OBJECTIVES: Conventional balloon angioplasty for treatment of femoropopliteal arterial disease is associated with a high restenosis rates 12 months post-procedure.  Recent clinical data have showed that use of DEBs may substantially reduce restenosis. This suggests that DEB may decrease number of revascularizations and therefore be a cost-effectiveness treatment for peripheral artery disease (PAD). This study evaluated the economic impact of using a drug-eluting balloon (DEB) for treatment of femoropoliteal arterial disease. METHODS: A decisional tree model has been developed to compare two alternative treatment strategies for superficial femoral artery disease (SFA): standard balloon angioplasty (PTA) and provisional stenting versus DEB. Cost for initial hospital care and the long term management of the disease, including reintervention, has been accounted for according to National Health Care Service and societal perspectives. Probabilities have been retrieved by available literature review of RCT and from an observational study on DEB that evaluated risk of target lesion revascularization (TLR) at 1 year. Uncertainty around the model inputs was tested using unvaried and  multivariate sensitivity analyses RESULTS: Specific procedure costs (including angioplasty balloon, DEB, stent, contrast medium) were 1500€ in both group because incremental cost for use of DEB was offset by reduction of number of stents used in the DEB arm. No difference has been noted also for initial hospitalization. Given a 1 year TLR rate of 8.7% and 14% for DEB and stenting respectively, DEB resulted a cost-saving strategy for the treatment of superficial femoral artery disease. Results were sensitive to hypothesis on number of stents and DEB used and their relative cost.   CONCLUSIONS: PTA of femoropopliteal arterial disease using DEB appears to be a clinical improvement for treatment of PAD and a potentially cost saving strategy compared to use of stents in the Italian Health Care System.