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SESAMI, 2007 - sirolimus ES vs bare-metal stent

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See also:

  • All acute myocardial infarction clinical trials
  • All clinical trials of PCI
  • All clinical trials of primary stenting
  •  

    STENTIM-2 (Maillard) study, 2000

    Treatments

    Studied treatment systematic stenting with Stent Wiktor
    Control treatment conventional balloon angioplasty
    Concomittant treatment Ticlopidine 500 mg/d for 4 weeks in stent group only
    Treatments description
    Crossover from Balloon Angioplasty to Stenting (%) 36  
    stent type Wiktor GX 

    Patients

    Patients patients with AMI <12 h from symptom onset, with an occluded native coronary artery
    Baseline characteristics
    Age 57y 
    male (%) 82% 

    Method and design

    Randomized effectives 101 / 110 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 months


    Results

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

    Long term death

    3 / 101
    2 / 110
    classic 1,63 [0,28;9,58]

    reinfarction

    4 / 101
    4 / 110
    classic 1,09 [0,28;4,24]

    Revascularization

    5 / 101
    6 / 110
    classic 0,91 [0,29;2,88]

    Bleeding

    2 / 101
    3 / 110
    classic 0,73 [0,12;4,26]

    All cause death

    1 / 101
    0 / 110
    classic 5,45 [0,07;395,61]

    long term MI

    4 / 101
    6 / 110
    classic 0,73 [0,21;2,50]

    long term revascularization

    17 / 101
    30 / 110
    0,62 [0,36;1,05]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Long term death 3 / 101 (3,0%) 2 / 110 (1,8%) 1,63 [0,28;9,58]   7028 
    reinfarction 4 / 101 (4,0%) 4 / 110 (3,6%) 1,09 [0,28;4,24]   7028 
    Revascularization 5 / 101 (5,0%) 6 / 110 (5,5%) 0,91 [0,29;2,88]   7028 
    Bleeding 2 / 101 (2,0%) 3 / 110 (2,7%) 0,73 [0,12;4,26]   7028 
    All cause death 1 / 101 (1,0%) 0 / 110 (0,5%) 2,18 [0,07;64,24]   7028 
    long term MI 4 / 101 (4,0%) 6 / 110 (5,5%) 0,73 [0,21;2,50]   7028 
    long term revascularization 17 / 101 (16,8%) 30 / 110 (27,3%) 0,62 [0,36;1,05]   7028 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7028: Nordmann AJ, Bucher H, Hengstler P, Harr T, Young JPrimary stenting versus primary balloon angioplasty for treating acute myocardial infarction.Cochrane Database Syst Rev 2005;:CD005313

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Long term death 2,97% 1,82% 1,2%
    reinfarction 3,96% 3,64% 3,2‰
    Revascularization 4,95% 5,45% -5,0‰
    Bleeding 1,98% 2,73% -7,5‰
    long term MI 3,96% 5,45% -14,9‰
    long term revascularization 16,83% 27,27% -104,4‰


    Reference(s)

    Trials register # NA
    • Maillard L, Hamon M, Khalife K, Steg PG, Beygui F, Guermonprez JL, Spaulding CM, Boulenc JM, Lipiecki J, Lafont A, Brunel P, Grollier G, Koning R, Coste P, Favereau X, Lancelin B, Van Belle E, Serruys P, Monassier JP, Raynaud P. A comparison of systematic stenting and conventional balloon angioplasty during primary percutaneous transluminal coronary angioplasty for acute myocardial infarction. STENTIM-2 Investigators.. J Am Coll Cardiol 2000;35:1729-36
      Pubmed | Hubmed | Fulltext

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