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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 sirolimus eluting stent
  •  

    ISAR-LEFT-MAIN study, 2009

    [NCT00133237] download pdf: sirolimus eluting stent | myocardial revascularization for stable angina

    Treatments

    Studied treatment Paclitaxel-eluting stent
    Control treatment Sirolimus-eluting stent
    Concomittant treatment clopidogrel 600 mg at least 2 hours before the procedure in addition to 500 mg of intravenous aspirin; clopidogrel (150 mg/day until discharge, 75 mg/day thereafter) and aspirin 200 mg/day indefinitely.

    Patients

    Patients Unprotected Left Main Coronary Artery Disease
    Exclusion criteria Age <18 years; Cardiogenic shock; ST-elevation acute MI within 48 hours of symptom onset; In-stent restenosis; Prior coronary artery bypass surgery; LM size >4.5 mm by visual estimation; Malignancies with life expectancy <1 year; Planned staged percutaneous coronary intervention (PCI) within 30 days from index PCI; Planned elective surgical procedure necessitating discontinuation of clopidogrel during the first 6 months
    Baseline characteristics
    age 69y 
    unstable angina (%) 42% 
    reference-vessel diameter 3.8mm 
    Female (%) 23% 
    ostial lesion 11% 
    multi vessels patients 75% 

    Method and design

    Randomized effectives 302 / 305 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 1 year
    Hypothesis Non inferiority
    Primary endpoint death, MI, TLR


    Results

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

    MACE

    NA / 302
    NA / 305
    0,85 [0,55;1,32]

    All cause death

    15 / 302
    20 / 305
    0,76 [0,40;1,45]

    MI (fatal and non fatal)

    15 / 302
    14 / 305
    classic 1,08 [0,53;2,20]

    angiographic restenosis

    48 / 302
    59 / 305
    0,82 [0,58;1,16]
    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 15 / 302 (5,0%) 20 / 305 (6,6%) 0,76 [0,40;1,45]
    MI (fatal and non fatal) 15 / 302 (5,0%) 14 / 305 (4,6%) 1,08 [0,53;2,20]
    angiographic restenosis 48 / 302 (15,9%) 59 / 305 (19,3%) 0,82 [0,58;1,16]
    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 4,97% 6,56% -15,9‰
    MI (fatal and non fatal) 4,97% 4,59% 3,8‰
    angiographic restenosis 15,89% 19,34% -34,5‰

    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 unprotected left main artery stenosis

    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 # NCT00133237
    Study web site link ,
    • Mehilli J, Kastrati A, Byrne RA, Bruskina O, Iijima R, Schulz S, Pache J, Seyfarth M, Massberg S, Laugwitz KL, Dirschinger J, Schömig A. Paclitaxel- versus sirolimus-eluting stents for unprotected left main coronary artery disease.. J Am Coll Cardiol 2009 May 12;53:1760-8
      Pubmed | Hubmed | Fulltext

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