IS INTERMITTENT CLAUDICATION IMPROVED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY - A RANDOMIZED CONTROLLED TRIAL

Purpose: Percutaneous transluminal angioplasty (PTA) is an increasingl y popular invasive treatment for peripheral arterial disease, but ther e have been very few controlled trials to justify its use. This random ized controlled clinical trial was performed to determine in patients with mild and moderate intermittent claudication differences in outcom e between PTA and conventional medical treatment after 2 years. Method s: Six hundred patients with claudication were screened at the Periphe ral Vascular Clinic, Royal Infirmary of Edinburgh. Sixty-two patients with short femoral artery stenoses or occlusions (47 patients) and ili ac stenoses (15 patients) were randomized to either PTA plus medical t reatment (PTA group, 30 patients) or to medical treatment alone (contr ol group, 32 patients). Medical treatment consisted of daily low-dose aspirin and advice on smoking and exercise. Outcome measures studied w ere patient-reported maximum walking distance, exercise treadmill dist ance until onset of claudication, tread mill maximum walking distance, ankle-brachial pressure index (ABPI), quality of life (Nottingham Hea lth Profile), and duplex ultrasound-measured extent of occlusive disea se. Results: At 2 years of follow-up, the PTA group and control subjec ts did not differ significantly in patient-reported maximum walking, t readmill onset to claudication, treadmill maximum walking distances, o r ABPI (p > 0.05). However, the PTA group had significantly fewer occl uded arteries (p = 0.003) and a lesser degree of stenosis (expressed i n terms of the velocity ratio; p = 0.004) in patent arteries. Quality of life was not demonstrably different between the two groups (p > 0.0 5). Conclusions: Two years after PTA, patients had less extensive dise ase than medically treated patients, but this did not translate into a significant advantage in terms of improved walking or quality of life . There are important implications for patient management and future c linical research.