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See also:

  • All acute myocardial infarction clinical trials
  • All clinical trials of PCI
  • All clinical trials of primary ballon angioplasty
  •  

    TRIANA study, 2009

    [NCT00257309] Facebook    pdf : primary ballon angioplasty - myocardial revascularization for acute myocardial infarction

    Treatments

    Studied treatment Tenecteplase + UFH (+/- clopidogrel)
    Control treatment Primary angioplasty
    single weight-adjusted dose of TNK along with UFH (60 U/kg bolus plus infusion with an aPTT 1.5-2)
    Treatments description
    Stent (%) 84% 

    Patients

    Patients >=75 years old with ST-segment elevation or LBBB AMI <6 hours of evolution without contraindications for thrombolytic therapy
    Inclusion criteria age >=75 years; chest pain or any symptom of myocardial ischemia >=20 minutes of duration, not responding to nitrate therapy within first 6 hours and at least one of the following: ST-elevation >=2 mm in >=2 precordial leads, ST-elevation >=1 mm in >=2 anterior leads, or de novo (or probably de novo) LBBB
    Exclusion criteria Cardiogenic shock, estimated door-to-balloon time >120 minutes, administration of thrombolysis within 14 days prior to randomization, GP IIa/IIIb inhibitor within 24 hours prior to randomization, or LMWH within 8 hours prior to randomization, current oral anticoagulant treatment, suspected AMI secondary to occlusion of a coronary lesion treated previously with PCI, known renal failure, reduced expected life expectancy (<12 months), documented contraindication to the use of thrombolytics, including active internal bleeding or known history of hemorrhagic diathesis; history of previous stroke; intracranial tumor, arteriovenous malformation, aneurysm or cerebral aneurysm repair; major surgery, parenchymal biopsy, ocular surgery or severe trauma within 6 weeks prior to randomization; unexplained puncture in a non-compressible vascular location within 24 hours of randomization; confirmed arterial hypertension during the acute phase prior to randomization with one reliable measurement of systolic BP>180 mmHg or diastolic BP >110 mmHg; known thrombocytopenia < 100.000 platelets/µL; prolonged (>20 minutes) or traumatic cardiopulmonary resuscitation in the 2 weeks prior to randomization; symptoms or signs suggesting aortic dissection
    Baseline characteristics
    Delay to treatment (PTCA vs thr) 195min (Thr) / 245min (PCI) 
    % female 44% 
    mean age 81y 

    Method and design

    Randomized effectives 132 / 134 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 30 days (12 months)
    Primary endpoint Death or Reinfarction or Disabling stroke


    Results

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

    MACE

    NA / 132
    NA / 134
    classic 1,46 [0,81;2,63]

    reinfarction

    NA / 132
    NA / 134
    classic 1,60 [0,60;4,26]

    In-hospital death

    NA / 132
    NA / 134
    classic 1,31 [0,67;2,56]

    stroke (fatal and non fatal)

    NA / 132
    NA / 134
    classic 4,03 [0,44;36,86]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    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.

    Meta-analysis of all similar trials:

    myocardial revascularization in acute myocardial infarction for Elderly patients

    myocardial revascularization in acute myocardial infarction for all type of patients

    PCI in acute myocardial infarction for all type of patients

    PCI in acute myocardial infarction for Elderly patients



    Reference(s)

    Trials register # NCT00257309
    • Clauw et al. The efficacy and safety of milnacpran in the treatment of fibromyalgia. 2007, poster 716
      Pubmed | Hubmed | Fulltext
    • Bueno H, Betriu A, Heras M, Alonso JJ, Cequier A, García EJ, López-Sendón JL, Macaya C, Hernández-Antolín R. Primary angioplasty vs. fibrinolysis in very old patients with acute myocardial infarction: TRIANA (TRatamiento del Infarto Agudo de miocardio eN Ancianos) randomized trial and pooled analysis with previous studies.. Eur Heart J 2010;: - 10.1093/eurheartj/ehq375
      Pubmed | Hubmed | Fulltext

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