title: Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Severe limb ischaemia is defined by ischaemic rest/night pain, tissue loss, or both, secondary to arterial insufficiency and is increasingly caused by infra-popliteal (below the knee) disease, mainly as a result of the increasing worldwide prevalence of diabetes. Currently, it is unknown whether vein bypass surgery or the best endovascular treatment (angioplasty or stenting) represents the optimal revascularisation strategy in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and cost-effective use of health care resources.
  
  
  METHODS
  The Bypass vs. Angioplasty in Severe Ischaemia of the Leg - 2 Trial is a UK National Institute of Health Research, Health Technology Assessment funded, multi-centre randomised controlled trial that compares, at the point of clinical equipoise, the clinical and cost-effectiveness of a 'vein bypass first' and a 'best endovascular treatment first' revascularisation strategy for severe limb ischaemia due to infra-popliteal disease. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the trial limb or death from any cause. The primary outcome for the cost-effectiveness analysis is cost per quality-adjusted life year. Secondary outcomes include overall survival, quality of life, in-hospital mortality and morbidity, repeat and crossover interventions, healing of tissue loss and haemodynamic changes following revascularisation. Sample size is estimated at 600 patients. An economic evaluation will be conducted from the perspective of the National Health Service and comprise a 'within-study' analysis, based on prospectively collected trial data and a 'model-based' analysis, which will extrapolate and compare costs and effects beyond the study follow-up period.
  
  
  CONCLUSIONS
  The BASIL-2 trial is designed to be pragmatic and represent current practice within the United Kingdom. Patients with severe limb ischaemia can only be randomised into the trial where clinical equipose exists. The advent of hybrid operating procedures should not be a barrier to randomisation, should a patient require inflow correction prior to tibial revascularisation.
  
  
  BACKGROUND
  
  27728689 Date of registration: 12 May 2014.
authors.affiliation: University Department of Vascular Surgery, Heart of England Foundation Trust, Netherwood House, Solihull Hospital, Lode Lane, Solihull, B91 2JL, UK. Popplewell@doctors.org.uk.
authors.forename: Matthew A
authors.initials: MA
authors.lastname: Popplewell
authors.affiliation: University Department of Vascular Surgery, Heart of England Foundation Trust, Netherwood House, Solihull Hospital, Lode Lane, Solihull, B91 2JL, UK. huw.davies@heartofengland.nhs.uk.
authors.forename: Huw
authors.initials: H
authors.lastname: Davies
authors.affiliation: Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT, UK. h.jarrett@bham.ac.uk.
authors.forename: Hugh
authors.initials: H
authors.lastname: Jarrett
authors.affiliation: University Department of Vascular Surgery, Heart of England Foundation Trust, Netherwood House, Solihull Hospital, Lode Lane, Solihull, B91 2JL, UK. gareth.bate@heartofengland.nhs.uk.
authors.forename: Gareth
authors.initials: G
authors.lastname: Bate
authors.affiliation: Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT, UK. m.r.grant@bham.ac.uk.
authors.forename: Margaret
authors.initials: M
authors.lastname: Grant
authors.affiliation: Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT, UK. s.a.patel@bham.ac.uk.
authors.forename: Smitaa
authors.initials: S
authors.lastname: Patel
authors.affiliation: Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT, UK. s.mehta.1@bham.ac.uk.
authors.forename: Samir
authors.initials: S
authors.lastname: Mehta
authors.affiliation: Health Economics Unit, School of Health and Population Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT, UK. l.andronis@bham.ac.uk.
authors.forename: Lazaros
authors.initials: L
authors.lastname: Andronis
authors.affiliation: Health Economics Unit, School of Health and Population Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT, UK. t.e.roberts@bham.ac.uk.
authors.forename: Tracy
authors.initials: T
authors.lastname: Roberts
authors.affiliation: Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT, UK. j.deeks@bham.ac.uk.
authors.forename: Jon
authors.initials: J
authors.lastname: Deeks
authors.affiliation: University Department of Vascular Surgery, Heart of England Foundation Trust, Netherwood House, Solihull Hospital, Lode Lane, Solihull, B91 2JL, UK. andrew.bradbury@btinternet.com.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bradbury
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000379:methods*; D002985:Clinical Protocols; D057510:Endovascular Procedures / Q000379:methods*; D005260:Female; D006801:Humans; D007511:Ischemia / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D018401:Sample Size