Key result
Drug coated balloon PCI did not significantly differ from drug eluting stents in cardiovascular death (OR 1.06; 95% CI 0.75-1.49; p=0.76) or MI (OR 1.02; p=0.91) in de novo coronary disease.
Why the study?
Drug coated balloon only PCI has an established evidence base in small vessel de novo disease, and recent randomised studies have investigated its use compared with drug eluting stent PCI across a broader spectrum of de novo coronary disease.
Does drug coated balloon PCI reduce cardiovascular death, myocardial infarction, and revascularisation compared to drug eluting stent PCI in patients with de novo coronary artery disease?
Meta-Analysis (n=7,832)
Does drug coated balloon PCI reduce cardiovascular death, myocardial infarction, and revascularisation compared to drug eluting stent PCI in patients with de novo coronary artery disease?
In patients with de novo coronary artery disease, DCB and DES PCI show comparable rates of cardiovascular death and myocardial infarction, though DCB may be associated with higher revascularisation rates in non-small-vessel disease.
Supports comparable CV mortality with DCB versus DES; confirms safety equivalence across revascularization trials.
Background Drug coated balloon (DCB) only percutaneous coronary intervention (PCI) has an established evidence base in small vessel de novo disease, but recent randomised studies have investigated its use across a broader spectrum of coronary disease. We systematically reviewed randomised evidence comparing DCB with drug eluting stent (DES) PCI for de novo coronary disease. Methods This systematic review and meta-analysis was conducted in line with the PRISMA statement. PubMed, Scopus, and Embase were systematically searched from inception until 30th May 2026 for randomised trials comparing DCB with DES PCI for de novo coronary disease. Principal outcomes were cardiovascular death, myocardial infarction (MI) and revascularisation. Random-effects models generated odds ratios with 95% confidence intervals. Heterogeneity was assessed using I 2 and publication bias by visual inspection of funnel plots. Risk of bias was assessed using Cochrane RoB2. This study was prospectively registered with PROSPERO (CRD420251167202). Findings Ten RCTs including 7832 patients were identified. There was no significant difference between DCB and DES in cardiovascular death [OR 1.06 (0.75–1.49), p=0.76, I 2 = 0%] or MI [OR: 1.02 (0.76–1.36), p=0.91, I 2 = 0%]. These findings remained consistent after excluding small-vessel-only trials. Revascularisation did not differ across all trials [OR 1.39 (0.88, 2.20), p=0.16, I 2 = 57%] but was higher with DCB after excluding small-vessel-only trials [OR 1.84 (1.06–3.19), p=0.03, I 2 = 54%]. This finding was sensitive to exclusion of REC-CAGEFREE I. Visual inspection of funnel plots did not suggest substantial publication bias. Interpretation DCB and DES strategies had comparable rates of cardiovascular death and MI across the studied de novo coronary populations. The higher revascularisation rates observed after excluding small-vessel-only trials requires cautious interpretation given between-study heterogeneity and sensitivity to one trial. Further adequately powered RCTs with longer follow-up are required to establish the efficacy of DCB strategies in large vessels and more complex coronary lesions. Funding No funding was received for this study.
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Corballis et al. (2026) conducted a meta-analysis in De novo coronary artery disease (n=7,832). Drug coated balloon (DCB) PCI vs. Drug eluting stent (DES) PCI was evaluated on Cardiovascular death (OR 1.06, 95% CI 0.75-1.49, p=0.76). Drug coated balloon PCI did not significantly differ from drug eluting stents in cardiovascular death (OR 1.06; 95% CI 0.75-1.49; p=0.76) or MI (OR 1.02; p=0.91) in de novo coronary disease.
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