Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised controlled trial for patients with complex lesions of the superficial femoral artery

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The number of patients treated for peripheral arteriosclerotic occlusive disease (PAOD) is increasing. Approximately 50% of PAOD-patients suffer from Intermittent claudication (IC) caused very often by atherosclerotic lesions of the superficial femoral artery (SFA). Short stenoses or occlusions (<10 cm) are mostly treated by percutaneous transluminal angioplasty (PTA) with or without stenting whereas patients with very long lesions (>20 cm) are usually treated surgically. The optimal revascularising modality for lesions with a length of 10-20 cm is widely based on personal preferences and an institution’s policy rather than on evidence. This may lead to an ineffective usage of either endovascular or surgical procedures with unsatisfactory outcomes and high costs for the community. The ABC-trial is a prospective randomized multi-centre-trial to compare best endovascular treatment (stent-supported angioplasty) and above knee femoropopliteal bypass (preferentially with autologous vein) for patients suffering from IC caused by atherosclerotic SFA-lesions with a length of 10-20cm. The primary endpoint of the trial will be “the clinical improvement of >1 class (Rutherford classification) without the need for repeated target lesion revascularization (TLR) within 24 months as assessed by treadmill testing (3.2 km/h, 12% incline)”. Based on data from the literature we expect an endpoint-difference of 15% in favour of the surgery. 330 patients will be analysed to prove superiority (significance level 5%, 80% power). Secondary endpoints include clinical, hemodynamic and morphological criteria, economic costs and quality of life. Pre-, intra- and postprocedural angiograms will be evaluated by an independent radiological core lab.