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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 polymer free sirolimus stent
  •  

    ISAR TEST 3 (PF) study, 2009

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

    Treatments

    Studied treatment polymer free 2% rapamycin (479 mg rapamycin/cm2) stent
    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 201 / 202 (studied vs. control)
    Blinding open
    Follow-up duration 12 months
    Number of centre 2
    Geographic area Germany
    Hypothesis Non inferiority
    Primary endpoint in-stent late luminal loss
    Remarks

    Remarks / Comments



    Results

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

    All cause death

    4 / 201
    4 / 202
    classic 1,00 [0,25;3,96]

    MI (fatal and non fatal)

    5 / 201
    4 / 202
    classic 1,26 [0,34;4,61]

    CABG

    3 / 201
    3 / 202
    classic 1,00 [0,21;4,92]

    in-lesion binary restenosis

    31 / 201
    21 / 202
    classic 1,48 [0,88;2,49]

    Stent thrombosis (any, end of follow up)

    3 / 201
    4 / 202
    classic 0,75 [0,17;3,32]
    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 / 201 (2,0%) 4 / 202 (2,0%) 1,00 [0,25;3,96]
    MI (fatal and non fatal) 5 / 201 (2,5%) 4 / 202 (2,0%) 1,26 [0,34;4,61]
    CABG 3 / 201 (1,5%) 3 / 202 (1,5%) 1,00 [0,21;4,92]
    in-lesion binary restenosis 31 / 201 (15,4%) 21 / 202 (10,4%) 1,48 [0,88;2,49] in segment restenosis
    Stent thrombosis (any, end of follow up) 3 / 201 (1,5%) 4 / 202 (2,0%) 0,75 [0,17;3,32]
    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 1,99% 1,98% 0,1‰
    MI (fatal and non fatal) 2,49% 1,98% 5,1‰
    CABG 1,49% 1,49% 0,1‰
    in-lesion binary restenosis 15,42% 10,40% 5,0%
    Stent thrombosis (any, end of follow up) 1,49% 1,98% -4,9‰

    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

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