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Systematic review and meta-analysis

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

atrial fibrillation - antithrombotics - primary prevention of thromboembolic events


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See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of triflusal
  •  
     NASPEAF (triflusal vs coumadin standard dose)) study, 2004 TRC2652 
    download pdf: triflusal | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment Triflusal 600 mg/d
    The antiplatelet agent used was triflusal (Grupo Uriach,Spain), a drug structurally related to acetylsalicylic acid ,of which clinical trials showed that 600 mg/day has similar biologic effects and clinical efficacy to aspirin 300 mg/day with fewer bleeding complications.
    Control treatment coumadin standard dose(target INR 2-3)
    The anticoagulant used was acenocoumarol (Novartis Farmaceutica,Spain), the coumarin derivative most used in several European countries.

    Patients

    Patients Non valvular atrial fibrillation. Intermediate risk patients.
    Inclusion criteria Eligible patients were divided in two groups: the high-risk group included nonvalvular plus prior embolism and patients with mitral stenosis with and without prior embolism. All others were included in the intermediate-risk group.
    Exclusion criteria Patients at low risk according to Stroke Prevention in Atrial Fibrillation (SPAF) III stratification or younger than 60 years of age were not included.Exclusion criteria were mechanical valve prosthesis, stroke in the previous six months, serum creatinine over 3 mg/dl, alcoholism or drug addiction, severe uncontrolled hypertension, diffuse arteriosclerosis, and indication for non-steroidal anti-inflammatory drugs or indication/contraindication for antiplatelet or anticoagulant therapy.
    Baseline characteristics
    age(mean) 69.75 
    male(%) 55.81 
    systolic blood pressure(mean) 136.52 
    diastolic blood pressure(mean) 79.51 
    hypertension(%) 43.84 
    diabete mellitus(%) 17.05 
    prior TIA or stroke(%)
    paroxysmal AF(%) 10.25 
    left atrial dimension(mean in mm) 46.79 
    heart failure(%) 16.89 
    current smoker(%) 38.19 
    subgroup test

    Method and design

    Randomized effectives 242 / 237 (studied vs. control)
    Design Parallel groups
    Blinding Open
    Follow-up duration 2.76 years
    Lost to follow-up 2.5%
    Number of centre 13
    Geographic area Spain
    Hypothesis superiority
    Primary endpoint vascular death,TIA,nonfatal stroke or systemic embolism
    Remarks Withdrawals from study treatments are not reported separetely:9% were withdrawn for adverse events without significant difference among groups,9.3% were withdrawn secondary to gp or patient's decision.
    Withdrawals (T1/T0) nr / nr


    Results

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

    thrombo-embolic event (cerebral or systemic)

    15 / 235
    7 / 232
    classic 2,12 [0,88;5,09]

    systemic thrombo-embolic complication

    1 / 235
    1 / 232
    classic 0,99 [0,06;15,69]

    stroke (fatal and non fatal)

    11 / 235
    6 / 232
    classic 1,81 [0,68;4,81]

    myocardial infarction (fatal and non fatal)

    1 / 235
    0 / 232
    classic 4,94 [0,07;360,29]

    All cause death

    15 / 235
    20 / 232
    0,74 [0,39;1,41]

    Major bleeding

    2 / 235
    10 / 232
    0,20 [0,04;0,89]

    Minor bleeding

    5 / 235
    15 / 232
    0,33 [0,12;0,89]

    Haemmorhagic stroke

    2 / 235
    1 / 232
    classic 1,97 [0,18;21,63]

    Fatal bleeding

    0 / 235
    0 / 232
    classic 0,99 [0,00;251,62]

    Cardiovascular death

    8 / 235
    11 / 232
    0,72 [0,29;1,75]

    Fatal stroke

    1 / 235
    3 / 232
    classic 0,33 [0,03;3,14]

    TE event or ischemic stroke or systemic embolism

    15 / 235
    7 / 232
    classic 2,12 [0,88;5,09]

