title: Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial.
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.
  
  
  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.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120406.
authors.affiliation: 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.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Dake
authors.affiliation: 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.).
authors.forename: Gary M
authors.initials: GM
authors.lastname: Ansel
authors.affiliation: 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.).
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: 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.).
authors.forename: Takao
authors.initials: T
authors.lastname: Ohki
authors.affiliation: 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.).
authors.forename: Richard R
authors.initials: RR
authors.lastname: Saxon
authors.affiliation: 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.).
authors.forename: H Bob
authors.initials: HB
authors.lastname: Smouse
authors.affiliation: 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.).
authors.forename: Lindsay S
authors.initials: LS
authors.lastname: Machan
authors.affiliation: 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.).
authors.forename: Scott A
authors.initials: SA
authors.lastname: Snyder
authors.affiliation: 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.).
authors.forename: Erin E
authors.initials: EE
authors.lastname: O'Leary
authors.affiliation: 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.).
authors.forename: Anthony O
authors.initials: AO
authors.lastname: Ragheb
authors.affiliation: 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.).
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000328:Adult; D000368:Aged; D017130:Angioplasty; D000925:Anticoagulants / Q000627:therapeutic use; D001157:Arterial Occlusive Diseases / Q000188:drug therapy / Q000628:therapy*; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D003131:Combined Modality Therapy; D018450:Disease Progression; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D004868:Equipment Failure; D005260:Female; D005263:Femoral Artery / Q000187:drug effects; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000628:therapy; D007511:Ischemia / Q000601:surgery / Q000628:therapy; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D011150:Popliteal Artery / Q000187:drug effects; D012008:Recurrence; D015607:Stents; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D014654:Vascular Patency
chemical_list: D000925:Anticoagulants; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel; D001241:Aspirin
keywords: angioplasty; drug-eluting stents; paclitaxel; peripheral artery disease; stents