Metoprolol versus amiodarone in the prevention of atrial fibrillation after cardiac surgery: a randomized trial.
BACKGROUND
Current guidelines recommend β-blockers as the first-line preventive treatment of atrial fibrillation (AF) after cardiac surgery. Despite this, 19% of physicians report using amiodarone as first-line prophylaxis of postoperative AF. Data directly comparing the efficacy of these agents in preventing postoperative AF are lacking.


OBJECTIVE
To determine whether intravenous metoprolol and amiodarone are equally effective in preventing postoperative AF after cardiac surgery.


METHODS
Randomized, prospective, equivalence, open-label, multicenter study. (ClinicalTrials.gov registration number: NCT00784316)


METHODS
3 cardiac care referral centers in Finland.


METHODS
316 consecutive patients who were hemodynamically stable and free of mechanical ventilation and AF within 24 hours after cardiac surgery.


METHODS
Patients were randomly assigned to receive 48-hour infusion of metoprolol, 1 to 3 mg/h, according to heart rate, or amiodarone, 15 mg/kg of body weight daily, with a maximum daily dose of 1000 mg, starting 15 to 21 hours after cardiac surgery.


METHODS
The primary end point was the occurrence of the first AF episode or completion of the 48-hour infusion.


RESULTS
Atrial fibrillation occurred in 38 of 159 (23.9%) patients in the metoprolol group and 39 of 157 (24.8%) patients in the amiodarone group (P = 0.85). However, the difference (-0.9 percentage point [90% CI, -8.9 to 7.0 percentage points]) does not meet the prespecified equivalence margin of 5 percentage points. The adjusted hazard ratio of the metoprolol group compared with the amiodarone group was 1.09 (95% CI, 0.67 to 1.76).


CONCLUSIONS
Caregivers were not blinded to treatment allocation, and the trial evaluated only stable patients who were not at particularly elevated risk for AF. The withdrawal of preoperative β-blocker therapy may have increased the risk for AF in the amiodarone group.


CONCLUSIONS
The occurrence of AF was similar in the metoprolol and amiodarone groups. However, because of the wide range of the CIs, the authors cannot conclude that the 2 treatments were equally effective.


BACKGROUND
The Finnish Foundation for Cardiovascular Research and the Kuopio University EVO Foundation.
Kuopio University Hospital, Kuopio, Finland. jari.halonen@kuh.fi
Jari
J
Halonen
Pertti
P
Loponen
Otso
O
Järvinen
Jari
J
Karjalainen
Ilkka
I
Parviainen
Pirjo
P
Halonen
Jarkko
J
Magga
Anu
A
Turpeinen
Mikko
M
Hippeläinen
Juha
J
Hartikainen
Tapio
T
Hakala
D000319:Adrenergic beta-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000638:Amiodarone / Q000009:adverse effects / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000517:prevention & control*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D005260:Female; D005387:Finland; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008790:Metoprolol / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies
D000319:Adrenergic beta-Antagonists; D000889:Anti-Arrhythmia Agents; D008790:Metoprolol; D000638:Amiodarone