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Related trials

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

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

ISAR-DESIRE-2, 2010 - sirolimus eluting stent vs paclitaxel eluting stent

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

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

RESOLUTE, 2010 - zotarolimus eluting stent vs everolimus eluting stent

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

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

SYNTAX, 2009 - paclitaxel eluting stent vs CABG

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

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

NORDISTEMI, 2009 - thrombolysis + angioplasty vs immediate thrombolysis

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

Juwana, 2009 - sirolimus eluting stent vs paclitaxel eluting stent

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

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

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

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

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

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

COMPARE, 2009 - everolimus eluting stent vs paclitaxel eluting 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



See also:

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

    PROSIT study, 2006

    Facebook    pdf : sirolimus eluting stent - myocardial revascularization for coronary artery disease

    Treatments

    Studied treatment SES Cordis
    Control treatment PES Boston Scientific

    Patients

    Patients AMI or persistent ischaemia 12-24h
    Baseline characteristics
    age 61 
    diabetes (%) 26% 
    Lesion diameter inclusion criteria NA 
    Female (%) 26% 

    Method and design

    Randomized effectives 154 / 154 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 1 year
    Number of centre 3
    Geographic area Korea
    Hypothesis Superiority
    Primary endpoint Late lumen loss


    Results

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

    MACE

    9 / 154
         18 / 154
         0,50 [0,23;1,08]

    All cause death

    10 / 154
         12 / 151
         0,82 [0,36;1,83]

    cardiac death

    4 / 154
         7 / 151
         0,56 [0,17;1,87]

    MI (fatal and non fatal)

    3 / 154
         3 / 151
         classic 0,98 [0,20;4,78]

    target lesion revascularisation

    7 / 154
         11 / 151
         0,62 [0,25;1,57]

    Acute stent thrombosis (<=24h)

    0 / 154
         1 / 154
         classic 0,20 [0,00;14,57]

    sub acute stent thrombosis (1-30 days)

    0 / 154
         1 / 154
         classic 0,20 [0,00;14,57]

    late stent thrombosis (31days - 1year)

    0 / 154
         0 / 154
         classic 1,00 [0,00;254,48]

    4y stent thrombosis (ARC)

    2 / 154
         2 / 151
         classic 0,98 [0,14;6,87]

    Stent thrombosis (any, end of follow up)

    0 / 154
         2 / 154
         classic 0,11 [0,00;6,88]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    MACE 9 / 154 (5,8%) 18 / 154 (11,7%) 0,50 [0,23;1,08]    
    All cause death 10 / 154 (6,5%) 12 / 151 (7,9%) 0,82 [0,36;1,83]    
    cardiac death 4 / 154 (2,6%) 7 / 151 (4,6%) 0,56 [0,17;1,87]    
    MI (fatal and non fatal) 3 / 154 (1,9%) 3 / 151 (2,0%) 0,98 [0,20;4,78]    
    target lesion revascularisation 7 / 154 (4,5%) 11 / 151 (7,3%) 0,62 [0,25;1,57]    
    Acute stent thrombosis (<=24h) 0 / 154 (0,3%) 1 / 154 (0,6%) 0,50 [0,02;14,80]   0 
    sub acute stent thrombosis (1-30 days) 0 / 154 (0,3%) 1 / 154 (0,6%) 0,50 [0,02;14,80]   0 
    late stent thrombosis (31days - 1year) 0 / 154 (0,3%) 0 / 154 (0,3%) 1,00 [0,02;50,08]    
    4y stent thrombosis (ARC) 2 / 154 (1,3%) 2 / 151 (1,3%) 0,98 [0,14;6,87]    
    Stent thrombosis (any, end of follow up) 0 / 154 (0,3%) 2 / 154 (1,3%) 0,25 [0,01;5,50]    
    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 5,84% 11,69% -58,4‰
    All cause death 6,49% 7,95% -14,5‰
    cardiac death 2,60% 4,64% -20,4‰
    MI (fatal and non fatal) 1,95% 1,99% -0,4‰
    target lesion revascularisation 4,55% 7,28% -27,4‰
    4y stent thrombosis (ARC) 1,30% 1,32% -0,3‰

    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 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 # NA
    • Lee JH, Kim HS, Lee SW, et al.. Prospective randomized trial of asirolimus eluting versus a paclitaxel eluting stent for the treatmentof acute ST-elevation myocardial infarction. Annual Scientifi cMeeting of the American College of Cardiology; Atlanta, GA, USA;March 1114, 2006.
      Pubmed | Hubmed | Fulltext
    • Kornowski R. Drug-eluting stents in ST elevation myocardial infarction: In light of the PROSIT trial.. Catheter Cardiovasc Interv 2008 Jul 1;72:33-5
      Pubmed | Hubmed | Fulltext
    • Lee JH, Kim HS, Lee SW, Park JH, Choi SW, Jeong JO, Cho Y, Lee N, Rhee KS, Ko JK, Seong IW. Prospective randomized comparison of sirolimus- versus paclitaxel-eluting stents for the treatment of acute ST-elevation myocardial infarction: pROSIT trial.. Catheter Cardiovasc Interv 2008 Jul 1;72:25-32
      Pubmed | Hubmed | Fulltext

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