title: Cost-effectiveness of endovascular revascularization compared to supervised hospital-based exercise training in patients with intermittent claudication: a randomized controlled trial.
abstract: BACKGROUND
  The optimal first-line treatment for intermittent claudication is currently unclear.
  
  
  OBJECTIVE
  To compare the cost-effectiveness of endovascular revascularization vs supervised hospital-based exercise in patients with intermittent claudication during a 12-month follow-up period.
  
  
  METHODS
  Randomized controlled trial with patient recruitment between September 2002-September 2006 and a 12-month follow-up per patient.
  
  
  METHODS
  A large community hospital.
  
  
  METHODS
  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.
  
  
  METHODS
  Participants were randomly assigned to endovascular revascularization (76 patients) or supervised hospital-based exercise (75 patients).
  
  
  METHODS
  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 vs 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 vs 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, 0.07; P = .73). The total mean cumulative costs per patient was significantly higher in the revascularization group (mean difference euro2318; 99% CI 2130 euros, 2506 euros; P < .001) and the incremental cost per QALY was 231 800 euro/QALY adjusted for the baseline variables. One-way sensitivity analysis demonstrated improved effectiveness after revascularization (mean difference 0.03; CI 0.02, 0.05; P < .001), making the incremental costs 75 208 euro/QALY.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands. s.spronk@erasmusmc.nl
authors.forename: Sandra
authors.initials: S
authors.lastname: Spronk
authors.forename: Johanna L
authors.initials: JL
authors.lastname: Bosch
authors.forename: Pieter T
authors.initials: PT
authors.lastname: den Hoed
authors.forename: Hermanus F
authors.initials: HF
authors.lastname: Veen
authors.forename: Peter M T
authors.initials: PM
authors.lastname: Pattynama
authors.forename: M G Myriam
authors.initials: MG
authors.lastname: Hunink
mesh_terms: D000368:Aged; D003362:Cost-Benefit Analysis; D005081:Exercise Therapy / Q000191:economics* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D017721:Hospital Costs; D006801:Humans; D007383:Intermittent Claudication / Q000191:economics / Q000628:therapy*; D008297:Male; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000191:economics* / Q000379:methods