Drug-Coated Balloon in De Novo Coronary Lesions: The “Leaving Nothing Behind” Strategy in Contemporary PCI

Abstract

Background: Drug-coated balloons (DCB) have emerged as an alternative revascularization strategy in percutaneous coronary intervention (PCI), aiming to deliver antiproliferative therapy without permanent metallic implantation. This “leave nothing behind” approach may mitigate long-term complications associated with drug-eluting stents (DES), including stent thrombosis, chronic inflammation, and neo atherosclerosis. Objectives: To provide a comprehensive review of the current evidence, clinical applications, technical considerations, and guideline perspectives regarding the use of DCB in de novo coronary artery lesions. Methods: A narrative review of randomized controlled trials, meta-analyses, and contemporary consensus documents was conducted, focusing on DCB use across key clinical scenarios including small vessel disease, diffuse coronary artery disease, bifurcation lesions, high bleeding risk (HBR) patients, and large vessel disease. Results: In small vessel disease, DCB has demonstrated non-inferiority to second-generation DES with reduced late lumen loss. In diffuse coronary disease, DCB-either alone or in combination with DES-achieves comparable rates of major adverse cardiovascular events (MACE), target lesion revascularization (TLR), and target vessel revascularization (TVR) to DES-only strategies. In bifurcation lesions, DCB is most effective inside branch treatment, reducing restenosis while minimizing metal implantation. In HBR patients, DCB allows shorter dual antiplatelet therapy duration while maintaining favorable clinical outcomes. Emerging evidence also supports the feasibility of DCB in selected large vessel lesions, particularly in strategies aimed at reducing total metal burden and preserving vascular physiology. However, outcomes remain highly dependent on optimal lesion preparation and device-specific characteristics. Conclusions: DCB represents a promising alternative or complementary strategy to DES in selected de novo coronary lesions. Its advantages in reducing metal burden and enabling shorter dual antiplatelet therapy to make it particularly attractive in specific patient populations. Nevertheless, wider adoption is currently limited by heterogeneity in available evidence, lack of a clear class effect, and insufficient large-scale randomized trials. Future studies are required to define its role in contemporary PCI practice and to harmonize international guideline recommendations.