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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

coronary artery disease - Drug eluting stent - all type of patients

coronary artery disease - myocardial revascularization - all type of patient


Related trials

SORT-OUT-3, 2010 - zotarolimus eluting stent vs sirolimus eluting stent

BASKET-PROVE (EES), 2010 - everolimus eluting stent vs bare-metal stent

BASKET-PROVE (SES), 2010 - sirolimus eluting stent vs bare-metal stent

SPIRIT IV, 2010 - everolimus eluting stent vs paclitaxel eluting stent

RESOLUTE All comers, 2010 - zotarolimus eluting stent vs everolimus eluting stent

GISSOC II, 2010 - sirolimus eluting stent vs bare-metal stent

STICH (ventricular reconstruction), 2009 - CABG+surgical ventricular reconstruction vs CABG

COMPARE, 2009 - everolimus eluting stent vs paclitaxel eluting stent

ZEST (vs SES), 2009 - zotarolimus eluting stent vs sirolimus eluting stent

ISAR TEST 2 (vs ZES), 2009 - dual sirolimus, probucol eluting stent vs zotarolimus eluting stent

ZEST (vs PES), 2009 - zotarolimus eluting stent vs paclitaxel eluting stent

BARI 2D, 2009 - CABG or PCI vs medical treatment

PASEO, 2009 - drug-eluting stents vs bare-metal stent

SYNTAX, 2009 - paclitaxel eluting stent vs CABG

ISAR-TEST-4 (biodegradable polymer), 2009 - sirolimus biodegradable polymer vs sirolimus eluting stent

ISAR TEST 2 (vs SES), 2009 - dual sirolimus, probucol eluting stent vs sirolimus eluting stent

ISAR TEST 3 (PF), 2009 - polymer free sirolimus stent vs sirolimus eluting stent

GENIUS-STEMI, 2009 - Genous stent vs bare-metal stent

Thiele, 2009 - sirolimus ES vs MIDCAB

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

ZEST AMI (vs SES), 2009 - zotarolimus eluting stent vs sirolimus eluting stent

DEBATER (SES vs BMS), 2009 - sirolimus eluting stent vs bare-metal stent

ISAR TEST 3 (BP), 2009 - sirolimus biodegradable polymer vs sirolimus eluting stent

ENDEAVOR IV, 2009 - zotarolimus eluting stent vs paclitaxel eluting stent

ZEST AMI (vs PES), 2009 - zotarolimus eluting stent vs paclitaxel eluting stent



See also:

  • All coronary artery disease clinical trials
  • All clinical trials of myocardial revascularization
  • All clinical trials of dual sirolimus, probucol eluting stent
  •  

    ISAR TEST 2 (vs SES) study, 2009

    [NCT00332397] download pdf: dual sirolimus, probucol eluting stent | myocardial revascularization for coronary artery disease

    Treatments

    Studied treatment dual DES (polymer-free stent consisting of probucol and rapamycin)
    Control treatment SES
    Concomittant treatment loading dose of 600 mg of clopidogrel at least 2 hours prior to the PCI; 500 mg of aspirin, and unfractionated heparin up to a total amount of 140 U/kg; after PCI, 200 mg/day aspirin indefinitely, clopidogrel 150 mg for the first 3 days, then 75 mg/day for at least 6 months

    Patients

    Patients patients with De novo lesions in native coronary arteries
    Inclusion criteria age >18 years; de novo lesions in native coronary arteries; ischemic symptoms or objective evidence of ischemia in the presence of ¡Ý50% de novo stenosis located in native coronary vessels
    Exclusion criteria Left main lesion Cardiogenic shock Comorbidities with a life expectancy < 12 months Contraindication to aspirin, limus agents, probucol, stainless steel, thienopyridines
    Baseline characteristics
    age 67y 
    diabetes (%) 28% 
    unstable angina (%) 27% 
    LAD (%) 45% 
    lesion length (mm) 14.5mm 
    male (%) 76% 
    reference-vessel diameter 2.7mm 
    Female (%) 24% 
    totally occluded lesions 12% 
    STEMI 13% 
    Stable angina 58% 
    multi vessels patients 83% 

    Method and design

    Randomized effectives 333 / 335 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 months
    Number of centre 2
    Geographic area Germany
    Primary endpoint in-segment binary restenosis
    Remarks

    Remarks / Comments



    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Death or myocardial infarction 20 / 333 (6,0%) 20 / 335 (6,0%) 1,01 [0,55;1,83]
    Death 8 / 333 (2,4%) 9 / 335 (2,7%) 0,89 [0,35;2,29]
    Cardiac death 7 / 333 (2,1%) 8 / 335 (2,4%) 0,88 [0,32;2,40]
    Myocardial infarction 14 / 333 (4,2%) 12 / 335 (3,6%) 1,17 [0,55;2,50]
    Q wave MI 4 / 333 (1,2%) 3 / 335 (0,9%) 1,34 [0,30;5,95]
    Definite stent thrombosis 3 / 333 (0,9%) 3 / 335 (0,9%) 1,01 [0,20;4,95]
    acute or subacute Definite stent thrombosis 3 / 333 (0,9%) 1 / 335 (0,3%) 3,02 [0,32;28,87]
    Probable stent thrombosis 0 / 333 (0,2%) 0 / 335 (0,1%) 1,01 [0,02;50,55]
    Definite or probable stent thrombosis 3 / 333 (0,9%) 3 / 335 (0,9%) 1,01 [0,20;4,95]
    Possible stent thrombosis 3 / 333 (0,9%) 2 / 335 (0,6%) 1,51 [0,25;8,97]
    TLR 29 / 333 (8,7%) 30 / 335 (9,0%) 0,97 [0,60;1,58]
    Repeat PCI 29 / 333 (8,7%) 28 / 335 (8,4%) 1,04 [0,63;1,71]
    Repeat CABG 0 / 333 (0,2%) 2 / 335 (0,6%) 0,25 [0,01;5,56]
    Remote target vessel revascularization 14 / 333 (4,2%) 15 / 335 (4,5%) 0,94 [0,46;1,91]

