Die ABC- ("angioplasty or bypass surgery in intermittent claudication"-)studie: Hintergrund und studienaufbau

As shown by the number of published articles as well as by the absolute treatment numbers, endovascular therapy for arteriosclerotic vascular disease has increased in recent years. Although this development does not have an evidence-based background, it was included in the German S3 guideline for the treatment of peripheral occlusive disease (.,Diagnostik und Therapie der peripheren arteriellen Verschlusskrankheit (PAVK)") and even in international publications [Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)]. Because of the lack of valid level-I data on the treatment of intermittent claudication with established invasive therapies, the ABC (Angioplasty or Bypass Surgery in Intermittent Claudication) trial was designed. This is a randomized controlled trial involving patients with complex lesions of the superficial femoral artery (10-20 cm) for the purpose of comparing endovascular treatment (stent-protected angioplasty) and the best surgical treatment (femoropopliteal bypass above the knee). The primary efficacy end point is clinical improvement by one class without the need for repeated target lesion revascularization within 24 months in surviving patients, as assessed by treadmill testing (3.2 km/h, 12% incline). To detect a difference of 15% for the primary end point between the two study arms with a power of 80, 470 patients must be recruited.