Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery
OhioHealth · University of British Columbia · +11 more institutions
Abstract
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%, P40% 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.
Citation impact
- FWCI
- 59.80
- Percentile
- 100%
- References
- 37
Authors
11- MDMichael D. DakeCorresponding
OhioHealth, University of British Columbia, Riverside Methodist Hospital, Tri-City Medical Center, OSF Saint Francis Medical Center, Massachusetts General Hospital, Cook Research (United States), The Jikei University Hospital, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Stanford Medicine, St. Francis Medical Center, St Francis Medical Center, Stanford University
- GMGary M. Ansel
OhioHealth, University of British Columbia, Riverside Methodist Hospital, Tri-City Medical Center, OSF Saint Francis Medical Center, Massachusetts General Hospital, Cook Research (United States), The Jikei University Hospital, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Stanford Medicine, St. Francis Medical Center, St Francis Medical Center, Stanford University
- MRMichael R. Jaff
OhioHealth, University of British Columbia, Riverside Methodist Hospital, Tri-City Medical Center, OSF Saint Francis Medical Center, Massachusetts General Hospital, Cook Research (United States), The Jikei University Hospital, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Stanford Medicine, St. Francis Medical Center, St Francis Medical Center, Stanford University
- TOTakao Ohki
OhioHealth, University of British Columbia, Riverside Methodist Hospital, Tri-City Medical Center, OSF Saint Francis Medical Center, Massachusetts General Hospital, Cook Research (United States), The Jikei University Hospital, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Stanford Medicine, St. Francis Medical Center, St Francis Medical Center, Stanford University
- RRRichard R. Saxon
OhioHealth, University of British Columbia, Riverside Methodist Hospital, Tri-City Medical Center, OSF Saint Francis Medical Center, Massachusetts General Hospital, Cook Research (United States), The Jikei University Hospital, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Stanford Medicine, St. Francis Medical Center, St Francis Medical Center, Stanford University
Topics & keywords
- Medicine
- Restenosis
- Revascularization
- Claudication
- Target lesion
- Surgery
- Angioplasty
- Stent