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Related trials

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
    		•  

    MISSION study, 2008

    [ISRCTN62825862] Facebook    pdf : sirolimus eluting stent - myocardial revascularization for coronary artery disease

    Treatments

    Studied treatment Cypher
    Control treatment Vision

    Patients

    Patients primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (<9h)
    Inclusion criteria STEMI symptoms <9 h before the procedure ECG demonstrated STEMI (ST-segment elevation >=0.2 mV in >=2 contiguous leads in V1 through V3 or >=0.1 mV in other leads, or presumed new left bundle branch block target lesion length <=24 mm.
    Exclusion criteria age <18 years or >80 years; left main stenosis of >=50%; triple-vessel disease, defined as >=50% stenosis in >=3 major epicardial branches; previous PCI or coronary artery bypass grafting of the infarct-related artery; thrombolytic therapy for the index infarction; target vessel reference diameter <2.25 mm or >3.75 mm; need for mechanical ventilation; contraindication to the use of aspirin, clopidogrel, heparin, or abciximab; known renal failure; a life expectancy <12 months
    Baseline characteristics
    age 59y 
    history of MI (%) 3.86 
    diabetes (%) 9.71 
    Smoker (%) 54.52 
    LAD (%) 54.85 
    RCA (%) 29.37 
    LCx (%) 15.78 
    lesion length (mm) 14.44 
    reference-vessel diameter 2.84 
    lesion length inclusion criteria <=24mm 
    Lesion diameter inclusion criteria 2.25 - 3.75mm 
    Female (%) 22% 
    multi vessels patients 34.17 

    Method and design

    Randomized effectives 158 / 152 (studied vs. control)
    Design Parallel groups
    Blinding single-blind
    Follow-up duration 12 months
    Number of centre single-center
    Geographic area the Netherlands
    Hypothesis Non inferiority
    Primary endpoint in segment Late lumen loss at 9mo


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Death 2 / 158 (1,3%) 4 / 152 (2,6%) 0,48 [0,09;2,59]
    Not calculable (data not available)
    Cardiac 2 / 158 (1,3%) 2 / 152 (1,3%) 0,96 [0,14;6,74]
    Target vessel related 2 / 158 (1,3%) 2 / 152 (1,3%) 0,96 [0,14;6,74]
    Recurrent myocardial infarction 9 / 158 (5,7%) 14 / 152 (9,2%) 0,62 [0,28;1,39]
    Spontaneous 2 / 158 (1,3%) 3 / 152 (2,0%) 0,64 [0,11;3,79]
    Target vessel related 2 / 158 (1,3%) 3 / 152 (2,0%) 0,64 [0,11;3,79]
    Procedure related 7 / 158 (4,4%) 11 / 152 (7,2%) 0,61 [0,24;1,54]
    Target vessel related 2 / 158 (1,3%) 6 / 152 (3,9%) 0,32 [0,07;1,56]
    Revascularization procedure 19 / 158 (12,0%) 35 / 152 (23,0%) 0,52 [0,31;0,87]
    PCI Revascularization procedure 17 / 158 (10,8%) 30 / 152 (19,7%) 0,55 [0,31;0,95]
    CABG Revascularization procedure 2 / 158 (1,3%) 5 / 152 (3,3%) 0,38 [0,08;1,95]
    Target vessel revascularization 8 / 158 (5,1%) 20 / 152 (13,2%) 0,38 [0,17;0,85]
    PCI TVR 6 / 158 (3,8%) 17 / 152 (11,2%) 0,34 [0,14;0,84]
    CABG TVR 2 / 158 (1,3%) 3 / 152 (2,0%) 0,64 [0,11;3,79]
    Target lesion revascularization 5 / 158 (3,2%) 17 / 152 (11,2%) 0,28 [0,11;0,75]
    PCI TLR 3 / 158 (1,9%) 14 / 152 (9,2%) 0,21 [0,06;0,70]
    CABG TLR 2 / 158 (1,3%) 3 / 152 (2,0%) 0,64 [0,11;3,79]
    Clinically driven TLR 4 / 158 (2,5%) 12 / 152 (7,9%) 0,32 [0,11;0,97]
    Any event 22 / 158 (13,9%) 40 / 152 (26,3%) 0,53 [0,33;0,85]
    Target vessel failure 11 / 158 (7,0%) 23 / 152 (15,1%) 0,46 [0,23;0,91]
    Stent thrombosis 2 / 158 (1,3%) 3 / 152 (2,0%) 0,64 [0,11;3,79]
    Not calculable (data not available)
    Subacute (1 day to 30 days) 2 / 158 (1,3%) 2 / 152 (1,3%) 0,96 [0,14;6,74]
    Not calculable (data not available)
    Angiographically documented Stent thrombosis 1 / 158 (0,6%) 1 / 152 (0,7%) 0,96 [0,06;15,24]

