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Díaz de la Llera, 2007 - sirolimus eluting stent vs bare-metal stent

SESAMI, 2007 - sirolimus eluting stent vs bare-metal stent

PROSIT, 2006 - sirolimus eluting stent vs paclitaxel eluting stent

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senior PAMI, 2005 - primary PCI vs Thrombolysis

CAPITAL AMI, 2005 - thrombolysis + angioplasty vs immediate thrombolysis



See also:

  • All coronary artery disease clinical trials
  • All acute myocardial infarction clinical trials
  • All clinical trials of PCI
  • All clinical trials of sirolimus eluting stent
  •  

    Díaz de la Llera study, 2007

    Facebook    pdf : sirolimus eluting stent - myocardial revascularization for acute myocardial infarction

    Treatments

    Studied treatment sirolimus-eluting stents
    Control treatment uncoated stents
    Concomittant treatment abciximab bolus 0.25µg/kg, infuson 0.125µg/kg/min for 12 hours; heparin bolus 17U/kg [max 7000U] aditional dose for ACT 200-250s; aspirin loasing dose 300-500mg then 100mg/d indefinitely; clopidogrel loading dose 300 or 600 mg then 75mg/d for at leat 1 (BMS) or 9 months (SES)

    Patients

    Patients primary percutaneous coronary intervention for acute myocardial infarction with ST-segment elevation
    Exclusion criteria reference diameter <2.25 mm and >4.0 mm by visual estimation in the infarction-related artery (IRA)
    Baseline characteristics
    age 64.47 
    history of MI (%) 7.37 
    diabetes (%) 27.46 
    Smoker (%) 68.3 
    unstable angina (%) 0% 
    LAD (%) 42.36 
    RCA (%) 43.67 
    LCx (%) 13.26 
    lesion length (mm) 29.54 (stent) 
    male (%) 79.19 
    Lesion diameter inclusion criteria 2.25-4.0 mm 
    left main coronary artery disease 0.81 
    STEMI 100% 
    Stable angina 0% 
    single vessel patients 53.44 
    multi vessels patients 46.56 

    Method and design

    Randomized effectives 60 / 54 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 1y
    Geographic area Spain
    Hypothesis Superiority
    Primary endpoint cardiac death, MI, TLR


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Death at 30D 2 / 60 (3,3%) 2 / 54 (3,7%) 0,90 [0,13;6,17]
    Death or nonfatal reinfarction at 30D 3 / 60 (5,0%) 3 / 54 (5,6%) 0,90 [0,19;4,27]
    Urgent TVR at 30D 1 / 60 (1,7%) 1 / 54 (1,9%) 0,90 [0,06;14,04]
    Acute or subacute stent thrombosis at 30D 1 / 60 (1,7%) 1 / 54 (1,9%) 0,90 [0,06;14,04]
    Death/reinfarction/urgent TVR at 30D 3 / 60 (5,0%) 3 / 54 (5,6%) 0,90 [0,19;4,27]
    Death at 1y 3 / 60 (5,0%) 2 / 54 (3,7%) 1,35 [0,23;7,78]
    Death or nonfatal reinfarction at 1y 4 / 60 (6,7%) 3 / 54 (5,6%) 1,20 [0,28;5,12]
    TVR at 1y 0 / 60 (0,8%) 3 / 54 (5,6%) 0,15 [0,01;2,93]
    Late stent thrombosis at 1y 1 / 60 (1,7%) 0 / 54 (0,9%) 1,80 [0,06;52,60]
    Total death/reinfarction/TVR at 1y 4 / 60 (6,7%) 6 / 54 (11,1%) 0,60 [0,18;2,01]

    Meta-analysis of all similar trials:

    Drug eluting stent in coronary artery disease for acute myocardial infarction

    myocardial revascularization in acute myocardial infarction for all type of patients

    PCI in acute myocardial infarction for all type of patients



    Reference(s)

    Trials register # NA
    • Daz de la Llera LS, Ballesteros S, Nevado J, Fernndez M, Villa M, Snchez A, Retegui G, Garca D, Martnez A. Sirolimus-eluting stents compared with standard stents in the treatment of patients with primary angioplasty.. Am Heart J 2007;154:164.e1-6
      Pubmed | Hubmed | Fulltext

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