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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 warfarin low dose
  •  

    MWNAF study, 1998

    download pdf: warfarin low dose | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment warfarin low dose (1.25mg/d)
    Control treatment warfarin standard dose( target INR 2.0-3.0)

    Patients

    Patients Patients over 60 with non rheumatic atrial fibrillation
    Inclusion criteria Patients were considered for this study if they were >60 years with chronic AF (documented by 2 electrocardiograms >2 weeks apart).
    Exclusion criteria Exclusion criteria comprised the following: (1) inability to obtain informed consent; (2) uncontrolled systolic hypertension (>180 mm Hg); (3) chronic renal failure (serum creatinine >3 mg/dl); (4) chronic liver failure (basal International Normalized Ratio [INR] >1.5); (5) chronic alcoholism or a psychiatric disorder; (6) major bleeding in the preceding 6 months; (7)heart failure (New York Heart Association classes III to IV); (8) if the patient was receiving antiplatelet therapy > or =1 week before; (9) life expectancy of <12 months; (10) planned cardioversion; (11) previous cerebral ischemia; (12) recent (<1 month) myocardial infarction; and (13) treatment with barbiturate or carbamazepine. Moreover, patients were excluded if they had mitral stenosis, moderate or severe mitral incompetence, dilated cardiomyopathy, or intracardiac thrombus.
    Baseline characteristics
    age(mean) 74.14 
    male(%) 45.04 
    hypertension(%) 60.03 
    diabete mellitus(%) 13.01 

    Method and design

    Randomized effectives 150 / 153 (studied vs. control)
    Design Parallel groups
    Blinding Open
    Follow-up duration 14.5 months
    Lost to follow-up 0.9%
    Number of centre nr but multicentric
    Geographic area Italy
    Hypothesis non inferiority
    Primary endpoint thromboembolic event,cerebral or fatal bleeding and vascular death
    Remarks Withdrawal from study treatment is reported here only unrelated to primary or secondary endpoints.
    Withdrawals (T1/T0) 16% / 15%


    Results

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

    Cardiovascular death

    5 / 150
    3 / 153
    classic 1,70 [0,41;6,99]

    thrombo-embolic event (cerebral or systemic)

    5 / 150
    0 / 153
    classic 21,42 [0,39;1 176,44]

    TE event or ischemic stroke or systemic embolism

    5 / 150
    0 / 153
    classic 21,42 [0,39;1 176,44]

    ischemic stroke

    5 / 150
    0 / 153
    classic 21,42 [0,39;1 176,44]

    MI (fatal and non fatal)

    1 / 150
    0 / 153
    classic 5,10 [0,07;371,47]

    Haemmorhagic stroke

    0 / 150
    1 / 153
    classic 0,20 [0,00;14,86]

    Major bleeding

    1 / 150
    4 / 153
    classic 0,26 [0,03;2,26]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Cardiovascular death 5 / 150 (3,3%) 3 / 153 (2,0%) 1,70 [0,41;6,99] death in which a non vacsular cause was not clearly documented
    thrombo-embolic event (cerebral or systemic) 5 / 150 (3,3%) 0 / 153 (0,3%) 10,20 [0,56;185,08]
    TE event or ischemic stroke or systemic embolism 5 / 150 (3,3%) 0 / 153 (0,3%) 10,20 [0,56;185,08] thrombo-embolic event, ischemic stroke or systemic embolism
    ischemic stroke 5 / 150 (3,3%) 0 / 153 (0,3%) 10,20 [0,56;185,08] sudden neurologic deficit lasting more than 24 hours in the absence of cerebral hemorrhage at neuroimaging
    MI (fatal and non fatal) 1 / 150 (0,7%) 0 / 153 (0,3%) 2,04 [0,07;60,36] typical chest pain,ECG changes,significant increase in cardiac enzymes
    Haemmorhagic stroke 0 / 150 (0,3%) 1 / 153 (0,7%) 0,51 [0,02;15,09] documented at neuroimaging
    Major bleeding 1 / 150 (0,7%) 4 / 153 (2,6%) 0,26 [0,03;2,26] fatal ;intracranial ,ocular,articular or retroperitoneal; requiring surgery or angiographic intervention; Hb reduction of 2 g/dL and/or need for transfusion of 2 blood units
    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.
    Cardiovascular death 3,33% 1,96% 1,4%
    Major bleeding 6,67‰ 2,61% -19,5‰

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events



    Reference(s)

    Trials register # NA
    • Pengo V, Zasso A, Barbero F, Banzato A, Nante G, Parissenti L, John N, Noventa F, Dalla Volta S. Effectiveness of fixed minidose warfarin in the prevention of thromboembolism and vascular death in nonrheumatic atrial fibrillation.. Am J Cardiol 1998 Aug 15;82:433-7
      Pubmed | Hubmed | Fulltext

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