Drug-coated balloon versus drug-eluting stent for treating de novo coronary lesions in large vessels: a meta-analysis of clinical trials

Background. Studies examining the efficiency of drug-coated balloon (DCB) compared to drug-eluting stents (DES) for de novo lesions in large vessels have reported inconsistent results. Objective. This comprehensive meta-analysis of clinical trials compared the efficacy and safety of DCB and DES for the treatment of de novo coronary lesions. Methods. The authors formally searched electronic databases before October 2019 to identify randomized and non-randomized clinical trials (RCTs and non-RCTs, respectively). Clinical trials were eligible for inclusion if they compared DCB with DES in patients with coronary lumen diameters > 2.5 mm. Results. Three RCTs and one non-RCT with a total of 321 patients were included in our meta-analysis (DCB group = 152, DES group = 169). The primary endpoint was in-segment late lumen loss (LLL) with a standardized mean difference (SMD) of -0.07 (95% confidence interval [CI]: -0.31, 0.316;P = 0.548) and the secondary endpoint was target lesion revascularization (TLR) with a risk ratio (RR) of 1.17 (95% CI: 0.46, 2.95;P = 0.746). Conclusion. This meta-analysis indicated that DCB might be non-inferior to DES as evidenced by quantitative coronary angiography (QCA) assessed at 6-9 months after percutaneous coronary intervention in patients presenting with coronary artery disease.

Automated summary

This meta-analysis suggests that drug-coated balloons (DCB) may be comparable to drug-eluting stents (DES) in terms of efficacy and safety for treating de novo coronary lesions in patients with coronary artery disease.