The role of drug-coated balloons in in-stent restenosis.

INTRODUCTION: Despite a constantly expanding spectrum of therapeutic options for lower limb artery disease, there is not yet a well-defined consensus on the specific type of endovascular treatment that is best suited. Clinical data on patients with femoropopliteal disease treated with drug-coated balloons have not been elaborated sufficiently, especially in the case of in-stent restenosis (ISR). EVIDENCE ACQUISITION: For this review a systematic research of the medical databases (http://www.ncbi.nlm.nih.gov/pubmed/) has been conducted. EVIDENCE SYNTHESIS: Keywords such as drug-coated balloons (DCB)/drug-eluting balloons (DEB), in-stent restenosis, de novo stenosis, angioplasty, superficial femoral artery(SFA), popliteal artery (PA), above the knee (ATK), below the knee (BTK), peripheral artery disease (PAD) have been used. Furthermore, data from reviews, original contributions regarding randomized controlled studies, observational studies, registries and single center experiences have been included. CONCLUSIONS: Many trials have shown superiority for DCB- over PTA-treatment alone in TASC IIA and TASC IIB femoropopliteal lesions. However, the currently available DCB systems are different in terms of efficacy and long-term outcomes depending on their mechanical and pharmacological features. Moreover, angiographic characteristics of femoropopliteal lesions classified by Tosaka seem to influence subsequent outcomes of DCB treatment. Lastly, there is still lack of reliable prospective long-term data regarding DCB technology.