Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial.
OBJECTIVE
To evaluate whether angioplasty or above-knee bypass is the best treatment for symptomatic superficial femoral artery occlusive lesions, we performed a multicentre randomised trial.


METHODS
Between October 1995 and August 1998, 56 patients were enrolled, all with symptoms related to a 5-15 cm long occlusive lesion of the superficial femoral artery. Thirty-one patients were randomly assigned to percutaneous transluminal angioplasty (PTA); 25 patients to bypass surgery. All patients were followed at 1, 6 and 12 months after the procedure. The primary outcome of our study was re-occlusion of the femoral artery.


RESULTS
Thirty patients underwent the allocated PTA and 24 patients underwent bypass surgery. Cumulative 1-year primary patency after PTA was 43 and 82% after bypass surgery. After PTA more than half of the patients had a re-occlusion with an absolute risk reduction of 31% (CI: 6-56%) in favour of bypass surgery. The hazard ratio for occlusion comparing PTA with bypass surgery is 2.24 (95% CI: 0.9-5.58).


CONCLUSIONS
Despite 18 participating centres only 56 patients were randomised to PTA our bypass surgery. Based on our results, for every three patients treated with bypass surgery instead of PTA, one additional re-occlusion is prevented. Therefore, we conclude that with respect to patency, for long superficial femoral artery (SFA) stenoses or occlusions, surgery is better than PTA.
van der Zaag
E S
ES
Department of Surgery, Academic Medical Centre Amsterdam, Maastricht, The Netherlands.
Legemate
D A
DA
Prins
M H
MH
Reekers
J A
JA
Jacobs
M J
MJ
D000328:Adult; D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000601:surgery*; D005260:Female; D005263:Femoral Artery; D006801:Humans; D008297:Male; D008875:Middle Aged; D014654:Vascular Patency; D014656:Vascular Surgical Procedures; D014680:Veins / Q000637:transplantation*