A vein bypass first versus a best endovascular treatment first revascularization strategy for patients with chronic limb-threatening ischaemia who require an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularization procedure to restore limb perfusion: the BASIL-2 within-trial health economic analysis.

Abstract

Chronic limb-threatening ischaemia (CLTI) places a considerable socioeconomic burden health and social care systems worldwide. The objective of this health economic analysis was to investigate the cost-effectiveness (CEA) and cost-utility (CUA) of a vein bypass (VB) first versus a best endovascular treatment (BET) first revascularization strategy in patients with CLTI who require an infra-popliteal revascularization procedure to restore limb perfusion. CEA and CUA analyses were conducted from the perspective of the UK National Health Service. Patient-level resource use and health outcomes data collected from the BASIL-2 trial over 2-7 years of follow-up were utilized to estimate incremental cost-effectiveness ratios expressed as cost per amputation-free life year (AFLY) and cost per quality-adjusted life year (QALY). EQ-5D-5L was used to generate participant QALYs at 2 and 3 years. At two years, the mean(s.d.) discounted hospital cost was £15 742.59(16 182.60) and £13 273.66(15 446.92) in the VB-first and BET-first revascularization strategy groups respectively. The lower costs (-£2524.23, 95% c.i., -£5844.93 to £1131.52) in the BET-first group were mainly due to the reduced number of days in hospital and lower procedural costs. BET-first was also more effective leading to additional AFLYs (0.429, 95% c.i., 0.03 to 0.88) at 7 years and discounted QALYs (0.016, 95% c.i., -0.08 to 0.12) at 2 years. A best endovascular first revascularization strategy dominated a vein bypass first strategy in the cost-effectiveness and cost-utility analyses. The findings were robust across different scenarios and prespecified subgroups.