title: PTFE bypass or thrupass for superficial femoral artery occlusion? A randomised controlled trial.
abstract: Early results of a thrupass endograft in the treatment of femoral lesions are promising. Less morbidity and better cost-effectiveness are suggested to be achieved in the treatment of chronic lower limb ischaemia with endovascular treatment compared to surgical treatment.
  
  
  METHODS
  This randomised multicentre trial aimed to enroll a group of 60+60 patients for the treatment of 5-25-cm occlusions of superficial femoral artery (SFA) to be followed up for 3 years. Patients were treated either with endoluminal PTFE thrupass (WL Gore & Ass) or with surgical polytetrafluoroethylene (PTFE) bypass to proximal popliteal artery. Primary patency at 3 years was scheduled to be the primary end-point and secondary patency, functional success, costs and quality of life the secondary end-points.
  
  
  RESULTS
  A sample of 100 consecutive SFA occlusions in one of the centres revealed that only 4% of the lesions were amenable for the study. The trial was prematurely terminated due to the results of an interim analysis at the time when 44 patients were recruited: the 1-year primary patency (excluding technical failures) was 48% for thrupass and 95% for bypass (p=0.02). The patency difference in favour of surgical bypass over endovascular thrupass was also sustained after completion of 1-year follow-up, the primary patencies being 46% and 84% at 1 year with grossly equilinear life-table curves thereafter (p=0.18), respectively. The corresponding secondary patencies were 63% and 100% (p=0.05) when excluding technical failures and 58% and 100% (p=0.02) according to intention-to-treat analysis. Secondary outcomes were thus not analysed.
  
  
  CONCLUSIONS
  Treatment of SFA occlusions (TASC IIB and C or Imelda Ia and II) should be done by PTFE bypass rather than by PTFE thrupass, as thrupass is connected with worse early outcome. These results represent only a small category of femoral disease.
authors.affiliation: Department of Vascular Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Lepäntalo
authors.forename: K
authors.initials: K
authors.lastname: Laurila
authors.forename: W-D
authors.initials: WD
authors.lastname: Roth
authors.forename: P
authors.initials: P
authors.lastname: Rossi
authors.forename: J
authors.initials: J
authors.lastname: Lavonen
authors.forename: K
authors.initials: K
authors.lastname: Mäkinen
authors.forename: H
authors.initials: H
authors.lastname: Manninen
authors.forename: P
authors.initials: P
authors.lastname: Romsi
authors.forename: J
authors.initials: J
authors.lastname: Perälä
authors.forename: D
authors.initials: D
authors.lastname: Bergqvist
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical / Q000379:methods; D000792:Angiography; D017546:Angioscopy; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D020099:Coated Materials, Biocompatible; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D012537:Scandinavian and Nordic Countries; D015607:Stents; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible; D011138:Polytetrafluoroethylene