Plain balloon angioplasty with or without bare-metal stenting versus drug-coated balloon angioplasty with or without bare-metal stenting versus primary drug-eluting stenting in patients requiring femoropopliteal, with or without infrapopliteal, endovascular revascularization for chronic limb-threatening ischaemia: BASIL-3 within-trial health economic analysis

Background
The BASIL-3 trial demonstrated that patients with chronic limb-threatening ischaemia secondary to femoropopliteal disease who were randomized to plain balloon angioplasty (PBA) ± bare-metal stenting (BMS), drug-coated balloon angioplasty (DCBA) ± BMS, or drug-eluting stenting (DES) had similar clinical outcomes. Herein, the in-trial health economic analysis is presented.

Methods
Cost-utility analysis (CUA) and cost-effectiveness analysis (CEA) were conducted from the perspective of the UK National Health Service (NHS) and Personal Social Services Research Unit. Patient-level resource use and health outcome data were collected from the BASIL-3 trial during 2–7 years of follow-up and were utilized to estimate incremental cost-effectiveness ratios expressed as a cost per amputation-free life-year and per quality-adjusted life-year (QALY). EQ-5D-5L was used to generate participant QALYs at baseline and during follow-up.

Results
In the CUA, DCBA was associated with slightly lower NHS costs (−£250.71 (95% c.i. −£4630.34 to £3652.10)), but slightly lower QALY gains (−0.007 (95% c.i. −0.116 to 0.097) QALYs) when compared with PBA. When compared with PBA, DES was less costly (−£724.52 (95% c.i. −£4975.04 to £2631.57)) and resulted in an additional 0.048 (95% c.i. −0.060 to 0.148) QALYs.

Conclusion
In BASIL-3, the probability of DCBA and of DES being cost-effective at £20 000 per QALY was 52% and 76% respectively. At a higher willingness-to-pay threshold (£30 000 per QALY) DES may be cost-effective and further research is required to explore the economic case.