Comparison of Percutaneous Intervention With Drug Coated Balloons and Drug Eluting Stents for De Novo Coronary Artery Disease: CIRCE, a Systematic Review and Meta-Analysis.

Comparative data on clinical outcomes between drug-coated balloons (DCB) and drug-eluting stents (DES) in percutaneous coronary intervention (PCI) for de novo coronary artery disease (CAD) remain limited. To assess the short- and long-term safety and efficacy of DCB versus DES in patients with de novo CAD. A total of 14 randomized controlled trials, including 7,983 patients (3,999 assigned to DCB and 3,984 to DES), were analyzed. The primary endpoint was a composite endpoint of all-cause mortality, myocardial infarction (MI), and target lesion or vessel revascularization (TLR/TVR). The study was registered in PROSPERO (CRD420251172926). In a mean follow-up of 2.1 years (ranging from 6 months to 5 years), DCB and DES showed no significant difference in the primary composite endpoint (risk ratio [RR] 0.95; 95% confidence interval [CI] 0.68 to 1.32; p = 0.76). There were no differences in all-cause mortality (RR 1.02; 95% CI 0.79 to 1.31; p = 0.88), cardiac death (RR 1.04; 95% CI 0.75 to 1.45; p = 0.80), MI (RR 0.90; 95% CI 0.68 to 1.20; p = 0.47), target vessel MI (RR 1.09; 95% CI 0.78 to 1.53; p = 0.60), TLR (RR 1.27; 95% CI 0.70 to 2.31; p = 0.43), or target vessel thrombosis (RR 0.51; 95% CI 0.04 to 6.20; p = 0.60). However, DCB therapy was associated with a significantly lower incidence of Bleeding Academic Research Consortium 3 to 5 bleedings (RR 0.65; 95% CI 0.43 to 0.98; p = 0.04). In conclusion, DCB demonstrated comparable safety and efficacy to DES in patients with de novo CAD, with a significantly lower rate of major bleeding events at 2-year follow-up. These findings support DCB therapy as a viable "leave-nothing-behind" alternative to stent implantation across diverse vessel sizes and follow-up durations.