Trial-Results center  
Clinical trial results database in cardiology Feedback    Home


Related trials

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

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

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

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

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

NORDISTEMI, 2009 - thrombolysis + angioplasty vs immediate thrombolysis

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

Juwana, 2009 - sirolimus eluting stent vs paclitaxel eluting stent

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

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

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

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

SYNTAX, 2009 - paclitaxel eluting stent vs CABG

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

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

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

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

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

Thiele, 2009 - sirolimus ES vs MIDCAB

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

TRIANA, 2009 - primary ballon angioplasty vs tenecteplase

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

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

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

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



See also:

  • All acute myocardial infarction clinical trials
  • All coronary artery disease clinical trials
  • All clinical trials of PCI
  • All clinical trials of zotarolimus eluting stent
    		•  

    ZEST AMI (vs SES) study, 2009

    [NCT00422565] download pdf: zotarolimus eluting stent | myocardial revascularization for coronary artery disease

    Treatments

    Studied treatment zotarolimus-eluting stent (Endeavor)
    Endeavor (ABT 578-eluting balloon expandable stent, Medtronic)
    Control treatment sirolimus-eluting stents (Cypher)
    Concomittant treatment Pretreatement with aspirin 300mg and clopidogrel 600 mg. During the procedure: bolus of heparin 100 U/kg, with a repeat bolus of 2,000 U to maintain an activated clotting time 300 seconds. Aspirin 100 to 200 mg daily given indefinitely and clopidogrel 75mg daily for 12 months

    Patients

    Patients Acute Myocardial Infarction Patients (STEMI)requiring primary angioplasty with symptom onset <= 12 hours
    Inclusion criteria chest pain 30 minutes, presentation within 12 hours after onset of symptoms, and ST-segment elevation (1mm in 2 standard leads or 2mm in 2 contiguous precordial leads)
    Exclusion criteria Previous administration of fibrinolytic agents; Previously documented left ventricular ejection fraction <30%; Previous MI Concomitant left main disease; cardiogenic shock Estimated life expectancy of <12 months
    Baseline characteristics
    age 60 y 
    diabetes (%) 26% 
    unstable angina (%) 0% 
    LAD (%) 46.8% 
    RCA (%) 44.5% 
    LCx (%) 8.7% 
    lesion length (mm) 27.15 mm 
    reference-vessel diameter 2.99 mm 
    Female (%) 18% 
    bifurcated lesions 10.3% 
    ostial lesion 8.71% 
    STEMI 100% 
    Stable angina 0% 
    multi vessels patients 45% 

    Method and design

    Randomized effectives 108 / 110 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 1 year (mean)
    Number of centre 12
    Geographic area Korea
    Hypothesis Superiority
    Primary endpoint death, MI, or ischemia-driven TVR
    Remarks

    Remarks / Comments



    Results

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

    MACE

    12 / 108
         10 / 110
         classic 1,22 [0,55;2,71]

    All cause death

    3 / 108
         4 / 110
         classic 0,76 [0,18;3,33]

    MI (fatal and non fatal)

    0 / 108
         2 / 110
         classic 0,11 [0,00;6,99]

    target-vessel revascularization

    9 / 108
         6 / 110
         classic 1,53 [0,56;4,15]

    Stent thrombosis (any, end of follow up)

    0 / 108
         4 / 110
         classic 0,06 [0,00;3,35]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    MACE 12 / 108 (11,1%) 10 / 110 (9,1%) 1,22 [0,55;2,71] 0
    All cause death 3 / 108 (2,8%) 4 / 110 (3,6%) 0,76 [0,18;3,33] 0
    MI (fatal and non fatal) 0 / 108 (0,5%) 2 / 110 (1,8%) 0,25 [0,01;5,58] 0
    target-vessel revascularization 9 / 108 (8,3%) 6 / 110 (5,5%) 1,53 [0,56;4,15] 0
    Stent thrombosis (any, end of follow up) 0 / 108 (0,5%) 4 / 110 (3,6%) 0,13 [0,01;2,38] 0
    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 11,11% 9,09% 2,0%
    All cause death 2,78% 3,64% -8,6‰
    target-vessel revascularization 8,33% 5,45% 2,9%

    Meta-analysis of all similar trials:

    Drug eluting stent in coronary artery disease for acute myocardial infarction

    myocardial revascularization in acute myocardial infarction for all type of patients

    myocardial revascularization in coronary artery disease for all type of patient

    PCI in acute myocardial infarction for all type of patients



    Reference(s)

    Trials register # NCT00422565
    • Lee CW, Park DW, Lee SH, Kim YH, Hong MK, Kim JJ, Park SW, Yun SC, Seong IW, Lee JH, Lee NH, Cho YH, Cheong SS, Lim DS, Yang JY, Lee SG, Kim KS, Yoon J, Jeong MH, Seung KB, Hong TJ, Park SJ. Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with ST-elevation myocardial infarction.. Am J Cardiol 2009;104:1370-6
      Pubmed | Hubmed | Fulltext

    (c) 2004-2011 TrialResults-center - All Rights Reserved

    Tweet this  |  Facebook  |  notify a friend