Five-Year Results Published From Cook's Zilver PTX Randomized Trial

March 18, 2016—The 5-year results of the Zilver PTX randomized, controlled trial were published by Michael D. Dake, MD, et al online ahead of print in Circulation. The clinical trial, which evaluated the Zilver PTX paclitaxel-eluting stent (Cook Medical) for treating peripheral arterial disease (PAD) in femoropopliteal arteries, confirmed long-term patency for patients treated with the device.

Dr. Dake commented to Endovascular Today, “This study of Zilver PTX is one of the largest randomized, controlled trials of an endovascular device to treat patients with femoropopliteal arterial disease and the first to detail outcomes through 5 years of follow-up. In summary, the data support the sustained safety and more durable clinical benefit of drug-eluting stent treatments compared to standard care treatment options. The results also demonstrate the long-term benefits of Zilver PTX use over bare-metal stent (BMS) placement."

He continued, "At 5 years, Zilver PTX demonstrated a 48% reduction in reintervention and a 41% reduction in restenosis compared to standard care, which consists of a strategy of provisional BMS placement, for management of lesions < 14 cm. Five-year data for Zilver PTX versus BMS confirm a sustained benefit for the paclitaxel-eluting stent.”

As summarized in Circulation, patients with symptomatic femoropopliteal artery disease were randomized to Zilver PTX (n = 236) or percutaneous transluminal angioplasty (PTA) (n = 238). Patients experiencing acute PTA failure underwent secondary randomization to provisional BMS or Zilver PTX. The trial compared primary Zilver PTX stenting versus PTA; overall Zilver PTX stenting (primary and provisional) versus standard care (PTA and provisional Zilver BMS [Cook Medical]); and provisional Zilver PTX stenting versus provisional BMS. The investigators reported that 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.