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Related trials

BASKET-PROVE (SES), 2010 - sirolimus eluting stent vs bare-metal stent

SORT-OUT-3, 2010 - zotarolimus eluting stent vs sirolimus eluting stent

RESOLUTE All comers, 2010 - zotarolimus eluting stent vs everolimus eluting stent

SPIRIT IV, 2010 - everolimus eluting stent vs paclitaxel eluting stent

BASKET-PROVE (EES), 2010 - everolimus eluting stent vs bare-metal stent

GISSOC II, 2010 - sirolimus eluting stent vs bare-metal stent

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

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

ZEST (vs SES), 2009 - zotarolimus eluting stent vs sirolimus eluting stent

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

COMPARE, 2009 - everolimus eluting stent vs paclitaxel eluting stent

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

SYNTAX, 2009 - paclitaxel eluting stent vs CABG

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

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

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

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

PASEO, 2009 - drug-eluting stents vs bare-metal stent

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

Thiele, 2009 - sirolimus ES vs MIDCAB

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 SES), 2009 - dual sirolimus, probucol eluting stent vs sirolimus eluting stent

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

Costar II, 2008 - CoStar stent vs paclitaxel 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 everolimus eluting stent
    		•  

    COMPARE study, 2009

    [NCT01016041] download pdf: everolimus eluting stent | myocardial revascularization for stable angina

    Treatments

    Studied treatment polymer based, everolimus-eluting stent (Xience V)
    Control treatment polymer-based, paclitaxel-eluting stent (Taxus Liberte)
    Treatments description
    multivessel treatment 26.5% 

    Patients

    Patients unselected patients
    Inclusion criteria patients aged 18�85 years; referred for elective or emergent percutaneous coronary intervention; no limitations about the number of lesions or vessels, location of lesions, or their length; life expectancy >5 years
    Exclusion criteria no dual antiplatelet therapy for 1 year; cardiogenic shock; planned major surgery within 1 month
    Baseline characteristics
    age 63.2 y 
    history of MI (%) 16.5% 
    diabetes (%) 18% 
    Smoker (%) 31% 
    unstable angina (%) 23% 
    LAD (%) 38.5% 
    RCA (%) 33% 
    LCx (%) 24.5% 
    lesion length (mm) 16.4 mm 
    reference-vessel diameter 2.55 mm 
    Female (%) 30% 
    lesions in a bypass graft 2% 
    left main coronary artery disease 2% 
    totally occluded lesions 3.5% 
    bifurcated lesions 17.5% 
    ostial lesion 19% 
    STEMI 25% 
    Stable angina 38% 
    No of lesions per patients 1.46  

    Method and design

    Randomized effectives 897 / 903 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 1 y (2y)
    Number of centre single centre
    Geographic area the Netherlands
    Primary endpoint death, MI,TVR


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    All-cause mortality 18 / 897 (2,0%) 15 / 903 (1,7%) 1,21 [0,61;2,38]
    Cardiac death 11 / 897 (1,2%) 10 / 903 (1,1%) 1,11 [0,47;2,59]
    Myocardial infarction 25 / 897 (2,8%) 48 / 903 (5,3%) 0,52 [0,33;0,84]
    Q wave MI 3 / 897 (0,3%) 11 / 903 (1,2%) 0,27 [0,08;0,98]
    Non-Q wave MI 22 / 897 (2,5%) 39 / 903 (4,3%) 0,57 [0,34;0,95]
    All-cause mortality or myocardial infarction 42 / 897 (4,7%) 62 / 903 (6,9%) 0,68 [0,47;1,00]
    Cardiac death or myocardial infarction 35 / 897 (3,9%) 57 / 903 (6,3%) 0,62 [0,41;0,93]
    Target vessel revascularisation (clinically justified) 19 / 897 (2,1%) 51 / 903 (5,6%) 0,38 [0,22;0,63]
    Percutaneous TVR(clinically justified) 13 / 897 (1,4%) 38 / 903 (4,2%) 0,34 [0,18;0,64]
    Surgical TVR(clinically justified) 6 / 897 (0,7%) 13 / 903 (1,4%) 0,46 [0,18;1,22]
    Target vessel revascularisation (any) 21 / 897 (2,3%) 54 / 903 (6,0%) 0,39 [0,24;0,64]
    Percutaneous TVR (any) 15 / 897 (1,7%) 41 / 903 (4,5%) 0,37 [0,21;0,66]
    Surgical TVR (any) 6 / 897 (0,7%) 13 / 903 (1,4%) 0,46 [0,18;1,22]
    Target lesion revascularisation (clinically justified) 15 / 897 (1,7%) 43 / 903 (4,8%) 0,35 [0,20;0,63]
    Percutaneous TLR(clinically justified) 9 / 897 (1,0%) 31 / 903 (3,4%) 0,29 [0,14;0,61]
    Surgical TLR(clinically justified) 6 / 897 (0,7%) 12 / 903 (1,3%) 0,50 [0,19;1,34]
    Target lesion revascularisation (any) 18 / 897 (2,0%) 48 / 903 (5,3%) 0,38 [0,22;0,64]
    Percutaneous TLR (any) 12 / 897 (1,3%) 36 / 903 (4,0%) 0,34 [0,18;0,64]
    Surgical TLR (any) 6 / 897 (0,7%) 12 / 903 (1,3%) 0,50 [0,19;1,34]
    death, MI, TVR 56 / 897 (6,2%) 82 / 903 (9,1%) 0,69 [0,50;0,95]
    Secondary endpoint 44 / 897 (4,9%) 74 / 903 (8,2%) 0,60 [0,42;0,86]
    Stent thrombosis (definite and probable) 6 / 897 (0,7%) 23 / 903 (2,5%) 0,26 [0,11;0,64]
    Late stent thrombosis (30 days to 1 year after procedure) 4 / 897 (0,4%) 8 / 903 (0,9%) 0,50 [0,15;1,67]
    Definite stent thrombosis 4 / 897 (0,4%) 18 / 903 (2,0%) 0,22 [0,08;0,66]

