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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 aspirin
  •  
     AFASAK II (aspirin vs warfarin low dose) study, 1998 TRC2617 
    download pdf: aspirin | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment aspirin 300 mg/d
    Control treatment warfarin low dose (1.25mg/d)
    Concomittant treatment Patients are informed not to take aspirin or NSAI drugs during the study period. If NSAI drugs are temporarily needed,the study treatment is interrupted for safety reasons.
    Remarks The trial includes 4 arms: fixed low dose warfarin (1.25mg/d),fixed low dose warfarin (1.25mg/d)+ aspirin 300mg,aspirin 300 mg and conventional warfarin therapy(target INR 2-3). The protocol allows 4 weeks per year without study treatment.

    Patients

    Patients chronic non valvular atrial fibrillation
    Inclusion criteria age>18;non valvuar atrial fibrillation documented on ECG twice,with an interval of at least one month.
    Exclusion criteria Patient under 60 with lone atrial fibrillation;thrombo-embolic event within the last 6 months;systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg;mitral stenosis;contraindication for warfarin or aspirin therapy;warfarin therapy based on other medical conditions,medical conditions requiring permanent nonsteroidal antiinflammatory drug therapy;noncompliance(alcoholism,psychiatric disease,dementia and foreign language);pregnancy and breast feeding.
    Baseline characteristics
    age(mean) 73.65 
    male(%) 62.02 
    systolic blood pressure(mean) 147.45 
    diastolic blood pressure(mean) 87.1 
    hypertension(%) 42.01 
    diabete mellitus(%) 11.99 
    prior TIA(%) 2.01 
    prior stroke(%) 4.5 
    left atrial dimension(mean in mm) 25.74 
    heart failure(%) 69.5 
    current smoker(%) 33.53 
    subgroup test

    Method and design

    Randomized effectives 169 / 167 (studied vs. control)
    Design Parallel groups
    Blinding Open
    Follow-up duration 3.5 years
    Lost to follow-up no lost to follow up
    Number of centre 1
    Geographic area Denmark
    Primary endpoint all stroke or systemic thromboembolic event
    Remarks Mean follow-up duration was not reported. The discontinuation of study treatment was reported globally(25.1% for reasons other than primary or secondary adverse events). Though the primary analysis of the study was made according to an "on treatment" approach ,an "intention to treat" analysis was performed for thrombo-embolic events to allow comparison with other studies.
    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)

    5 / 169
    6 / 167
    classic 0,82 [0,26;2,65]

    systemic thrombo-embolic complication

    1 / 169
    1 / 167
    classic 0,99 [0,06;15,67]

    stroke (fatal and non fatal)

    9 / 169
    14 / 167
    0,64 [0,28;1,43]

    ischemic stroke

    5 / 169
    6 / 167
    classic 0,82 [0,26;2,65]

    myocardial infarction (fatal and non fatal)

    4 / 169
    6 / 167
    classic 0,66 [0,19;2,29]

    All cause death

    14 / 169
    6 / 167
    classic 2,31 [0,91;5,86]

    Major bleeding

    5 / 169
    3 / 167
    classic 1,65 [0,40;6,78]

    Minor bleeding

    26 / 169
    21 / 167
    classic 1,22 [0,72;2,09]

    Haemmorhagic stroke

    1 / 169
    0 / 167
    classic 4,94 [0,07;360,09]

    Cardiovascular death

    4 / 169
    3 / 167
    classic 1,32 [0,30;5,80]

    Fatal stroke

    2 / 169
    2 / 167
    classic 0,99 [0,14;6,93]

    TE event or ischemic stroke or systemic embolism

    5 / 169
    6 / 167
    classic 0,82 [0,26;2,65]

    intracranial hemorrhage

    1 / 169
    1 / 167
    classic 0,99 [0,06;15,67]

