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

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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
    		•  

    SESAMI study, 2007

    [NCT00288210] Facebook    pdf : sirolimus eluting stent - myocardial revascularization for coronary artery disease

    Treatments

    Studied treatment Cypher
    Control treatment BX stent, Cordis

    Patients

    Patients AMI
    Inclusion criteria >18 years of age, had symptoms of acute MI for >=30 min but <=12 h, and had >=1 mm ST-segment elevation in at least 2 contiguous leads or left bundle-branch blocks; infarct-related vessel had to be a native coronary artery with a visually estimated reference diameter >2.5 and <=4.0 mm
    Exclusion criteria cardiogenic shock; history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction; noncardiac illness associated with a life expectancy of <1 year; left main coronary artery or graft disease; participation in another study; or inability to give informed consent owing to prolonged cardiopulmonary resuscitation
    Baseline characteristics
    age 62 
    history of MI (%) 9.05 
    diabetes (%) 21% 
    Smoker (%) 54.25 
    unstable angina (%) 0% 
    LAD (%) 49.65 
    RCA (%) 37.55 
    LCx (%) 12.8 
    lesion length inclusion criteria no retsriction 
    Lesion diameter inclusion criteria 2.5 - 4.0 mm 
    Female (%) 20% 
    STEMI 100% 
    Stable angina 0% 
    single vessel patients 58.1 

    Method and design

    Randomized effectives 160 / 160 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 months
    Number of centre 1
    Geographic area Italy
    Hypothesis Superiority
    Primary endpoint Binary restenosis at 1y


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Death at hospital 1 / 154 (0,6%) 4 / 153 (2,6%) 0,25 [0,03;2,20]
    Reinfarction at hospital 2 / 154 (1,3%) 2 / 153 (1,3%) 0,99 [0,14;6,96]
    Target vessel revascularization at hospital 1 / 154 (0,6%) 1 / 153 (0,7%) 0,99 [0,06;15,74]
    Death at 1y 3 / 154 (1,9%) 7 / 153 (4,6%) 0,43 [0,11;1,62]
    Reinfarction at 1y 3 / 154 (1,9%) 3 / 153 (2,0%) 0,99 [0,20;4,85]
    Not calculable (data not available)
    Definite Stent thrombosis at 1y 2 / 154 (1,3%) 1 / 153 (0,7%) 1,99 [0,18;21,69]
    Probable/possible Stent thrombosis at 1y 5 / 154 (3,2%) 6 / 153 (3,9%) 0,83 [0,26;2,66]
    Target lesion revascularization at 1y 7 / 154 (4,5%) 18 / 153 (11,8%) 0,39 [0,17;0,90]
    Target vessel revascularization at 1y 8 / 154 (5,2%) 22 / 153 (14,4%) 0,36 [0,17;0,79]
    Major adverse coronary events at 1y 11 / 154 (7,1%) 27 / 153 (17,6%) 0,40 [0,21;0,79]
    Target vessel failure at 1y 13 / 154 (8,4%) 29 / 153 (19,0%) 0,45 [0,24;0,82]

    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

    11 / 154
         27 / 153
         0,40 [0,21;0,79]

    All cause death

    3 / 154
         7 / 153
         0,43 [0,11;1,62]

    MI (fatal and non fatal)

    3 / 154
         3 / 153
         classic 0,99 [0,20;4,85]

    target-vessel revascularization

    8 / 154
         22 / 153
         0,36 [0,17;0,79]

    target lesion revascularisation

    7 / 154
         18 / 153
         0,39 [0,17;0,90]

    angiographic restenosis

    8 / 86
         17 / 80
         0,44 [0,20;0,96]

    4y stent thrombosis (ARC)

    2 / 154
         1 / 153
         classic 1,99 [0,18;21,69]

    Stent thrombosis (any, end of follow up)

    2 / 154
         1 / 153
         classic 1,99 [0,18;21,69]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    MACE 11 / 154 (7,1%) 27 / 153 (17,6%) 0,40 [0,21;0,79] Major adverse coronary events at 1y   
    All cause death 3 / 154 (1,9%) 7 / 153 (4,6%) 0,43 [0,11;1,62] Death at 1y   
    MI (fatal and non fatal) 3 / 154 (1,9%) 3 / 153 (2,0%) 0,99 [0,20;4,85] Reinfarction at 1y   
    target-vessel revascularization 8 / 154 (5,2%) 22 / 153 (14,4%) 0,36 [0,17;0,79] Target vessel revascularization at 1y   
    target lesion revascularisation 7 / 154 (4,5%) 18 / 153 (11,8%) 0,39 [0,17;0,90] Target lesion revascularization at 1y   
    angiographic restenosis 8 / 86 (9,3%) 17 / 80 (21,3%) 0,44 [0,20;0,96]    
    4y stent thrombosis (ARC) 2 / 154 (1,3%) 1 / 153 (0,7%) 1,99 [0,18;21,69] Definite Stent thrombosis at 1y   
    Stent thrombosis (any, end of follow up) 2 / 154 (1,3%) 1 / 153 (0,7%) 1,99 [0,18;21,69] Definite Stent thrombosis at 1y   
    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 7,14% 17,65% -105,0‰
    All cause death 1,95% 4,58% -26,3‰
    MI (fatal and non fatal) 1,95% 1,96% -0,1‰
    target-vessel revascularization 5,19% 14,38% -91,8‰
    target lesion revascularisation 4,55% 11,76% -72,2‰
    angiographic restenosis 9,30% 21,25% -119,5‰
    4y stent thrombosis (ARC) 1,30% 6,54‰ 6,5‰
    Stent thrombosis (any, end of follow up) 1,30% 6,54‰ 6,5‰

    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 # NCT00288210
    • Menichelli M, Parma A, Pucci E, Fiorilli R, De Felice F, Nazzaro M, Giulivi A, Alborino D, Azzellino A, Violini R. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI).. J Am Coll Cardiol 2007;49:1924-30
      Pubmed | Hubmed | Fulltext
    • Violini R, Musto C, De Felice F, Nazzaro MS, Cifarelli A, Petitti T, Fiorilli R. Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Stents in Patients With ST-Segment Elevation Myocardial Infarction 3-Year Results of the SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent In Acute Myocardial Infarction) Trial.. J Am Coll Cardiol 2010 Feb 23;55:810-814 - 10.1016/j.jacc.2009.09.046
      Pubmed | Hubmed | Fulltext

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