Drug-coated Balloons - History and Peripheral Vascular Opportunities

Speck and colleagues’ first key experiment was the addition of an antiproliferative drug to a contrast agent. 8 The contrast agent served as a carrier for local intravascular drug delivery. It improved the solubility of the drug far beyond the concentrations applied in previous investigations. In the porcine coronary model, the intracoronary bolus administration of a taxane-iopromide formulation led to a significant reduction of neointimal formation after experimental coronary stent implantation despite the short application time. 9,10 In the next step the team looked for a more lesion- than vessel-specific method of intravascular drug delivery. In 2001, the basic idea of a drug-coated balloon providing a similarly short-lasting application was proposed and the first experiments were performed. However, in the same year the angiographic follow-up results of the Randomized Study with the Sirolimus-Coated Bx Velocity (RAVEL) trial were presented at the meeting of the European Society of Cardiology Abstract One of the most innovative fields of modern medical research is the percutaneous transluminal treatment of vascular disease. During recent decades considerable advances have been made in intravascular interventions for the treatment of coronary and peripheral arterial disease. Despite these advances, the long-term outcome remains an area of concern in many applications. Restenosis is still a challenge in endovascular medicine and has thus been referred to as the Achilles’ heel of percutaneous intervention. Therefore, novel strategies have been developed to overcome this problem. These include drug-eluting stents and the more recently introduced non-stent-based local drug delivery systems (in particular the drug-coated balloon). Results from several pre-clinical and clinical studies indicate that short-term exposure of injured arteries to paclitaxel delivered from regular angioplasty balloons may be sufficient to reduce late lumen loss and restenosis rates during a critical period of time after the angioplasty of diseased coronary and peripheral arteries. Although the number of published trials and patients treated is still limited, data available seem to prove that restenosis inhibition by immediate drug release is feasible. This article reviews the history of the drug-coated balloon and then focuses on peripheral artery trials.