Drug-coated balloons versus drug-eluting stents for de novo coronary lesions: a systematic review and meta-analysis of randomised trials

Background Drug-coated balloon (DCB) angioplasty has emerged as a potential stent-free strategy for percutaneous coronary intervention (PCI) in de novo coronary artery disease, but robust randomised evidence on safety and efficacy compared with drug-eluting stents (DES) remains limited. Methods We conducted a comprehensive systematic review and meta-analysis of randomised controlled trials comparing DCB angioplasty with DES for de novo coronary lesions in adult patients reporting clinical outcomes at ≥9 months. PubMed, Embase and Cochrane CENTRAL were searched from inception to October 2025 without language restriction; trial registries and reference lists were screened manually. Studies limited to in-stent restenosis, bifurcation PCI or observational designs were excluded. Data were extracted independently by two reviewers. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models (DerSimonian–Laird method with Hartung–Knapp adjustment). Heterogeneity was assessed with I² and τ² statistics and 95% prediction intervals were reported. Risk of bias was appraised with the Cochrane Risk of Bias 2 tool. Results Seven trials encompassing 7138 patients (DCB 3570; DES 3568) were included. At 12 months, the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and target lesion revascularisation) showed no difference between strategies (RR 1.02, 95% CI 0.63 to 1.64; p=0.93; I²=52%). Secondary outcomes were comparable: cardiac death (1.26, 0.75 to 2.14), target vessel MI (0.71, 0.36 to 1.39), target lesion revascularisation (1.09, 0.52 to 2.30) and target vessel revascularisation (0.98, 0.58 to 1.65). Sensitivity analysis supported the stability of the primary findings. Trials using sirolimus coated balloons demonstrated similar results. Conclusions DCB angioplasty shows comparable short-term safety and efficacy to modern DES for de novo coronary disease. Long-term follow-up is necessary to confirm whether avoidance of permanent implants translates into clinical benefit. PROSPERO registration number CRD420251175063.