Economic analysis of a randomized trial of percutaneous angioplasty, supervised exercise or combined treatment for intermittent claudication due to femoropopliteal arterial disease

Background: The aim was to compare costs and utilities of percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA+SEP) in patients with intermittent claudication (IC) to establish the most cost-effective treatment. Methods: Patients with IC due to femoropopliteal disease were randomized to receive PTA, SEP or PTA+SEP. Assessments were performed before, and at 1, 3, 6 and 12 months postintervention. Clinical and quality-of-life indicators were recorded. The SF-6D Health Utilities index was calculated from the Short Form 36, plotted, and quality-adjusted life-years (QALYs) were generated by calculating the area under the curve. Costs were calculated using National Health Service 2009-2010 payment-by-results tariffs and the National Institute for Health Research Clinical Research Network Investigation pricing index, and adjusted for reinterventions. Cost per QALY and incremental costs were calculated, and sensitivity analyses performed. Results: A total of 178 patients (PTA, 60; SEP, 60; PTA+SEP, 58) were randomized. All treatments resulted in significant improvement in the SF-6D index (P < 0.001). There was no significant difference between treatments in mean QALYs gained (PTA: 0.620, 95 per cent confidence interval 0.588 to 0.652; SEP: 0.629, 0.597 to 0.660; PTA+SEP: 0.649, 0.622 to 0.675). The adjusted mean cost per procedure was significantly higher for PTA ((sic)7301.74) compared with SEP ((sic)3866.49) and PTA+SEP ((sic)6911.68) (P < 0.001). The cost per QALY was significantly higher for PTA ((sic)11 777.00) compared with SEP ((sic)6147.04) and PTA+SEP ((sic)10 649.74). QALYs were lost when PTA alone was used as first-line treatment in comparison with SEP or PTA+SEP. These results were robust and valid in sensitivity analyses. Conclusion: Supervised exercise is the most cost-effective first-line treatment for IC, and when combined with PTA is more cost-effective than PTA alone.