    Adverse events

    10 / 169
    0 / 167
    classic 40,51 [0,77;2 129,02]
    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) 5 / 169 (3,0%) 6 / 167 (3,6%) 0,82 [0,26;2,65]  
    systemic thrombo-embolic complication 1 / 169 (0,6%) 1 / 167 (0,6%) 0,99 [0,06;15,67] systemic thromboembolic events in extremities,kidneys,mesenteric arteries,lungs,spleen,retina or grafts;verified using angiography,surgery,scintigraphy or autopsy 
    stroke (fatal and non fatal) 9 / 169 (5,3%) 14 / 167 (8,4%) 0,64 [0,28;1,43] acute onset of a focal neurogical deficit of presumed vascular genesis lasting for 24 hours or more 
    ischemic stroke 5 / 169 (3,0%) 6 / 167 (3,6%) 0,82 [0,26;2,65]  
    myocardial infarction (fatal and non fatal) 4 / 169 (2,4%) 6 / 167 (3,6%) 0,66 [0,19;2,29] 2 of the following criteria:history of typical chest pain,serial creatine kinase-MB changes typical of acute myocardial infarction, or ECG changes typical of acute myocardial infarction 
    All cause death 14 / 169 (8,3%) 6 / 167 (3,6%) 2,31 [0,91;5,86]  
    Major bleeding 5 / 169 (3,0%) 3 / 167 (1,8%) 1,65 [0,40;6,78] fatal,life threatening, requiring surgical treatment or blood transfusion(intracerebral bleeding included) 
    Minor bleeding 26 / 169 (15,4%) 21 / 167 (12,6%) 1,22 [0,72;2,09] overt or occult gastrointestinal tract bleeding, hemoptysis,gross hematuria,nose bleeding,bruising,symptomatic anemia ascribed to bleeding and chronic bleeding with moderate loss of blood 
    Haemmorhagic stroke 1 / 169 (0,6%) 0 / 167 (0,3%) 1,98 [0,07;58,52] traumatic intracranial hemorrhage excluded 
    Cardiovascular death 4 / 169 (2,4%) 3 / 167 (1,8%) 1,32 [0,30;5,80]  
    Fatal stroke 2 / 169 (1,2%) 2 / 167 (1,2%) 0,99 [0,14;6,93]  
    TE event or ischemic stroke or systemic embolism 5 / 169 (3,0%) 6 / 167 (3,6%) 0,82 [0,26;2,65] thrombo-embolic event, ischemic stroke or systemic embolism 
    intracranial hemorrhage 1 / 169 (0,6%) 1 / 167 (0,6%) 0,99 [0,06;15,67] traumatic intracranial hemorrhage excluded 
    Adverse events 10 / 169 (5,9%) 0 / 167 (0,3%) 19,76 [1,16;335,65]  
    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 3.5 years)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) 2,96% 3,59% -0,63%
    systemic thrombo-embolic complication 5,92‰ 5,99‰ -0,01%
    stroke (fatal and non fatal) 5,33% 8,38% -3,06%
    ischemic stroke 2,96% 3,59% -0,63%
    myocardial infarction (fatal and non fatal) 2,37% 3,59% -1,23%
    All cause death 8,28% 3,59% 4,7%
    Major bleeding 2,96% 1,80% 1,2%
    Minor bleeding 15,38% 12,57% 2,8%
    Cardiovascular death 2,37% 1,80% 0,57%
    Fatal stroke 1,18% 1,20% -0,01%
    TE event or ischemic stroke or systemic embolism 2,96% 3,59% -0,63%
    intracranial hemorrhage 5,92‰ 5,99‰ -0,01%

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events



    Reference(s)

    TrialResults-center ID TRC2617
    Trials register # NA
    • Gullov AL, Koefoed BG, Petersen P, Pedersen TS, Andersen ED, Godtfredsen J, Boysen G. Fixed minidose warfarin and aspirin alone and in combination vs adjusted-dose warfarin for stroke prevention in atrial fibrillation: Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study.. Arch Intern Med 1998 Jul 27;158:1513-21
      Pubmed | Hubmed | Fulltext

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