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Review
. 2025 Aug 15;61(8):1470.
doi: 10.3390/medicina61081470.

Coronary Angioplasty with Drug-Coated Balloons: Pharmacological Foundations, Clinical Efficacy, and Future Directions

Valentin Chioncel  1   2 , Flavius Gherasie  1   2 , Alexandru Iancu  2 , Anamaria-Georgiana Avram  2
Affiliations
Review

Coronary Angioplasty with Drug-Coated Balloons: Pharmacological Foundations, Clinical Efficacy, and Future Directions

Valentin Chioncel et al. Medicina (Kaunas). .

Abstract

Drug-coated balloons (DCBs) have transformed percutaneous coronary intervention (PCI) by delivering antiproliferative drugs directly to the arterial wall, offering a stent-less approach that mitigates the risks associated with permanent metallic implants. Initially developed for in-stent restenosis (ISR), DCBs have demonstrated robust efficacy in reducing neointimal hyperplasia and target lesion revascularization (TLR) rates across diverse coronary lesions, including small vessel disease (SVD), de novo lesions, and complex anatomies such as bifurcation lesions. Paclitaxel-coated balloons have long been the cornerstone of DCB therapy due to their established clinical outcomes, but sirolimus-coated balloons are emerging as a promising alternative with potentially superior safety profiles and sustained drug release. The pharmacological mechanism of DCBs relies on rapid drug transfer during brief balloon inflation, achieving high local concentrations without residual foreign material. Landmark trials, such as BASKET-SMALL 2, RESTORE SVD, and AGENT IDE, have demonstrated comparable or non-inferior outcomes of DCBs versus drug-eluting stents (DESs) in specific settings, with lower rates of stent thrombosis and shorter dual antiplatelet therapy (DAPT) requirements. Despite these advances, challenges persist, including optimizing drug formulations, ensuring uniform delivery, and addressing calcified lesions. Ongoing research into novel coatings, dual-drug systems, and artificial intelligence (AI)-guided interventions is poised to redefine PCI strategies. This review provides a comprehensive analysis of drug-coated balloon (DCB) angioplasty, not limited to specific clinical scenarios such as in-stent restenosis, small vessel disease, or bifurcation lesions, highlighting their transformative role in coronary artery disease (CAD) management. Instead, it addresses the full spectrum of pharmacological principles, mechanisms of action, clinical indications, comparative efficacy across various coronary artery disease contexts, and future directions of DCBs.

Keywords: de novo lesions; drug-coated balloons; in-stent restenosis; paclitaxel; percutaneous coronary intervention; sirolimus; small vessel disease.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Graphical comparison of clinical outcomes at 12 months vs. 5 years across PCI techniques.
Figure 2
Figure 2
Mechanisms of action of paclitaxel and sirolimus drug-coated balloons (DCBs) within coronary artery walls.
Figure 3
Figure 3
Distinct cellular mechanisms of paclitaxel and sirolimus during coronary angioplasty with DCBs.
Figure 4
Figure 4
One year clinical outcomes: paclitaxel-coated vs. uncoated balloon.
Figure 5
Figure 5
Clinical outcomes at 3 years: DCBs vs. DESs.
Figure 6
Figure 6
DCB vs. EES outcomes in PICCOLETO II trial.
See this image and copyright information in PMC

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