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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 everolimus eluting stent
  •  

    SPIRIT IV study, 2010

    [NCT00307047] download pdf: everolimus eluting stent | myocardial revascularization for stable angina

    Treatments

    Studied treatment XIENCE V Everolimus Eluting Coronary Stent System
    Control treatment TAXUS EXPRESS2 Paclitaxel Eluting Coronary Stent System (TAXUS).
    Concomittant treatment clopidogrel >=300mg, aspirin >=300mg before PCI; after PCI, aspirin >=80 mg daily for an indefinite period and clopidogrel 75 mg daily for at least 1 year, unless they were at high risk for bleeding

    Patients

    Patients patients with de novo native coronary artery lesions and reference vessel diameters between 2.5 mm to 4.25 mm and lesion lengths <= 28 mm
    Inclusion criteria Maximum of three lesions with a maximum of two per epicardial vessel
    Exclusion criteria Left main or ostial LAD/left circumflex lesion In or distal to a bypass graft conduit Bifurcation lesion with sidebranch diameter ¡Ý2 mm and ostial diameter stenosis >50% or requiring pre-dilatatation; total occlusion, thrombus, restenosis, excessive tortuosity, angulation, or heavy calcification; prior coronary brachytherapy; high probability of additional PCI within 9 months
    Baseline characteristics
    age 63.3 y 
    history of MI (%) 21% 
    diabetes (%) 32% 
    unstable angina (%) 28% 
    LAD (%) 40% 
    RCA (%) 35% 
    lesion length (mm) 14.7 mm 
    reference-vessel diameter 2.75 mm 
    lesion length inclusion criteria <=28 mm 
    Lesion diameter inclusion criteria 2.5-3.75 mm 
    Female (%) 32% 
    multi vessels patients 25% 

    Method and design

    Randomized effectives 2458 / 1229 (studied vs. control)
    Design Parallel groups
    Blinding 270 days (5 years)
    Follow-up duration 1 y (2y)
    Number of centre 66
    Geographic area USA
    Hypothesis Superiority
    Primary endpoint target lesion failure


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    All Death 25 / 2458 (1,0%) 15 / 1229 (1,2%) 0,83 [0,44;1,57]
    Cardiac Death 10 / 2458 (0,4%) 5 / 1229 (0,4%) 1,00 [0,34;2,92]
    Noncardiac Death 15 / 2458 (0,6%) 10 / 1229 (0,8%) 0,75 [0,34;1,66]
    All MI 45 / 2458 (1,8%) 37 / 1229 (3,0%) 0,61 [0,40;0,93]
    Target-vessel MI 44 / 2458 (1,8%) 35 / 1229 (2,8%) 0,63 [0,41;0,97]
    Non–target-vessel MI 1 / 2458 (0,0%) 2 / 1229 (0,2%) 0,25 [0,02;2,75]
    Q-wave MI 3 / 2458 (0,1%) 5 / 1229 (0,4%) 0,30 [0,07;1,25]
    Non–Q-wave MI 42 / 2458 (1,7%) 33 / 1229 (2,7%) 0,64 [0,41;1,00]
    Death or myocardial infarction 68 / 2458 (2,8%) 49 / 1229 (4,0%) 0,69 [0,48;1,00]
    Cardiac death or myocardial infarction 54 / 2458 (2,2%) 39 / 1229 (3,2%) 0,69 [0,46;1,04]
    Cardiac death or target-vessel myocardial infarction 53 / 2458 (2,2%) 38 / 1229 (3,1%) 0,70 [0,46;1,05]
    Stent thrombosis - Protocol definition 4 / 2458 (0,2%) 10 / 1229 (0,8%) 0,20 [0,06;0,64]
    Stent thrombosis <24 hr: acute thrombosis 3 / 2458 (0,1%) 5 / 1229 (0,4%) 0,30 [0,07;1,25]
    Stent thrombosis 24 hr–30 days: subacute thrombosis 0 / 2458 (0,0%) 2 / 1229 (0,2%) 0,13 [0,01;2,77]
    Stent thrombosis >30 days: late thrombosis 1 / 2458 (0,0%) 4 / 1229 (0,3%) 0,13 [0,01;1,12]
    Stent thrombosis - ARC definition 7 / 2458 (0,3%) 13 / 1229 (1,1%) 0,27 [0,11;0,67]
    Definite Stent thrombosis 6 / 2458 (0,2%) 10 / 1229 (0,8%) 0,30 [0,11;0,82]
    Probable Stent thrombosis 1 / 2458 (0,0%) 3 / 1229 (0,2%) 0,17 [0,02;1,60]
    Target-lesion revascularization (ischemia-driven events) 61 / 2458 (2,5%) 55 / 1229 (4,5%) 0,55 [0,39;0,79]
    Target-vessel revascularization (ischemia-driven events) 94 / 2458 (3,8%) 70 / 1229 (5,7%) 0,67 [0,50;0,91]
    Target-lesion failure (ischemia-driven events) 101 / 2458 (4,1%) 81 / 1229 (6,6%) 0,62 [0,47;0,83]
    Major adverse cardiac events (ischemia-driven events) 102 / 2458 (4,1%) 82 / 1229 (6,7%) 0,62 [0,47;0,83]
    Target-vessel failure (ischemia-driven events) 135 / 2458 (5,5%) 94 / 1229 (7,6%) 0,72 [0,56;0,93]

