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See also:

  • All acute myocardial infarction clinical trials
  • All coronary artery disease clinical trials
  • All clinical trials of revascularization with drug eluting stent
  • All clinical trials of sirolimus ES
    		•  

    MISSION study, 2008

    [ISRCTN62825862]

    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]

    All cause death

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

    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]

    MACE

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

    Stent thrombosis (any, end of follow up)

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

    cardiac death

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

    sub acute stent thrombosis (1-30 days)

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

    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]

    4y stent thrombosis (ARC)

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

    target-vessel revascularization

    8 / 158
         20 / 152
         0,38 [0,17;0,85]     0 2 1.0

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


    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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