5-Year Results of Zilver PTX Trial

Study Questions:

What are the 5-year comparative outcomes of drug-eluting stents (DES) to standard endovascular treatments for femoropopliteal disease?


Patients with symptomatic femoropopliteal artery disease were randomized to DES (n = 236) or percutaneous transluminal angioplasty (PTA) (n = 238). Approximately 91% had claudication; 9% had critical limb ischemia. Patients experiencing acute PTA failure underwent secondary randomization to provisional bare-metal stent (BMS) (n = 59) or DES (n = 61). Follow-up included telephone contact at 1, 3, 9, and 18 months to assess overall patient condition. At 6 months, 1 year, and annually thereafter through 5 years, patients underwent an in-clinic assessment, which included Rutherford classification, ankle brachial index (ABI), and Walking Impairment Questionnaire (WIQ). Analysis of patency was performed using a multivariable Cox proportional hazards model that accounted for multiple lesions and included relevant covariates.


The 1-year primary endpoints of event-free survival and patency showed superiority of primary DES compared to PTA; these results were sustained through 5 years. Clinical benefit (freedom from persistent or worsening symptoms of ischemia; 79.8% vs. 59.3%, p < 0.01), patency (66.4% vs. 43.4%, p < 0.01), and freedom from reintervention (target lesion revascularization [TLR], 83.1% vs. 67.6%, p < 0.01) for the overall DES group were superior to standard care in nonrandomized comparisons. Similarly, clinical benefit (81.8% vs. 63.8%, p = 0.02), patency (72.4% vs. 53.0%, p = 0.03), and freedom from TLR (84.9% vs. 71.6%, p = 0.06) with provisional DES were improved over provisional BMS. These results represent >40% relative risk reduction for restenosis and TLR through 5 years for the overall DES compared to standard care and provisional DES compared to provisional BMS.


The authors concluded that the Zilver PTX DES provided sustained safety and clinical durability compared to standard endovascular treatments.


This post hoc study reports the sustained safety and more durable clinical benefit of the DES group compared to the standard care group among patients with symptomatic disease of the above-the-knee femoropopliteal arteries. Furthermore, the patency benefit is not only sustained, but continues to increase through 5 years. These data also demonstrate the long-term benefit of the drug coating over the corresponding BMS. Together, these results appear to suggest DES implantation as the preferred strategy in the endovascular treatment of femoropopliteal disease.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Interventions and Vascular Medicine, Chronic Angina

Keywords: Angioplasty, Ankle Brachial Index, Coronary Restenosis, Disease-Free Survival, Drug-Eluting Stents, Endovascular Procedures, Intermittent Claudication, Paclitaxel, Peripheral Arterial Disease, Stents, Treatment Outcome, Vascular Diseases

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