2026 revised CVIT clinical expert consensus on drug coated balloons for coronary artery disease

Abstract Drug-coated balloons (DCBs) are attracting attention as a therapeutic alternative to drug-eluting stents (DES) in percutaneous coronary interventions. DCB technology allows direct delivery of antiproliferative drugs to the vessel wall without implantation of a permanent metallic prosthesis, thereby avoiding late stent-related complications. Compared with DES, DCB remain a developing technology, and a number of DCB devices are still undergoing development or clinical evaluation. There is currently no consensus supporting a ”class effect” among DCBs due to substantial differences in drug type, dosage, excipients, release kinetics, and tissue drug concentrations. Following consistent scientific evidence regarding the safety and efficacy of paclitaxel- or sirolimus-based DCBs in the treatment of in-stent restenosis, clinical interest has expanded over the past decade to include de novo coronary lesions. DCB angioplasty is now generally accepted in de novo small vessel disease, whereas its use in large vessel lesions remains an evolving topic compared with the current gold-standard DES. Optimal lesion preparation remains a fundamental prerequisite for successful and effective DCB angioplasty, irrespective of the specific DCB platform. In this context, intracoronary imaging and physiological assessments may offer important guidance in tailoring lesion preparation and optimizing treatment strategies. The Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) convened a task force to revise an expert consensus document outlining indications, lesion preparation strategies, and the role of intravascular imaging and physiological assessment in optimizing DCB-based treatment.