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Related trials

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See also:

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

    PASSION study, 2006

    [ISRCTN65027270] Facebook    pdf : paclitaxel eluting stent - myocardial revascularization for coronary artery disease

    Treatments

    Studied treatment Taxus Express2
    Control treatment Express2 or Libert�

    Patients

    Patients Myocardial Infarction with ST-Segment Elevation
    Inclusion criteria acute myocardial infarction with ST-segment elevation (>20 minutes of chest pain and at least 1 mm of ST-segment elevation in at least two contiguous leads or a new left bundle-branch block), reperfusion was expected to be achieved within 6 hours after the onset of symptoms, and the native coronary artery was considered to be suitable for primary acute myocardial infarction with ST-segment elevation (>20 minutes of chest pain and at least 1 mm of ST-segment elevation in at least two contiguous leads or a new left bundle-branch block), reperfusion was expected to be achieved within 6 hours after the onset of symptoms, and the native coronary artery was considered to be suitable for primary PCI with stent implantation.
    Exclusion criteria thrombolytic therapy; the infarction was caused by in-stent thrombosis or restenosis; there was a contraindication to aspirin, clopidogrel, or both; patients were participating in another clinical trial; cardiogenic shock
    Baseline characteristics
    age 61 
    diabetes (%) 11% 
    Lesion diameter inclusion criteria >2.5 
    Female (%) 24% 

    Method and design

    Randomized effectives 310 / 309 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 months (5y)
    Number of centre 2
    Geographic area The Netherlands
    Primary endpoint cardiac death, AMI, TLR


    Results

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

    All cause death

    14 / 302
         20 / 303
         0,70 [0,36;1,36]

    MI (fatal and non fatal)

    5 / 302
         6 / 303
         classic 0,84 [0,26;2,71]

    target lesion revascularisation

    16 / 302
         23 / 303
         0,70 [0,38;1,29]

    angiographic restenosis

    NA / 310
         NA / 309

    4 yr MI

    NA / 310
         NA / 309
         classic 1,49 [0,72;3,09]

    4 yr TLR

    NA / 310
         NA / 309
         0,67 [0,39;1,16]

    4 yr stent thrombosis

    NA / 310
         NA / 309
         classic 1,98 [0,67;5,84]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    All cause death 14 / 302 (4,6%) 20 / 303 (6,6%) 0,70 [0,36;1,36]    
    MI (fatal and non fatal) 5 / 302 (1,7%) 6 / 303 (2,0%) 0,84 [0,26;2,71]    
    target lesion revascularisation 16 / 302 (5,3%) 23 / 303 (7,6%) 0,70 [0,38;1,29]    
    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.
    All cause death 4,64% 6,60% -19,6‰
    MI (fatal and non fatal) 1,66% 1,98% -3,2‰
    target lesion revascularisation 5,30% 7,59% -22,9‰

    Meta-analysis of all similar trials:

    Drug eluting stent in coronary artery disease for all type of patients

    Drug eluting stent in coronary artery disease for acute myocardial infarction

    myocardial revascularization in acute myocardial infarction for all type of patients

    myocardial revascularization in coronary artery disease for all type of patient

    PCI in acute myocardial infarction for all type of patients



    Reference(s)

    Trials register # ISRCTN65027270
    • Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention.. N Engl J Med 2006;355:1105-13
      Pubmed | Hubmed | Fulltext
    • Dirksen MT, Vink MA, Suttorp MJ, Tijssen JG, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ. . EuroIntervention 2008 May;4:64-70
      Pubmed | Hubmed | Fulltext

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