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ISAR-LEFT-MAIN, 2009 - sirolimus eluting stent vs paclitaxel eluting stent

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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 biodegradable polymer
  •  

    ISAR-TEST-4 (biodegradable polymer) study, 2009

    [NCT00598676).] download pdf: sirolimus biodegradable polymer | myocardial revascularization for stable angina

    Treatments

    Studied treatment biodegradable polymer rapamycin-eluting stent
    Control treatment permanent polymer-based rapamycin-eluting or everolimus-eluting
    rapamycin-eluting Cypher or everolimus-eluting Xience
    Concomittant treatment prior to PCI: clopidogrel 600 mg and aspirin 500 mg; post PCI: clopidogrel 150 mg daily until discharge and 75 mg daily thereafter for at least 6 months; aspirin 200 mg daily indefinitely

    Patients

    Patients patients with stable coronary disease or acute coronary syndromes with de novo native-vessel stent implantation
    Baseline characteristics
    age 66.7 y 
    history of MI (%) 28.6% 
    diabetes (%) 29.45% 
    unstable angina (%) 29% 
    LAD (%) 44.5% 
    RCA (%) 28.6% 
    LCx (%) 26.9% 
    lesion length (mm) 14.9 mm 
    male (%) 76% 
    reference-vessel diameter 2.8 mm 
    Female (%) 24% 
    totally occluded lesions 5.2% 
    ostial lesion 16.95% 
    STEMI 11.8% 
    Stable angina 59.3% 

    Method and design

    Randomized effectives 1299 / 1304 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 mo
    Number of centre 2
    Geographic area Germany
    Hypothesis Non inferiority
    Primary endpoint cardiac death, MI (target vessel), TLR


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Cardiac death at 30 days 12 / 1299 (0,9%) 18 / 1304 (1,4%) 0,67 [0,32;1,38]
    MI related to target vessel at 30 days 45 / 1299 (3,5%) 40 / 1304 (3,1%) 1,13 [0,74;1,72]
    Cardiac death or MI related to target vessel at 30 days 55 / 1299 (4,2%) 56 / 1304 (4,3%) 0,99 [0,69;1,42]
    TLR at 30 days 7 / 1299 (0,5%) 8 / 1304 (0,6%) 0,88 [0,32;2,42]
    Cardiac death, MI (target vessel), TLR at 30 days 57 / 1299 (4,4%) 59 / 1304 (4,5%) 0,97 [0,68;1,38]
    Cardiac death at 1 year 35 / 1299 (2,7%) 41 / 1304 (3,1%) 0,86 [0,55;1,34]
    MI related to target vessel at 1 year 53 / 1299 (4,1%) 46 / 1304 (3,5%) 1,16 [0,79;1,70]
    Cardiac death or MI related to target vessel at 1 year 81 / 1299 (6,2%) 80 / 1304 (6,1%) 1,02 [0,75;1,37]
    Target lesion revascularization at 1 year 109 / 1299 (8,4%) 116 / 1304 (8,9%) 0,94 [0,73;1,21]
    Cardiac death, MI (target vessel), TLR at 1 year 176 / 1299 (13,5%) 183 / 1304 (14,0%) 0,97 [0,80;1,17]
    All-cause death at 1 year 60 / 1299 (4,6%) 61 / 1304 (4,7%) 0,99 [0,70;1,40]
    All myocardial infarction at 1 year 55 / 1299 (4,2%) 53 / 1304 (4,1%) 1,04 [0,72;1,51]
    Target vessel revascularization at 1 year 170 / 1299 (13,1%) 172 / 1304 (13,2%) 0,99 [0,81;1,21]
    Non-target vessel revascularization at 1 year 114 / 1299 (8,8%) 109 / 1304 (8,4%) 1,05 [0,82;1,35]

    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

    176 / 1299
    183 / 1304
    0,97 [0,80;1,17]

    All cause death

    60 / 1299
    61 / 1304
    0,99 [0,70;1,40]

    cardiac death

    35 / 1299
    41 / 1304
    0,86 [0,55;1,34]

    MI (fatal and non fatal)

    55 / 1299
    53 / 1304
    1,04 [0,72;1,51]

    target-vessel revascularization

    170 / 1299
    172 / 1304
    0,99 [0,81;1,21]

    target lesion revascularisation

    109 / 1299
    116 / 1304
    0,94 [0,73;1,21]

    4y stent thrombosis (ARC)

    13 / 1299
    19 / 1304
    0,69 [0,34;1,38]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    MACE 176 / 1299 (13,5%) 183 / 1304 (14,0%) 0,97 [0,80;1,17] Cardiac death, MI (target vessel), TLR at 1 year
    All cause death 60 / 1299 (4,6%) 61 / 1304 (4,7%) 0,99 [0,70;1,40] All-cause death at 1 year
    cardiac death 35 / 1299 (2,7%) 41 / 1304 (3,1%) 0,86 [0,55;1,34] Cardiac death at 1 year
    MI (fatal and non fatal) 55 / 1299 (4,2%) 53 / 1304 (4,1%) 1,04 [0,72;1,51] All myocardial infarction at 1 year
    target-vessel revascularization 170 / 1299 (13,1%) 172 / 1304 (13,2%) 0,99 [0,81;1,21] Target vessel revascularization at 1 year
    target lesion revascularisation 109 / 1299 (8,4%) 116 / 1304 (8,9%) 0,94 [0,73;1,21] Target lesion revascularization at 1 year
    4y stent thrombosis (ARC) 13 / 1299 (1,0%) 19 / 1304 (1,5%) 0,69 [0,34;1,38] definite or probable at 1 y
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    MACE 13,55% 14,03% -4,8‰
    All cause death 4,62% 4,68% -0,6‰
    cardiac death 2,69% 3,14% -4,5‰
    MI (fatal and non fatal) 4,23% 4,06% 1,7‰
    target-vessel revascularization 13,09% 13,19% -1,0‰
    target lesion revascularisation 8,39% 8,90% -5,0‰
    4y stent thrombosis (ARC) 1,00% 1,46% -4,6‰

    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 # NCT00598676).
    • Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, Schulz S, Pache J, Fusaro M, Seyfarth M, Schömig A, Mehilli J. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial.. Eur Heart J 2009 Aug 30;:
      Pubmed | Hubmed | Fulltext

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