Vein bypass first vs. best endovascular treatment first revascularisation strategy for chronic limb-threatening ischaemia due to infra-popliteal disease: the BASIL-2 RCT
Moakes, Catherine A Bradbury, Andrew W Abdali, Zainab Bate, Gareth R Hall, Jack Jarrett, Hugh Kelly, Lisa Kigozi, Jesse Lockyer, Suzanne Meecham, Lewis
Moakes, Catherine A
Bradbury, Andrew W
Abdali, Zainab
Bate, Gareth R
Hall, Jack
Jarrett, Hugh
Kelly, Lisa
Kigozi, Jesse
Lockyer, Suzanne
Meecham, Lewis
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2024-10-28
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Abstract
Participants were randomised to a vein bypass-first or a best endovascular treatment-first revascularisation strategy. The original sample size of 600 participants (247 events) was based on a hazard ratio of 0.66 with amputation-free survival rates of 0.72, 0.62, 0.53, 0.47 and 0.35 in years 1-5 in the best endovascular treatment-first group with 90% power and alpha at pā
=ā
0.05. The sample size was revised to an event-based approach as a result of increased follow-up time due to slower than anticipated recruitment rates. Participants were followed up for a minimum of 2 years. A cost-effectiveness analysis was employed to estimate differences in total hospital costs and amputation-free survival between the groups. Additionally, a cost-utility analysis was carried out and the total cost and quality-adjusted life-years, 2 and 3 years after randomisation were used.
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Moakes CA, Bradbury AW, Abdali Z, Bate GR, Hall J, Jarrett H, Kelly L, Kigozi J, Lockyer S, Meecham L, Patel S, Popplewell M, Slinn G, Deeks JJ; BASIL-2 Investigators. Vein bypass first vs. best endovascular treatment first revascularisation strategy for chronic limb-threatening ischaemia due to infra-popliteal disease: the BASIL-2 RCT. Health Technol Assess. 2024 Oct;28(65):1-72. doi: 10.3310/YTFV4524.
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