Drug-Coated Balloons Versus Drug-Eluting Stents for the Treatment of De Novo Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials

Overview

Journal Rev Cardiovasc Med

Specialty Cardiology & Vascular Diseases

Date 2025 Jan 1

PMID 39742237

Authors

Jialong Niu

Kexin Wang

Wenjie Wang

Yixuan Liu

Jiaxin Yang

Yan Sun

Furong Wang

Wen Gao

Hailong Ge

Affiliations

Soon will be listed here.

Abstract

Background: Because of the limitations in new-generation drug-eluting stents (DES), treatments advocating for non-stents with a drug-coated balloon (DCB) is now of great interest. Here, we conducted a meta-analysis to testify whether a DCB was more effective and safer than a DES in treating de novo coronary artery disease (CAD).

Methods: We searched PubMed, Embase, Cochrane Library, and Web of Science to obtain high-quality trials comparing DCB with DES for the treatment of de novo CAD. The primary endpoint was target lesion revascularization (TLR), and the secondary endpoints were in-lesion late lumen loss (LLL), all-cause death, myocardial infarction and binary restenosis.

Results: We enrolled 1661 patients from seven randomized clinical trials. Compared with the DES group, the MD (mean difference) of in-lesion LLL was significantly lower in the DCB group (MD -0.19, 95% CI -0.23 to -0.16, < 0.00001, I = 0%). The DCB group showed superiority in small vessel disease (SVD) in in-lesion LLL (MD -0.21, 95% CI -0.34 to -0.08, = 0.001).

Conclusions: The DCB group exhibited a lower in-lesion LLL compared to the DES group, and DCB was not inferior to DES in other endpoints, including in the SVD subgroup. Hence, to our knowledge, DCB is non-inferior to DES for de novo CVD and SVD. DCB in patients with CVD needs further large and long-term clinical trials to demonstrate its long-term efficacy.

The Prospero Registration: CRD42021268965, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=268965.

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