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This trial is included in the following systematic reviews and meta-analyses:

CABG surgery - off-pump CABG - all type of patients  


Related trials

BBS, 2010 - off-pump vs on-pump

PROMISS (Uva), 2010 - off-pump vs on-pump

ROOBY, 2009 - off-pump vs on-pump

Ozkara, 2007 - off-pump vs on-pump

Kunes, 2007 - off-pump vs on-pump

Jares, 2006 - off-pump vs on-pump

Motallebzadeh, 2006 - off-pump vs on-pump

Tatoulis, 2006 - off-pump vs on-pump

Al-Ruzzeh, 2006 - off-pump vs on-pump

Vedin, 2006 - off-pump vs on-pump

Michaux, 2006 - off-pump vs on-pump

Paparella, 2006 - off-pump vs on-pump

Ascione, 2006 - off-pump vs on-pump

Niranjan, 2006 - off-pump vs on-pump

Kobayashi, 2005 - off-pump vs on-pump

Ascione, 2005 - off-pump vs on-pump

Wan, 2004 - off-pump vs on-pump

Gasz, 2004 - off-pump vs on-pump

Alwan, 2004 - off-pump vs on-pump

Syed, 2004 - off-pump vs on-pump

Legare, 2004 - off-pump vs on-pump

Dorman, 2004 - off-pump vs on-pump

Selvanayagam, 2004 - off-pump vs on-pump

Khan, 2004 - off-pump vs on-pump

PRAGUE-4, 2004 - off-pump vs on-pump



See also:

  • All CABG surgery clinical trials
  • All clinical trials of off-pump CABG
  • All clinical trials of off-pump
    		•  

    BBS study, 2010

    [NCT00120991]

    Treatments

    Studied treatment off-pump CABG
    Control treatment on-pump CABG
    Concomittant treatment unfractionated heparin: off pump: 100 U/kg to achieve an activated clotting time >200s on-pump: 300 U/kg to achieve an activated clotting time >480s

    Patients

    Patients patients > 54 years of age with three-vessel coronary artery disease with EuroSCORE of 5-16 undergoing elective or sub-acute coronary artery bypass grafting
    Exclusion criteria previous heart surgery; left ventricular ejection fraction <30%; unstable preoperative condition
    Baseline characteristics
    Age (mean), years 76y 
    female (%) 35% 
    LVEF >50% 51% 
    Diabetes (%) 18% 

    Method and design

    Randomized effectives 177 / 164 (studied vs. control)
    Design Parallel groups
    Blinding open blind assessor
    Follow-up duration 30 days
    Primary endpoint cardiovascular events


    Results

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

    All cause death

    6 / 177
         11 / 164
         0,51 [0,19;1,34]

    stroke (fatal and non fatal)

    7 / 177
         6 / 164
         classic 1,08 [0,37;3,15]

    new cardiac revascularization

    1 / 177
         3 / 164
         classic 0,31 [0,03;2,94]

    MI (fatal and non fatal)

    9 / 177
         15 / 164
         0,56 [0,25;1,24]

    atrial fibrillation

    76 / 177
         72 / 164
         0,98 [0,77;1,25]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    All cause death 6 / 177 (3,4%) 11 / 164 (6,7%) 0,51 [0,19;1,34] at 30 days   
    stroke (fatal and non fatal) 7 / 177 (4,0%) 6 / 164 (3,7%) 1,08 [0,37;3,15]    
    new cardiac revascularization 1 / 177 (0,6%) 3 / 164 (1,8%) 0,31 [0,03;2,94] at 30 days   
    MI (fatal and non fatal) 9 / 177 (5,1%) 15 / 164 (9,1%) 0,56 [0,25;1,24] at 30 days   
    atrial fibrillation 76 / 177 (42,9%) 72 / 164 (43,9%) 0,98 [0,77;1,25]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 3,39% 6,71% -33,2‰
    stroke (fatal and non fatal) 3,95% 3,66% 3,0‰
    new cardiac revascularization 5,65‰ 1,83% -12,6‰
    MI (fatal and non fatal) 5,08% 9,15% -40,6‰
    atrial fibrillation 42,94% 43,90% -9,6‰


    Reference(s)

    Trials register # NCT00120991
    Study web site link NCT00120991
    • Jensen BØ, Rasmussen LS, Steinbrüchel DA. Cognitive outcomes in elderly high-risk patients 1 year after off-pump versus on-pump coronary artery bypass grafting. A randomized trial.. Eur J Cardiothorac Surg 2008;34:1016-21
      Pubmed | Hubmed | Fulltext
    • Møller CH, Perko MJ, Lund JT, Andersen LW, Kelbaek H, Madsen JK, Winkel P, Gluud C, Steinbrüchel DA. No major differences in 30-day outcomes in high-risk patients randomized to off-pump versus on-pump coronary bypass surgery: the best bypass surgery trial.. Circulation 2010 Feb 2;121:498-504
      Pubmed | Hubmed | Fulltext

    External links about this trial

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