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

Background—This randomized controlled trial evaluated clinical durability of Zilver PTX, a paclitaxel-coated drug-eluting stent (DES), for femoropopliteal artery lesions. Outcomes compare primary DES versus percutaneous transluminal angioplasty (PTA), overall DES (primary and provisional) versus standard care (PTA and provisional Zilver bare metal stent [BMS]), and provisional DES versus provisional BMS.Methods and Results—Patients with symptomatic femoropopliteal artery disease were randomly assigned to DES (n=236) or PTA (n=238). Approximately 91% had claudication; 9% had critical limb ischemia. Patients experiencing acute PTA failure underwent secondary randomization to provisional BMS (n=59) or DES (n=61). The 1-year primary end points of event-free survival and patency showed superiority of primary DES in comparison with PTA; these results were sustained through 5 years. Clinical benefit (freedom from persistent or worsening symptoms of ischemia; 79.8% versus 59.3%, P<0.01), patency (66.4% versus 43.4%, P<0.01), and freedom from reintervention (target lesion revascularization, 83.1% versus 67.6%, P<0.01) for the overall DES group were superior to standard care in nonrandomized comparisons. Similarly, clinical benefit (81.8% versus 63.8%, P=0.02), patency (72.4% versus 53.0%, P=0.03), and freedom from target lesion revascularization (84.9% versus 71.6%, P=0.06) with provisional DES were improved over provisional BMS. These results represent >40% relative risk reduction for restenosis and target lesion revascularization through 5 years for the overall DES in comparison with standard care and for provisional DES in comparison with provisional BMS.Conclusions—The 5-year results from this large study provide long-term information previously unavailable regarding endovascular treatment of femoropopliteal artery disease. The Zilver PTX DES provided sustained safety and clinical durability in comparison with standard endovascular treatments.Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.

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Two-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal artery disease, including the long-term superiority of the DES to PTA and to provisional BMS placement. (Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery; NCT00120406; Zilver(®) PTX™ Global Registry; NCT01094678).

Hepatic encephalopathy is a common complication that develops after creation of a transjugular intrahepatic portosystemic shunt (TIPS). Although most patients respond well to conservative medical therapy (ie, protein-restricted diet, nonabsorbable disaccharides, nonabsorbable antibiotics), a small percentage of patients (3%-7%) do not benefit from these methods and require more invasive therapeutic approaches. One option is emergent liver transplantation, but the majority of patients are not suitable candidates. Recently, various percutaneous techniques have been described that alter the hemodynamics through the shunt by occluding it with coils or balloons or by reducing its diameter by inserting constrained stents or stent-grafts. Other techniques have been used for patients with TIPS-related hepatic encephalopathy in whom spontaneous splenorenal shunts are present. In many patients with refractory hepatic encephalopathy, these percutaneous techniques have produced symptomatic improvement, with either a complete resolution or a substantial reduction in hepatic encephalopathy symptoms that can be controlled with medical therapy. Unfortunately, despite all attempts, some patients remain incapacitated and ultimately die. Further research is necessary to improve our understanding of TIPS-related hepatic encephalopathy so that newer, less invasive and safer procedures can be developed to treat this difficult clinical problem.