Drug-Coated Balloon Versus Drug-Eluting Stent for Treating De Novo Large Vessel Coronary Artery Disease: A Systematic Review and Meta-Analysis of 13 Studies Involving 2,888 Patients

IntroductionDrug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, little is known about its performance in the treatment of de novo, large vessel CAD (LV-CAD). A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting. MethodsA comprehensive literature search was performed including Medline, Embase and Cochrane electronic databases up to October 24th 2023, for studies which compared efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels ([≥] 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The outcomes analysed were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all cause death (ACD) and late lumen loss (LLL) at follow-up. The effect size was estimated using a random-effect model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI). ResultsA total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2,888 patients (DCB n=1,334; DES n=1,533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. A DCB-only strategy was non inferior to percutaneous coronary intervention (PCI) with DES in terms of CVD (RR 0.49; 95% CI [0.23 - 1.03]; p=0.06), MI (RR 0.48; 95% CI [0.16 - 1.45]; p=0.89), TLR (RR 0.73; 95% CI [0.40 - 1.34]; p=0.32), ACD (RR 0.78; 95% CI [0.57 - 1.07]; p=0.12) and LLL (MD -0.14; 95% CI [-0.30 - 0.02]; p=0.18) at follow-up. ConclusionOur meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal free" strategy in this subset of CAD.