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See also:

  • All coronary artery disease clinical trials
  • All stable angina clinical trials
  • All clinical trials of myocardial revascularization
  • All clinical trials of paclitaxel eluting stent
  •  

    SYNTAX study, 2009

    [NCT00114972] download pdf: paclitaxel eluting stent | myocardial revascularization for stable angina

    Treatments

    Studied treatment paclitaxel (taxus Express SR)
    Control treatment Coronary Artery Bypass Surgery (on- or off-pump bypass)
    Concomittant treatment aspirin indefinitely. In the PCI arm, thienopyridines were mandatory for 6 months

    Patients

    Patients patients with previously untreated three-vessel or left main coronary artery disease (or both) (complex lesions)
    Exclusion criteria previous PCI or CABG; acute MI with creatine kinase >2 × ULN; >=50% target vessel stenosis with stable/unstable angina or atypical chest pain; concomitant cardiac surgery
    Baseline characteristics
    age 65.5 y 
    male (%) 74% 

    Method and design

    Randomized effectives 903 / 897 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 1 year
    Number of centre 85
    Hypothesis Non inferiority
    Primary endpoint major adverse cardiac or cerebrovascular event

    Remarks / Comments

    doublons aussi dasn la MA stent vs CABG



    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Major adverse cardiac or cerebrovascular event In hospital 39 / 903 (4,3%) 47 / 897 (5,2%) 0,82 [0,54;1,25]
    Major adverse cardiac or cerebrovascular event 30 Days after procedure 54 / 903 (6,0%) 45 / 897 (5,0%) 1,19 [0,81;1,75]
    Major adverse cardiac or cerebrovascular event 6 Mo after randomization 111 / 903 (12,3%) 85 / 897 (9,5%) 1,30 [0,99;1,69]
    Major adverse cardiac or cerebrovascular event 12 Mo after randomization 159 / 903 (17,6%) 105 / 897 (11,7%) 1,50 [1,20;1,89]
    Death, stroke, or MI 68 / 903 (7,5%) 65 / 897 (7,2%) 1,04 [0,75;1,44]
    Death 39 / 903 (4,3%) 30 / 897 (3,3%) 1,29 [0,81;2,06]
    Death From cardiac causes 33 / 903 (3,7%) 18 / 897 (2,0%) 1,82 [1,03;3,21]
    Death From cardiovascular causes 1 / 903 (0,1%) 3 / 897 (0,3%) 0,33 [0,03;3,18]
    Death From noncardiovascular causes 5 / 903 (0,6%) 9 / 897 (1,0%) 0,55 [0,19;1,64]
    Stroke 5 / 903 (0,6%) 19 / 897 (2,1%) 0,26 [0,10;0,70]
    MI 43 / 903 (4,8%) 28 / 897 (3,1%) 1,53 [0,96;2,43]
    Repeat revascularization 120 / 903 (13,3%) 50 / 897 (5,6%) 2,38 [1,74;3,27]
    CABG 25 / 903 (2,8%) 11 / 897 (1,2%) 2,26 [1,12;4,56]
    PCI 102 / 903 (11,3%) 40 / 897 (4,5%) 2,53 [1,78;3,61]
    Graft occlusion or stent thrombosis 28 / 903 (3,1%) 27 / 897 (3,0%) 1,03 [0,61;1,73]
    Graft occlusion or stent thrombosis Acute (at ¡Ü1 day) 2 / 903 (0,2%) 3 / 897 (0,3%) 0,66 [0,11;3,95]
    Graft occlusion or stent thrombosis Early (within 2¨C30 days) 18 / 903 (2,0%) 3 / 897 (0,3%) 5,96 [1,76;20,16]
    Graft occlusion or stent thrombosis Late (within 31¨C365 days) 9 / 903 (1,0%) 21 / 897 (2,3%) 0,43 [0,20;0,92]

    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

    159 / 903
    105 / 897
    1,50 [1,20;1,89]

    All cause death

    39 / 903
    31 / 897
    1,25 [0,79;1,98]

    cardiac death

    33 / 903
    18 / 897
    classic 1,82 [1,03;3,21]

    MI (fatal and non fatal)

    43 / 903
    29 / 897
    classic 1,47 [0,93;2,34]

    CABG

    25 / 903
    11 / 897
    classic 2,26 [1,12;4,56]

    target lesion revascularisation

    124 / 903
    53 / 897
    classic 2,32 [1,71;3,16]

    Acute stent thrombosis (<=24h)

    2 / 903
    3 / 897
    classic 0,66 [0,11;3,95]

    sub acute stent thrombosis (1-30 days)

    18 / 903
    3 / 897
    classic 5,96 [1,76;20,16]

    late stent thrombosis (31days - 1year)

    9 / 903
    21 / 897
    0,43 [0,20;0,92]

    4y stent thrombosis (ARC)

