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Amiodarone Prophylaxis for Atrial Fibrillation After CABG - Amiodarone Prophylaxis for Atrial Fibrillation After CABG
Description:
The goal of the trial was to evaluate the safety and efficacy of amiodarone therapy compared with placebo for the prevention of postoperative atrial fibrillation (AF) after coronary artery bypass grafting (CABG).
Study Design
Study Design:
Patients Screened: 374
Patients Enrolled: 110
Mean Follow Up: Hospital discharge
Mean Patient Age: Mean age 66 years
Female: 18
Mean Ejection Fraction: Mean baseline ejection fraction 62%
Patient Populations:
Scheduled for CABG, normal sinus rhythm with heart rate >50 bpm, and met P-SAECG high-risk criteria
Exclusions:
Undergoing concomitant valve surgery; had a heart rate <50 bpm at rest, a second-degree or higher degree AV block, symptomatic sick sinus syndrome, pre-existing class I or III antiarrhythmic therapy, untreated thyroid disease, hemodynamically unstable condition, myocardial infarction in week prior to surgery, serum creatinine >2 mg/dl or serum aspartate aminotransferase or alanine aminotransferase concentration ≥4 normal values
Primary Endpoints:
Occurrence of AF in the postoperative period, defined as an electrocardiographically confirmed episode lasting >10 minutes
Secondary Endpoints:
Ventricular tachyarrhythmia after CABG, postoperative length of stay in ICU and in hospital associated with corresponding costs, amiodarone concentration, and incidence of an effective amiodarone concentration
Drug/Procedures Used:
Patients undergoing CABG and at high-risk for AF based on the P-wave signal-averaged electrocardiogram (P-SAECG) were randomized in a double-blind manner to amiodarone therapy (600 mg/d in 3 doses plus presurgery IV dose; n = 55) or placebo (n = 55). Therapy was to be administered for 1 day prior to surgery through 2-7 days after surgery.
Principal Findings:
No patients had a history of AF prior to the study. Baseline characteristics were similar between groups, with 91% of patients receiving an internal mammary artery graft and a mean surgery time of approximately 200 minutes.
The primary endpoint of AF occurred less frequently in the amiodarone arm compared with placebo (34% vs. 85%, p < 0.0001). There was no difference in the frequency of symptomatic AF (22% vs. 31%, p = 0.49). Symptomatic bradycardia after surgery occurred in 5% of the amiodarone group and 2% of the placebo group (p = 0.31). Length of hospital stay was shorter in the amiodarone arm (mean 11.3 days vs. 13.0 days, p = 0.03), as was intensive care unit (ICU) length of stay (1.8 days vs. 2.4 days, p = 0.001). As a result, hospitalization costs were lower in the amiodarone arm (18428 € vs. 19352 €, p = 0.007). Three patients in the amiodarone arm had adverse events requiring treatment withdraw.
Interpretation:
Among patients undergoing CABG surgery at high risk for AF, prophylaxis treatment with amiodarone was associated with a reduction in the primary endpoint of postoperative AF compared with placebo.
Results of the present study are similar to the larger PAPABEAR trial, which showed a reduction in postoperative AF/atrial flutter associated with prophylaxis amiodarone therapy. Beta-blocker therapy is the most studied prophylaxis therapy for preventing AF; however, there are many contraindications in high-risk cardiac surgery patients, and as such, it is not widely used. Amiodarone may offer another potential therapy to prevent AF in these patients, a complication that has been associated with hemodynamic deterioration, stroke and thromboembolic events, longer hospital stays, and increased costs.
References:
Budeus M, Hennersdorf M, Perings S, et al. Amiodarone prophylaxis for atrial fibrillation of high-risk patients after coronary bypass grafting: a prospective, double-blinded, placebo-controlled, randomized study. Eur Heart J 2006;27:1584-91.
Keywords: Stroke, Coronary Disease, Electrocardiography, Heart Rate, Length of Stay, Mammary Arteries, Bradycardia, Cardiac Surgical Procedures, Coronary Artery Bypass, Atrial Flutter
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