    Non fatal stroke

    10 / 235
    3 / 232
    classic 3,29 [0,92;11,81]

    intracranial hemorrhage

    2 / 235
    4 / 232
    classic 0,49 [0,09;2,67]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) 15 / 235 (6,4%) 7 / 232 (3,0%) 2,12 [0,88;5,09]  
    systemic thrombo-embolic complication 1 / 235 (0,4%) 1 / 232 (0,4%) 0,99 [0,06;15,69] abrupt vascular insufficiency without previous clinical symptoms 
    stroke (fatal and non fatal) 11 / 235 (4,7%) 6 / 232 (2,6%) 1,81 [0,68;4,81] focal neurologic deficit lasting more than 24 hours,the ischemic or hemorrhagic etiology was defined by neuroimaging 
    myocardial infarction (fatal and non fatal) 1 / 235 (0,4%) 0 / 232 (0,2%) 1,97 [0,07;58,57]  
    All cause death 15 / 235 (6,4%) 20 / 232 (8,6%) 0,74 [0,39;1,41]  
    Major bleeding 2 / 235 (0,9%) 10 / 232 (4,3%) 0,20 [0,04;0,89] bleeding requiring hospital admission, blood transfusion or surgery (intracranial and intracerebral bleedings included) 
    Minor bleeding 5 / 235 (2,1%) 15 / 232 (6,5%) 0,33 [0,12;0,89]  
    Haemmorhagic stroke 2 / 235 (0,9%) 1 / 232 (0,4%) 1,97 [0,18;21,63]  
    Fatal bleeding 0 / 235 (0,2%) 0 / 232 (0,2%) 0,99 [0,02;49,55]  
    Cardiovascular death 8 / 235 (3,4%) 11 / 232 (4,7%) 0,72 [0,29;1,75] either sudden or any other death occuring within 30 days after a vascular event or progressive heart failure 
    Fatal stroke 1 / 235 (0,4%) 3 / 232 (1,3%) 0,33 [0,03;3,14]  
    TE event or ischemic stroke or systemic embolism 15 / 235 (6,4%) 7 / 232 (3,0%) 2,12 [0,88;5,09] thrombo-embolic event, ischemic stroke or systemic embolism 
    Non fatal stroke 10 / 235 (4,3%) 3 / 232 (1,3%) 3,29 [0,92;11,81]  
    intracranial hemorrhage 2 / 235 (0,9%) 4 / 232 (1,7%) 0,49 [0,09;2,67]  
    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 (for a follow-up of 2.76 years)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) 6,38% 3,02% 3,4%
    systemic thrombo-embolic complication 4,26‰ 4,31‰ -0,01%
    stroke (fatal and non fatal) 4,68% 2,59% 2,1%
    All cause death 6,38% 8,62% -2,24%
    Major bleeding 8,51‰ 4,31% -3,46%
    Minor bleeding 2,13% 6,47% -4,34%
    Haemmorhagic stroke 8,51‰ 4,31‰ 0,42%
    Cardiovascular death 3,40% 4,74% -1,34%
    Fatal stroke 4,26‰ 1,29% -0,87%
    TE event or ischemic stroke or systemic embolism 6,38% 3,02% 3,4%
    Non fatal stroke 4,26% 1,29% 3,0%
    intracranial hemorrhage 8,51‰ 1,72% -0,87%

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events



    Reference(s)

    TrialResults-center ID TRC2652
    Trials register # NA
    • Perez-Gomez F, Alegria E, Berjon J, Iriarte JA, Zumalde J, Salvador A, Mataix L. Comparative effects of antiplatelet, anticoagulant, or combined therapy in patients with valvular and nonvalvular atrial fibrillation: a randomized multicenter study.. J Am Coll Cardiol 2004 Oct 19;44:1557-66
      Pubmed | Hubmed | Fulltext

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