Atrial fibrillation: paroxysmal or chronic: amiodarone maintained sinus rhythm better than sotalol but caused more adverse effects

Clinical bottom line (level 1b)

  1. Patients with paroxysmal or chronic atrial fibrillation, currently in sinus rhythm who received amiodarone compared with sotalol were less likely to relapse into AF (NNT = 3 at 22 months) , but more likely to stop medication due to adverse effects (NNH = 8 at 22 months) .
Kochiadakis et al: Heart 2000; 84 : 251-257
Expires November 2003

The study

Single-blinded concealed randomised trial with intention-to-treat
Setting: university hospital, Greece

186 patients (aged mean 63, 52% male) with symptomatic paroxysmal or chronic atrial fibrillation (confirmed on ECG) who successfully cardioverted to sinus rhythm

Excluded if
  • previous exposure to either amiodarone or sotalol
  • aged < 18
  • acute myocardial infarction within previous 7 dahys
  • cardiogenic shock
  • transient AF related to ongoing process such as pneumonia, recenty cardiac surgery, uncontrolled heart failure, pulmonary embolism
  • ejection fraction < 40%
  • hyperthyroidism
  • major medical problem with a life expectancy < 1 year

    Control Group: (n = 60, 60 analysed): placebo
    Experimental Group: (n = 65, 65 analysed): amiodarone 15 mg/kg for 7 days, then 10 mg/kg for 7 days, then tapered to 200 mg daily over 7-12 days
    Experimental Group: (n = 61, 61 analysed): sotalol 80 mg twice daily, increased in 40-80 mg increments every 48 hours until a maximum dose of 480 mg daily was reached

    100% followed for 22 months

    The evidence

    amiodarone v. sotalol
    Outcome Time to outcome CER EER RRR
    (95% CI)    		 ARR
    (95% CI)    		 NN T
    (95% CI)
    reversion to AF 22 months 47
    (77.1%)    		 31
    (47.7%)    		 38%
    (17% to 54%)    		 29.4%
    (13.3% to 45.4%)    		 3
    (2 to 8)
    adverse effects leading to withdrawal 22 months 3
    (4.92%)    		 11
    (16.9%)    		 -240%
    (-1100% to -1%)    		 -12.0%
    (-22.6% to -1.40%)    		 -8
    (-72 to -4)

    Comments

    1. As reported in other studies, both amiodarone and sotalol were more effective than placebo at preventing relapse to AF (p < 0.001)

    Citation

    1. Kochiadakis GE, Igoumenidis NE, Marketou ME, et al: low dose amiodarone and sotalol in the treatment of recurrent, symptomatic atrial fibrillation: a comparative, placebo-controlled study. Heart 2000; 84 : 251-257
    Search Terms: from ACP Journal Club
    Contributor: Chris Ball, November 2001
    Reviewer:

    Clinical Question.
    Patient paroxysmal or chronic AF in sinus rhythm
    Intervention or Exposure amiodarone
    Comparison sotalol
    Outcome adverse effects, sinus rhythm