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See also:

  • All coronary artery disease clinical trials
  • All acute myocardial infarction clinical trials
  • All clinical trials of PCI
  • All clinical trials of drug-eluting stents
    		•  

    DEDICATION study, 2008

    [NCT00192868] Facebook    pdf : drug-eluting stents - myocardial revascularization for acute myocardial infarction

    Treatments

    Studied treatment DES currently used with or without distal protection
    47% sirolimus, 40% paclitaxel, 13% zotarolimus
    Control treatment BMS with or without distal protection
    Remarks patients were also randomized to treatment with or without distal protection using a filter wire system (factorial design)

    Patients

    Patients patients referred within 12 hours from symptom onset of an ST-elevation myocardial infarction
    Inclusion criteria chest pain of >30-minute duration; cumulated ST-segment elevation of >4 mm in at least 2 contiguous leads; >18 years of age; high-grade stenosis or occlusion of a coronary artery without excessive tortuosity or calcification prohibiting advancement of a filter wire to the distal vascular bed of the vessel
    Exclusion criteria previous myocardial infarction in the target vessel area, development of cardiogenic shock before enrollment, culprit lesions in an unprotected left main coronary artery, gastrointestinal bleeding within 1 month, pregnancy, known renal failure, life expectancy <1 year
    Baseline characteristics
    age 62.2 
    history of MI (%) 6.55 
    diabetes (%) 10.4 
    Smoker (%) 53.7 
    LAD (%) 41.5 
    RCA (%) 46 
    LCx (%) 12.5 
    male (%) 73.15 
    single vessel patients 62.5 

    Method and design

    Randomized effectives 313 / 313 (studied vs. control)
    Design Factorial plan
    Blinding open
    Follow-up duration 8 mo (15 mo, 3y)
    Number of centre 2
    Geographic area Denmark.
    Hypothesis Superiority
    Primary endpoint loss of the lumen diameter
    Remarks

    Remarks / Comments



    Results

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

    MACE

    28 / 313
         45 / 313
         0,62 [0,40;0,97]

    All cause death

    16 / 313
         8 / 313
         classic 2,00 [0,87;4,61]

    cardiac death

    13 / 313
         5 / 313
         classic 2,60 [0,94;7,21]

    target-vessel revascularization

    16 / 313
         41 / 313
         0,39 [0,22;0,68]

    Stent thrombosis (any, end of follow up)

    7 / 313
         8 / 313
         classic 0,88 [0,32;2,38]

    2 yr Death (all cause)

    33 / 313
         20 / 312
         classic 1,64 [0,97;2,80]

    2 yr MACE

    36 / 313
         57 / 312
         0,63 [0,43;0,93]

    2 yr TLR

    19 / 313
         51 / 312
         0,37 [0,22;0,61]

    4 yr MI

    NA / 313
         NA / 313
         classic 1,49 [0,72;3,09]

    4 yr TLR

    NA / 313
         NA / 313
         0,67 [0,39;1,16]

    4 yr stent thrombosis

    NA / 313
         NA / 313
         classic 1,98 [0,67;5,85]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    MACE 28 / 313 (8,9%) 45 / 313 (14,4%) 0,62 [0,40;0,97]   0 
    All cause death 16 / 313 (5,1%) 8 / 313 (2,6%) 2,00 [0,87;4,61]   0 
    cardiac death 13 / 313 (4,2%) 5 / 313 (1,6%) 2,60 [0,94;7,21]   0 
    target-vessel revascularization 16 / 313 (5,1%) 41 / 313 (13,1%) 0,39 [0,22;0,68]   0 
    Stent thrombosis (any, end of follow up) 7 / 313 (2,2%) 8 / 313 (2,6%) 0,88 [0,32;2,38]   0 
    2 yr Death (all cause) 33 / 313 (10,5%) 20 / 312 (6,4%) 1,64 [0,97;2,80] 3 year   0 
    2 yr MACE 36 / 313 (11,5%) 57 / 312 (18,3%) 0,63 [0,43;0,93] at 3 years  0 
    2 yr TLR 19 / 313 (6,1%) 51 / 312 (16,3%) 0,37 [0,22;0,61] at 3 years  0 
    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 8,95% 14,38% -54,3‰
    All cause death 5,11% 2,56% 2,6%
    cardiac death 4,15% 1,60% 2,6%
    target-vessel revascularization 5,11% 13,10% -79,9‰
    Stent thrombosis (any, end of follow up) 2,24% 2,56% -3,2‰
    2 yr Death (all cause) 10,54% 6,41% 4,1%
    2 yr MACE 11,50% 18,27% -67,7‰
    2 yr TLR 6,07% 16,35% -102,8‰

    Meta-analysis of all similar trials:

    Drug eluting stent in coronary artery disease for acute myocardial infarction

    myocardial revascularization in acute myocardial infarction for all type of patients

    PCI in acute myocardial infarction for all type of patients



    Reference(s)

    Trials register # NCT00192868
    • Kelbaek H, Thuesen L, Helqvist S, Clemmensen P, Klvgaard L, Kaltoft A, Andersen B, Thuesen H, Engstrm T, Btker HE, Saunamki K, Krusell LR, Jrgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kber L, Kofoed KF, Terkelsen CJ, Lassen JF. Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial.. Circulation 2008 Sep 9;118:1155-62
      Pubmed | Hubmed | Fulltext
    • Kaltoft A, Kelb�k H, Thuesen L, Lassen JF, Clemmensen P, Kl�vgaard L, Engstr�m T, B�tker HE, Saunam�ki K, Krusell LR, J�rgensen E, Tilsted HH, Christiansen EH, Ravkilde J, K�ber L, Kofoed KF, Terkelsen CJ, Helqvist S. Long-Term Outcome After Drug-Eluting Versus Bare-Metal Stent Implantation in Patients With ST-Segment Elevation Myocardial Infarction 3-Year Follow-Up of the Randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial.. J Am Coll Cardiol 2010 Jun 14;: - 10.1016/j.jacc.2010.05.009
      Pubmed | Hubmed | Fulltext

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