Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial

Michael D Dake; Gary M Ansel; Michael R Jaff; Takao Ohki; Richard R Saxon; H Bob Smouse; Lindsay S Machan; Scott A Snyder; Erin E O'Leary; Anthony O Ragheb; Thomas Zeller; Zilver PTX Investigators

doi:10.1161/CIRCULATIONAHA.115.016900

Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial

Circulation. 2016 Apr 12;133(15):1472-83; discussion 1483. doi: 10.1161/CIRCULATIONAHA.115.016900. Epub 2016 Mar 11.

Affiliations

¹ From Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.). mddake@stanford.edu.
² From Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA (M.D.D.); Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.); The Vascular Center, Massachusetts General Hospital, Boston (M.R.J.); Department of Surgery, Jikei University Hospital, Tokyo, Japan (T.O.); Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, CA (R.R.S.); Department of Radiology, OSF St. Francis Medical Center, Peoria, IL (H.B.S.); Department of Radiology, The University of British Columbia, Vancouver, Canada (L.S.M.); Cook Research Incorporated, West Lafayette, IN (S.A.S., E.E.O'L., A.O.R.); and Department of Angiology, Herz Zentrum, Bad Krozingen, Germany (T.Z.).

Abstract

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.

Keywords: angioplasty; drug-eluting stents; paclitaxel; peripheral artery disease; stents.

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Angioplasty*
Anticoagulants / therapeutic use
Arterial Occlusive Diseases / drug therapy
Arterial Occlusive Diseases / therapy*
Aspirin / therapeutic use
Clopidogrel
Combined Modality Therapy
Disease Progression
Disease-Free Survival
Drug-Eluting Stents*
Equipment Failure
Female
Femoral Artery* / drug effects
Follow-Up Studies
Humans
Intermittent Claudication / therapy
Ischemia / surgery
Ischemia / therapy
Male
Middle Aged
Paclitaxel / administration & dosage
Paclitaxel / therapeutic use*
Popliteal Artery* / drug effects
Recurrence
Stents
Ticlopidine / analogs & derivatives
Ticlopidine / therapeutic use
Vascular Patency

Substances

Anticoagulants
Clopidogrel
Ticlopidine
Paclitaxel
Aspirin

Associated data

ClinicalTrials.gov/NCT00120406