BACKGROUND:Postoperative atrial fibrillation occurs in 5% to 65% of patients undergoing thoracic surgery. Although postoperative atrial fibrillation often is regarded as a temporary, benign, operation-related problem, it is associated with a twofold to threefold increase in risk of adverse events, including transient or permanent stroke, acute myocardial infarction, and death. METHODS: A total of 254 consecutively eligible enrolled patients undergoing surgery for lung cancer were included in this randomized, controlled, double-blinded trial. Patients received 300 mg of amiodarone or placebo intravenously over 20 minutes immediately after surgery and an oral dose of 600 mg of amiodarone or placebo twice daily during the first 5 postoperative days. RESULTS: The patients in the amiodarone prophylaxis group had a reduction in the risk of atrial fibrillation of 23% (12 to 31); number needed to treat was 4.4 (3.1 to 7.8). A total of 38 in the control group and 11 in the amiodarone group experienced atrial fibrillation (p<0.001). Adverse effects were observed in 10 patients equally distributed in both trial arms. CONCLUSIONS: Postoperative prophylaxis with a high dose of oral amiodarone after an intravenous bolus infusion is a safe, practical, feasible, and effective regimen for patients with lung cancer undergoing surgery. It significantly reduced the incidence of postoperative atrial fibrillation.
RCT Entities:
BACKGROUND:Postoperative atrial fibrillation occurs in 5% to 65% of patients undergoing thoracic surgery. Although postoperative atrial fibrillation often is regarded as a temporary, benign, operation-related problem, it is associated with a twofold to threefold increase in risk of adverse events, including transient or permanent stroke, acute myocardial infarction, and death. METHODS: A total of 254 consecutively eligible enrolled patients undergoing surgery for lung cancer were included in this randomized, controlled, double-blinded trial. Patients received 300 mg of amiodarone or placebo intravenously over 20 minutes immediately after surgery and an oral dose of 600 mg of amiodarone or placebo twice daily during the first 5 postoperative days. RESULTS: The patients in the amiodarone prophylaxis group had a reduction in the risk of atrial fibrillation of 23% (12 to 31); number needed to treat was 4.4 (3.1 to 7.8). A total of 38 in the control group and 11 in the amiodarone group experienced atrial fibrillation (p<0.001). Adverse effects were observed in 10 patients equally distributed in both trial arms. CONCLUSIONS: Postoperative prophylaxis with a high dose of oral amiodarone after an intravenous bolus infusion is a safe, practical, feasible, and effective regimen for patients with lung cancer undergoing surgery. It significantly reduced the incidence of postoperative atrial fibrillation.
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