title: Dacron or PTFE for above-knee femoropopliteal bypass. a multicenter randomised study.
abstract: OBJECTIVE
  To compare polytetrafluorethylene (PTFE) and polyester grafts (Dacron) for above knee femoropopliteal bypass.
  
  
  METHODS
  Multicenter randomised clinical trial.
  
  
  METHODS
  427 patients were randomised between 6mm Dacron (Uni-Graft, B. Braun Melsungen AG, 34212 Melsungen, Germany) and PTFE (Goretex, W. L. Gore & Ass. Inc., Newark DE 19711, USA) above-knee femoropopliteal bypass grafts within 13 centres in Denmark (n=261), Norway (n=113) & Finland (n=53) between 1993 and 1998. Fourteen (3%) patients were excluded, leaving 413 patients with 208 Dacron and 205 PTFE grafts for analysis. Age, gender, indication (claudication: 65%), run-off (2 or 3 vessels: 76%), diabetes (17%) and hypertension (31%) as well as cerebrovascular (9%) and cardiac (33%) risks were evenly distributed. Patients were followed postoperatively at 1, 12 and 24 months. Patency assessment was based on ankle-brachial pressures or imaging in case of doubt.
  
  
  RESULTS
  The two-year primary patency rates for Dacron and PTFE were 70% and 57% (p=0.02), whereas the secondary patency rates were 76% and 65% (p=0.04), respectively. Primary patency at two years was significantly influenced by the number of patent crural vessels (two or three 67%, one 50%, p=0.01). Amputations at two years, major in 4% and minor in 3%, 30-days mortality and complications (wound infections: 3% and other wound complications: 13%) occurred equally frequent in both groups. At two years, patients treated for critical limb ischemia had a major amputation more often than patients operated on for intermittent claudication, 10 and 3 respectively (p=0.003), and had higher mortality rates, 20% and 8% respectively (p=0.001).
  
  
  CONCLUSIONS
  This trial confirms that Dacron is at least as durable as PTFE for above-knee bypass procedures, and might even be superior.
authors.affiliation: Department of Vascular Surgery B, Copenhagen University Gentofte Hospital, , Copenhagen, Denmark. ljp@dadlnet.dk
authors.forename: L P
authors.initials: LP
authors.lastname: Jensen
authors.forename: M
authors.initials: M
authors.lastname: Lepäntalo
authors.forename: J E
authors.initials: JE
authors.lastname: Fossdal
authors.forename: O C
authors.initials: OC
authors.lastname: Røder
authors.forename: B S
authors.initials: BS
authors.lastname: Jensen
authors.forename: M S
authors.initials: MS
authors.lastname: Madsen
authors.forename: O
authors.initials: O
authors.lastname: Grenager
authors.forename: H
authors.initials: H
authors.lastname: Fasting
authors.forename: H O
authors.initials: HO
authors.lastname: Myhre
authors.forename: N
authors.initials: N
authors.lastname: Baekgaard
authors.forename: O M
authors.initials: OM
authors.lastname: Nielsen
authors.forename: U
authors.initials: U
authors.lastname: Helgstrand
authors.forename: T V
authors.initials: TV
authors.lastname: Schroeder
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011093:Polyethylene Terephthalates; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D011474:Prosthesis Design; D012189:Retrospective Studies; D016896:Treatment Outcome; D014463:Ultrasonography; D014654:Vascular Patency
chemical_list: D011093:Polyethylene Terephthalates; D011138:Polytetrafluoroethylene