Comparison of femoro-popliteal plain balloon angioplasty for chronic limb threatening ischaemia in the BASIL trial and in a UK contemporary series

Abstract Background Since the turn of the millennium there has been a world-wide trend towards an endovascular first where possible revascularisation strategy for chronic limb threatening (CLTI). There is concern that this may be inappropriate and can result in net patient harm. The aim of this study, therefore, is to compare important clinical outcomes following femoro-popliteal plain balloon angioplasty (FP-PBA), with selective use of bare metal stents (BMS), in a contemporary series (CS) of patients treated in our unit between 2009 and 2014 with those observed following FP-PBA +/- BMS in the UK NIHR HTA-funded Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL-1, B1) trial (treated 1999-2004). Methods Baseline and clinical outcome data (amputation free survival, AFS; overall survival, OS; limb salvage, LS; freedom from re-intervention, FF-R; freedom from major adverse limb events, FF-MALE) were obtained from prospectively gathered hospital data and B1 trial case record forms. Results There were 237 CS and 218 B1 patients. CS patients were older (77 vs 73 years, p=.0002). B1 patients were more likely to be current smokers, less likely to be on best medical therapy, and underwent more extensive endovascular interventions. CS had more hospital admissions (4 vs 2, p Conclusions CLTI patients managed in our unit (2009-2014) by means of a FP-PBA +/- BMS first where possible revascularisation strategy experience significantly worse AFS and OS than patients treated with FP-PBA +/- BMS in the B1 trial ten years earlier (1999-2004).