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See also:

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

    SESAM study, 1997

    Treatments

    Studied treatment saruplase 80 mg/hour
    Control treatment alteplase 100 mg every 3 hours

    Patients

    Patients patients with acute myocardial infarction

    Method and design

    Randomized effectives 236 / 237 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration hospital stay
    Lost to follow-up ND
    Geographic area Europe
    Primary endpoint patency
    Withdrawals (T1/T0) ND /


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Death 11 / 236 (4,7%) 9 / 237 (3,8%) 1,23 [0,52;2,91]
    Reinfarction 10 / 236 (4,2%) 10 / 237 (4,2%) 1,00 [0,43;2,37]
    Recurrent angina 41 / 236 (17,4%) 40 / 237 (16,9%) 1,03 [0,69;1,53]
    Coronary bypass surgery 9 / 236 (3,8%) 9 / 237 (3,8%) 1,00 [0,41;2,49]
    Angioplasty* 88 / 236 (37,3%) 74 / 237 (31,2%) 1,19 [0,93;1,54]
    Severe bleeding 22 / 236 (9,3%) 20 / 237 (8,4%) 1,10 [0,62;1,97]
    Hemorrhagic stroke 2 / 236 (0,8%) 2 / 237 (0,8%) 1,00 [0,14;7,07]
    Embolic stroke 2 / 236 (0,8%) 3 / 237 (1,3%) 0,67 [0,11;3,97]
    No major events 121 / 236 (51,3%) 131 / 237 (55,3%) 0,93 [0,78;1,10]

    Endpoints used by the meta-analysis and data retained for this trial

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

    short term death

    11 / 236
         9 / 237
         classic 1,23 [0,52;2,91]

    stroke (fatal and non fatal)

    4 / 236
         5 / 237
         classic 0,80 [0,22;2,95]

    Major bleeding

    22 / 236
         20 / 237
         1,10 [0,62;1,97]

    Haemmorhagic stroke

    2 / 236
         2 / 237
         classic 1,00 [0,14;7,07]

    reinfarction

    10 / 236
         10 / 237
         classic 1,00 [0,43;2,37]     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 11 / 236 (4,7%) 9 / 237 (3,8%) 1,23 [0,52;2,91] Death   
    stroke (fatal and non fatal) 4 / 236 (1,7%) 5 / 237 (2,1%) 0,80 [0,22;2,95]    
    Major bleeding 22 / 236 (9,3%) 20 / 237 (8,4%) 1,10 [0,62;1,97] Severe bleeding   
    Haemmorhagic stroke 2 / 236 (0,8%) 2 / 237 (0,8%) 1,00 [0,14;7,07] Hemorrhagic stroke   
    reinfarction 10 / 236 (4,2%) 10 / 237 (4,2%) 1,00 [0,43;2,37] Reinfarction   
    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 4,66% 3,80% 8,6‰
    stroke (fatal and non fatal) 1,69% 2,11% -4,1‰
    Major bleeding 9,32% 8,44% 8,8‰
    Haemmorhagic stroke 8,47‰ 8,44‰ 0,0‰
    reinfarction 4,24% 4,22% 0,2‰


    Reference(s)

    Trials register # NA
    • Bär FW, Meyer J, Vermeer F, Michels R, Charbonnier B, Haerten K, Spiecker M, Macaya C, Hanssen M, Heras M, Boland JP, Morice MC, Dunn FG, Uebis R, Hamm C, Ayzenberg O, Strupp G, Withagen AJ, Klein W, Windeler J, Hopkins G, Barth H, von Fisenne MJ. Comparison of saruplase and alteplase in acute myocardial infarction. SESAM Study Group. The Study in Europe with Saruplase and Alteplase in Myocardial Infarction.. Am J Cardiol 1997 Mar 15;79:727-32
      Pubmed | Hubmed | Fulltext

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