Innovations in Drug-Coated Balloons and Stentless Coronary Interventions: Evaluating the Evidence, Limitations, and Future Prospects in De-Novo Lesion Management

Abstract

Coronary artery disease (CAD) remains a major cause of morbidity and mortality, and percutaneous coronary intervention (PCI) is central to the management of obstructive coronary disease. Although drug-eluting stents (DESs) have reduced restenosis and repeat revascularisation, their permanent metallic structure is associated with persistent concerns, including chronic vascular inflammation, impaired vasomotion, delayed healing, neoatherosclerosis, stent thrombosis and difficulties during future revascularisation. Drug-coated balloons (DCBs) provide a stentless approach by delivering an antiproliferative agent to the vessel wall during balloon inflation without leaving a permanent scaffold. This narrative review evaluates the evidence, limitations and future prospects of DCB-based coronary intervention for de novo coronary artery lesions. Contemporary randomised trials, systematic reviews, meta-analyses, pooled analyses and expert reviews were examined, with emphasis on clinical outcomes, angiographic findings, lesion preparation, device-related considerations and long-term safety. The reviewed evidence indicates that DCBs can achieve clinical and angiographic outcomes broadly comparable to those of DESs in appropriately selected patients, particularly in small-vessel coronary artery disease. Three-year and longer-term analyses also suggest similar rates of major adverse cardiovascular events, target lesion revascularisation and cardiac mortality in selected populations. Emerging evidence supports possible use in selected large-vessel lesions, although this indication is less established. The principal advantage of DCB therapy is its leave-nothing-behind strategy, which preserves native vessel architecture and avoids complications related to permanent implants. However, outcomes depend strongly on adequate lesion preparation, careful patient selection and device-specific performance. Current evidence supports DCB-based stentless intervention as a maturing revascularisation strategy for selected de novo lesions, while further standardised trials are required to define its role in complex anatomy and acute coronary syndromes.