Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis

J Vasc Surg. 2010 May;51(5 Suppl):43S-51S. doi: 10.1016/j.jvs.2010.01.076.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / economics*
  • Angioplasty, Balloon / mortality
  • Blood Vessel Prosthesis Implantation / economics
  • Constriction, Pathologic
  • Cost-Benefit Analysis
  • Female
  • Health Resources / economics
  • Health Resources / statistics & numerical data*
  • Hospital Costs*
  • Humans
  • Ischemia / diagnostic imaging
  • Ischemia / economics
  • Ischemia / mortality
  • Ischemia / surgery
  • Ischemia / therapy*
  • Length of Stay
  • Lower Extremity / blood supply*
  • Male
  • Middle Aged
  • Peripheral Vascular Diseases / diagnostic imaging
  • Peripheral Vascular Diseases / economics
  • Peripheral Vascular Diseases / mortality
  • Peripheral Vascular Diseases / surgery
  • Peripheral Vascular Diseases / therapy*
  • Prospective Studies
  • Quality of Life*
  • Quality-Adjusted Life Years
  • Radiography
  • Saphenous Vein / transplantation
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • United Kingdom
  • Vascular Surgical Procedures / adverse effects
  • Vascular Surgical Procedures / economics*
  • Vascular Surgical Procedures / mortality

Associated data

  • ISRCTN/ISRCTN45398889