title: Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis.
abstract: BACKGROUND
  The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that survival in patients with severe lower limb ischemia (rest pain, tissue loss) who survived postintervention for >2 years after initial randomization to bypass surgery (BSX) vs balloon angioplasty (BAP) was associated with an improvement in subsequent amputation-free and overall survival of about 6 and 7 months, respectively. We now compare the effect on hospital costs and health-related quality of life (HRQOL) of the BSX-first and BAP-first revascularization strategies using a within-trial cost-effectiveness analysis.
  
  
  METHODS
  We measured HRQOL using the Vascular Quality of Life Questionnaire (VascuQol), the Short Form 36 (SF-36), and the EuroQol (EQ-5D) health outcome measure up to 3 years from randomization. Hospital use was measured and valued using United Kingdom National Health Service hospital costs over 3 years. Analysis was by intention-to-treat. Incremental cost-effectiveness ratios were estimated for cost per quality-adjusted life-year (QALY) gained. Uncertainty was assessed using nonparametric bootstrapping of incremental costs and incremental effects.
  
  
  RESULTS
  No significant differences in HRQOL emerged when the two treatment strategies were compared. During the first year from randomization, the mean cost of inpatient hospital treatment in patients allocated to BSX ($34,378) was estimated to be about $8469 (95% confidence interval, $2,417-$14,522) greater than that of patients allocated to BAP ($25,909). Owing to increased costs subsequently incurred by the BAP patients, this difference decreased at the end of follow-up to $5521 ($45,322 for BSX vs $39,801 for BAP) and was no longer significant. The incremental cost-effectiveness ratio of a BSX-first strategy was $184,492 per QALY gained. The probability that BSX was more cost-effective than BAP was relatively low given the similar distributions in HRQOL, survival, and hospital costs.
  
  
  CONCLUSIONS
  Adopting a BSX-first strategy for patients with severe limb ischemia does result in a modest increase in hospital costs, with a small positive but insignificant gain in disease-specific and generic HRQOL. However, the real-world choice between BSX-first and BAP-first revascularization strategies for severe limb ischemia due to infrainguinal disease cannot depend on costs alone and will require a more comprehensive consideration of individual patient preferences conditioned by expectations of survival and other health outcomes.
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh Medical School, Teviot Place, Edinburgh, United Kingdom. j.f.forbes@ed.ac.uk
authors.forename: John F
authors.initials: JF
authors.lastname: Forbes
authors.forename: Donald J
authors.initials: DJ
authors.lastname: Adam
authors.forename: Jocelyn
authors.initials: J
authors.lastname: Bell
authors.forename: F Gerry R
authors.initials: FG
authors.lastname: Fowkes
authors.forename: Ian
authors.initials: I
authors.lastname: Gillespie
authors.forename: Gillian M
authors.initials: GM
authors.lastname: Raab
authors.forename: Charles Vaughan
authors.initials: CV
authors.lastname: Ruckley
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Bradbury
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000191:economics* / Q000401:mortality; D019917:Blood Vessel Prosthesis Implantation / Q000191:economics; D003251:Constriction, Pathologic; D003362:Cost-Benefit Analysis; D005260:Female; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data*; D017721:Hospital Costs; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000191:economics / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D007902:Length of Stay; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000000981:diagnostic imaging / Q000191:economics / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D011859:Radiography; D012501:Saphenous Vein / Q000637:transplantation; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000191:economics* / Q000401:mortality