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ISAR-TEST-4 (biodegradable polymer), 2009 - sirolimus biodegradable polymer vs sirolimus eluting stent

ISAR-LEFT-MAIN, 2009 - sirolimus eluting stent vs paclitaxel eluting stent

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

ENDEAVOR IV, 2009 - zotarolimus eluting stent vs paclitaxel eluting stent

ZEST AMI (vs PES), 2009 - zotarolimus eluting stent vs paclitaxel eluting stent

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



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
    		•  

    RESOLUTE All comers study, 2010

    [NCT00617084.)] download pdf: zotarolimus eluting stent | myocardial revascularization for stable angina

    Treatments

    Studied treatment zotarolimus-eluting stent
    Control treatment everolimus-eluting stent (Xience)

    Patients

    Patients adult patients with chronic, stable coronary artery disease or acute coronary syndromes, including myocardial infarction with or without ST-segment elevation
    Inclusion criteria at least one coronary lesion with stenosis of more than 50% in a vessel with a reference diameter of 2.25 to 4.0 mm
    Exclusion criteria known intolerance to a study drug, metal alloys, or contrast media; planned surgery within 6 months after the index procedure; childbearing potential;
    Baseline characteristics
    age 64.3y 
    history of MI (%) 30% 
    diabetes (%) 23.4% 
    Smoker (%) 26.5% 
    unstable angina (%) 19.2% 
    LAD (%) 50.6% 
    RCA (%) 39.3% 
    LCx (%) 33% 
    male (%) 77% 
    lesion length inclusion criteria no restriction 
    Lesion diameter inclusion criteria 2.25 to 4.0 mm 
    STEMI 34% 
    Stable angina 33.9% 

    Method and design

    Randomized effectives 1140 / 1152 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 months (5y)
    Hypothesis Non inferiority
    Primary endpoint target-lesion failure


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Target-lesion failure 92 / 1140 (8,1%) 94 / 1152 (8,2%) 0,99 [0,75;1,30]
    Death From any cause 18 / 1140 (1,6%) 31 / 1152 (2,7%) 0,59 [0,33;1,04]
    Death From cardiac cause 15 / 1140 (1,3%) 19 / 1152 (1,6%) 0,80 [0,41;1,56]
    Target-vessel myocardial infarction 47 / 1140 (4,1%) 46 / 1152 (4,0%) 1,03 [0,69;1,54]
    Q-wave Target-vessel myocardial infarction 8 / 1140 (0,7%) 5 / 1152 (0,4%) 1,62 [0,53;4,93]
    Non�CQ-wave Target-vessel myocardial infarction 40 / 1140 (3,5%) 41 / 1152 (3,6%) 0,99 [0,64;1,51]
    Clinically indicated target-lesion revascularization 44 / 1140 (3,9%) 38 / 1152 (3,3%) 1,17 [0,76;1,79]
    Coronary-artery bypass grafting target-lesion 6 / 1140 (0,5%) 8 / 1152 (0,7%) 0,76 [0,26;2,18]
    Percutaneous coronary intervention target-lesion 38 / 1140 (3,3%) 31 / 1152 (2,7%) 1,24 [0,78;1,98]
    Myocardial infarction target-lesion 151 / 1140 (13,2%) 153 / 1152 (13,3%) 1,00 [0,81;1,23]
    Clinically indicated target-vessel revascularization 55 / 1140 (4,8%) 54 / 1152 (4,7%) 1,03 [0,71;1,48]
    Coronary-artery bypass grafting target-vessel 7 / 1140 (0,6%) 9 / 1152 (0,8%) 0,79 [0,29;2,10]
    Percutaneous coronary intervention target-vessel 48 / 1140 (4,2%) 48 / 1152 (4,2%) 1,01 [0,68;1,49]
    Death from cardiac causes or target-vessel myocardial 60 / 1140 (5,3%) 61 / 1152 (5,3%) 0,99 [0,70;1,41]
    Major adverse cardiac event�� 97 / 1140 (8,5%) 109 / 1152 (9,5%) 0,90 [0,69;1,17]
    Target-vessel failure** 101 / 1140 (8,9%) 108 / 1152 (9,4%) 0,95 [0,73;1,22]
    Patient-oriented composite end point†† 163 / 1140 (14,3%) 164 / 1152 (14,2%) 1,00 [0,82;1,23]
    Definite stent thrombosis (0�C360 days) 13 / 1140 (1,1%) 3 / 1152 (0,3%) 4,38 [1,25;15,33]
    Acute Definite stent thrombosis (0�C1 day) 4 / 1140 (0,4%) 1 / 1152 (0,1%) 4,04 [0,45;36,11]
    Subacute Definite stent thrombosis (2�C30 days) 5 / 1140 (0,4%) 0 / 1152 (0,0%) 10,11 [0,55;184,76]
    Late Definite stent thrombosis (31�C360 days) 5 / 1140 (0,4%) 2 / 1152 (0,2%) 2,53 [0,49;13,00]
    Probable stent thrombosis (0�C360 days) 6 / 1140 (0,5%) 5 / 1152 (0,4%) 1,21 [0,37;3,96]
    Acute Probable stent thrombosis (0�C1 day) 1 / 1140 (0,1%) 1 / 1152 (0,1%) 1,01 [0,06;16,14]
    Subacute Probable stent thrombosis (2�C30 days) 3 / 1140 (0,3%) 4 / 1152 (0,3%) 0,76 [0,17;3,38]
    Late Probable stent thrombosis (31�C360 days) 2 / 1140 (0,2%) 0 / 1152 (0,0%) 4,04 [0,18;89,54]
    Possible Stent thrombosis (0�C360 days) 9 / 1140 (0,8%) 9 / 1152 (0,8%) 1,01 [0,40;2,54]
    Definite or probable Stent thrombosis (0�C360 days) 18 / 1140 (1,6%) 8 / 1152 (0,7%) 2,27 [0,99;5,21]
    Definite, probable, or possible Stent thrombosis (0�C360 days) 26 / 1140 (2,3%) 17 / 1152 (1,5%) 1,55 [0,84;2,83]

