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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 coumadin low dose
    		•  

    PATAF (coumadin low dose vs coumadin standard dose) study, 1999

    Facebook    pdf : coumadin low dose - antithrombotics for atrial fibrillation

    Treatments

    Studied treatment coumarin low dose(target INR 1.1-1.6)
    Control treatment coumarin standard dose(target INR 2.5-3.5)
    Remarks The PATAF trial includes 2 strata: -patients eligible for standard intensity coumarin:randomly assigned to standard anticoagulation(INR 2.5-3.5),very low intensity anticoagulation(INR 1.1-1.6) or aspirin(150mg/d). -patients ineligible for standard anticoagulation:randomly assigned to very low intensity anticoagulation(INR 1.1-1.6) or aspirin(150mg/d).

    Patients

    Patients non rheumatic AF,recruited in general practice,with no established indication for anticoagulation.
    Inclusion criteria age >60;chronic or intermittent AF confirmed by ECG within the 2 past years;no established indication for coumarin
    Exclusion criteria General exclusion criteria:treatable cause of AF;previous stroke;rheumatic valvular disease,myocardial infarction or cardiovascular surgery in past year;cardiomyopathy(left ventricular ejection < 40%;chronic heart failure;cardiac aneurysm;history of systemic embolism;retinal infarction;coumarin use in the past 3 month;contra-indications for aspirin or coumarin;pacemaker;life expectancy < 2 years. Exclusion criteria for standard anticoagulation:age >78;retinopathy;ventricular or duodenal ulcer;history of gastro-intestinal or genito-urinary bleeding;diastolic blood pressure>105 mmHg or systolic pressure >185 mmHg or both.
    Baseline characteristics
    age(mean) 69.71 
    male(%) 50.27 
    systolic blood pressure(mean) 148.04 
    diastolic blood pressure(mean) 84 
    hypertension(%) 31.97 
    diabete mellitus(%) 13.74 
    prior myocardial infarction(%) 8.25 
    paroxysmal AF(%) 22.5 
    current smoker(%) 10.6 

    Method and design

    Randomized effectives 122 / 131 (studied vs. control)
    Design Parallel groups
    Blinding Simple aveugle
    Follow-up duration 2.7 years
    Lost to follow-up no lost to follow up
    Geographic area Netherlands
    Hypothesis non inferiority
    Primary endpoint stroke,systemic embolism,major haemorrhage and vascular death
    Remarks The study was carried out to show that aspirin is equivalent to warfarin, but the methodology used was inappropriate.The study team conducted an intention to treat analysis and assumed they could conclude to equivalence if no significant difference was found between treatments at the end of the study.But this hypothesis is wrong :if no difference has been found,no conclusion is possible,and particularly, equivalence can't be proven.
    Withdrawals (T1/T0) 26.2% / 32%


    Results

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

    All cause death

    8 / 122
         12 / 131
         0,72 [0,30;1,69]

    Cardiovascular death

    4 / 122
         9 / 131
         0,48 [0,15;1,51]

    Fatal stroke

    2 / 122
         0 / 131
         classic 9,66 [0,16;597,69]

    thrombo-embolic event (cerebral or systemic)

    3 / 122
         3 / 131
         classic 1,07 [0,22;5,22]

    TE event or ischemic stroke or systemic embolism

    3 / 122
         3 / 131
         classic 1,07 [0,22;5,22]

    stroke (fatal and non fatal)

    4 / 122
         3 / 131
         classic 1,43 [0,33;6,27]

    ischemic stroke

    3 / 122
         2 / 131
         classic 1,61 [0,27;9,48]

    Haemmorhagic stroke

    1 / 122
         1 / 131
         classic 1,07 [0,07;16,98]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    All cause death 8 / 122 (6,6%) 12 / 131 (9,2%) 0,72 [0,30;1,69]    
    Cardiovascular death 4 / 122 (3,3%) 9 / 131 (6,9%) 0,48 [0,15;1,51] within 4 weeks after stroke,systemic embolism,myocardial infarction,congestive heart failure or major bleeding or sudden death   
    Fatal stroke 2 / 122 (1,6%) 0 / 131 (0,4%) 4,30 [0,20;94,32]    
    thrombo-embolic event (cerebral or systemic) 3 / 122 (2,5%) 3 / 131 (2,3%) 1,07 [0,22;5,22]    
    TE event or ischemic stroke or systemic embolism 3 / 122 (2,5%) 3 / 131 (2,3%) 1,07 [0,22;5,22] thrombo-embolic event, ischemic stroke or systemic embolism   
    stroke (fatal and non fatal) 4 / 122 (3,3%) 3 / 131 (2,3%) 1,43 [0,33;6,27] classified as ischemic or hemorrhagic according to computed tomography   
    ischemic stroke 3 / 122 (2,5%) 2 / 131 (1,5%) 1,61 [0,27;9,48]    
    Haemmorhagic stroke 1 / 122 (0,8%) 1 / 131 (0,8%) 1,07 [0,07;16,98]    
    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.
    All cause death 6,56% 9,16% -26,0‰
    Cardiovascular death 3,28% 6,87% -35,9‰
    thrombo-embolic event (cerebral or systemic) 2,46% 2,29% 1,7‰
    TE event or ischemic stroke or systemic embolism 2,46% 2,29% 1,7‰
    stroke (fatal and non fatal) 3,28% 2,29% 9,9‰
    ischemic stroke 2,46% 1,53% 9,3‰
    Haemmorhagic stroke 8,20‰ 7,63‰ 0,6‰

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events



    Reference(s)

    Trials register # NA
    • Hellemons BS, Langenberg M, Lodder J, Vermeer F, Schouten HJ, Lemmens T, van Ree JW, Knottnerus JA. Primary prevention of arterial thromboembolism in non-rheumatic atrial fibrillation in primary care: randomised controlled trial comparing two intensities of coumarin with aspirin.. BMJ 1999 Oct 9;319:958-64
      Pubmed | Hubmed | Fulltext

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