Drug-Coated Balloon vs. Stent for de novo Non-small Coronary Artery Disease: A Systematic Review and Meta-Analysis

Introduction: Drug-coated balloon (DCB) has been an attractive option in de novo vessels. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB vs. stent for treating de novo lesions in non-small vessels.Methods: Studies in PubMed, Embase, the Cochrane Central Register of Controlled Trials, and Web of Science were searched (from their commencement to March 2021). This meta-analysis was performed by Review Manager 5.3.Results: A total of 3 random controlled trials (RCTs) with 255 patients and 2 observational studies (OS) with 265 patients were included in this meta-analysis following our inclusion criteria. It could be observed that DCB presented no significant difference in cardiac death (CD) (RR 0.33, 95% CI [0.01, 8.29], p = 0.50 in OS), myocardial infarction (MI) (RR 0.49, 95% CI [0.09, 2.50], p = 0.39 in RCT), target lesion revascularization (TLR) (RR 0.64, 95% CI [0.19, 2.18], p = 0.47 in RCT) (RR 1.72, 95% CI [0.56, 5.26], p = 0.34 in OS), and late lumen loss (LLL) (SMD -0.48, 95% CI [-1.32, 0.36], p = 0.26 in RCT) for de novo non-small coronary artery disease (CAD) compared with stents, whereas minimal lumen diameter (MLD) including MLD1 (SMD -0.67, 95% CI [-0.92 -0.42], p < 0.00001 in RCT) and MLD2 (SMD -0.36, 95% CI [-0.61 -0.11], p = 0.004 in RCT) was smaller in DCB group.Conclusion: This systematic review showed that DCB might provide a promising way on de novo non-small coronary artery disease compared with stents. However, more RCTs are still needed to further prove the benefits of the DCB strategy.

Automated summary

The study found that drug-coated balloons (DCB) may provide a promising treatment option for de novo non-small coronary artery disease compared with stents, showing no significant differences in outcomes such as cardiac death, myocardial infarction, and target lesion revascularization. However, DCB group had smaller minimal lumen diameter compared to the stent group. More randomized controlled trials are needed to further confirm the benefits of DCB strategy.