Trial-Results center  
Clinical trial results database Feedback    Home


Related trials

SPIRIT IV, 2010 - everolimus ES vs paclitaxel ES

SORT-OUT-3, 2010 - zotarolimus ES vs sirolimus ES

ISAR-DESIRE-2, 2010 - sirolimus ES vs paclitaxel ES

RESOLUTE, 2010 - zotarolimus ES vs everolimus ES

ZEST (vs PES), 2009 - zotarolimus ES vs paclitaxel ES

PASEO, 2009 - drug ES vs bare-metal stent

Thiele, 2009 - sirolimus ES vs MIDCAB

ISAR TEST 2 (vs ZES), 2009 - dual sirolimus, probucol ES vs zotarolimus ES

ISAR TEST 3 (PF), 2009 - polymer free sirolimus stent vs sirolimus ES

ENDEAVOR IV, 2009 - zotarolimus ES vs paclitaxel ES

GENIUS-STEMI, 2009 - Genous stent vs bare-metal stent

ZEST AMI (vs PES), 2009 - zotarolimus ES vs paclitaxel ES

STICH (ventricular reconstruction), 2009 - CABG+surgical ventricular reconstruction vs CABG

ISAR TEST 2 (vs SES), 2009 - dual sirolimus, probucol ES vs sirolimus ES

COMPARE, 2009 - everolimus ES vs paclitaxel ES

ISAR TEST 3 (BP), 2009 - biodegradable-polymer sirolimus stent vs sirolimus ES

ZEST (vs SES), 2009 - zotarolimus ES vs sirolimus ES

ZEST AMI (vs SES), 2009 - zotarolimus ES vs sirolimus ES

BARI 2D, 2009 - CABG or PCI vs medical treatment

DEBATER (SES vs BMS), 2009 - sirolimus ES vs bare-metal stent

ISAR-TEST-4, 2009 - sirolimus biodegradable polymer vs sirolimus ES

SYNTAX, 2009 - paclitaxel ES vs CABG

ISAR-LEFT-MAIN, 2009 - sirolimus ES vs paclitaxel ES

Kim, 2008 - sirolimus ES vs paclitaxel ES

MISSION, 2008 - sirolimus ES vs bare-metal stent



See also:

  • All coronary artery disease clinical trials
  • All stable angina clinical trials
  • All clinical trials of revascularization with drug eluting stent
  • All clinical trials of sirolimus ES
    		•  

    RAVEL study, 2002

    [NCT00233805]

    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 <18 
    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]

    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]

    MACE

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

    Stent thrombosis (any, end of follow up)

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

    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]     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 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]    
    MACE 7 / 120 (5,8%) 35 / 118 (29,7%) 0,20 [0,09;0,43]    
    Stent thrombosis (any, end of follow up) 0 / 120 (0,4%) 0 / 118 (0,4%) 0,98 [0,02;49,15]    
    late stent thrombosis (31days - 1year) 0 / 120 (0,4%) 0 / 118 (0,4%) 0,98 [0,02;49,15]   3831 
    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.
    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‰
    MACE 5,83% 29,66% -238,3‰


    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

    (c) 2004-2010 TrialResults-center - All Rights Reserved

    Tweet this  |  notify a friend