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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

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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

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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
    		•  

    C-SIRIUS study, 2004

    [NCT00381420]

    Treatments

    Studied treatment coated Bx-VELOCITY
    Control treatment Bx-VELOCITY
    Concomittant treatment Clopidogrel 2 months
    Treatments description
    molécule sirolimus 

    Patients

    Patients Stable or unstable AP, silent ischaemia
    Baseline characteristics
    age 60 
    diabetes (%) 24% 
    lesion length (mm) 14.5 (6.3) 
    %QCA follow-up 86 
    QCA follow-up duration 8 
    reference-vessel diameter 2.65 (0.30) 
    lesion length inclusion criteria 15-32 
    Lesion diameter inclusion criteria 2.5-3.0 
    Female (%) 31% 

    Method and design

    Randomized effectives 50 / 50 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 9 months
    Number of centre 8
    Geographic area Canada
    Primary endpoint Minimal lumen diameter


    Results

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

    All cause death

    0 / 50
         0 / 50
         classic 1,00 [0,00;252,10]

    MI (fatal and non fatal)

    1 / 50
         2 / 50
         classic 0,50 [0,05;5,34]

    CABG

    1 / 50
         0 / 50
         classic 5,00 [0,07;359,84]

    MACE

    2 / 50
         9 / 50
         0,22 [0,05;0,98]

    Stent thrombosis (any, end of follow up)

    1 / 50
         1 / 50
         classic 1,00 [0,06;15,55]

    target lesion revascularisation

    2 / 50
         9 / 50
         0,22 [0,05;0,98]

    angiographic restenosis

    NA / 43
         NA / 43

    late stent thrombosis (31days - 1year)

    0 / 50
         1 / 50
         classic 0,20 [0,00;14,39]     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 0 / 50 (1,0%) 0 / 50 (1,0%) 1,00 [0,02;49,42]    
    MI (fatal and non fatal) 1 / 50 (2,0%) 2 / 50 (4,0%) 0,50 [0,05;5,34]    
    CABG 1 / 50 (2,0%) 0 / 50 (1,0%) 2,00 [0,07;58,28]    
    target lesion revascularisation 2 / 50 (4,0%) 9 / 50 (18,0%) 0,22 [0,05;0,98] clinically driven TLR   
    angiographic restenosis 1 / 43 (2,3%) 23 / 43 (53,5%) 0,04 [0,01;0,31]    
    MACE 2 / 50 (4,0%) 9 / 50 (18,0%) 0,22 [0,05;0,98]    
    Stent thrombosis (any, end of follow up) 1 / 50 (2,0%) 1 / 50 (2,0%) 1,00 [0,06;15,55]    
    late stent thrombosis (31days - 1year) 0 / 50 (1,0%) 1 / 50 (2,0%) 0,50 [0,02;14,57]   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.
    MI (fatal and non fatal) 2,00% 4,00% -20,0‰
    target lesion revascularisation 4,00% 18,00% -140,0‰
    angiographic restenosis 2,33% 53,49% -511,6‰
    MACE 4,00% 18,00% -140,0‰
    Stent thrombosis (any, end of follow up) 2,00% 2,00% 0,0‰


    Reference(s)

    Trials register # NCT00381420
    • Schampaert E, Cohen EA, Schlter M, Reeves F, Traboulsi M, Title LM, Kuntz RE, Popma JJ. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS).. J Am Coll Cardiol 2004;43:1110-5
      Pubmed | Hubmed | Fulltext

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