Vein bypass first vs. best endovascular treatment first revascularisation strategy for chronic limb-threatening ischaemia due to infra-popliteal disease: the BASIL-2 RCT

• DOI: 10.3310/ytfv4524
• Publication Date: 2024-10-14T07:22:29Z
• Authors: Catherine A Moakes; Andrew W Bradbury; Zainab Abdali; Gareth R Bate; Jack Hall; Hugh Jarrett; Lisa Kelly; Jesse Kigozi; Suzanne Lockyer; Lewis Meecham; Smitaa Patel; Matthew Popplewell; Gemma Slinn; Jonathan J Deeks
• Keywords: Critical limb ischemia

Background Chronic limb-threatening ischaemia with ischaemic pain and/or tissue loss. Objective To examine the clinical and cost-effectiveness of a vein bypass-first compared to best endovascular treatment-first revascularisation strategy in preventing major amputation or death. Design Superiority, open, pragmatic, multicentre, phase III randomised trial. Setting Thirty-nine vascular surgery units United Kingdom, one each Sweden Denmark. Participants Patients chronic due atherosclerotic peripheral arterial disease who required an infra-popliteal revascularisation, without additional more proximal infra-inguinal procedure, restore limb perfusion. Interventions A infra-popliteal, strategy. Main outcome measures The primary was amputation-free survival. Secondary outcomes included overall survival, amputation, further interventions, adverse event, health-related quality life serious events. Methods were original sample size 600 participants (247 events) based on hazard ratio 0.66 survival rates 0.72, 0.62, 0.53, 0.47 0.35 years 1–5 group 90% power alpha at p = 0.05. revised event-based approach as result increased follow-up time slower than anticipated recruitment rates. followed up for minimum 2 years. analysis employed estimate differences total hospital costs between groups. Additionally, cost–utility carried out cost quality-adjusted life-years, 3 after randomisation used. Results Between 22 July 2014 30 November 2020, 345 randomised, 172 173 treatment-first. Non-amputation-free occurred 108 (63%) patients 92 (53%) [adjusted 1.35 (95% confidence interval 1.02 1.80); 0.037]. Ninety-one 77 (45%) died 1.37 1.00 1.87)]. Over follow-up, economic evaluation discounted results showed that associated £1690 less bypass-first. utility bypass-first, £224 £2233 0.016 0.085 life-year gain from randomisation. Limitations Recruiting Bypass versus Angioplasty Severe Ischaemia Leg Trial-2 trial difficult target number events not achieved. Conclusions better which largely driven by fewer deaths. Overall, suggest dominates it costly effective Future work investigators have data sharing agreement BEst Surgical Therapy Limb threatening investigators. One output this collaboration will be individual patient meta-analysis. Study registration Current Controlled Trials ISRCTN27728689. Funding This award funded National Institute Health Care Research (NIHR) Technology Assessment programme (NIHR ref: 12/35/45) is published full ; Vol. 28, No. 65. See NIHR Awards website information.