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See also:

  • All acute myocardial infarction clinical trials
  • All clinical trials of PCI
  • All clinical trials of primary ballon angioplasty
    		•  

    Zwolle study, 1994

    Treatments

    Studied treatment primary PTCA
    Control treatment streptokinase 1.5 M IU over 1h
    Concomittant treatment aspirin 300mg IV followed by 300mg/d, nitroglycerin to maintain a SBP of 100 mmHg, heparin APTT x2-3 during >2d

    Patients

    Patients patients with acute myocardial infarction
    Inclusion criteria Patients with symptoms of acute myocardial infarction that persisted for more than 30 min, accompagnied by an elevation of more than 1mm in the ST-segment in two or more contiguous leads, within 6 hrs after the onset of symptoms (or between 6 and 24 hours, if there was evidence of continuing ischemia)
    Exclusion criteria >76 y, contraindication to thrombolytic therapy (cardiogenic shock was not reason for exclusion).

    Method and design

    Randomized effectives 152 / 149 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration discharge
    Lost to follow-up NA
    Number of centre single center
    Geographic area The Netherland
    Hypothesis superiority
    Withdrawals (T1/T0) ND /


    Results

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

    In-hospital death

    3 / 152
         11 / 149
         0,27 [0,08;0,94]

    stroke (fatal and non fatal)

    1 / 152
         3 / 149
         classic 0,33 [0,03;3,11]

    Major bleeding

    8 / 152
         9 / 149
         classic 0,87 [0,35;2,20]

    MACE

    5 / 152
         23 / 149
         0,21 [0,08;0,55]

    reinfarction

    2 / 152
         15 / 149
         0,13 [0,03;0,56]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    In-hospital death 3 / 152 (2,0%) 11 / 149 (7,4%) 0,27 [0,08;0,94]    
    stroke (fatal and non fatal) 1 / 152 (0,7%) 3 / 149 (2,0%) 0,33 [0,03;3,11]    
    MACE 5 / 152 (3,3%) 23 / 149 (15,4%) 0,21 [0,08;0,55]    
    reinfarction 2 / 152 (1,3%) 15 / 149 (10,1%) 0,13 [0,03;0,56]    
    Major bleeding 8 / 152 (5,3%) 9 / 149 (6,0%) 0,87 [0,35;2,20]    
    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.
    In-hospital death 1,97% 7,38% -54,1‰
    stroke (fatal and non fatal) 6,58‰ 2,01% -13,6‰
    MACE 3,29% 15,44% -121,5‰
    reinfarction 1,32% 10,07% -87,5‰
    Major bleeding 5,26% 6,04% -7,8‰


    Reference(s)

    Trials register # NA
    • de Boer MJ, Hoorntje JC, Ottervanger JP, Reiffers S, Suryapranata H, Zijlstra F. Immediate coronary angioplasty versus intravenous streptokinase in acute myocardial infarction: left ventricular ejection fraction, hospital mortality and reinfarction.. J Am Coll Cardiol 1994;23:1004-8
      Pubmed | Hubmed | Fulltext

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