Atrial fibrillation: new-onset: digoxin was not clearly better than placebo.

Clinical bottom line (level 1b-)

  1. Half of patients with new-onset atrial fibrillation reverted to normal sinus rhythm within 18 hours.
  2. Digoxin was not clearly better than placebo at making patients revert to normal sinus rhythm.
  3. The commonest causes of new-onset AF were alcohol, valvular heart disease and pulmonary disease.
Falk et al: Annals of Internal Medicine 1987; 106 (4): 503-506
Expires November 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: acute hospital, USA

36 patients (aged mean 59 years, ?% male) atrial fibrillation of > or = 7 days duration

Excluded if
  • on digitalis glycosides or antiarrhythmic agents
  • clinical or radiologic evidence of moderate or severe congestive heart failure
  • ventricular rate < 85, > 175
  • acute MI or unstable angina
  • ECG evidence of pre-excitation syndrome
  • potassium < 3.2 mmol/l
  • renal impairment: urea > 29 mmol/l, creatinine > 167 µ mol/l
  • severe acute hypoxia: pO 2 < 55 mmHg
  • severe metabolic disturbances, acidosis, sepsis or thyrotoxicosis


    • Control Group: (n = 18, 18 analysed): placebo
    Experimental Group: (n = 18, 18 analysed): digoxin loaded with 600 µ g and then 400 µ g 4hours later and then 200 µ g at 8 hours and 14 hours
    The study drug was not administered if the ventricular rate was < 70 beats/min at 8 or 14 hours.
    100% followed for 18 hours
    Outcome notes:
    • failure to revert to normal sinus rhythm : assessed by 12-lead ECG

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    failure to revert to normal sinus rhythm 18 hours 10
    (55.6%)    		 9
    (50.0%)    		 10%
    (-67% to 52%)    		 5.56%
    (-27.0% to 38.1%)    		 18
    (NNT = 3 to infinity;
    NNH = 4 to infinity)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    time to revert (hours) 3.3
    ()     		5.1
    ()     		1.8
    (-3.6 to 7.0)

  • Cause of AF:
    • alcohol: 10/36; 28% (13% to 42%)
    • valve disease: 7/36; 19% (6.5% to 32%)
    • pulmonary disease: 6/36; 17% (4.5% to 29%)
    • heart muscle disease: 3/36; 8.3% (0.0% to 17%)
    • hypertension: 2/36; 5.6% (0.0% to 13%)
    • coronary artery disease: 2/36; 5.6% (0.0% to 13%)

    • Comments

    1. The study is too small to show any potential benefit from using digoxin.

    Citation

    1. Falk RH, Knowlton AA, Bernard SA, et al: Digoxin for converting recent-onset atrial fibrillation to sinus rhythm: A randomized, double-blinded trial. Annals of Internal Medicine 1987; 106 (4): 503-506
    Contributor: Nick Shenker and Chris Ball, November 2000
    Reviewer:

    Clinical Question.
    Patient new onset AF
    Intervention or Exposure digoxin
    Comparison placebo
    Outcome reversion to sinus rhythm