Randomised controlled trial of percutaneous transluminal angioplasty for intermittent claudication

Objectives: To determine differences between I PTA and conventional medical treatment in treadmill distance until onset of claudication, treadmill maximum walking distance, patient reported maximum walking distance, ankle brachial pressure index (ABPI), quality of life (Nottingham Health Profile, NHP) and Duplex measured extent of occlusive disease. Design: Randomised controlled clinical trial. Methods: Six hundred claudicants were screened. Fifty-one men and 11 women with intermittent claudication due to shout femoral stenoses or occlusions (n = 47) and iliac stenoses (n = 15) were randomised to either PTA plus medical treatment (PTA group, n = 30) or to medical treatment alone (control group, n = 32). Medical treatment consisted of daily low dose aspirin and advice on smoking and exercise. Results: At 6 month follow up: In the PTA group more patients reported no claudication (p less than or equal to 0.05) and were asymptomatic on the treadmill (p less than or equal to 0.01) compared to the control group. The ABPI was significantly higher in the PTA group. More of the PTA group reported lower NHP pain scores (p less than or equal to 0.05). In the control group there were more occluded arteries (p less than or equal to 0.001), and the stenosis velocity untie of patent arteries tons significantly higher (p less than or equal to 0.001). Conclusions: Only 10% of claudicants had discrete lesions suitable for PTA. Treatment of these patients with PTA produces a greater short-term improvement in walking and quality of life than medical treatment alone and is associated with less progression of disease.