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See also:

  • All coronary artery disease clinical trials
  • All stable angina clinical trials
  • All clinical trials of myocardial revascularization
  • All clinical trials of sirolimus eluting stent
    		•  

    RAVEL study, 2002

    [NCT00233805] download pdf: sirolimus eluting stent | myocardial revascularization for stable angina

    Treatments

    Studied treatment coated Bx Velocity
    Control treatment Bx Velocity
    Concomittant treatment Clopidogrel or ticlopidine 8 weeks
    Treatments description
    molécule sirolimus 

    Patients

    Patients Stable or unstable AP, silent ischaemia; single primary target lesion in a native coronary artery
    Baseline characteristics
    age 62 
    diabetes (%) 19% 
    lesion length (mm) 9.6 (3.3) 
    %QCA follow-up 89 
    QCA follow-up duration 6 
    reference-vessel diameter 2.60 (0.54) 
    lesion length inclusion criteria
    Lesion diameter inclusion criteria 2.5-3.5 
    Female (%) 37% 

    Method and design

    Randomized effectives 120 / 118 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 12 months
    Number of centre 19
    Geographic area Global
    Primary endpoint Late lumen loss


    Results

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

    MACE

    7 / 120
         35 / 118
         0,20 [0,09;0,43]

    All cause death

    2 / 120
         2 / 118
         classic 0,98 [0,14;6,87]

    MI (fatal and non fatal)

    4 / 120
         5 / 118
         classic 0,79 [0,22;2,86]

    CABG

    1 / 120
         1 / 118
         classic 0,98 [0,06;15,54]

    target lesion revascularisation

    0 / 120
         27 / 118
         0,01 [0,00;0,46]

    angiographic restenosis

    NA / 120
         NA / 118

    late stent thrombosis (31days - 1year)

    0 / 120
         0 / 118
         classic 0,98 [0,00;249,91]

    Stent thrombosis (any, end of follow up)

    0 / 120
         0 / 118
         classic 0,98 [0,00;249,91]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    MACE 7 / 120 (5,8%) 35 / 118 (29,7%) 0,20 [0,09;0,43]
    All cause death 2 / 120 (1,7%) 2 / 118 (1,7%) 0,98 [0,14;6,87]
    MI (fatal and non fatal) 4 / 120 (3,3%) 5 / 118 (4,2%) 0,79 [0,22;2,86]
    CABG 1 / 120 (0,8%) 1 / 118 (0,8%) 0,98 [0,06;15,54]
    target lesion revascularisation 0 / 120 (0,4%) 27 / 118 (22,9%) 0,02 [0,00;0,30]
    angiographic restenosis 0 / 120 (0,4%) 31 / 118 (26,3%) 0,02 [0,00;0,26]
    late stent thrombosis (31days - 1year) 0 / 120 (0,4%) 0 / 118 (0,4%) 0,98 [0,02;49,15] 3831
    Stent thrombosis (any, end of follow up) 0 / 120 (0,4%) 0 / 118 (0,4%) 0,98 [0,02;49,15]
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 3831: Moreno R, Fernandez C, Hernandez R, Alfonso F, Angiolillo DJ, Sabate M, Escaned J, Banuelos C, Fernandez-Ortiz A, Macaya CDrug-eluting stent thrombosis: results from a pooled analysis including 10 randomized studies.J Am Coll Cardiol 2005 Mar 15;45:954-9
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    MACE 5,83% 29,66% -238,3‰
    All cause death 1,67% 1,69% -0,3‰
    MI (fatal and non fatal) 3,33% 4,24% -9,0‰
    CABG 8,33‰ 8,47‰ -0,1‰

    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 unparticular patients

    myocardial revascularization in coronary artery disease for all type of patient

    myocardial revascularization in stable angina for all type of patient



    Reference(s)

    Trials register # NCT00233805
    • Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnr F, Falotico R. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.. N Engl J Med 2002;346:1773-80
      Pubmed | Hubmed | Fulltext
    • Morice MC, Serruys PW, Barragan P, Bode C, Van Es GA, Stoll HP, Snead D, Mauri L, Cutlip DE, Sousa E. Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial.. J Am Coll Cardiol 2007 Oct 2;50:1299-304
      Pubmed | Hubmed | Fulltext

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