Jari Halonen, MD; Pertti Loponen, MD; Otso Järvinen, MD, PhD; Jari Karjalainen, MD, PhD; Ilkka Parviainen, MD, PhD; Pirjo Halonen, PhD; Jarkko Magga, MD, PhD; Anu Turpeinen, MD, PhD; Mikko Hippeläinen, MD, PhD; Juha Hartikainen, MD, PhD; Tapio Hakala, MD, PhD
Halonen J, Loponen P, Järvinen O, Karjalainen J, Parviainen I, Halonen P, et al. Metoprolol Versus Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Trial. Ann Intern Med. 2010;153:703-709. doi: 10.7326/0003-4819-153-11-201012070-00003
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Published: Ann Intern Med. 2010;153(11):703-709.
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.
To determine whether intravenous metoprolol and amiodarone are equally effective in preventing postoperative AF after cardiac surgery.
Randomized, prospective, equivalence, open-label, multicenter study. (ClinicalTrials.gov registration number: NCT00784316)
3 cardiac care referral centers in Finland.
316 consecutive patients who were hemodynamically stable and free of mechanical ventilation and AF within 24 hours after cardiac surgery.
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.
The primary end point was the occurrence of the first AF episode or completion of the 48-hour infusion.
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).
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.
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.
The Finnish Foundation for Cardiovascular Research and the Kuopio University EVO Foundation.
β-Blockers and amiodarone are used to prevent atrial fibrillation after cardiac surgery, although data directly comparing the 2 drugs are lacking.
In this study, β-blocker and amiodarone therapy started within 24 hours and continued for 48 hours after cardiac surgery resulted in similar rates of atrial fibrillation, but the CIs could not rule out a difference between the groups.
The study could not definitively establish the equivalence of the 2 treatments.
Additional studies are warranted.
* Reasons for exclusions: >24 h in the intensive care unit (n = 18), atrial fibrillation occurred before randomization (n = 6), temporary pacing was not functioning properly (n = 40), the operation was unexpectedly performed off pump (n = 7), patients had new second- or third-degree atrioventricular block (n = 13), heart rate <60 beats/min (n = 15), systolic blood pressure <100 mm Hg at randomization (n = 34), and patient received metoprolol before randomization (n = 6).
The exact time of atrial fibrillation was unknown for 1 patient in each group.
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