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See also:

  • All coronary artery disease clinical trials
  • All stable angina clinical trials
  • All clinical trials of myocardial revascularization
  • All clinical trials of CABG or PCI
    		•  

    BARI 2D study, 2009

    [NCT00006305] download pdf: CABG or PCI | myocardial revascularization for stable angina

    Treatments

    Studied treatment prompt revascularization with intensive medical therapy
    Control treatment intensive medical therapy alone
    Concomittant treatment with either insulin-sensitization or insulin-provision therapy (factorial design)
    Remarks factorial design with 2nd comparison: insulin-sensitization or insulin-provision therapy

    Patients

    Patients patients with type 2 diabetes and heart disease
    Baseline characteristics
    Age (yr) 62.4 y 
    Female (%) 29.6% 

    Method and design

    Randomized effectives 1176 / 1192 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 5.3 y
    Number of centre 49
    Geographic area US, Canada, Brazil, Mexico, Czech Republic, Austria
    Primary endpoint death


    Results

    Endpoint Studied treat.
    n/N     Control treat.
    n/N     Graph RR [95% CI]

    5-year death

    155 / 1176
         161 / 1192
         0,98 [0,79;1,20]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    5-year death 155 / 1176 (13,2%) 161 / 1192 (13,5%) 0,98 [0,79;1,20] end of trial
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    5-year death 13,18% 13,51% -3,3‰

    Meta-analysis of all similar trials:

    myocardial revascularization in coronary artery disease for all type of patient

    myocardial revascularization in coronary artery disease for diabetic patients

    myocardial revascularization in stable angina for diabetic patients

    myocardial revascularization in stable angina for all type of patient



    Reference(s)

    Trials register # NCT00006305
    • . Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.. Am Heart J 2008;156:528-536, 536.e1-5
      Pubmed | Hubmed | Fulltext
    • . A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease.. N Engl J Med 2009;:
      Pubmed | Hubmed | Fulltext
    • Chaitman BR, Hardison RM, Adler D, Gebhart S, Grogan M, Ocampo S, Sopko G, Ramires JA, Schneider D, Frye RL. The Bypass Angioplasty Revascularization Investigation 2 Diabetes Randomized Trial of Different Treatment Strategies in Type 2 Diabetes Mellitus With Stable Ischemic Heart Disease. Impact of Treatment Strategy on Cardiac Mortality and Myocardial Infarction.. Circulation 2009;:
      Pubmed | Hubmed | Fulltext
    • Dagenais GR, Lu J, Faxon DP, Kent K, Lago RM, Lezama C, Hueb W, Weiss M, Slater J, Frye RL. Effects of Optimal Medical Treatment With or Without Coronary Revascularization on Angina and Subsequent Revascularizations in Patients With Type 2 Diabetes Mellitus and Stable Ischemic Heart Disease.. Circulation 2011;123:1492-1500 - 10.1161/CIRCULATIONAHA.110.978247
      Pubmed | Hubmed | Fulltext

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