Atrial fibrillation: acute and chronic: oral propafenone helped prevent symptomatic arrhythmias.

Clinical bottom line (level 1b)

  1. Patients with atrial fibrillation who received iv propafenone were not clearly more likely to cardiovert to sinus rhythm than patients on placebo. It had no clear effect on success of any subsequent DC cardioversion.
  2. Patients on oral propafenone were more likely to be free of symptomatic arrhythmias than patients on placebo (NNT = 3 at 6 months) .
  3. There was no clear difference in side-effects.
Stroobandt et al: American Journal of Cardiology 1997; 79: 418-423
Expires February 2004

The study

Double-blinded concealed randomised trial without intention-to-treat
Setting: 23 hospitals, Belgium & Holland

136 patients (aged range 27 to 84 years; mean 62, 73% male) with
  • recent-onset AF (lasting < 2 weeks)
  • chronic AF (lasting > 2 weeks)


Excluded if
  • <18 years old
  • NYHA class > 2 or signs/symptoms of heart failure
  • recent MI or cardiac surgery within two months, severe angina
  • hypotension (bp < 90 mmHg)
  • ECG evidence of ventricular pre-excitation, previous ECG evidence of 2nd, 3rd AV block, bpm < 50, sick sinus syndrome
  • history of life-threatening ventricular arrhythmias, severe COPD, PE
  • metabolic disturbances or thyroid dysfunction
  • unstable hepatic or renal function
  • evidence of digitalis intoxication and hypokalaemia (K < 4.0 mmol./l)
  • on amiodarone within 6 months, or currently on antiarrhythmics or cardiovascular drugs (except digoxin, diuretics) not discontinued within 5 half-lives


    • Control Group: (n = 35, 35 analysed): placebo
    Experimental Group: (n = 101, 101 analysed): propafenone iv 2mg/kg over 30 minutes, then 2 hours later 150 mg po every 8 hours

    100% followed for 6 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no pharmacological cardioversion 48 hours 29
    (82.9%)    		 72
    (71.3%)    		 14%
    (-5% to 29%)    		 11.6%
    (-3.72% to 26.9%)    		 9
    (NNT = 4 to infinity;
    NNH = 27 to infinity)
    no electrical cardioversion 48 hours 8
    (29.6%)    		 21
    (30.4%)    		 -3%
    (-103% to 48%)    		 -0.81%
    (-21.2% to 19.6%)    		 -120
    (NNT = 5 to infinity;
    NNH = 5 to infinity)
    not free from arrhythmia 6 months 23
    (65.7%)    		 33
    (32.7%)    		 50%
    (28% to 66%)    		 33.0%
    (14.9% to 51.2%)    		 3
    (2 to 7)
    side effects 6 months 5
    (14.3%)    		 10
    (9.90%)    		 31%
    (-89% to 75%)    		 4.38%
    (-8.59% to 17.4%)    		 23
    (NNT = 6 to infinity;
    NNH = 12 to infinity)

  • One patient on placebo died from VF following MI. No patients had a stroke.

    • Comments

    1. The study is too small to exclude any potential benefit from cardioversion with propafenone.

    Citation

    1. Stroobandt R, Stiels B, Hoebrechts R, et al: Propafenone for conversion and prophylaxis of atrial fibrillation. American Journal of Cardiology 1997; 79: 418-423
    Search Terms: atrial fibril* in Cochrane
    Contributor: Chris Ball and Clare Wotton, November 2000
    Reviewer:

    Clinical Question.
    Patient AF
    Intervention or Exposure propafenone
    Comparison placebo
    Outcome cardioversion