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Related trials

SORT-OUT-3, 2010 - zotarolimus eluting stent vs sirolimus eluting stent

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ISAR-DESIRE-2, 2010 - sirolimus eluting stent vs paclitaxel eluting stent

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ZEST (vs SES), 2009 - zotarolimus eluting stent vs sirolimus eluting stent

ZEST AMI (vs SES), 2009 - zotarolimus eluting stent vs sirolimus eluting stent

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See also:

  • All coronary artery disease clinical trials
  • All stable angina clinical trials
  • All clinical trials of myocardial revascularization
  • All clinical trials of sirolimus eluting stent
    		•  

    GISSOC II study, 2010

    [NCT00220558] download pdf: sirolimus eluting stent | myocardial revascularization for stable angina

    Treatments

    Studied treatment Sirolimus Eluting Stent
    Cypher Select-TM
    Control treatment Bare Metal Stent
    SONIC-TM
    Concomittant treatment clopidogrel for 6 months

    Patients

    Patients patients with Chronic Total Occlusion older than 1 month, and successful recanalization

    Method and design

    Randomized effectives 78 / 74 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 8 months
    Number of centre 13
    Geographic area Italy
    Primary endpoint in-segment minimal luminal diameter


    Results

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

    angiographic restenosis

    8 / 78
         50 / 74
         0,15 [0,08;0,30]

    2 yr TLR

    35 / 78
         6 / 74
         classic 5,53 [2,47;12,38]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    angiographic restenosis 8 / 78 (10,3%) 50 / 74 (67,6%) 0,15 [0,08;0,30]
    2 yr TLR 35 / 78 (44,9%) 6 / 74 (8,1%) 5,53 [2,47;12,38]
    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.
    angiographic restenosis 10,26% 67,57% -573,1‰
    2 yr TLR 44,87% 8,11% 36,8%

    Meta-analysis of all similar trials:

    Drug eluting stent in coronary artery disease for all type of patients

    Drug eluting stent in coronary artery disease for total occlusion

    myocardial revascularization in coronary artery disease for all type of patient

    myocardial revascularization in stable angina for all type of patient



    Reference(s)

    Trials register # NCT00220558
    Study web site link ,
    • Rubartelli P, Petronio AS, Guiducci V, Sganzerla P, Bolognese L, Galli M, Sheiban I, Chirillo F, Ramondo A, Bellotti S. Comparison of sirolimus-eluting and bare metal stent for treatment of patients with total coronary occlusions: results of the GISSOC II-GISE multicentre randomized trial.. Eur Heart J 2010;: - 10.1093/eurheartj/ehq199
      Pubmed | Hubmed | Fulltext

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