Bypass Vs Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial - PowerPoint PPT Presentation

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Bypass Vs Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial

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Bypass Vs Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial Multi-centre, prospective, double blinded randomised controlled trial Lancet Nov-Dec 2005: 366:1925-34 – PowerPoint PPT presentation

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Title: Bypass Vs Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial


1
Bypass Vs Angioplasty in Severe Ischaemia of the
Leg (BASIL) Trial
  • Multi-centre, prospective, double blinded
    randomised controlled trial
  • Lancet Nov-Dec 2005 3661925-34

2
Trial particulars
  • Pedigree of the trial-
  • Prof Bradbury from University of Birmingham,
    Heart of England NHS Foundation Hospitals
  • Multi-centre randomised controlled trial

3
Introduction
  • Severe limb ischaemia def presence of tissue
    loss( ulceration, gangrene) or pain at rest or at
    night
  • 2 types of Treatment of severe lower limb
    ischaemia
  • Pros and cons of each

4
Introduction
  • Stated aim of the trial-
  • Compare the outcomes of a surgery-first strategy
    to an angioplasty-first strategy in patients with
    severe limb ischaemia
  • No level 1 trial present in literature
  • Is this a level 1 trial?

5
Levels of EvidenceBased on CEBM table
Level Type of Study
1 Based on randomised, controlled trials (or meta-analysis of such trials) of adequate size to ensure a low risk of incorporating false-positive or false-negative results
2 Based on randomised, controlled trials that are too small to provide level 1 evidence.  These may show either positive trends that are not statistically significant or no trends which are associated with a high risk of false-negative results
3 Based on non-randomised, controlled or cohort studies, case series, case-controlled studies or cross-sectional surveys
4 Based on the opinion of respected authorities or that of expert committees as indicated in published consensus conferences or guidelines
5 Based on the opinion of those individuals who have written and reviewed these guidelines, based on their experience, knowledge of the relevant literature and discussion with their peers
6
Design of Trial
7
Eligibility criteria
  • All patients with severe limb ischaemia of
    arterial origin
  • More than 2 weeks
  • infra-inguinal disease that could be treated with
    both angioplasty or a bypass graft
  • All signed a consent form
  • Trial approved by Multi-centre Research Ethics
    Committee of Scotland

8
Locations and Time-span
  • 27 UK Hospitals
  • Patients were recruited in England and Scotland
  • Ran for 5 ½ yrs between Aug 1999 and June 2004

9
Randomisation
  • Trial manager randomly assigns patients for
    surgery or angioplasty-operator blinded
  • Randomisation was computer generated
  • Supplied in identical envelopes to all
  • Stratification by centre
  • Further into 4 groups
  • Clinical presentation( rest pain with/out tissue
    loss)
  • Ankle pressure( lt50 mm or gt50mm of Hg)

10
Interventions
  • Intervention asap after randomisation
  • Only 95 of patients imaged
  • Vascular surgeon and Interventional radiologist
    jointly decided type of intervention
  • Operator allowed to use their preferred techniques

11
Outcomes
  • Primary outcome
  • time to amputation of the trial leg above ankle
    or death from any cause .
  • Secondary outcome
  • All cause mortality
  • 30-day morbidity and mortality
  • Health Related Quality of Life (HRQL)
  • Patient hospital stay and procedure costs

12
Follow up
  • All patients followed up till amputation or 5
    years
  • Follow-up data obtained by research nurses-hence
    evaluator blinded
  • All results collated in an independent trial
    office
  • Registered with National Research Register and as
    an International Standard Randomised Controlled
    Trial

13
Results
14
Patient Flow
15
Primary Outcome Analysis
  • Surgery
  • Surgery195
  • 12m FU109 (56)
  • _at_ primary end point
  • Lower rate of
  • re-intervention41
  • Angioplasty
  • Angio216
  • 12m FU107 (50)
  • _at_ primary end point
  • High re-intervention rate 59

16
Secondary Outcome Analysis
  • Surgery vs Angioplasty
  • 30 day morbidity and mortality higher in surgery
  • All cause mortality up to 6 months higher
  • After 2 years significant fall in all outcomes in
    surgery
  • No significant difference in HRQL between the two

17
Other Results
  • Hospital resource used more with surgery- both
    bed wise and HDU/ITU use
  • Cost outcomes Surgery obviously more costly-
    3104 vs 1159 per procedure
  • Longer time in hospital for surgical patients
    23322 vs 17419 per patient stay

18
Article Summary
  • In medium term both are broadly similar in
    amputation free survival, all-cause mortality and
    quality of life.
  • Short term better mortality and morbidity results
    with angioplasty
  • 2 year results show that reduced risk of
    amputation, death or both.

19
Article Summary-Contd
  • Patient stay was less in angioplasty
  • Cost effectiveness though was much better in
    angioplasty
  • Quality of life was not much changed between the
    two.

20
Is it a good paper?
  • Fits in with CONSORT criteria fairly well
  • Is a good example of a double blinded controlled
    and randomised trial
  • I think that the numbers are large enough to
    constitute a level 1 trial
  • Does it affect day to day practice??
  • Any other points to be made?

21
Thank you
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