Drug-Coated Balloon Versus Drug-Eluting Stent for De Novo Lesions of Large Coronary Arteries: A Systematic Review and Meta-Analysis of Angiographic and Clinical Outcomes.

Background: Efficacy of drug-coated balloons (DCBs) has been established in the treatment of in-stent restenosis and small vessel coronary artery disease, while utility in large-vessel de novo lesions remains controversial.

Aims: We sought to study the angiographic and clinical outcomes after treatment of large vessel de novo coronary lesions with DCB versus drug-eluting stent (DES).

Methods: We systematically searched electronic databases through March 2025 for relevant studies. Outcomes were compared using random effects modeling for summary estimates. We performed subgroup analyses by study design.

Results: Our analysis included 16 studies (eight randomized controlled trials and eight observational) with 9745 patients. Follow-up duration was 17 ± 8 months for DCB and 16 ± 4 months for DES. While acute gain was significantly lower with DCB (MD = -0.45, 95% CI: -0.63 to -0.26; p < 0.00001; I² = 74%), no significant differences were observed in late lumen loss (MD = -0.03, 95% CI: -0.09 to 0.04; p = 0.47; I² = 47%) or binary restenosis (RR = 2.22, 95% CI: 0.94 to 5.24; p = 0.07; I² = 13%). Clinically, there was no significant difference between DCB and DES in target lesion failure and overall major adverse cardiac events, and this was consistent regardless of the study design (randomized vs. observational).

Conclusion: Compared with DES, treatment with DCB yields a less optimal immediate angiographic result but comparable clinical outcomes in patients with de novo lesions of large coronary arteries.