Drug-Coated Balloons in Percutaneous Coronary Interventions: Insights into Device Design and Translation to the Clinic

Percutaneous coronary intervention has evolved significantly due to advancements in interventional strategies and device technologies. Drug-coated balloons (DCB) have emerged as drug delivery devices that don’t use a metallic scaffold, delivering antiproliferative drugs directly to the arterial wall. Paclitaxel-coated balloons have demonstrated efficacy in treating in-stent restenosis and small vessel disease; however, there is still limited evidence regarding their efficacy and safety in treating bifurcation and large vessel de novo lesions. Sirolimus-coated balloons (SCB) have shown promising outcomes in preclinical studies, exhibiting reduced smooth muscle cell loss and lower downstream embolisation. SCBs have demonstrated efficacy in treating in-stent restenosis and small vessel disease in clinical trials, but long-term outcome studies remain limited. This review explores preclinical and clinical data on DCBs, highlighting the vascular response, pharmacokinetics, and comparison of effectiveness between paclitaxel-coated balloons and SCBs. Furthermore, novel technologies, including everolimus and dual-drug formulations, are being investigated to enhance therapeutic outcomes. While DCBs provide a viable alternative to drug-eluting stents for specific indications, further research is needed to establish optimal patient selection, refine drug delivery mechanisms, and evaluate long-term outcomes. The evolution of DCBs continues to shape future percutaneous coronary intervention strategies, potentially offering a scaffold-free approach with equivalent or improved clinical outcomes.