Atrial fibrillation: supraventricular tachycardia: paroxysmal: propafenone and flecainide were equally effective at prevention.

Clinical bottom line (level 1b-)

  1. A quarter of patients with recurrent episodes of atrial fibrillation or supraventricular tachycardia who received propafenone or flecainide had recurrent episodes within a year.
  2. A quarter of patients suffered adverse effects and a sixth stopped the medication.
  3. There were no clear differences between the two drugs.
Chimienti et al: European Heart Journal 1995; 16: 1943-1951
Expires November 2004

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: 18 acute hospitals, Italy

335 patients (aged mean 55 years, 50% male) paroxysmal atrial fibrillation or supraventricular tachycardia (two documented events within last four months)

Excluded if
  • aged <18 or >70
  • ejection fraction <35%
  • AV or intraventricular conduction defects, QRS duration >0.14 seconds, suspected or documented sick sinus syndrome
  • persistent AF >72 hours, documented ventricular tachycardia >30 seconds
  • heart failure NYHA class III or IV
  • hypertrophic cardiomyopathy
  • systolic blood pressure <90 mmHg
  • clinically significant valvular heart disease
  • hepatic disorders or renal insufficiency
  • thyroid disease
  • treatment with other antiarrhythmic drugs within five half-lives or 6 months if amiodarone


    • Control Group: (n = 166, 166 analysed): propafenone 150 mg tds po increased to 300 mg tds if required
    Experimental Group: (n = 169, 169 analysed): flecainide 50 mg po bd for SVT, 100 mg po bd for AF, increased to 150 mg bd if required

    95% followed for 12 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    recurrent paroxysms 12 months 43
    (25.9%)    		 40
    (23.7%)    		 9%
    (-33% to 37%)    		 2.23%
    (-7.01% to 11.5%)    		 45
    (NNT = 9 to infinity;
    NNH = 14 to infinity)
    adverse effects 12 months 37
    (22.3%)    		 39
    (23.1%)    		 -4%
    (-54% to 30%)    		 -0.79%
    (-9.76% to 8.18%)    		 -127
    (NNT = 12 to infinity;
    NNH = 10 to infinity)
    withdrawals 12 months 30
    (18.1%)    		 30
    (17.8%)    		 2%
    (-55% to 38%)    		 0.32%
    (-7.89% to 8.53%)    		 310
    (NNT = 12 to infinity;
    NNH = 13 to infinity)

  • One patient on propafenone developed VT.

    • Comments

    1. Patients were randomised in blocks of four.

    Citation

    1. Chimienti M, Cullen MT, Casadei G: Safety of flecainide versus propafenone for the long-term management of symptomatic paroxysmal supraventricular tachyarrhythmias: Report from the Flecainide and Propafenone Italian Safety (FAPIS) group. European Heart Journal 1995; 16: 1943-1951
    Contributor: Chris Ball and Clare Wotton, November 2000
    Reviewer:

    Clinical Question.
    Patient AF or SVT
    Intervention or Exposure flecainide
    Comparison propafenone
    Outcome recurrent paroxysms, adverse effects