Key result
Drug-coated balloons offer a safe and effective alternative to DES for ISR and small vessel disease.
Why the study?
Despite appealing advantages over drug-eluting stents and widespread use, robust evidence supporting drug-coated balloons in coronary artery disease remains limited outside specific in-stent restenosis indications.
Does percutaneous transluminal coronary angioplasty with drug-coated balloons improve outcomes in patients with coronary artery disease compared to drug-eluting stents?
Does percutaneous transluminal coronary angioplasty with drug-coated balloons improve outcomes in patients with coronary artery disease compared to drug-eluting stents?
Drug-coated balloons are emerging as a viable alternative to drug-eluting stents for coronary artery disease, particularly for in-stent restenosis, supported by recent FDA approvals.
Percutaneous transluminal coronary angioplasty with drug-coated balloons (DCBs) is the modality of coronary artery revascularization with local application of antiproliferative agents, paclitaxel or sirolimus. It has become an appealing alternative to drug-eluting stents (DESs) due to intervention simplification, absence of permanent metallic mesh implantation, preserved vasomotion, and shorter duration of dual antiplatelet therapy because of reduced risk of acute thrombosis. Numerous studies have assessed DCB safety and efficacy for various aspects of coronary artery disease (CAD) for in-stent restenosis (ISR) and de novo CAD, while interventional cardiologists worldwide report good results with DCB in everyday practice. However, data is not robust enough to recommend DCB according to the European Society of Cardiology guidelines, except for the ISR of bare-metal stents (BMSs). At the same time, the United States Food and Drug Administration approved the DCB usage for ISR of both BMS and DES in March 2024. Further studies are underway to increase the body of evidence, and new technologies, including DCB with combined paclitaxel and sirolimus, are developing.
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Vedran Radonić (2025) conducted a review in Coronary Artery Disease. Drug-coated balloons (paclitaxel or sirolimus) vs. Drug-eluting stents or plain balloon angioplasty was evaluated. Drug-coated balloons provide a safe and effective alternative to drug-eluting stents for coronary artery revascularization, particularly for in-stent restenosis and small vessel disease.
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