    Endpoints used by the meta-analysis and data retained for this trial

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

    All cause death

    18 / 1140
         31 / 1152
         0,59 [0,33;1,04]

    cardiac death

    15 / 1140
         19 / 1152
         0,80 [0,41;1,56]

    MI (fatal and non fatal)

    47 / 1140
         46 / 1152
         1,03 [0,69;1,54]

    CABG

    6 / 1140
         8 / 1152
         classic 0,76 [0,26;2,18]

    target-vessel revascularization

    55 / 1140
         54 / 1152
         1,03 [0,71;1,48]

    target lesion revascularisation

    44 / 1140
         38 / 1152
         1,17 [0,76;1,79]

    Acute stent thrombosis (<=24h)

    4 / 1140
         1 / 1152
         classic 4,04 [0,45;36,11]

    sub acute stent thrombosis (1-30 days)

    5 / 1140
         0 / 1152
         classic 21,22 [0,38;1�171,93]

    late stent thrombosis (31days - 1year)

    5 / 1140
         2 / 1152
         classic 2,53 [0,49;13,00]

    4y stent thrombosis (ARC)

    26 / 1140
         17 / 1152
         classic 1,55 [0,84;2,83]

    Stent thrombosis (any, end of follow up)

    26 / 1140
         17 / 1152
         classic 1,55 [0,84;2,83]     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 18 / 1140 (1,6%) 31 / 1152 (2,7%) 0,59 [0,33;1,04] Death From any cause
    cardiac death 15 / 1140 (1,3%) 19 / 1152 (1,6%) 0,80 [0,41;1,56] Death From cardiac cause
    MI (fatal and non fatal) 47 / 1140 (4,1%) 46 / 1152 (4,0%) 1,03 [0,69;1,54] Target-vessel myocardial infarction
    CABG 6 / 1140 (0,5%) 8 / 1152 (0,7%) 0,76 [0,26;2,18] Coronary-artery bypass grafting target-lesion
    target-vessel revascularization 55 / 1140 (4,8%) 54 / 1152 (4,7%) 1,03 [0,71;1,48] Clinically indicated target-vessel revascularization
    target lesion revascularisation 44 / 1140 (3,9%) 38 / 1152 (3,3%) 1,17 [0,76;1,79] Clinically indicated target-lesion revascularization
    Acute stent thrombosis (<=24h) 4 / 1140 (0,4%) 1 / 1152 (0,1%) 4,04 [0,45;36,11] Acute Definite stent thrombosis (0�C1 day)
    sub acute stent thrombosis (1-30 days) 5 / 1140 (0,4%) 0 / 1152 (0,0%) 10,11 [0,55;184,76] Subacute Definite stent thrombosis (2�C30 days)
    late stent thrombosis (31days - 1year) 5 / 1140 (0,4%) 2 / 1152 (0,2%) 2,53 [0,49;13,00] Late Definite stent thrombosis (31�C360 days)
    4y stent thrombosis (ARC) 26 / 1140 (2,3%) 17 / 1152 (1,5%) 1,55 [0,84;2,83] Definite, probable, or possible Stent thrombosis (0�C360 days)
    Stent thrombosis (any, end of follow up) 26 / 1140 (2,3%) 17 / 1152 (1,5%) 1,55 [0,84;2,83] Definite, probable, or possible Stent thrombosis (0�C360 days)
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 1,58% 2,69% -11,1‰
    cardiac death 1,32% 1,65% -3,3‰
    MI (fatal and non fatal) 4,12% 3,99% 1,3‰
    CABG 5,26‰ 6,94‰ -1,7‰
    target-vessel revascularization 4,82% 4,69% 1,4‰
    target lesion revascularisation 3,86% 3,30% 5,6‰
    Acute stent thrombosis (<=24h) 3,51‰ 0,87‰ 2,6‰
    late stent thrombosis (31days - 1year) 4,39‰ 1,74‰ 2,6‰
    4y stent thrombosis (ARC) 2,28% 1,48% 8,1‰
    Stent thrombosis (any, end of follow up) 2,28% 1,48% 8,1‰

    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 # NCT00617084.)
    • Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelb�k H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, Dimario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M. Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents.. N Engl J Med 2010 Jun 16;: - 10.1056/NEJMoa1004130
      Pubmed | Hubmed | Fulltext
    • Silber S, Windecker S, Vranckx P, Serruys PW. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial.. Lancet 2011 Apr 1;: - 10.1016/S0140-6736(11)60395-4
      Pubmed | Hubmed | Fulltext

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