Key result
Drug-coated balloons fail non-inferiority against DES in unrestricted de novo lesions despite clear niche benefits.
Why the study?
With the accumulation of clinical evidence and the development of new-generation devices, the use of drug-coated balloons has expanded beyond in-stent restenosis to a wide range of clinical settings. This review summarizes the fundamental principles, contemporary device characteristics, technical considerations, major clinical indications, and relevant evidence for drug-coated balloons.
Do drug-coated balloons provide comparable or superior angiographic and clinical outcomes compared with drug-eluting stents or plain old balloon angioplasty across various coronary artery disease indications?
Do drug-coated balloons provide comparable or superior angiographic and clinical outcomes compared with drug-eluting stents or plain old balloon angioplasty across various coronary artery disease indications?
Drug-coated balloons represent an established 'leave nothing behind' therapy for in-stent restenosis and small-vessel coronary disease, but require adequately powered clinical outcome trials before routine adoption in unrestricted de novo and complex coronary lesions.
Drug-coated balloons (DCBs) are a percutaneous coronary intervention technology that enables rapid and homogeneous delivery of antiproliferative agents to the vessel wall without leaving a permanent metallic scaffold. With the accumulation of clinical evidence and the development of new-generation devices, the use of DCBs has expanded beyond the treatment of in-stent restenosis (ISR) to include a wide range of clinical settings such as small vessel disease, bifurcation lesions, acute coronary syndromes (ACS), and chronic total occlusions (CTO). Contemporary DCB platforms are primarily based on paclitaxel- or sirolimus-coated technologies, while advances in carrier systems and coating techniques have improved drug transfer efficiency, safety, and long-term outcomes. Appropriate lesion preparation, optimal device selection, and the integration of intravascular imaging techniques remain essential determinants of procedural success. Randomized trials support DCB use in ISR and in small-vessel coronary disease, although current European guidelines favor repeat drug-eluting stent (DES) implantation over DCB for restenosis of DES. Evidence in bifurcation lesions, ACS, and CTO is more limited and derives largely from trials powered for angiographic rather than clinical endpoints; in unrestricted de novo lesions, a DCB-based strategy did not meet non-inferiority against DES in the REC-CAGEFREE I trial. This review summarizes the fundamental principles of DCB technology, contemporary device characteristics, technical considerations, major clinical indications, and the most relevant evidence from current literature. DCB technology is an established component of the “leave nothing behind” strategy in selected indications, whereas its role in several de novo settings remains to be defined by adequately powered randomized trials with long-term clinical endpoints.
No takes yet. Share an insight, caveat, or question.
Gulyigit et al. (2026) conducted a review in Obstructive coronary artery disease including in-stent restenosis, small vessel disease, bifurcation lesions, acute coronary syndromes, and chronic total occlusions. Drug-coated balloons (paclitaxel- or sirolimus-coated) vs. Drug-eluting stents (DES) or plain old balloon angioplasty (POBA) was evaluated. Drug-coated balloons are supported by randomized trials in in-stent restenosis and small-vessel disease, but did not meet non-inferiority vs DES in unrestricted de novo lesions (6.4% vs 3.4%).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: