Welcome to BASIL-3
The Results of the BASIL-3 trial were presented at the Charing Cross Symposium on 23 April 2024
Results
Our findings suggest that neither drug coated balloon angioplasty +/- bare metal stent (DCBA +/- BMS), nor drug eluting stent (DES), conferred significant clinical benefit over plain ballon angioplasty (PBA) +/- BMS when used in the femoro-popliteal segment in patients undergoing FP +/- infra-popliteal revascularisation for chronic limb threatening ischaemia.
Introduction
Basil-3 is a multi-centre randomised controlled trial of clinical and cost-effectiveness of drug coated balloons, drug eluting stents, and plain balloon angioplasty with bail-out bare metal stent revascularisation strategies for severe limb ischaemia secondary to femoro-popliteal disease. Severe limb ischemia is the most serious and debilitating form of lower limb peripheral artery disease and is a seriously disabling, life and limb threatening, condition. The aim of BASIL-3 is to evaluate the clinical efficacy and cost-effectiveness of the interventions for people with severe limb ischaemia.
Information about MHRA report on drug eluting devices
Basil-3 suspended recruitment in December 2018 following a meta-analysis published in JAMA regarding trend to increased mortality for PAD patients receiving paclitaxel coated devices.
MHRA published a report in June 2019 recommending that trials involving patients with critical limb ischaemia should consider resuming recruitment. Following discussion with BASIL-3 funders, the BASIL-3 Data Monitoring Committee and Trial Steering Committee, it was decided to re-open to recruitment on 16 September 2019.
You can read more about the pause to recruitment.
Basil 2 & 3 Twitter
The BASIL-3 Trial is funded by a NIHR Health Technology Assessment grant (project number 13/81/02).