Abstract
Objectives: This meta-analysis compared the efficacy and safety of drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) for the treatment of de novo coronary artery disease.
Following PRISMA guidelines, we conducted a systematic search of major databases, including Cochrane, Medline, Embase and ClinicalTrials.gov, to identify eligible randomized controlled trials (RCTs) comparing DCB and DES. Mantel-Haenszel model was used for dichotomous outcomes. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using a random-effects model using RevMan software.
Thirteen RCTs with a total of 4,686 patients were included. The analysis found no significant differences between DCB and DES for all-cause mortality (RR: 1.11, 95% CI: 0.81-1.53, p = 0.51) or myocardial infarction (RR: 0.80, 95% CI: 0.56-1.15, p = 0.23). Similarly, no significant differences were observed for cardiac death (RR: 1.33, 95% CI: 0.86-2.05, p = 0.19), target lesion revascularization (RR: 1.19, 95% CI: 0.64-2.21, p = 0.59), or target vessel revascularization (RR: 1.34, 95% CI: 0.79-2.28, p = 0.28).
This meta-analysis demonstrates comparable efficacy and safety outcomes for DCBs and DES in the treatment of de novo coronary artery disease. While DCBs offer a viable alternative, particularly for high-risk patients or those unsuitable for prolonged dual antiplatelet therapy, further large-scale studies are warranted to strengthen these findings and refine clinical recommendations. .