title: Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results.
abstract: BACKGROUND
  Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease.
  
  
  RESULTS
  Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4% versus 82.6%; P=0.004) and primary patency (83.1% versus 32.8%; P<0.001), satisfying the primary hypotheses. In the secondary evaluations, (1) the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3% versus 75.8%; P<0.001), (2) the provisional DES group exhibited superior primary patency (89.9% versus 73.0%; P=0.01) and superior clinical benefit (90.5% and 72.3%, P=0.009) compared with the provisional BMS group, and (3) the stent fracture rate (both DES and BMS) was 0.9% (4/457).
  
  
  CONCLUSIONS
  Femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement.
authors.affiliation: Department of Cardiothoracic Surgery, Stanford University School of Medicine, Falk Cardiovascular Research Center, 300 Pasteur Drive, Stanford, CA 94305-5407, USA. mddake@stanford.edu
authors.forename: Michael D
authors.initials: MD
authors.lastname: Dake
authors.forename: Gary M
authors.initials: GM
authors.lastname: Ansel
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.forename: Takao
authors.initials: T
authors.lastname: Ohki
authors.forename: Richard R
authors.initials: RR
authors.lastname: Saxon
authors.forename: H Bob
authors.initials: HB
authors.lastname: Smouse
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Gary S
authors.initials: GS
authors.lastname: Roubin
authors.forename: Mark W
authors.initials: MW
authors.lastname: Burket
authors.forename: Yazan
authors.initials: Y
authors.lastname: Khatib
authors.forename: Scott A
authors.initials: SA
authors.lastname: Snyder
authors.forename: Anthony O
authors.initials: AO
authors.lastname: Ragheb
authors.forename: J King
authors.initials: JK
authors.lastname: White
authors.forename: Lindsay S
authors.initials: LS
authors.lastname: Machan
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D019917:Blood Vessel Prosthesis Implantation; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data; D005260:Female; D005263:Femoral Artery / Q000378:metabolism / Q000473:pathology*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D058729:Peripheral Arterial Disease / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000378:metabolism / Q000473:pathology*; D011446:Prospective Studies; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D017239:Paclitaxel