Clinical value of drug-coated balloon versus second-generation drug-eluting stent for de novo lesions in large coronary arteries: insights from the real world

Abstract Background This study aims to evaluate the long-term outcomes of patients with large coronary arteries (LCA, reference vessel diameter more than 3.0 mm) de novo lesions treated by drug-coated balloon (DCB) versus second-generation drug-eluting stent (sDES) in real-world clinical practice. Methods Between January 2020 and June 2021, 2857 consecutive patients with equal number of LCA de novo lesions, including 708 lesions treated with paclitaxel DCB-only (DCB-only cohort) and 2149 lesions with sDES-only (sDES-only cohort), were enrolled in this retrospective study. The primary outcome was the clinically driven target lesion revascularization (CD-TLR) rate at two years. After propensity score matching, 708 patients treated with DCB-only and another 704 patients with sDES-only were successfully matched to study adjusted associations between treatment strategy and outcomes. Results CD-TLR rate was higher in the DCB-only group than sDES-only group (DCB: 5.5%, sDES: 3.1%, P = 0.028). However, lower major bleeding rate was observed in the DCB-only group compared to sDES-only group (0.8% vs. 3.0%, P = 0.003), which benefited from its short duration of antiplatelet therapy. Multivariate logistic regression analysis revealed that hypercholesteremia [odds ratio (OR), 2.516], diabetes (OR, 2.773), severe calcified lesions (OR, 5.184) and residual stenosis>30% (OR, 8.676) were risk predictors (P