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Related trials

PIVOTAL (Ouriel), 2010 - endovascular repair vs surveillance

OVER, 2009 - endovascular repair vs open repair

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EVAR trial 2, 2005 - endovascular repair vs surveillance



See also:

  • All abdominal aortic aneurysm clinical trials
  • All clinical trials of endovascular treatment
  • All clinical trials of endovascular repair
    		•  

    OVER study, 2009

    [NCT00094575]

    Treatments

    Studied treatment endovascular repair
    endovascular systems approved by the FDA (Cook Zenith 39%, Gore Excluder 37%)
    Control treatment open repair
    Concomittant treatment Aspirin 59%, beta-blockers 64%, anticoagulants 9%, ACEI 42%

    Patients

    Patients men (aged >=49 years) with abdominal aortic aneurysms candidate for both both elective endovascular repair and open repair
    Inclusion criteria maximum external diameter >5 cm; associated iliac aneurysm with a maximum diameter of at least 3.0 cm; maximum diameter of at least 4.5 cm plus either rapid enlargement (at least 0.7 cm in 6 months or 1.0 cm in 12 months) or saccular morphology; manufacturer¡¯s indications for the endovascular system that would be used if so assigned
    Exclusion criteria previous AAA repair; need for urgent repair
    Baseline characteristics
    aneurysm diameter 5.7 cm mean 
    concomitant coronary artery disease 41% 
    history of cerebrovascular accident 16% 
    low surgical risk score 53% 

    Method and design

    Randomized effectives 444 / 437 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 1.8y
    Number of centre 42
    Geographic area USA
    Hypothesis Superiority
    Primary endpoint Long-term all-cause mortality


    Results

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

    Long term death

    31 / 444
         43 / 437
         0,71 [0,46;1,10]

    30-day death

    1 / 444
         10 / 437
         0,10 [0,01;0,77]

    In-hospital death

    2 / 444
         13 / 437
         0,15 [0,03;0,67]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Long term death 31 / 444 (7,0%) 43 / 437 (9,8%) 0,71 [0,46;1,10] 2 years  11320 
    In-hospital death 2 / 444 (0,5%) 13 / 437 (3,0%) 0,15 [0,03;0,67]   11320 
    30-day death 1 / 444 (0,2%) 10 / 437 (2,3%) 0,10 [0,01;0,77] Within 30 d after repair  11320 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 11320: Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT Jr, Matsumura JS, Kohler TR, Lin PH, Jean-Claude JM, Cikrit DF, Swanson KM, Peduzzi PNOutcomes Following Endovascular vs Open Repair of Abdominal Aortic Aneurysm: A Randomized Trial.JAMA 2009;302:1535-1542

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Long term death 6,98% 9,84% -28,6‰
    In-hospital death 4,50‰ 2,97% -25,2‰
    30-day death 2,25‰ 2,29% -20,6‰


    Reference(s)

    Trials register # NCT00094575
    • Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT Jr, Matsumura JS, Kohler TR, Lin PH, Jean-Claude JM, Cikrit DF, Swanson KM, Peduzzi PN. Outcomes Following Endovascular vs Open Repair of Abdominal Aortic Aneurysm: A Randomized Trial.. JAMA 2009;302:1535-1542
      Pubmed | Hubmed | Fulltext

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