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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 sirolimus biodegradable polymer
  •  

    ISAR TEST 3 (BP) study, 2009

    download pdf: sirolimus biodegradable polymer | myocardial revascularization for coronary artery disease

    Treatments

    Studied treatment biodegradable-polymer 0.4% rapamycin stent (180 mg rapamycin/cm2)
    Control treatment permanent-polymer rapamycin-eluting stent (Cypher) (140 mg rapamycin/cm2)
    Concomittant treatment oral loading dose of 600 mg clopidogrel at least 2 h prior to the intervention, regardless of whether the patient was taking clopidogrel prior to admission. During the procedure: intravenous aspirin, heparin or bivalirudin; glycoprotein IIb/IIIa inhibitor usage was at the discretion of the operators. After the intervention, all patients received 200 mg/day aspirin indefinitely, clopidogrel 150 mg for the first 3 days (or until discharge) followed by 75 mg/day for at least 6 months

    Patients

    Patients Patients with de novo coronary lesions in native vessels
    Baseline characteristics
    age 66.1y 
    history of MI (%) 32.9% 
    diabetes (%) 27.4% 
    unstable angina (%) 30.9% 
    LAD (%) 43% 
    RCA (%) 30.3% 
    LCx (%) 26.7% 
    lesion length (mm) 14.3mm 
    male (%) 79.3ù 
    reference-vessel diameter 2.75mm 
    totally occluded lesions 7.7% 
    bifurcated lesions 26% 
    single vessel patients 17.4% 
    multi vessels patients 82.6% 

    Method and design

    Randomized effectives 202 / 202 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 months
    Number of centre 2
    Geographic area Germany
    Hypothesis Non inferiority
    Primary endpoint in-stent late luminal loss


    Results

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

    All cause death

    4 / 202
    4 / 202
    classic 1,00 [0,25;3,94]

    MI (fatal and non fatal)

    3 / 202
    4 / 202
    classic 0,75 [0,17;3,31]

    CABG

    1 / 202
    3 / 202
    classic 0,33 [0,03;3,18]

    target-vessel revascularization

    12 / 202
    16 / 202
    0,75 [0,36;1,54]

    in-lesion binary restenosis

    12 / 202
    13 / 202
    0,92 [0,43;1,97]

    Stent thrombosis (any, end of follow up)

    2 / 202
    4 / 202
    classic 0,50 [0,09;2,70]
    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 4 / 202 (2,0%) 4 / 202 (2,0%) 1,00 [0,25;3,94]
    MI (fatal and non fatal) 3 / 202 (1,5%) 4 / 202 (2,0%) 0,75 [0,17;3,31] Q and non Q
    CABG 1 / 202 (0,5%) 3 / 202 (1,5%) 0,33 [0,03;3,18]
    target-vessel revascularization 12 / 202 (5,9%) 16 / 202 (7,9%) 0,75 [0,36;1,54]
    in-lesion binary restenosis 12 / 202 (5,9%) 13 / 202 (6,4%) 0,92 [0,43;1,97] in segment
    Stent thrombosis (any, end of follow up) 2 / 202 (1,0%) 4 / 202 (2,0%) 0,50 [0,09;2,70]
    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.
    All cause death 1,98% 1,98% 0,0‰
    MI (fatal and non fatal) 1,49% 1,98% -5,0‰
    CABG 4,95‰ 1,49% -9,9‰
    target-vessel revascularization 5,94% 7,92% -19,8‰
    in-lesion binary restenosis 5,94% 6,44% -5,0‰
    Stent thrombosis (any, end of follow up) 9,90‰ 1,98% -9,9‰

    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 # NA
    • Mehilli J, Byrne RA, Wieczorek A, Iijima R, Schulz S, Bruskina O, Pache J, Wessely R, Schömig A, Kastrati A. . Eur Heart J 2008 Aug;29:1975-82 - 10.1093/eurheartj/ehn253
      Pubmed | Hubmed | Fulltext
    • Byrne RA, Kufner S, Tiroch K, Massberg S, Laugwitz KL, Birkmeier A, Schulz S, Mehilli J. Randomised trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis: 2-year follow-up results.. Heart 2009;95:1489-94
      Pubmed | Hubmed | Fulltext

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