Drug-Coated Balloons in Complex Large-Vessel Coronary Artery Disease: A Comprehensive Review of Current Evidence and Future Perspectives

Abstract

Drug-coated balloons (DCBs) are emerging as a valuable alternative to drug-eluting stents (DES) in percutaneous coronary intervention (PCI), especially in the context of complex coronary artery disease (CAD). While DES remain the standard of care in PCI, their use is associated with several well-recognized limitations, including impairment of vascular physiology, inhibition of positive remodeling, and a persistent risk, estimated at approximately 2% per year, of stent-related adverse events, which increases with increasing stent length and anatomical and clinical complexity. DCBs deliver antiproliferative agents without leaving a permanent metallic scaffold, offering the potential to reduce stent burden, preserve native vessel physiology, and shorten the duration of dual antiplatelet therapy. Their efficacy is well established in the treatment of in-stent restenosis (ISR) and de novo lesions in small vessels (SVD). However, the use of DCBs in large-vessel and complex lesions (such as bifurcations, long lesions, and chronic total occlusions) remains under investigation. Preliminary observational data suggest feasibility and potential benefits, particularly in carefully selected cases with adequate lesion preparation. This review synthesizes current pathophysiological insights, procedural considerations, and clinical data on the use of DCBs in complex large-vessel CAD and underscores the need for large-scale randomized trials to define their long-term safety and efficacy in this setting.