Vein bypass first vs. best endovascular treatment first revascularisation strategy for chronic limb-threatening ischaemia due to infra-popliteal disease: the BASIL-2 RCT
Author
Moakes, Catherine ABradbury, Andrew W
Abdali, Zainab
Bate, Gareth R
Hall, Jack
Jarrett, Hugh
Kelly, Lisa
Kigozi, Jesse
Lockyer, Suzanne
Meecham, Lewis
Patel, Smitaa
Popplewell, Matthew
Slinn, Gemma
Deeks, Jonathan J
Publication date
2024-10-28Subject
SurgeryCardiology
Public health. Health statistics. Occupational health. Health education
Health services. Management
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Show full item recordAbstract
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 p = 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.Citation
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.Type
ArticleAdditional Links
https://www.journalslibrary.nihr.ac.uk/hta/YTFV4524DOI
10.3310/YTFV4524PMID
39397484Journal
Health Technology AssessmentPublisher
National Co-Ordinating Centre for HTAae974a485f413a2113503eed53cd6c53
10.3310/YTFV4524
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