on behalf of the Zilver PTX Investigators Background-Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease. Methods and Results-Patients were randomly assigned to primary DES implantation (nϭ236) or PTA (nϭ238).Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65Ϯ40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (nϭ61) or BMS (nϭ59