BASIL-3: Balloon vs Stenting in Severe Ischaemia of the Leg
Research type
Research Study
Full title
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 due to atherosclerotic femoro-popliteal, with or without infra-popliteal involvement, peripheral arterial disease
IRAS ID
183761
Contact name
Andrew Bradbury
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
5 years, 9 months, 1 days
Research summary
Summary of Research
One in every 1000-2000 people in the UK will be diagnosed with advanced cases of Severe Limb Ischemia (SLI) yearly. As a result of a combination of smoking, diabetes mellitus, high blood pressure, high cholesterol levels, kidney failure and the ageing process, some people develop atherosclerosis (aka ‘hardening’ of the arteries) in their legs. In SLI even minor injuries to the foot can fail to heal, resulting in the development of ulceration, even gangrene.
Unless the blood supply to the leg and foot is improved, many people affected by SLI will lose their limb and/or die within 12 months. As well as causing great suffering, SLI places a large economic burden upon health (NHS) and social care services.
Most SLI patients with disease in the femoro-popliteal arteries are treated by endovascular means, which involves opening up the diseased arteries with balloons and sometimes the use of metal tubes called stents. In recent years, a number of “advanced” endovascular technologies - drug eluting stent (DES) and drug coated balloons (DCB) - have become available but the evidence base for using these new technologies is weak and they are much more expensive than the traditional methods.The purpose of BASIL-3 is to determine which treatment is best at preventing amputation and death, getting the ulcers and gangrene to heal, and relieving pain in people with SLI. The costs of the 3 revascularisation strategies will be studied to see which offers the best value for money for the NHS.
Summary of Results
Chronic limb threatening ischaemia is the severest form of atherosclerotic peripheral arterial disease. This disease represents a growing global healthcare burden. Unless the blood supply to the leg is improved by a process called revascularisation, patients are at a high risk of amputation or death. There are different revascularisation methods, but no evidence on which is most effective. BASIL-3 is the only publicly funded randomised controlled trial to compare the clinical effectiveness of three revascularisation strategies. The methods compared were:
• Plain balloon angioplasty with or without bare metal stenting (PBA +/- BMS)
• Drug coated balloon angioplasty with or without bare metal stenting (DCBA +/- BMS)
• Drug eluting stent
Major amputation or death occurred in 66% of participants in the PBA +/- BMS group; in 60% of the DCBA+/-BMS group; and 58% in the DES group. No differences in serious adverse events were reported between the groups.
The BASIL-3 trial concluded that neither DCBA+/-BMS nor DES had a significant clinical benefit over PBA+/-BMS in the femoro-popliteal segment in patients undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.Published results: Bradbury, Andrew W et al (2025) BMJ 2025; 388:e080881
https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fdx.doi.org%2F10.1136%2Fbmj-2024%25E2%2580%2591080881&data=05%7C02%7Capprovals%40hra.nhs.uk%7Cac46b683d61947dd4da708dd58d07aa4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638764374620246593%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=XzocH1SODCxKNsCBUYB1Jbx54Q1z%2FqL4iwv39NCNWyQ%3D&reserved=0REC name
North of Scotland Research Ethics Committee 1
REC reference
15/NS/0070
Date of REC Opinion
26 Aug 2015
REC opinion
Further Information Favourable Opinion