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

coronary artery disease - revascularization with drug eluting stent - bifurcation lesion  


Related trials

CACTUS , 2009 - double stenting with SES vs single stenting

Nordic-Baltic Bifurcation Study III, 2009 - kissing balloon vs no kissing balloon

BBC ONE, 2008 - double stenting with PES vs single stenting

Ferenc, 2008 - double stenting with SES vs single stenting

Pan, 2007 - sirolimus ES vs paclitaxel ES

NORDIC , 2006 - double stenting with SES vs single stenting

Pan, 2004 - double stenting with SES vs single stenting

Colombo, 2004 - double stenting with SES vs single stenting



See also:

  • All coronary artery disease clinical trials
  • All clinical trials of revascularization with drug eluting stent
  • All clinical trials of kissing balloon
    		•  

    Nordic-Baltic Bifurcation Study III study, 2009

    Treatments

    Studied treatment Kissing balloon dilatation post-stenting of the main artery (one-stent technique)
    Control treatment no kissing balloon dilatation
    Concomittant treatment Sirolimus stents for stenting of the main vessel

    Patients

    Patients patients with bifurcation lesions
    Inclusion criteria PCI for any indication; lesion located on left anterior descending/diagonal, circumflex/obtuse marginal, right coronary artery/posterior descending artery/posterolateral branch or left main/LAD/CX; vessel size: main vessel diameter ¡Ý2.5 mm, side branch diameter ¡Ý2.25 mm
    Exclusion criteria ST-elevation acute myocardial infarction within 24 hours; expected survival <1 year; creatinine >200 µmol/L; allergy to aspirin, clopidogrel, ticlodipine, or sirolimus
    Baseline characteristics
    age 64.5 y 
    diabetes (%) 17% 
    LAD (%) 73% 
    lesion length (mm) main 17.5mm, side 3.5mm 
    reference-vessel diameter main 3.4mm, side 2.7mm 
    lesion length inclusion criteria main >=2.5mm, side >=2.25mm 
    Female (%) 27% 
    Stable angina 74% 
    multi vessels patients 52% 

    Method and design

    Randomized effectives 238 / 239 (studied vs. control)
    Design Parallel groups
    Follow-up duration 6 mo
    Primary endpoint MACE


    Results

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

    All cause death

    2 / 238
         0 / 239
         classic 9,04 [0,15;560,91]

    MACE

    7 / 238
         7 / 239
         classic 1,00 [0,36;2,82]

    target lesion revascularisation

    3 / 238
         5 / 239
         classic 0,60 [0,15;2,49]

    Stent thrombosis (any, end of follow up)

    1 / 238
         1 / 239
         classic 1,00 [0,06;15,96]     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 2 / 238 (0,8%) 0 / 239 (0,2%) 4,02 [0,18;88,62]    
    MACE 7 / 238 (2,9%) 7 / 239 (2,9%) 1,00 [0,36;2,82] at 6 mo   
    Stent thrombosis (any, end of follow up) 1 / 238 (0,4%) 1 / 239 (0,4%) 1,00 [0,06;15,96]    
    target lesion revascularisation 3 / 238 (1,3%) 5 / 239 (2,1%) 0,60 [0,15;2,49]    
    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.
    MACE 2,94% 2,93% 0,1‰
    Stent thrombosis (any, end of follow up) 4,20‰ 4,18‰ 0,0‰
    target lesion revascularisation 1,26% 2,09% -8,3‰


    Reference(s)

    Trials register # NA

    External links about this trial

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