    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

    20 / 333
    20 / 335
    1,01 [0,55;1,83]

    All cause death

    8 / 333
    9 / 335
    classic 0,89 [0,35;2,29]

    cardiac death

    7 / 333
    8 / 335
    classic 0,88 [0,32;2,40]

    MI (fatal and non fatal)

    14 / 333
    12 / 335
    classic 1,17 [0,55;2,50]

    CABG

    0 / 333
    2 / 335
    classic 0,11 [0,00;6,94]

    target-vessel revascularization

    29 / 333
    30 / 335
    0,97 [0,60;1,58]

    target lesion revascularisation

    23 / 333
    24 / 335
    0,96 [0,56;1,67]

    angiographic restenosis

    38 / 345
    42 / 350
    0,92 [0,61;1,39]

    Acute stent thrombosis (<=24h)

    3 / 333
    1 / 335
    classic 3,02 [0,32;28,87]

    4y stent thrombosis (ARC)

    3 / 333
    3 / 335
    classic 1,01 [0,20;4,95]

    Stent thrombosis (any, end of follow up)

    3 / 333
    3 / 335
    classic 1,01 [0,20;4,95]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    MACE 20 / 333 (6,0%) 20 / 335 (6,0%) 1,01 [0,55;1,83] Death or myocardial infarction 0
    All cause death 8 / 333 (2,4%) 9 / 335 (2,7%) 0,89 [0,35;2,29] Death 0
    cardiac death 7 / 333 (2,1%) 8 / 335 (2,4%) 0,88 [0,32;2,40] Cardiac death 0
    MI (fatal and non fatal) 14 / 333 (4,2%) 12 / 335 (3,6%) 1,17 [0,55;2,50] Myocardial infarction 0
    CABG 0 / 333 (0,2%) 2 / 335 (0,6%) 0,25 [0,01;5,56] Repeat CABG 0
    target-vessel revascularization 29 / 333 (8,7%) 30 / 335 (9,0%) 0,97 [0,60;1,58] TLR 0
    target lesion revascularisation 23 / 333 (6,9%) 24 / 335 (7,2%) 0,96 [0,56;1,67] 0
    angiographic restenosis 38 / 345 (11,0%) 42 / 350 (12,0%) 0,92 [0,61;1,39] 0
    Acute stent thrombosis (<=24h) 3 / 333 (0,9%) 1 / 335 (0,3%) 3,02 [0,32;28,87] acute or subacute Definite stent thrombosis 0
    4y stent thrombosis (ARC) 3 / 333 (0,9%) 3 / 335 (0,9%) 1,01 [0,20;4,95] Definite stent thrombosis 0
    Stent thrombosis (any, end of follow up) 3 / 333 (0,9%) 3 / 335 (0,9%) 1,01 [0,20;4,95] Definite or probable stent thrombosis 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 6,01% 5,97% 0,4‰
    All cause death 2,40% 2,69% -2,8‰
    cardiac death 2,10% 2,39% -2,9‰
    MI (fatal and non fatal) 4,20% 3,58% 6,2‰
    target-vessel revascularization 8,71% 8,96% -2,5‰
    target lesion revascularisation 6,91% 7,16% -2,6‰
    angiographic restenosis 11,01% 12,00% -9,9‰
    Acute stent thrombosis (<=24h) 9,01‰ 2,99‰ 6,0‰
    4y stent thrombosis (ARC) 9,01‰ 8,96‰ 0,1‰
    Stent thrombosis (any, end of follow up) 9,01‰ 8,96‰ 0,1‰

    Meta-analysis of all similar trials:

    Drug eluting stent in coronary artery disease for all type of patients

    myocardial revascularization in coronary artery disease for all type of patient



    Reference(s)

    Trials register # NCT00332397
    • Byrne RA, Mehilli J, Iijima R, Schulz S, Pache J, Seyfarth M, Schömig A, Kastrati A. A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents.. Eur Heart J 2009;:
      Pubmed | Hubmed | Fulltext
    • Byrne RA, Mehilli J, Iijima R, Schulz S, Pache J, Seyfarth M, Schömig A, Kastrati A. A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents.. Eur Heart J 2009;30:923-31
      Pubmed | Hubmed | Fulltext
    • Byrne RA, Kastrati A, Tiroch K, Schulz S, Pache J, Pinieck S, Massberg S, Seyfarth M, Laugwitz KL, Birkmeier KA, Schömig A, Mehilli J. 2-year clinical and angiographic outcomes from a randomized trial of polymer-free dual drug-eluting stents versus polymer-based Cypher and Endeavor, drug-eluting stents.. J Am Coll Cardiol 2010 Jun 8;55:2536-43 - 10.1016/j.jacc.2010.03.020
      Pubmed | Hubmed | Fulltext

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