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)

Record ID 32015000942
Authors' objectives: As a result of diabetes, smoking, high blood pressure, high cholesterol and kidney failure, some people develop atherosclerosis (aka hardening of the arteries ) in their legs. This atherosclerosis blocks their arteries so reducing the blood supply to their legs and feet. In the early stages, such disease often causes pain in the leg whilst walking but, as the disease progresses, the blood supply to the leg can become so poor that people get severe pain (requiring morphine) all the time, especially at night. At this stage, even minor injuries to the foot can fail to heal, allowing infection to enter the tissues, resulting in the development of ulceration, even gangrene. Unless the blood supply to the leg and foot is improved, many affected people will lose the limb and/or die within 12 months as a result of this so-called severe limb ischaemia (SLI). One in every 1000-2000 people in the UK will be diagnosed with SLI each year; and this rate is rising as a result of the ageing population, increases in diabetes, and continuing high rates of smoking. As well as causing great suffering, SLI places a very large economic burden upon health (NHS) and social care services. The two main treatments available are bypass surgery, where a vein is used to bypass the blockage, and endovascular treatment which involves opening up the diseased arteries with balloons and/or the use of little metal tubes called stents. Based on the results of the HTA-funded BASIL-1 trial, SLI patients with more limited disease affecting the arteries in their thigh (the so-called femoro-popliteal arteries) are usually offered endovascular treatment first because it is associated with a lower risk of death and major complications than surgery, and appears to work as well as, bypass surgery up to 2 years. For many years the standard of care endovascular treatment for such patients has been plain balloon angioplasty (PBA) with the use of so-called bail-out (bare metal) stenting (BMS) when PBA alone has been unsuccessful in satisfactorily opening up the artery. More recently, drug coated balloons (DCB) and drug eluting stents (DES) have entered the market and are widely used around the world. These DCB and DES release various drugs which act on the vessel wall and are believed to reduce the risks of the artery narrowing down or blocking off again. However, the evidence base underpinning the use of DCB and DES is weak and they are much more expensive than PBA+/-BMS. For that reason, both the NICE and the HTA have recommended randomised controlled trials to determine whether DCB and DES are better than PBA+/-BMS and should, therefore, be used by the NHS as first-line treatment. In the proposed study, we will invite people affected by SLI due to atherosclerosis in their thigh (femoro-popliteal) arteries, and who are considered suitable for DCB, DES and PBA+/-BMS, to be randomly allocated to one of these endovascular treatments in the first instance. If the allocated treatment doesn't work, then patients can go on to have one of the other treatments; or go on to have surgery as clinically appropriate. We will follow-up patients for an average of 3 years, during which time they will be offered further medical, surgical, and endovascular treatment as required. We will also study the costs of the treatments to see which offers best value for money for the NHS.
Project Status: Ongoing
Anticipated Publish Date: 2022
Requestor: NIHR Health Technology Assessment programme
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: England, United Kingdom
MeSH Terms
  • Angioplasty, Balloon
  • Cost-Benefit Analysis
  • Coated Materials, Biocompatible
  • Popliteal Artery
  • Peripheral Arterial Disease
  • Femoral Artery
  • Randomized Controlled Trials as Topic
  • Drug-Eluting Stents
  • Stents
  • Ischemia
  • Limb Salvage
  • Lower Extremity
  • Vascular Surgical Procedures
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
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