P ercutaneous revascularization is an established treatment for femoro-popliteal artery disease.1 Yet, restenosis, reocclusion, and ensuing symptom recurrence can occur in as many as 50% of patients undergoing percutaneous transluminal angioplasty (PTA), often requiring repeat percutaneous or surgical intervention.2,3 The superficial femoral artery represents a unique challenging vessel.4 Bare-metal stents reduce restenosis versus PTA and have gained widespread adoption. 5,6 Alternative therapies, such as drug-eluting balloon (DEB), may be valuable and worthwhile considering their promise and evidence to achieve patency outcomes at least similar to stents but with nothing left behind. 7Several studies in coronary artery disease indicate effective restenosis inhibition by DEB in the treatment of in-stent restenosis whereas drug-eluting stent are the preferred medicated devices in most coronary de novo lesions. Two published randomized trials have so far provided favorable data on the usage of DEB versus PTA for the treatment of femoropopliteal arterial disease. 8,9 More recently, the effect of a novel paclitaxel coating formulation with urea excipient, a naturally occurring highly biocompatible hydrophilic component (FreePac, Medtronic, Santa Rosa, CA) was investigated within a multicenter registry in patients affected by femoral-popliteal arterial disease. 10 To reach a more in-depth understanding onBackground-Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention.A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoropopliteal percutaneous transluminal angioplasty. Methods and Results-Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminalangioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0±5.3 and 6.6±5.5cm for DEB and control arm, respectively.

Paclitaxel coated PTA, with or without bare predilatation, is effective over 2 years in symptomatic patients with femoropopliteal stenotic lesions. Adequately powered randomised controlled comparisons are required to confirm these preliminary results.