BACKGROUND: The aim was to compare percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA plus SEP) for intermittent claudication due to femoropopliteal arterial disease. METHODS: Consenting patients with femoropopliteal arterial lesions were randomized to one of three treatment arms: PTA, SEP, or PTA plus SEP. All patients received optimal medical treatment. Patients were assessed at baseline and 1, 3, 6 and 12 months after intervention. Clinical (ankle pressures, walking distances, symptoms) and quality-of-life (QoL) outcomes (Short Form 36, VascuQol) were analysed. RESULTS: A total of 178 patients (108 men, median age 70 years) were included. All three treatment groups demonstrated significant clinical and QoL improvements. One year after PTA (60 patients, 8 withdrew), 37 patients (71%) had improved (16 mild, 16 moderate, 5 marked), nine (17%) showed no improvement and six (12%) had deteriorated. After SEP (60 patients, 14 withdrew), 32 patients (70%) had improved (19 mild, 10 moderate, 3 marked), six (13%) showed no improvement and eight (17%) had deteriorated. After PTA plus SEP (58 patients, 11 withdrew), 40 patients (85%) had improved (18 mild, 20 moderate, 2 marked), seven (15%) showed no improvement and none had deteriorated. On intergroup analysis, PTA and SEP alone were equally effective in improving clinical outcomes, although the effect was short-lived. PTA plus SEP produced a more sustained clinical improvement, but there was no significant QoL advantage. CONCLUSION: For patients with intermittent claudication due to femoropopliteal disease, PTA, SEP, and PTA plus SEP were all equally effective in improving walking distance and QoL after 12 months. REGISTRATION NUMBER: NCT00798850 (http://www.ClinicalTrials.gov).

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