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Related trials

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

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

RESOLUTE, 2010 - zotarolimus eluting stent vs everolimus eluting stent

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

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

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

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

COMPARE, 2009 - everolimus eluting stent vs paclitaxel eluting stent

NORDISTEMI, 2009 - thrombolysis + angioplasty vs immediate thrombolysis

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

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

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

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

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

SYNTAX, 2009 - paclitaxel eluting stent vs CABG

Juwana, 2009 - sirolimus eluting stent vs paclitaxel eluting stent

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

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

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

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

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



See also:

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

    DEBATER (SES vs BMS) study, 2009

    Facebook    pdf : sirolimus eluting stent - Drug eluting stent for coronary artery disease

    Treatments

    Studied treatment sirolimus-eluting stents
    Control treatment bare-metal stents
    Concomittant treatment Aspirin (160 mg), clopidogrel (600 mg), and unfractionated heparin (5000 U bolus)
    Remarks factorial design: sirolimus-eluting stents (SES) vsbare-metal stents (BMS), and abciximab vs no abciximab

    Patients

    Patients patients undergoing PCI for STEMI withon 12 hours
    Exclusion criteria contraindications for abciximab, clopidogrel, or stenting; glycoprotein IIb/IIIa inhibitors within 24h; thrombolytic therapy within 24h
    Baseline characteristics
    age 60y 
    diabetes (%) 10% 
    Female (%) 24% 

    Method and design

    Randomized effectives 424 / 446 (studied vs. control)
    Design Factorial plan
    Follow-up duration 1 y
    Primary endpoint TVF( TV MI, TVR, stent thrombosis, in-stent restenosis)


    Results

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

    angiographic restenosis

    8 / 424
         27 / 446
         0,31 [0,14;0,68]

    2 yr MACE

    55 / 424
         89 / 446
         0,65 [0,48;0,89]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    angiographic restenosis 8 / 424 (1,9%) 27 / 446 (6,1%) 0,31 [0,14;0,68] in stent restenosis at 1y   
    2 yr MACE 55 / 424 (13,0%) 89 / 446 (20,0%) 0,65 [0,48;0,89]    
    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.
    angiographic restenosis 1,89% 6,05% -41,7‰
    2 yr MACE 12,97% 19,96% -69,8‰

    Meta-analysis of all similar trials:

    Drug eluting stent in coronary artery disease for acute myocardial infarction

    Drug eluting stent in coronary artery disease for all type of patients

    PCI in acute myocardial infarction for all type of patients



    Reference(s)

    Trials register # NA

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