Drug-coated balloon catheters in the treatment of peripheral arterial occlusive disease. Development of methods and current level of evidence

Herten M., Stahlhoff S., Bisdas T., Donas K., Schwindt A., Torsello G., Schönefeld E.

Abstract

Background. Despite initially encouraging technical success of femoropopliteal percutaneous transluminal angioplasty (PTA) restenosis still remains the major challenge. The main reason for restenosis is neointimal hyperplasia which can be suppressed with antiproliferative drugs. Drug-coated balloons (DCB) or drug-coated stents (DCS) are used for the inhibition of restenosis. Aim. The present article gives an overview of the currently available DCB systems for femoropopliteal and infrapopliteal use and presents the completed, ongoing and planned trials and registries as well as the open questions for the use of DCBs in peripheral arterial occlusive disease. Material and methods. A comprehensive search for infrainguinal use of DCBs from 2008 until July 2013 was performed in databases of medical journals, registered randomized controlled trials and published scientific session abstracts. Results. The major advantages of DCBs are that no residual stent scaffold is left behind, immediate release of high drug concentrations with a single dose and efficacy in areas where DCSs are contraindicated. The clinical evidence of first generation paclitaxel drug-coated balloons (PTX-DCB) has been shown in several controlled randomized trials. Conclusions. Depending on the type and location of the lesion, DCBs are suitable for treatment of in-stent restenoses, restenoses in the region of the popliteal artery or side branches of the profunda artery for which stent application is contraindicated. © Springer-Verlag 2013.