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

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...

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Bibliographic Details
Published in:Circulation (New York, N.Y.) Vol. 133; no. 15; pp. 1472 - 83; discussion 1483
Main Authors: Dake, Michael D, Ansel, Gary M, Jaff, Michael R, Ohki, Takao, Saxon, Richard R, Smouse, H Bob, Machan, Lindsay S, Snyder, Scott A, O'Leary, Erin E, Ragheb, Anthony O, Zeller, Thomas
Format: Journal Article
Language:English
Published: United States 12.04.2016
Subjects:
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
paclitaxel
drug-eluting stents
peripheral artery disease
stents
angioplasty
ISSN:1524-4539
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Summary: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. 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. 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. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.
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ISSN:1524-4539
DOI:10.1161/CIRCULATIONAHA.115.016900