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Systematic review and meta-analysis

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

atrial fibrillation - rythm control - all type of patients


Related trials

P-OM3 (Kowey), 2010 - n-3 PUFA vs placebo

Hot cafe, 2004 - electrical cardioversion vs rate control

STAF, 2003 - electrical cardioversion vs rate control

AF-CHF, 2002 - pharmacological cardioversion vs rate control

RACE, 2002 - electrical cardioversion vs rate control

AFFIRM, 2002 - pharmacological cardioversion vs rate control

PIAF, 2000 - pharmacological cardioversion vs rate control



See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of rythm control
  • All clinical trials of pharmacological cardioversion
  •  

    AFFIRM study, 2002

    [NCT00000556] download pdf: pharmacological cardioversion | rythm control for atrial fibrillation

    Treatments

    Studied treatment rhythm control - the antiarrhythmic drugs used included amiodarone, disopyramide, flecainide, moricizine, procainamide, propafenone, quinidine, sotalol, dofetilide or combinations chosen by the treating physician. cardioversion could be employed if necess
    Control treatment necessaryrate control - beta-blockers, calcium-channel blockers, digoxin or combination of these drug.

    Patients

    Patients patients with recurrent atrial fibrillation and who were at least 65 years of age or who had other risk factors for stroke or death
    Baseline characteristics
    Age (yr) 69.7 y 
    Female (%) 39.3 % 
    heart failure 23.1% 

    Method and design

    Randomized effectives 2033 / 2027 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration mean 3.5y
    Lost to follow-up n=26
    Primary endpoint overall mortality


    Results

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

    combined endpoint

    438 / 2033
    388 / 2027
    1,13 [1,00;1,27]

    Major bleeding

    113 / 2033
    126 / 2027
    0,89 [0,70;1,14]

    stroke or TIA

    80 / 2033
    77 / 2027
    1,04 [0,76;1,41]

    All cause death

    356 / 2033
    310 / 2027
    1,14 [1,00;1,32]

    Hospitalization for any reason

    1374 / 2033
    1220 / 2027
    1,12 [1,07;1,18]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    combined endpoint 438 / 2033 (21,5%) 388 / 2027 (19,1%) 1,13 [1,00;1,27]   10160
    Major bleeding 113 / 2033 (5,6%) 126 / 2027 (6,2%) 0,89 [0,70;1,14]   10160
    stroke or TIA 80 / 2033 (3,9%) 77 / 2027 (3,8%) 1,04 [0,76;1,41]   10161
    All cause death 356 / 2033 (17,5%) 310 / 2027 (15,3%) 1,14 [1,00;1,32]  
    Hospitalization for any reason 1374 / 2033 (67,6%) 1220 / 2027 (60,2%) 1,12 [1,07;1,18]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 10161: de Denus S, Sanoski CA, Carlsson J, Opolski G, Spinler SAArch Intern Med 2005;165:258-62
  • 10160: Testa L, Biondi-Zoccai GG, Dello Russo A, Bellocci F, Andreotti F, Crea FEur Heart J 2005;26:2000-6

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    combined endpoint 21,54% 19,14% 2,4%
    Major bleeding 5,56% 6,22% -6,6‰
    stroke or TIA 3,94% 3,80% 1,4‰
    All cause death 17,51% 15,29% 2,2%
    Hospitalization for any reason 67,58% 60,19% 7,4%

    Meta-analysis of all similar trials:

    rythm control in atrial fibrillation for all type of patients



    Reference(s)

    Trials register # NCT00000556
    • Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD. A comparison of rate control and rhythm control in patients with atrial fibrillation.. N Engl J Med 2002;347:1825-33
      Pubmed | Hubmed | Fulltext

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