RCT of clinical and cost-effectiveness of drug coated balloons, drug eluting stents and balloon angioplasty with bail-out bare metal stent revascularisation strategies for severe limb ischaemia due to femoro-popliteal disease: BASIL-3 (Balloon vs Stenting in Severe Ischaemia of the Leg)
A clinical trial is testing whether drug-coated balloons or drug-eluting stents can save more legs and lives than standard balloon angioplasty in patients with severe limb ischaemia—a condition where blocked arteries in the leg cause excruciating pain, non-healing ulcers, and often lead to amputation. Current treatment options for these patients are limited, and it is unclear which revascularisation strategy works best in the long term. The trial directly compares three approaches: plain balloon angioplasty (with a bare metal stent used only if needed), a drug-coated balloon, and a drug-eluting stent. All three are already used in practice, but no robust head-to-head evidence exists for this specific patient group. If the trial identifies a superior strategy, it could change standard NHS practice for thousands of patients with severe leg artery disease. Better outcomes would mean fewer major amputations, less repeat surgery, and improved quality of life. The trial also includes a health economic analysis, so the findings will help the NHS decide which treatment offers the best value for money. By using a “tracker trial” method, the study can incorporate new technologies as they emerge, keeping the results relevant as devices evolve.
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Design: Individually randomised multi-centre pragmatic 3-arm open trial of 861 patients comparing drug coated balloon (DCB), drug eluting stent (DES) with plain balloon angioplasty and ‘bail-out’ bare metal stent (PBA+/-BMS) first revascularisation strategies for severe limb ischemia (SLI) due to femoro-popliteal (FP) atherosclerotic arterial disease; incorporating an internal pilot phase and within-trial health economic analysis. Randomisation will be undertaken by minimisation, stratifying for age, gender, DM, CKD and severity of clinical disease (ischaemic rest/night pain only, tissue loss, both). Setting: Approximately 60 sites throughout the UK using vascular and endovascular surgical services located within NHS Hospitals. Target Population: Patients admitted to hospital with SLI requiring early endovascular FP intervention in the opinion of a vascular multi-disciplinary team (MDT). Inclusion Criteria: Patients with SLI due to FP atherosclerotic arterial disease; who are judged by the responsible clinicians (consultant vascular surgeons, interventional radiologists, diabetologists) in an MDT to require early endovascular FP intervention; who have supra-inguinal ‘inflow’ adequate to support all 3 possible trial revascularisation strategies (this can be achieved by a prior successful inflow [aorto-iliac] procedure if required); and who are judged suitable for all 3 possible trial revascularisation strategies following diagnostic imaging and a formal discussion by the MDT. Exclusion criteria: Patients with life expectancy <6 months; who are unable to provide consent due to incapacity; who are non-English speakers and where translation facilities are insufficient; who are unsuitable for the 3 treatments being evaluated. Health Technologies Being Assessed: 3 FP revascularisation strategies of the FP arteries, with the initial procedure being a drug eluting stent (DES), plain balloon angioplasty (PBA) and ‘bail-out’ bare metal stent (BMS) or a drug coated balloon (DCB) also with or without a BMS. The trial will also monitor new technologies using the “tracker trial” methodology and working with the NIHR Horizon Scanning Centre at the University of Birmingham to incorporate relevant new technologies into the trial. Measurement of Costs and Outcomes: The primary outcome will be amputation free survival (AFS), defined as the time to major limb (above the ankle) amputation of the index (trial) limb or death from any cause. Follow-up will be between 2 and 5 years post randomisation. Secondary outcomes: Overall survival (OS), re- and cross-over intervention rates, the composite major adverse limb events (MALE) outcome; in-hospital and 30-day procedure related morbidity and mortality; major cardiovascular events (SLI affecting the contralateral limb, acute coronary syndrome, stroke); relief of ischaemic pain (VAS, medication usage); QoL assessed using generic (EQ-5D-5L, SF-12) and disease specific (VascuQoL) tools; healing of tissue loss (ulcers, gangrene) using the PEDIS and WiFi instruments; extent and healing of minor (toe and forefoot) amputations; haemodynamic changes; absolute ankle and toe pressures; and ankle and toe to brachial pressure indices (ABPI, TBPI) Measurement of outcomes: Research nurses will review participants at baseline, 1 month post-intervention and 6, 12, 24 and 36 months after randomisation.
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