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See also:

  • All acute myocardial infarction clinical trials
  • All clinical trials of myocardial revascularization
  • All clinical trials of reteplase
    		•  

    GUSTO III study, 1997

    Treatments

    Studied treatment reteplase, in two bolus doses or 10 MU each given 30 minutes apart
    Control treatment alteplase, up to 100 mg infused over a period of 90 minutes
    Concomittant treatment Aspirine (160 mg) le plus tôt possible, puis 160-325 mg/j; héparine bolus de 5000 U en IV puis 1000 U/h (800 U/h pour < 80 kg) (cible temps de thromboplastine: 50-70 s)

    Patients

    Patients patients within 6 hours after the onset of symptoms with ST-segment elevation or bundle-branch block
    Inclusion criteria Syptômes d'IDM > 30 min et < 6 h; sus-décalage de ST > ou = 1 mm dans > ou = 2 dérivations standard; sus-décalage de ST > ou = 2 mm dans dérivations précordiales; bloc de branche
    Exclusion criteria Hémorragies; antécédent d'AVC ou d'atteinte du système nerveux central; chirurgie majeure récente; PAS > ou = 200 mmHg, PAD > 110 mmHg; ponction vasculaire non compressible; prise concomittante d'anticoagulant oral

    Method and design

    Randomized effectives 10138 / 4921 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 30 days
    Lost to follow-up ND
    Number of centre 807
    Geographic area 20 countries
    Primary endpoint Mortality 30-day
    Withdrawals (T1/T0) ND /


    Results

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

    short term death

    757 / 10138
         356 / 4921
         1,03 [0,91;1,17]

    stroke (fatal and non fatal)

    166 / 10138
         88 / 4921
         0,92 [0,71;1,18]

    Major bleeding

    96 / 10138
         59 / 4921
         0,79 [0,57;1,09]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    short term death 757 / 10138 (7,5%) 356 / 4921 (7,2%) 1,03 [0,91;1,17]    
    stroke (fatal and non fatal) 166 / 10138 (1,6%) 88 / 4921 (1,8%) 0,92 [0,71;1,18]    
    Major bleeding 96 / 10138 (0,9%) 59 / 4921 (1,2%) 0,79 [0,57;1,09]    
    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.
    short term death 7,47% 7,23% 2,3‰
    stroke (fatal and non fatal) 1,64% 1,79% -1,5‰
    Major bleeding 9,47‰ 1,20% -2,5‰


    Reference(s)

    Trials register # NA
    • . A comparison of reteplase with alteplase for acute myocardial infarction. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) Investigators.. N Engl J Med 1997 Oct 16;337:1118-23
      Pubmed | Hubmed | Fulltext
    • . A comparison of reteplase with alteplase for acute myocardial infarction. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) Investigators.. N Engl J Med 1997;337:1118-23
      Pubmed | Hubmed | Fulltext

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