    28 / 903
    27 / 897
    1,03 [0,61;1,73]

    Stent thrombosis (any, end of follow up)

    28 / 903
    27 / 897
    1,03 [0,61;1,73]

    2 yr Death (all cause)

    56 / 903
    44 / 897
    1,26 [0,86;1,86]

    2 yr MACE

    211 / 903
    146 / 897
    1,44 [1,19;1,74]

    2 yr TLR

    157 / 903
    77 / 897
    classic 2,03 [1,57;2,62]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    MACE 159 / 903 (17,6%) 105 / 897 (11,7%) 1,50 [1,20;1,89] Major adverse cardiac or cerebrovascular event 12 Mo after randomization
    All cause death 39 / 903 (4,3%) 31 / 897 (3,5%) 1,25 [0,79;1,98]
    cardiac death 33 / 903 (3,7%) 18 / 897 (2,0%) 1,82 [1,03;3,21] Death From cardiac causes
    MI (fatal and non fatal) 43 / 903 (4,8%) 29 / 897 (3,2%) 1,47 [0,93;2,34]
    CABG 25 / 903 (2,8%) 11 / 897 (1,2%) 2,26 [1,12;4,56] CABG
    target lesion revascularisation 124 / 903 (13,7%) 53 / 897 (5,9%) 2,32 [1,71;3,16] revascularization
    Acute stent thrombosis (<=24h) 2 / 903 (0,2%) 3 / 897 (0,3%) 0,66 [0,11;3,95] Graft occlusion or stent thrombosis Acute (at ¡Ü1 day) 0
    sub acute stent thrombosis (1-30 days) 18 / 903 (2,0%) 3 / 897 (0,3%) 5,96 [1,76;20,16] Graft occlusion or stent thrombosis Early (within 2¨C30 days) 0
    late stent thrombosis (31days - 1year) 9 / 903 (1,0%) 21 / 897 (2,3%) 0,43 [0,20;0,92] Graft occlusion or stent thrombosis Late (within 31¨C365 days)
    4y stent thrombosis (ARC) 28 / 903 (3,1%) 27 / 897 (3,0%) 1,03 [0,61;1,73] Graft occlusion or stent thrombosis
    Stent thrombosis (any, end of follow up) 28 / 903 (3,1%) 27 / 897 (3,0%) 1,03 [0,61;1,73] Graft occlusion or stent thrombosis
    2 yr Death (all cause) 56 / 903 (6,2%) 44 / 897 (4,9%) 1,26 [0,86;1,86]
    2 yr MACE 211 / 903 (23,4%) 146 / 897 (16,3%) 1,44 [1,19;1,74] MACCE
    2 yr TLR 157 / 903 (17,4%) 77 / 897 (8,6%) 2,03 [1,57;2,62]
    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 17,61% 11,71% 5,9%
    All cause death 4,32% 3,46% 8,6‰
    cardiac death 3,65% 2,01% 1,6%
    MI (fatal and non fatal) 4,76% 3,23% 1,5%
    CABG 2,77% 1,23% 1,5%
    target lesion revascularisation 13,73% 5,91% 7,8%
    Acute stent thrombosis (<=24h) 2,21‰ 3,34‰ -1,1‰
    sub acute stent thrombosis (1-30 days) 1,99% 3,34‰ 1,7%
    late stent thrombosis (31days - 1year) 9,97‰ 2,34% -13,4‰
    4y stent thrombosis (ARC) 3,10% 3,01% 0,9‰
    Stent thrombosis (any, end of follow up) 3,10% 3,01% 0,9‰
    2 yr Death (all cause) 6,20% 4,91% 1,3%
    2 yr MACE 23,37% 16,28% 7,1%
    2 yr TLR 17,39% 8,58% 8,8%

    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 long or complex lesion

    myocardial revascularization in coronary artery disease for all type of patient

    myocardial revascularization in stable angina for all type of patient



    Reference(s)

    Trials register # NCT00114972
    Study web site link ,
    • Lee TH, Hillis LD, Nabel EG. CABG vs. stenting--clinical implications of the SYNTAX trial.. N Engl J Med 2009 Feb 19;360:e10 - 10.1056/NEJMp0900462
      Pubmed | Hubmed | Fulltext
    • Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease.. N Engl J Med 2009 Mar 5;360:961-72 - 10.1056/NEJMoa0804626
      Pubmed | Hubmed | Fulltext
    • Banning AP, Westaby S, Morice MC, Kappetein AP, Mohr FW, Berti S, Glauber M, Kellett MA, Kramer RS, Leadley K, Dawkins KD, Serruys PW. Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: comparison of outcomes with cardiac surgery and paclitaxel-eluting stents.. J Am Coll Cardiol 2010;55:1067-75 - 10.1016/j.jacc.2009.09.057
      Pubmed | Hubmed | Fulltext

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