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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

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 paclitaxel, non-polymeric ES
    		•  

    ASPECT study, 2003

    [NCT00196079]

    Treatments

    Studied treatment coated Supra-G stent
    Control treatment Supra-G stent
    Concomittant treatment Clopidogrel or ticlopidine 1 or 6 months, or cilostazol
    Remarks 3 arms study with 2 dose of paclitaxel: 3.1 µg/mm2 and 1.2 µg/mm2
    Treatments description
    molécule paclitaxel, non polymeric 

    Patients

    Patients patientswith discrete coronary lesions (<15 mm in length, 2.25 to 3.5 mm in diameter)
    Baseline characteristics
    age 58·0 
    diabetes (%) 18 
    lesion length (mm) 10.9 (3.6) 
    %QCA follow-up 89 
    QCA follow-up duration 6 
    reference-vessel diameter 2.94 (0.39) 

    Method and design

    Randomized effectives 117 / 58 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 6 months
    Number of centre multicenter
    Geographic area NA
    Primary endpoint stenosis percentage


    Results

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

    All cause death

    1 / 118
         0 / 59
         classic 2,50 [0,03;181,10]

    MI (fatal and non fatal)

    0 / 118
         0 / 59
         classic 0,50 [0,00;126,69]

    target lesion revascularisation

    1 / 118
         0 / 59
         classic 2,50 [0,03;181,10]

    angiographic restenosis

    NA / 100
         NA / 55

    late stent thrombosis (31days - 1year)

    0 / 117
         0 / 48
         classic 0,41 [0,00;103,81]

    MACE

    10 / 117
         3 / 58
         classic 1,65 [0,47;5,77]

    Stent thrombosis (any, end of follow up)

    4 / 118
         0 / 59
         classic 8,50 [0,15;474,18]     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 1 / 118 (0,8%) 0 / 59 (0,8%) 1,00 [0,03;29,38]    
    MI (fatal and non fatal) 0 / 118 (0,4%) 0 / 59 (0,8%) 0,50 [0,01;24,89]    
    MACE 10 / 117 (8,5%) 3 / 58 (5,2%) 1,65 [0,47;5,77]    
    late stent thrombosis (31days - 1year) 0 / 117 (0,4%) 0 / 48 (1,0%) 0,41 [0,01;20,38]   3831 
    target lesion revascularisation 1 / 118 (0,8%) 0 / 59 (0,8%) 1,00 [0,03;29,38]    
    angiographic restenosis 8 / 100 (8,0%) 15 / 55 (27,3%) 0,29 [0,13;0,65]    
    Stent thrombosis (any, end of follow up) 4 / 118 (3,4%) 0 / 59 (0,8%) 4,00 [0,22;74,41]    
    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 8,55% 5,17% 3,4%
    angiographic restenosis 8,00% 27,27% -192,7‰


    Reference(s)

    Trials register # NCT00196079
    • Park SJ, Shim WH, Ho DS, Raizner AE, Park SW, Hong MK, Lee CW, Choi D, Jang Y, Lam R, Weissman NJ, Mintz GS. A paclitaxel-eluting stent for the prevention of coronary restenosis.. N Engl J Med 2003;348:1537-45
      Pubmed | Hubmed | Fulltext

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