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

RESOLUTE, 2010 - zotarolimus ES vs everolimus ES

SPIRIT IV, 2010 - everolimus ES vs paclitaxel ES

SORT-OUT-3, 2010 - zotarolimus ES vs sirolimus ES

ISAR-DESIRE-2, 2010 - sirolimus ES vs paclitaxel ES

COMPARE, 2009 - everolimus ES vs paclitaxel ES

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

ZEST (vs SES), 2009 - zotarolimus ES vs sirolimus ES

ZEST AMI (vs SES), 2009 - zotarolimus ES vs sirolimus ES

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

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

ISAR-TEST-4, 2009 - sirolimus biodegradable polymer vs sirolimus ES

SYNTAX, 2009 - paclitaxel ES vs CABG

ISAR-LEFT-MAIN, 2009 - sirolimus ES vs paclitaxel ES

ZEST (vs PES), 2009 - zotarolimus ES vs paclitaxel ES

PASEO, 2009 - drug ES vs bare-metal stent

Thiele, 2009 - sirolimus ES vs MIDCAB

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

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

ENDEAVOR IV, 2009 - zotarolimus ES vs paclitaxel ES

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

ZEST AMI (vs PES), 2009 - zotarolimus ES vs paclitaxel ES

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

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

HORIZONS-AMI Stent, 2008 - paclitaxel ES vs bare-metal stent



See also:

  • All coronary artery disease clinical trials
  • All stable angina clinical trials
  • All clinical trials of revascularization with drug eluting stent
  • All clinical trials of sirolimus ES
    		•  

    PRISON II study, 2006

    [NCT00258596]

    Treatments

    Studied treatment Cypher
    Control treatment BxVelocity

    Patients

    Patients Chronic total occlusion, positive exercise stress test
    Baseline characteristics
    age 60 
    history of MI (%) 49 
    diabetes (%) 13% 
    LAD (%) 34.5 
    RCA (%) 42 
    LCx (%) 23.5 
    lesion length (mm) 16.15mm (occlusion) 
    reference-vessel diameter 2.57 
    Lesion diameter inclusion criteria No restrictions 
    Female (%) 20% 
    totally occluded lesions 100% 
    single vessel patients 49% 
    multi vessels patients 51% 
    No of lesions per patients 1.4 

    Method and design

    Randomized effectives 100 / 100 (studied vs. control)
    Design Parallel groups
    Blinding single-blind
    Follow-up duration 6 months
    Number of centre 2
    Geographic area Belgium
    Hypothesis Superiority
    Primary endpoint Binary restenosis


    Results

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

    All cause death

    0 / 100
         0 / 100
         classic 1,00 [0,00;253,86]

    MI (fatal and non fatal)

    2 / 100
         3 / 100
         classic 0,67 [0,11;3,90]

    MACE

    4 / 100
         20 / 100
         0,20 [0,07;0,56]

    Stent thrombosis (any, end of follow up)

    2 / 100
         0 / 100
         classic 9,00 [0,15;555,55]

    target lesion revascularisation

    4 / 100
         19 / 100
         0,21 [0,07;0,60]

    angiographic restenosis

    7 / 100
         36 / 100
         0,19 [0,09;0,42]

    target-vessel revascularization

    8 / 100
         22 / 100
         0,36 [0,17;0,78]     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 0 / 100 (0,5%) 0 / 100 (0,5%) 1,00 [0,02;49,91]    
    MI (fatal and non fatal) 2 / 100 (2,0%) 3 / 100 (3,0%) 0,67 [0,11;3,90]    
    target lesion revascularisation 4 / 100 (4,0%) 19 / 100 (19,0%) 0,21 [0,07;0,60]    
    angiographic restenosis 7 / 100 (7,0%) 36 / 100 (36,0%) 0,19 [0,09;0,42] in stent   
    target-vessel revascularization 8 / 100 (8,0%) 22 / 100 (22,0%) 0,36 [0,17;0,78]    
    MACE 4 / 100 (4,0%) 20 / 100 (20,0%) 0,20 [0,07;0,56]    
    Stent thrombosis (any, end of follow up) 2 / 100 (2,0%) 0 / 100 (0,5%) 4,00 [0,18;87,61]    
    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.
    MI (fatal and non fatal) 2,00% 3,00% -10,0‰
    target lesion revascularisation 4,00% 19,00% -150,0‰
    angiographic restenosis 7,00% 36,00% -290,0‰
    target-vessel revascularization 8,00% 22,00% -140,0‰
    MACE 4,00% 20,00% -160,0‰


    Reference(s)

    Trials register # NCT00258596
    • Suttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, Ten Berg JM, Bal ET, Rensing BJ, Eefting FD, Mast EG. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions.. Circulation 2006;114:921-8
      Pubmed | Hubmed | Fulltext

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