Drug Coated Balloons Versus Drug‐Eluting Stents in Patients With De Novo Coronary Artery Disease

BACKGROUND: In patients with de novo coronary artery disease (CAD), percutaneous coronary intervention (PCI) with drug eluting stent (DES) implantation is the gold standard therapy. New evidence is available with drug coated balloons (DCB) angioplasty. The objective of this meta-analysis was to compare the efficacy and safety of DCB angioplasty versus DES-based PCI for patients with de novo CAD. METHODS: A systematic search of PubMed, Scopus, Web of Science, and EMBASE databases was performed from January 1, 2006 up until November 1, 2024. Inclusion criteria were random treatment assignment; PCI with DCB versus DES; patients with de novo CAD; clinical follow-up available for ≥1 year; and studies published in a peer-reviewed journal. Trial-level incidence rate ratios (IRR) with 95% confidence intervals (CI) were pooled by random-effects models with inverse variance weighting. The primary outcome was major adverse cardiac events (MACE). Secondary outcomes included cardiac death, all-cause death, and target lesion revascularization. RESULTS: A total of nine clinical trials comprising of 4284 patients were included. The risk of the primary compositive endpoint of MACE was comparable with DCB versus DES (IRR 0.95, 95% CI 0.61 to 1.48). Secondary endpoints including cardiac death (IRR 1.49, 95% CI 0.96 to 2.33), all-cause death (IRR 1.18, 95% CI 0.80 to 1.74), and target lesion revascularization (IRR 1.17, 95% CI 0.68 to 2.01) were comparable though CIs around treatment effects were wide. CONCLUSIONS: DCB angioplasty for de novo CAD was associated with similar medium-term clinical outcomes compared with DES. Additional evidence is warranted in view of numerical trends in important secondary endpoints. TRIAL REGISTRATION: The analysis was registered at PROSPERO (CRD42024581222).