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Related trials

TAxi (diabetics), 3000 - sirolimus ES vs paclitaxel ES

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

RESOLUTE, 2010 - zotarolimus ES vs everolimus ES

SPIRIT IV, 2010 - everolimus ES vs paclitaxel ES

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

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

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

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

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

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

Thiele, 2009 - sirolimus ES vs MIDCAB

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

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

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

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PASEO, 2009 - drug ES vs bare-metal stent

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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
    		•  

    DECODE study, 2005

    [NCT00489164] unpublished (or not yet fully published) trial

    Treatments

    Studied treatment CYPHER (Up to 3 stents per patient were allowed)
    Control treatment Bx VELOCITY (Up to 3 stents per patient were allowed)
    Concomittant treatment Life-long Aspirin and 12 weeks post-procedure Plavix

    Patients

    Patients Stable or unstable angina in diabetic patients with with up to 2 de novo lesions in up to 2 native coronary vessels
    Baseline characteristics
    age 60 
    diabetes (%) 100% 
    Lesion diameter inclusion criteria NA 
    Female (%) 33% 

    Method and design

    Randomized effectives 54 / 29 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 1 year
    Number of centre NA
    Geographic area US, Asia/Pacific
    Hypothesis Superiority
    Primary endpoint Late lumen loss


    Results

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

    All cause death

    0 / 54
         2 / 29
         classic 0,06 [0,00;3,63]

    target lesion revascularisation

    5 / 54
         8 / 29
         0,34 [0,12;0,93]

    Stent thrombosis (any, end of follow up)

    0 / 54
         0 / 29
         classic 0,54 [0,00;134,78]     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 / 54 (0,9%) 2 / 29 (6,9%) 0,13 [0,01;2,88]    
    target lesion revascularisation 5 / 54 (9,3%) 8 / 29 (27,6%) 0,34 [0,12;0,93]    
    Stent thrombosis (any, end of follow up) 0 / 54 (0,9%) 0 / 29 (1,7%) 0,54 [0,01;26,37]    
    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.
    target lesion revascularisation 9,26% 27,59% -183,3‰


    Reference(s)

    Trials register # NCT00489164

    unpublished (or not yet fully published) trial

    • Chan C, Zambahari R, Kaul U, Cohen SA, Buchbinder M.. Outcomesin diabetic patients with multivessel disease and long lesions: resultsfrom the DECODE study. Am J Cardiol 2005; 96 (suppl 7A): 31H
      Pubmed | Hubmed | Fulltext

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