    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]

    MACE

    35 / 897
         57 / 903
         0,62 [0,41;0,93]

    All cause death

    18 / 897
         15 / 903
         classic 1,21 [0,61;2,38]

    cardiac death

    11 / 897
         10 / 903
         classic 1,11 [0,47;2,59]

    MI (fatal and non fatal)

    25 / 897
         48 / 903
         0,52 [0,33;0,84]

    target-vessel revascularization

    19 / 897
         51 / 903
         0,38 [0,22;0,63]

    target lesion revascularisation

    15 / 897
         43 / 903
         0,35 [0,20;0,63]

    Acute stent thrombosis (<=24h)

    1 / 897
         1 / 903
         classic 1,01 [0,06;16,07]

    sub acute stent thrombosis (1-30 days)

    1 / 897
         14 / 903
         0,07 [0,01;0,55]

    4y stent thrombosis (ARC)

    4 / 897
         18 / 903
         0,22 [0,08;0,66]

    Stent thrombosis (any, end of follow up)

    6 / 897
         23 / 903
         0,26 [0,11;0,64]

    2 yr MACE

    81 / 897
         124 / 903
         0,66 [0,50;0,86]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    MACE 35 / 897 (3,9%) 57 / 903 (6,3%) 0,62 [0,41;0,93] Cardiac death or myocardial infarction
    All cause death 18 / 897 (2,0%) 15 / 903 (1,7%) 1,21 [0,61;2,38] All-cause mortality
    cardiac death 11 / 897 (1,2%) 10 / 903 (1,1%) 1,11 [0,47;2,59] Cardiac death
    MI (fatal and non fatal) 25 / 897 (2,8%) 48 / 903 (5,3%) 0,52 [0,33;0,84] Myocardial infarction
    target-vessel revascularization 19 / 897 (2,1%) 51 / 903 (5,6%) 0,38 [0,22;0,63] Target vessel revascularisation (clinically justified)
    target lesion revascularisation 15 / 897 (1,7%) 43 / 903 (4,8%) 0,35 [0,20;0,63] Target lesion revascularisation (clinically justified)
    Acute stent thrombosis (<=24h) 1 / 897 (0,1%) 1 / 903 (0,1%) 1,01 [0,06;16,07] Acute stent thrombosis (on date of procedure)
    sub acute stent thrombosis (1-30 days) 1 / 897 (0,1%) 14 / 903 (1,6%) 0,07 [0,01;0,55] Subacute stent thrombosis (1�30 days after procedure)
    4y stent thrombosis (ARC) 4 / 897 (0,4%) 18 / 903 (2,0%) 0,22 [0,08;0,66] Definite stent thrombosis
    Stent thrombosis (any, end of follow up) 6 / 897 (0,7%) 23 / 903 (2,5%) 0,26 [0,11;0,64] Stent thrombosis (definite and probable) 1y
    2 yr MACE 81 / 897 (9,0%) 124 / 903 (13,7%) 0,66 [0,50;0,86] all death, nonfatal MI, and TVR
    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.
    MACE 3,90% 6,31% -24,1‰
    All cause death 2,01% 1,66% 3,5‰
    cardiac death 1,23% 1,11% 1,2‰
    MI (fatal and non fatal) 2,79% 5,32% -25,3‰
    target-vessel revascularization 2,12% 5,65% -35,3‰
    target lesion revascularisation 1,67% 4,76% -30,9‰
    Acute stent thrombosis (<=24h) 1,11‰ 1,11‰ 0,0‰
    sub acute stent thrombosis (1-30 days) 1,11‰ 1,55% -14,4‰
    4y stent thrombosis (ARC) 4,46‰ 1,99% -15,5‰
    Stent thrombosis (any, end of follow up) 6,69‰ 2,55% -18,8‰
    2 yr MACE 9,03% 13,73% -47,0‰

    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 stable angina for all type of patient



    Reference(s)

    Trials register # NCT01016041
    • Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial.. Lancet 2010 Jan 16;375:201-9 - 10.1016/S0140-6736(09)62127-9
      Pubmed | Hubmed | Fulltext

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