Atrial fibrillation: chronic, paroxsymal: no clear difference between propafenone and sotalol for controlling symptoms.

Clinical bottom line (level 1b-)

  1. Sotalol was not clearly more effective than propafenone at suppressing recurrent symptomatic atrial fibrillation in patients with chronic or paroxysmal atrial fibrillation.
  2. Two-thirds of patients had further symptoms within 12 months, but there was no clear difference between those given propafenone and those given sotalol.
  3. There was no clear difference in the number of withdrawals due to adverse effects.
Reimold et al: American Journal of Cardiology 1993; 71: 558-563
Expires November 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: university hospitals, USA

100 patients (aged mean 62 years, 64% male) with
  • atrial fibrillation or flutter on ECG
  • a history of at least one unsuccessful trial of antiarrhythmic (quinidine, procainamide, and disopyramide)
  • symptoms of light-headedness, palpitations, chest pain and dyspnoea with AF


Excluded if
  • <18 years old
  • acute MI within 7 days
  • transient AF or flutter related to pneumonia, PE, cardiac surgery, or uncontrolled heart failure
  • unstable hepatic or renal function
  • therapy with amiodarone for >1 month in the last year
  • history of polymorphic VT during treatment with antiarrhythmics
  • echo fraction < 30%


    • Note:
  • All patients had antiarrhythmics stopped for at least 5 half-lives.
  • Patients were stratified for type of fibrillation (chronic or paroxysmal) and size of left atrium before randomisation.


    • Control Group: (n = 50, 50 analysed): propafenone 150 to 300 mg po daily, increased to 300 mg tds if necessary. Patients with chronic AF received DC cardioversion if this failed
    Experimental Group: (n = 50, 50 analysed): sotalol 80 to 160 mg po daily increased to 480 mg po bd if necessary. Patients with chronic AF received DC cardioversion after a dose of 160 mg bd if this failed

    100% followed for 12 months
    Outcome notes:
    • recurrence of AF : confirmed by ECG, ambulatory or event monitoring

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    recurrence of AF 12 months 35
    (70.0%)    		 32
    (64.0%)    		 9%
    (-20% to 31%)    		 6.00%
    (-12.4% to 24.4%)    		 17
    (NNT = 4 to infinity;
    NNH = 8 to infinity)
    withdrawal due to side effects 12 months 4
    (8.00%)    		 6
    (12.0%)    		 -50%
    (-399% to 55%)    		 -4.00%
    (-15.7% to 7.73%)    		 -25
    (NNT = 13 to infinity;
    NNH = 6 to infinity)

    Comments

    1. The study is too small to show any clear differences between the two drugs.

    Citation

    1. Reimold SC, Cantillon CO, Friedman PL, et al: Propafenone versus sotalol for suppression of recurrent atrial fibrillation. American Journal of Cardiology 1993; 71: 558-563
    Contributor: Chris Ball and Clare Wotton, November 2000
    Reviewer:

    Clinical Question.
    Patient chronic AF
    Intervention or Exposure sotalol
    Comparison propafenone
    Outcome reversion to sinus rhythm, side effects