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Randomized Controlled Trial Multicenter Study
Metoprolol versus amiodarone in the prevention of atrial fibrillation after cardiac surgery: a randomized trial.
- Jari Halonen, Pertti Loponen, Otso Järvinen, Jari Karjalainen, Ilkka Parviainen, Pirjo Halonen, Jarkko Magga, Anu Turpeinen, Mikko Hippeläinen, Juha Hartikainen, and Tapio Hakala.
- Kuopio University Hospital, Kuopio, Finland. jari.halonen@kuh.fi
- Ann. Intern. Med. 2010 Dec 7;153(11):703-9.
BackgroundCurrent 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.ObjectiveTo determine whether intravenous metoprolol and amiodarone are equally effective in preventing postoperative AF after cardiac surgery.DesignRandomized, prospective, equivalence, open-label, multicenter study. (ClinicalTrials.gov registration number: NCT00784316)Setting3 cardiac care referral centers in Finland.Patients316 consecutive patients who were hemodynamically stable and free of mechanical ventilation and AF within 24 hours after cardiac surgery.InterventionPatients 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.MeasurementsThe primary end point was the occurrence of the first AF episode or completion of the 48-hour infusion.ResultsAtrial 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).LimitationsCaregivers 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.ConclusionThe 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.Primary Funding SourceThe Finnish Foundation for Cardiovascular Research and the Kuopio University EVO Foundation.
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