Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial
Background—This randomized controlled trial (RCT) 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 randomized 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 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% versus 59.3%, p<0.01), patency (66.4% versus 43.4%, p<0.01), and freedom from reintervention (TLR, 83.1% versus 67.6%, p<0.01) for the overall DES group were superior to standard care in non-randomized comparisons. Similarly, clinical benefit (81.8% versus 63.8%, p=0.02), patency (72.4% versus 53.0%, p=0.03), and freedom from TLR (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 TLR through 5 years for the overall DES compared to standard care and provisional DES compared to 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 compared to standard endovascular treatments.
Clinical Trial Registration Information—www.clinicaltrials.gov. Identifier: NCT00120406.
- peripheral artery disease
- drug-eluting stent
- paclitaxel-eluting stent
- bare metal stent
- angioplasty and stenting
- Received April 10, 2015.
- Revision received February 4, 2016.
- Accepted February 12, 2016.
Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis License (http://creativecommons.org/licenses/by-nc-nd/3.0/), which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.