Coronary drug-coated balloons: Current evidence and emerging trends

Abstract

Percutaneous coronary intervention (PCI) for coronary and peripheral stenoses has advanced rapidly over the past three decades, driven by a series of innovative techniques since the introduction of the first balloon angioplasty. Significant progress in stent technology, beginning with bare-metal stents and followed by drug-eluting stents, has expanded the scope for successful revascularisation in complex lesions. However, challenges such as late stent thrombosis and in-stent restenosis (ISR) persist. Thus, further improvement in PCI techniques and devices is essential to achieve better patient outcomes. In recent years, drug-coated balloons (DCBs) have emerged as a promising alternative designed to overcome the limitations associated with drug-eluting stents, including the risks of late stent thrombosis, ISR, and the need for prolonged dual antiplatelet therapy. Several DCBs have been evaluated for both coronary and peripheral lesions, showing encouraging results in preclinical and clinical studies. DCBs have demonstrated efficacy in the treatment of ISR and have shown potential in other clinical scenarios, such as small-vessel disease and diffuse lesions. In this review, we present the underlying technology, mechanisms of action, key preclinical findings, emerging clinical indications, recent trial outcomes, and future perspectives of DCBs as they continue to define their role in PCI.

Keywords: Clinical trials; Paclitaxel; Percutaneous coronary interventions; Restenosis; Small vessel disease.

Figure 1

Journey of various trials of sirolimus and paclitaxel drug-coated balloons in clinical practice. The blue color represents the paclitaxel drug, and green represents sirolimus. The names inside the balloon refer to commercially available drug-coated balloon (DCB), while the boxes represent the names of trials. It can be seen that initially all trials were done with paclitaxel-eluting DCBs, but of late studies have evaluated sirolimus DCBs.