BASIL-2. Version 1.0

• Research type

  Research Study

• Full title

  Multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of a ‘vein bypass first’ with a ‘best endovascular first’ revascularisation strategy for severe limb ischaemia due to infra-popliteal arterial disease: Bypass vs. Angioplasty in Severe Ischaemia of the Leg. The BASIL-2 trial

• IRAS ID

  144764

• Contact name

  Andrew Bradbury

• Contact email

  andrew.bradbury@btinternet.com

• Research summary

  RESEARCH SUMMARY:
  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. The two treatments currently available for SLI are: vein bypass (VB), where a vein is used to bypass the blockage and best endovascular treatment (BET), which involves opening up the diseased arteries with balloons and sometimes the use of little metal tubes called stents. Both treatments have pros and cons and there is debate and uncertainty as to which is preferable, when, in which arteries, and in which patients.

  In recent years, a number of “advanced” endovascular technologies - bare metal stent (BMS), drug eluting stent (DES), drug eluting balloon (DEB) have become available. These devices are more expensive than plain old balloon angioplasty (POBA) and, as yet, there no evidence that they are more clinically effective, or that they are cost-effective, in patients with SLI.

  The purpose of BASIL-2 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 severe limb ischemia. The costs of the two revascularisation strategies (VB first vs. BET first) will be studied to see which offers the best value for money for the NHS.

  LAY SUMMARY OF STUDY RESULTS:
  Atherosclerosis, or narrowing of the arteries, can occur as a result of smoking, high blood pressure, diabetes, or high cholesterol in the blood. Atherosclerosis can affect any artery, including those supplying the legs, where the condition is called peripheral arterial disease (PAD). The most severe form of PAD is chronic limb threatening ischaemia (CLTI) which can cause severe pain in the foot as well as ulcers and gangrene. Unless the blood supply to the leg and foot is improved, by a process called revascularisation, people with CLTI are at high risk of amputation and death. The blood supply can be improved by using a vein from the leg to bypass around the blockages (vein bypass, VB) or by using a balloon (angioplasty) or small metal tubes (stents) to reopen the blocked arteries (best endovascular treatment (BET)). There is debate about which type of revascularisation is best in terms of preventing amputation and death, especially in people who need revascularisation of the arteries below the knee. BASIL-2 is the first randomised controlled trial to compare VB and BET in this group of patients. BASIL-2 found that people randomised to a VB-first revascularisation strategy were 35% more likely to require a major amputation or die than those randomised to a BET-first strategy. Most of this difference in favour of BET was due to a higher number of patients dying in the VB group. BET was also cheaper for the NHS. The results of this study suggest that in patients with CLTI due to PAD in the arteries below the knee, who are suitable for both VB and BET and there is uncertainty as to which is best, BET should be offered first rather than VB

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  14/WM/0057

• Date of REC Opinion

  3 Mar 2014

• REC opinion

  Favourable Opinion