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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 zotarolimus eluting stent
    		•  

    ENDEAVOR IV study, 2009

    [NCT00217269] unpublished (or not yet fully published) trial download pdf: zotarolimus eluting stent | myocardial revascularization for stable angina

    Treatments

    Studied treatment zotarolimus-eluting stent (Endeavor)
    Control treatment paclitaxel-eluting stent (Taxus)

    Patients

    Patients single de novo lesions in native coronary arteries with a reference vessel diameter of 2.5-3.5 mm
    Baseline characteristics
    age 63.5 y 
    history of MI (%) 22% 
    LAD (%) 42% 
    lesion length inclusion criteria
    Lesion diameter inclusion criteria 2.5-3.5 mm 
    Female (%) 32% 

    Method and design

    Randomized effectives 773 / 775 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration mean 36 mo
    Number of centre 80
    Geographic area US
    Hypothesis Non inferiority
    Primary endpoint target vessel failure (death,MI, TVR)


    Results

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

    MACE

    84 / 734
         101 / 733
         0,83 [0,63;1,09]

    All cause death

    29 / 734
         32 / 733
         0,91 [0,55;1,48]

    cardiac death

    12 / 734
         17 / 733
         0,70 [0,34;1,47]

    MI (fatal and non fatal)

    16 / 734
         36 / 733
         0,44 [0,25;0,79]

    target-vessel revascularization

    73 / 734
         80 / 733
         0,91 [0,67;1,23]

    target lesion revascularisation

    48 / 734
         44 / 733
         1,09 [0,73;1,62]

    4y stent thrombosis (ARC)

    8 / 734
         12 / 733
         0,67 [0,27;1,62]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    MACE 84 / 734 (11,4%) 101 / 733 (13,8%) 0,83 [0,63;1,09] at 3 years
    All cause death 29 / 734 (4,0%) 32 / 733 (4,4%) 0,91 [0,55;1,48] at 3 years
    cardiac death 12 / 734 (1,6%) 17 / 733 (2,3%) 0,70 [0,34;1,47] at 3 years
    MI (fatal and non fatal) 16 / 734 (2,2%) 36 / 733 (4,9%) 0,44 [0,25;0,79] at 3 years
    target-vessel revascularization 73 / 734 (9,9%) 80 / 733 (10,9%) 0,91 [0,67;1,23] at 3 years
    target lesion revascularisation 48 / 734 (6,5%) 44 / 733 (6,0%) 1,09 [0,73;1,62] at 3 years
    4y stent thrombosis (ARC) 8 / 734 (1,1%) 12 / 733 (1,6%) 0,67 [0,27;1,62] definite/probable at 3 years
    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.
    MACE 11,44% 13,78% -23,3‰
    All cause death 3,95% 4,37% -4,1‰
    cardiac death 1,63% 2,32% -6,8‰
    MI (fatal and non fatal) 2,18% 4,91% -27,3‰
    target-vessel revascularization 9,95% 10,91% -9,7‰
    target lesion revascularisation 6,54% 6,00% 5,4‰
    4y stent thrombosis (ARC) 1,09% 1,64% -5,5‰

    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 # NCT00217269
    Study web site link ,

    unpublished (or not yet fully published) trial

    • Leon MB. Endeavor Clinical Program Overview,. FDA Advisory Panel, October 10th, 2007
      Pubmed | Hubmed | Fulltext
    • Waseda K, Miyazawa A, Ako J, Hasegawa T, Tsujino I, Sakurai R, Yock PG, Honda Y, Kandzari DE, Leon MB, Fitzgerald PJ. Intravascular ultrasound results from the ENDEAVOR IV trial: randomized comparison between zotarolimus- and paclitaxel-eluting stents in patients with coronary artery disease.. JACC Cardiovasc Interv 2009 Aug;2:779-84
      Pubmed | Hubmed | Fulltext
    • Leon MB, Kandzari DE, Eisenstein EL, Anstrom KJ, Mauri L, Cutlip DE, Nikolsky E, O'Shaughnessy C, Overlie PA, Kirtane AJ, McLaurin BT, Solomon SL, Douglas JS Jr, Popma JJ. Late Safety, Efficacy, and Cost-Effectiveness of a Zotarolimus-Eluting Stent Compared With a Paclitaxel-Eluting Stent in Patients With De Novo Coronary Lesions 2-Year Follow-Up From the ENDEAVOR IV Trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).. JACC Cardiovasc Interv 2009 Dec;2:1208-18 - 10.1016/j.jcin.2009.10.008
      Pubmed | Hubmed | Fulltext
    • Leon MB, Nikolsky E, Cutlip DE, Mauri L, Liberman H, Wilson H, Patterson J, Moses J, Kandzari DE. Improved late clinical safety with zotarolimus-eluting stents compared with paclitaxel-eluting stents in patients with de novo coronary lesions: 3-year follow-up from the ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial.. JACC Cardiovasc Interv 2010;3:1043-50 - 10.1016/j.jcin.2010.07.008
      Pubmed | Hubmed | Fulltext

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