Hany Zayed, Consultant vascular & endovascular surgeon, Guy's and St. Thomas Hospital (UK), gives its take on this clinical trial presented by Andrew Bradbury (UK) at Charing Cross 2023.

A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial.

Why this study?

BASIL-2 is a pragmatic multicentre Randomised Controlled Trial comparing the effectiveness of two treatment strategies for Chronic Limb Threatening Ischaemia (CLTI) caused by infra-popliteal arterial disease; Vein Bypass (VB) first vs Best Endovascular (EV) first strategies.

Methodology and results

The study involved 41 vascular centres and recruited 345 participants between July 2014 and November 2020. 172 participants received VB and 173 received EV first treatment. Primary end point was Amputation-Free Survival (AFS). 63% of patients in the VB group had a major amputation or died, compared to 53% in the EV group [Adjusted HR 1.35 (95% CI 1.02-1.8); p=0.037]. Death from any cause occurred in 53% in the VB group vs 45% in the EV group [HR 1.37 (95% CI 1.00-1.87)]. In summary, AFS was significantly better in EV group compared to VB group, which was driven by fewer deaths in the EV group. There was no difference in limb salvage rate, 30-day morbidity and mortality between the two groups. BASIL-2 also highlighted the overall poor long-term outcomes in patients with CLTI, with a median AFS of only 3.3 years in the VB group and 4.4 years in the EV group.

Comments

These findings confirm the need for better primary prevention and risk-factors modification to improve overall long-term outcomes. Further analysis will undoubtedly follow the initial trial results publication that will help better understand the reasons behind these outcomes which might seem different from the reported outcomes of the BEST-CLT trial, although both trials have fundamental differences.