Tong Zhang
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Contributions

Bing Sun: implementation of research, analyzed/interpreted data, article writing. Xu Tong Zhang: analyzed/interpreted data. Rui Rui Chen: designed the experiment, made a critical review of the content of the article, and provided research funding.

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Correspondence to Bing Sun.

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Sun, B., Zhang, X.T. & Chen, R.R. Comparison of Efficacy and Safety Between Drug-Coated Balloons Versus Drug-Eluting Stents in the Treatment of De Novo Coronary Lesions in Large Vessels: A Study-Level Meta-Analysis of Randomized Control Trials. Cardiovasc Drugs Ther (2023). https://doi.org/10.1007/s10557-023-07526-0

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