Lancet publication for HTA-funded BASIL trial

News release from the National Coordinating Centre for Health Technology Assessment

28 November 2005

HTA-funded research published in renowned international medical journal The Lancet this week (28 November), investigates for the first time within a multi centre, randomised, controlled trial the clinical and cost-effectiveness of two different interventional strategies for the treatment of severe leg ischaemia (SLI), a condition that may affect up to 100,000 people per year in the UK.

The bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial, led by Professor Andrew Bradbury of the Department of Vascular Surgery, University of Birmingham , compared bypass surgery with balloon angioplasty in a trial involving more than 450 patients treated in 27 UK hospitals. Two-hundred-and - twenty-eight patients were randomised to receive a bypass surgery-first strategy and 224 were randomised to a balloon angioplasty-first strategy to assess which was the most effective technique for treatment of SLI, which is characterised by the presence of rest/night pain and ulceration or gangrene of the leg.

The research team found that bypass surgery is associated with significantly lower immediate failure rates (3% vs 20%), higher 30-day morbidity (57% vs 41%) and lower 12 month re-intervention (18% vs 26%) compared with angioplasty. However, balloon angioplasty is associated with much shorter hospital stay. Over the first 12 months, the hospital costs associated with a bypass surgery-first strategy were approximately one third higher than associated with a balloon angioplasty-first strategy, mainly because of the significantly greater length of stay and the requirement for high dependency unit and intensive care. The 30-day mortality associated with the two strategies was similar (bypass surgery 5%, balloon angioplasty 3%) and the research team found little difference in rates of amputation free survival, all-cause mortality and health related quality of life between the two strategies up to 12 months after randomisation. However, after two years, the data suggest that a bypass surgery-first strategy is associated with a more durable outcome in terms of limb salvage and mortality.

"SLI imposes a very significant human cost as well as a major economic burden upon health and social care resources worldwide," says lead researcher Professor Andrew Bradbury . "The trial results suggest that both techniques are appropriate for treatment of SLI, and that the decision about which intervention to use first should be based on individual patient characteristics and local expertise. However, not withstanding the high immediate failure and re-intervention rates associated with angioplasty, it could be argued that an angioplasty-first strategy is most appropriate for patients with limited life expectancy. By contrast, in patients expected to live more than two years and who are relatively fit, the apparent improved durability of, and reduced re-intervention rate associated with a bypass surgery-first strategy may outweigh the short term considerations of increased morbidity and cost."

Notes for editors


  1. The HTA programme is a programme of the National Institute for Health Research (NIHR) and produces high quality research information about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS. It is the largest of the NIHR programmes and publishes the results of its research in the Health Technology Assessment journal, with more than 400 issues published to date. The journal’s 2007 Impact Factor (3.87) ranked it in the top 10% of medical and health-related journals. All issues are available for download free of charge from the website, www.hta.ac.uk The HTA programme is coordinated by the National Coordinating Centre for Health Technology Assessment (NCCHTA), based at the University of Southampton.
  2. The National Institute for Health Research provides the framework through which the research staff and research infrastructure of the NHS in England is positioned, maintained and managed as a national research facility.  The NIHR provides the NHS with the support and infrastructure it needs to conduct first-class research funded by the Government and its partners alongside high-quality patient care, education and training.  Its aim is to support outstanding individuals (both leaders and collaborators), working in world class facilities (both NHS and university), conducting leading edge research focused on the needs of patients. www.nihr.ac.uk

Contact details

Naomi Stockley, Programme Manager (Communications)
Telephone: 02380 595 646, Email: ns5@soton.ac.uk

Helen Nikandrou, Assistant Programme Manager (Communications)
Telephone: 02380 595 584, Email: h.nikandrou@soton.ac.uk

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