Outcomes of Drug-Coated Balloon Versus Drug-Eluting Stent for the Treatment of Large De Novo Coronary Lesions

Background: Although drug-coated balloons (DCBs) outperform drug-eluting stents (DESs) in the treatment of de novo small-vessel coronary lesions, no comparable studies are available for de novo large-vessel coronary lesions. Methods: This retrospective study examined 960 patients with de novo large-vessel coronary lesions (reference vessel diameter ≥3.0 mm) who underwent paclitaxel DCB angioplasty or DES implantation at Beijing Anzhen Hospital. The study endpoints included all-cause death, myocardial infarction (MI), stroke, and target vessel revascularization (TVR). Kaplan–Meier (KM) curves and Cox regression analysis were used to investigate the clinical outcomes of patients in the DCB and DES groups. Results: The overall incidence rates of major adverse cardiac and cerebrovascular events (MACCEs), all-cause death, MI, stroke, and TVR were 9.27% (89/960), 1.5% (14 patients), 0.9% (9 patients), 0.6% (6 patients), and 6.8% (65 patients), respectively. No significant differences were observed between the DCB and DES groups in MACCEs (13.2% vs. 5.6%; p = 0.511), all-cause death (1.9% vs. 1.0%; p = 0.763), MI (0.6% vs. 1.2%; p = 0.239), or stroke (0.6% vs. 0.6%; p = 0.361). However, the TVR rate was significantly higher in the DCB group than in the DES group (10.1% vs. 3.6%; p = 0.028), and this difference persisted after multivariate adjustment. Conclusions: For patients with de novo lesions in target vessels with diameters ≥3.0 mm, the safety and efficacy of DCB therapy were comparable to those of DES therapy, except for target vessel revascularization.