Angioplasty or Bypass for Superficial Femoral Artery Disease? A Randomised Controlled Trial

Aim. 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. Patients and methods. Between October 1995 and August 1998, 56 patients were enrolled, all with symptoms related...

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Bibliographic Details
Published in:European journal of vascular and endovascular surgery 2004-08, Vol.28 (2), p.132-137
Main Authors: van der Zaag, E.S, Legemate, D.A, Prins, M.H, Reekers, J.A, Jacobs, M.J
Format: Article
Language:English
Subjects:
Adult
Aged
Angioplasty, Balloon
ARR
Arterial Occlusive Diseases - surgery
Bypass surgery
Female
Femoral Artery
Femoro-popliteal occlusive disease
Humans
Male
Middle Aged
NNT
Percutaneous transluminal angioplasty
Primary patency
Randomised trial
SVS/ISCVS classification
Vascular Patency
Vascular Surgical Procedures
Veins - transplantation
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Summary:Aim. 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. Patients and 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). Conclusion. 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.
ISSN:1078-5884
1532-2165
DOI:10.1016/j.ejvs.2004.04.003