Drug-coated balloons for coronary artery disease: An updated review with future perspectives

• Published in: Cardiovascular revascularization medicine 2024-12, Vol.69, p.79-89
• Main Authors: Bhogal, Sukhdeep, Hill, Andrew P., Merdler, Ilan, Wermers, Jason P., Ben-Dor, Itsik, Waksman, Ron
• Format: Article
• Language: English
• Subjects: Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Cardiac Catheters; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Coated Materials, Biocompatible; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - therapy; Coronary Restenosis - etiology; Coronary Restenosis - prevention & control; Coronary Thrombosis - etiology; Coronary Thrombosis - prevention & control; De novo coronary lesion; Drug-coated balloon; Drug-eluting stent; Equipment Design; Forecasting; Humans; In-stent restenosis; Percutaneous coronary intervention; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - adverse effects; Platelet Aggregation Inhibitors - therapeutic use; Risk Factors; Small-vessel disease; Treatment Outcome
• ISSN: 1553-8389; 1878-0938; 1878-0938
• DOI: 10.1016/j.carrev.2024.05.027

Since the advent of coronary stents, two of the most common long-term complications after percutaneous coronary intervention (PCI) are in-stent restenosis (ISR) and stent thrombosis (ST). Although the rates of ST have been nearly abolished and ISR rates have declined with the current gold-standard second-generation drug-eluting stents (DES), late ISR of DES remains a valid concern in the field of interventional cardiology. The drug-coated balloon (DCB) is a non-stent technology that relies on the concept of targeted homogeneous drug delivery from an inflated balloon to restore luminal vascularity, treat atherosclerosis, and overcome some limitations of PCI, including ISR and prolonged dual antiplatelet therapy to prevent ST by leaving nothing behind. Most clinical evidence on coronary DCBs predominantly comes from small, randomized data and registries using paclitaxel DCBs for ISR and de novo lesions in the coronary space. Since 2014, outside the United States, DCBs have been approved for the treatment of ISR, with a class I recommendation by the European Society of Cardiology. The Food and Drug Administration very recently approved the Agent DCB to treat ISR in patients with coronary artery disease in the US. Additionally, recent randomized clinical data also showed DCB's safety and efficacy for the treatment of de novo small-vessel disease and high-bleeding-risk patients, while their role for other clinical situations including acute coronary syndrome, large-vessel disease, bifurcation lesions, and long-diffuse distal lesions is currently under investigation. Herein, we review the evidence-based role of DCBs in the treatment of coronary lesions and offer future perspectives. •ISR and stent thrombosis (ST) are 2 of the most common long-term complications PCI.•Late ISR of DES remains a valid concern in the field of interventional cardiology.•DCB has potential to avoid ISR and prevent ST by leaving nothing behind.•Most evidence on coronary DCBs comes from small, randomized data and registries.•We review the evidence of DCBs in treating CAD and offer future perspectives.