Drug-Coated Balloons in De Novo Large and Small Vessels: A State-of-the-Art Review

Percutaneous coronary intervention (PCI) using drug-eluting stents (DES) is currently the standard treatment due to the established safety and efficacy. PCI using a drug-coated balloon (DCB) is an alternative therapy for de novo lesions in small vessels and in in-stent restenosis based on data from randomized controlled trials (RCTs). Observational studies and RCTs have demonstrated comparable safety of DCB and conventional PCI using DES in large-vessel de novo coronary artery disease, as the rates of acute vessel occlusion, cardiovascular death, and myocardial infarction have been reported to be similar between the 2 approaches. Although PCI using DES results in good short-term clinical outcomes in noncomplex lesions in large vessels, the implantation of a metallic stent has limitations in the treatment of complex and multivessel coronary artery disease and in high-risk patients. Accumulating evidence together with growing experience in optimal lesion preparation, and the use of intravascular imaging, has led to expanding use of DCB in various anatomical and clinical scenarios. These include the treatment of complex lesions, such as bifurcations, calcified lesions, and chronic total occlusions, as well as multivessel disease—clinical scenarios in which stent implantation is technically challenging and associated with inherent limitations, including increased rates of target-vessel failure. In addition, DCB therapy may have advantages in high-risk patient populations, such as individuals with diabetes or those at high bleeding risk, by avoiding permanent atherogenic metallic implants and the possibility for shorter duration of antiplatelet therapy. DCBs can be used either as a stand-alone strategy following optimal lesion preparation or in combination with DES implantation in the hybrid/blended strategy to reduce overall stent burden. Ongoing randomized controlled trials are expected to further clarify the role of the DCB-oriented approach compared with the DES-only approach for revascularization in coronary artery disease. This state-of-the-art review summarizes the current evidence and provides future perspectives of DCB in PCI of de novo coronary artery lesions.