    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

    22 / 158
         40 / 152
         0,53 [0,33;0,85]

    All cause death

    2 / 158
         4 / 152
         classic 0,48 [0,09;2,59]

    cardiac death

    2 / 158
         2 / 152
         classic 0,96 [0,14;6,74]

    MI (fatal and non fatal)

    9 / 158
         14 / 152
         0,62 [0,28;1,39]

    CABG

    2 / 158
         5 / 152
         0,38 [0,08;1,95]

    target-vessel revascularization

    8 / 158
         20 / 152
         0,38 [0,17;0,85]

    target lesion revascularisation

    4 / 158
         12 / 152
         0,32 [0,11;0,97]

    angiographic restenosis

    3 / 158
         28 / 152
         0,10 [0,03;0,33]

    sub acute stent thrombosis (1-30 days)

    2 / 158
         2 / 152
         classic 0,96 [0,14;6,74]

    4y stent thrombosis (ARC)

    1 / 158
         1 / 152
         classic 0,96 [0,06;15,24]

    Stent thrombosis (any, end of follow up)

    2 / 158
         3 / 152
         classic 0,64 [0,11;3,79]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    MACE 22 / 158 (13,9%) 40 / 152 (26,3%) 0,53 [0,33;0,85] Any event   
    All cause death 2 / 158 (1,3%) 4 / 152 (2,6%) 0,48 [0,09;2,59] Death   
    cardiac death 2 / 158 (1,3%) 2 / 152 (1,3%) 0,96 [0,14;6,74] Cardiac   
    MI (fatal and non fatal) 9 / 158 (5,7%) 14 / 152 (9,2%) 0,62 [0,28;1,39] Recurrent myocardial infarction   
    CABG 2 / 158 (1,3%) 5 / 152 (3,3%) 0,38 [0,08;1,95] CABG Revascularization procedure   
    target-vessel revascularization 8 / 158 (5,1%) 20 / 152 (13,2%) 0,38 [0,17;0,85] Target vessel revascularization   
    target lesion revascularisation 4 / 158 (2,5%) 12 / 152 (7,9%) 0,32 [0,11;0,97] Clinically driven TLR   
    angiographic restenosis 3 / 158 (1,9%) 28 / 152 (18,4%) 0,10 [0,03;0,33] in stent   
    sub acute stent thrombosis (1-30 days) 2 / 158 (1,3%) 2 / 152 (1,3%) 0,96 [0,14;6,74] Subacute (1 day to 30 days)  0 
    4y stent thrombosis (ARC) 1 / 158 (0,6%) 1 / 152 (0,7%) 0,96 [0,06;15,24] Angiographically documented Stent thrombosis   
    Stent thrombosis (any, end of follow up) 2 / 158 (1,3%) 3 / 152 (2,0%) 0,64 [0,11;3,79] Stent thrombosis   
    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 13,92% 26,32% -123,9‰
    All cause death 1,27% 2,63% -13,7‰
    cardiac death 1,27% 1,32% -0,5‰
    MI (fatal and non fatal) 5,70% 9,21% -35,1‰
    CABG 1,27% 3,29% -20,2‰
    target-vessel revascularization 5,06% 13,16% -80,9‰
    target lesion revascularisation 2,53% 7,89% -53,6‰
    angiographic restenosis 1,90% 18,42% -165,2‰
    sub acute stent thrombosis (1-30 days) 1,27% 1,32% -0,5‰
    4y stent thrombosis (ARC) 6,33‰ 6,58‰ -0,2‰
    Stent thrombosis (any, end of follow up) 1,27% 1,97% -7,1‰

    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 # ISRCTN62825862
    • van der Hoeven BL, Liem S, Jukema JW, et al.. Prospectiverandomised trial to evaluate the effi cacy and safety of drug-elutingstents versus barem-metal stents for the treatment of acutemyocardial infarction (the MISSION! intervention study). AnnualScientifi c Meeting of the American Heart Association. Chicago, IL,USA; Nov 1215, 2006.
      Pubmed | Hubmed | Fulltext
    • van der Hoeven BL, Liem SS, Jukema JW, Suraphakdee N, Putter H, Dijkstra J, Atsma DE, Bootsma M, Zeppenfeld K, Oemrawsingh PV, van der Wall EE, Schalij MJ. Sirolimus-eluting stents versus bare-metal stents in patients with ST-segment elevation myocardial infarction: 9-month angiographic and intravascular ultrasound results and 12-month clinical outcome results from the MISSION! Intervention Study.. J Am Coll Cardiol 2008 Feb 12;51:618-26
      Pubmed | Hubmed | Fulltext

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