PTFE bypass or thrupass for superficial femoral artery occlusion? A randomised controlled trial.
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.
Lepäntalo
M
M
Department of Vascular Surgery, Helsinki University Central Hospital, Helsinki, Finland.
Laurila
K
K
Roth
W-D
WD
Rossi
P
P
Lavonen
J
J
Mäkinen
K
K
Manninen
H
H
Romsi
P
P
Perälä
J
J
Bergqvist
D
D
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
D020099:Coated Materials, Biocompatible; D011138:Polytetrafluoroethylene