BACKGROUND: The optimal first-line treatment for intermittent claudication is currently unclear. OBJECTIVE: To compare the cost-effectiveness of endovascular revascularization versus supervised hospital-based exercise in patients with intermittent claudication during a 12-month follow-up period. DESIGN: Randomized controlled trial with patient recruitment between September 2002 to September 2006 and a 12-month follow-up per patient. SETTING: A large community hospital. PARTICIPANTS: Patients with symptoms of intermittent claudication due to an iliac or femoro-popliteal arterial lesion (293) who fulfilled the inclusion criteria (151) were recruited. Excluded were, for example, patients with lesions unsuitable for revascularization (iliac or femoropopliteal TASC-type D and some TASC type-B/C. INTERVENTION: Participants were randomly assigned to endovascular revascularization (76 patients) or supervised hospital-based exercise (75 patients). MEASUREMENTS: Mean improvement of health-related quality-of-life and functional capacity over a 12-month period, cumulative 12-month costs, and incremental costs per quality-adjusted life year (QALY) were assessed from the societal perspective. RESULTS: In the endovascular revascularization group, 73% (55 patients) had iliac disease versus 27% (20 patients) femoral disease. Stents were used in 46/71 iliac lesions (34 patients) and in 20/40 femoral lesions (16 patients). In the supervised hospital-based exercise group, 68% (51 patients) had iliac disease versus 32% (24 patients) with femoral disease. There was a non-significant difference in the adjusted 6- and 12-month EuroQol, rating scale, and SF36-physical functioning values between the treatment groups. The gain in total mean QALYs accumulated during 12 months, adjusted for baseline values, was not statistically different between the groups (mean difference revascularization versus exercise 0.01; 99% CI -0.05 to 0.07; p = 0.73). The total mean cumulative costs per patient was significantly higher in the revascularization group (mean difference Euro 2,318; 99% CI 2,130 to 2,506; p < 0.001) and the incremental cost per QALY was Euro 231,800 per QALY adjusted for the baseline variables. One-way sensitivity analysis demonstrated improved effectiveness after revascularization (mean difference 0.03; CI 0.02 to 0.05; p < 0.001), making the incremental costs Euro 75,208 per QALY. CONCLUSION: In conclusion, there was no significant difference in effectiveness between endovascular revascularization compared to supervised hospital-based exercise during 12-months follow-up, any gains with endovascular revascularization found were non-significant, and endovascular revascularization costs more than the generally accepted threshold willingness-to-pay value, which favors exercise.

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