    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

    102 / 2458
    82 / 1229
    0,62 [0,47;0,83]

    All cause death

    25 / 2458
    15 / 1229
    0,83 [0,44;1,57]

    cardiac death

    10 / 2458
    5 / 1229
    classic 1,00 [0,34;2,92]

    MI (fatal and non fatal)

    45 / 2458
    37 / 1229
    0,61 [0,40;0,93]

    target-vessel revascularization

    94 / 2458
    70 / 1229
    0,67 [0,50;0,91]

    target lesion revascularisation

    61 / 2458
    55 / 1229
    0,55 [0,39;0,79]

    Acute stent thrombosis (<=24h)

    3 / 2458
    5 / 1229
    0,30 [0,07;1,25]

    sub acute stent thrombosis (1-30 days)

    0 / 2458
    2 / 1229
    classic 0,06 [0,00;3,46]

    late stent thrombosis (31days - 1year)

    1 / 2458
    4 / 1229
    0,13 [0,01;1,12]

    4y stent thrombosis (ARC)

    7 / 2458
    13 / 1229
    0,27 [0,11;0,67]

    Stent thrombosis (any, end of follow up)

    4 / 2458
    10 / 1229
    0,20 [0,06;0,64]

    2 yr TLR

    111 / 2458
    85 / 1229
    0,65 [0,50;0,86]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    MACE 102 / 2458 (4,1%) 82 / 1229 (6,7%) 0,62 [0,47;0,83] Major adverse cardiac events (ischemia-driven events)
    All cause death 25 / 2458 (1,0%) 15 / 1229 (1,2%) 0,83 [0,44;1,57] All Death
    cardiac death 10 / 2458 (0,4%) 5 / 1229 (0,4%) 1,00 [0,34;2,92] Cardiac Death
    MI (fatal and non fatal) 45 / 2458 (1,8%) 37 / 1229 (3,0%) 0,61 [0,40;0,93] All MI
    target-vessel revascularization 94 / 2458 (3,8%) 70 / 1229 (5,7%) 0,67 [0,50;0,91] Target-vessel revascularization (ischemia-driven events)
    target lesion revascularisation 61 / 2458 (2,5%) 55 / 1229 (4,5%) 0,55 [0,39;0,79] Target-lesion revascularization (ischemia-driven events)
    Acute stent thrombosis (<=24h) 3 / 2458 (0,1%) 5 / 1229 (0,4%) 0,30 [0,07;1,25] Stent thrombosis <24 hr: acute thrombosis 0
    sub acute stent thrombosis (1-30 days) 0 / 2458 (0,0%) 2 / 1229 (0,2%) 0,13 [0,01;2,77] Stent thrombosis 24 hr–30 days: subacute thrombosis 0
    late stent thrombosis (31days - 1year) 1 / 2458 (0,0%) 4 / 1229 (0,3%) 0,13 [0,01;1,12] Stent thrombosis >30 days: late thrombosis
    4y stent thrombosis (ARC) 7 / 2458 (0,3%) 13 / 1229 (1,1%) 0,27 [0,11;0,67] Stent thrombosis - ARC definition
    Stent thrombosis (any, end of follow up) 4 / 2458 (0,2%) 10 / 1229 (0,8%) 0,20 [0,06;0,64] Stent thrombosis - Protocol definition
    2 yr TLR 111 / 2458 (4,5%) 85 / 1229 (6,9%) 0,65 [0,50;0,86] Ischemia-driven TLR
    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 4,15% 6,67% -25,2‰
    All cause death 1,02% 1,22% -2,0‰
    cardiac death 4,07‰ 4,07‰ 0,0‰
    MI (fatal and non fatal) 1,83% 3,01% -11,8‰
    target-vessel revascularization 3,82% 5,70% -18,7‰
    target lesion revascularisation 2,48% 4,48% -19,9‰
    Acute stent thrombosis (<=24h) 1,22‰ 4,07‰ -2,8‰
    late stent thrombosis (31days - 1year) 0,41‰ 3,25‰ -2,8‰
    4y stent thrombosis (ARC) 2,85‰ 1,06% -7,7‰
    Stent thrombosis (any, end of follow up) 1,63‰ 8,14‰ -6,5‰
    2 yr TLR 4,52% 6,92% -24,0‰

    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 unparticular patients

    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 # NCT00307047
    Study web site link ,
    • Nikolsky E, Lansky AJ, Sudhir K, Doostzadeh J, Cutlip DE, Piana R, Su X, White R, Simonton CA, Stone GW. SPIRIT IV trial design: a large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease.. Am Heart J 2009;158:520-526.e2
      Pubmed | Hubmed | Fulltext
    • Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease.. N Engl J Med 2010 May 6;362:1663-74 - 10.1056/NEJMoa0910496
      Pubmed | Hubmed | Fulltext
    • Kereiakes DJ, Cutlip DE, Applegate RJ, Wang J, Yaqub M, Sood P, Su X, Su G, Farhat N, Rizvi A, Simonton CA, Sudhir K, Stone GW. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System).. J Am Coll Cardiol 2010;56:2084-9 - 10.1016/j.jacc.2010.10.006
      Pubmed | Hubmed | Fulltext

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