Log in to MyACC
Amiodarone Reduction in Coronary Heart Trial - ARCH
Description:
Amiodarone Reduction in Coronary Heart (ARCH) was a single-center, randomized, double-blinded trial designed to test whether low-dose intravenous (IV) amiodarone (1 g/day) would prevent atrial fibrillation and decrease hospital stay after open heart surgery compared with placebo.
Hypothesis:
Compared to placebo, treatment with low-dose IV amiodarone would be associated with a reduction in postoperative incidence of atrial fibrillation and reduced hospital stays.
Study Design
Study Design:
Patients Enrolled: 300
Mean Follow Up: One month
Mean Patient Age: Mean of 64
Female: 25
Mean Ejection Fraction: Mean 45%
Patient Populations:
Patients undergoing standard open heart surgery; concurrent digoxin, beta-blockers, or calcium channel blockers for reasons other than any cardiac arrhythmia were allowed.
Exclusions:
Patients undergoing other methods of cardiac surgery (standard median sternotomy), including lateral thoracotomy, “mid-cab,” or various thoracoscopic approaches; any history of atrial fibrillation; or taking class I or class III antiarrhythmic drugs
Primary Endpoints:
Incidence of atrial fibrillation requiring any treatment, and length of hospital stay
Secondary Endpoints:
Time to first episode of atrial fibrillation, major morbidity and mortality, and cost of hospital stay
Drug/Procedures Used:
Patients were randomized to amiodarone 1 g/day IV for two days or placebo. No loading dose was given; the drug was started within three hours of entry into the postoperative intensive care unit. The infusion was terminated for systolic blood pressure that was consistently <80 mg.
Concomitant Medications:
All patients had temporary atrial and ventricular pacing wires.
Principal Findings:
A total of 300 patients undergoing open heart surgery with no history of preoperative atrial fibrillation were randomized. There were no differences in baseline characteristics between the study groups; approximately 50% of patients were taking preoperative beta-blockers. Study drug was terminated prematurely in 4.4% of amiodarone-treated patients and 1.4% of placebo-treated patients (p=0.12).
In intention-to-treat analyses, atrial fibrillation developed in 47% of patients in the placebo group compared to 35% of patients in the amiodarone group (relative risk reduction of 26%, p=0.01), and these effects were observed within the first few days of treatment. The first episode of postoperative atrial fibrillation occurred on mean postoperative day 2.9 in the amiodarone-treated group and day 2.3 in the placebo group (p<0.01). Average hospital charges were not different among groups, and length of hospital stay was not significantly different for amiodarone versus placebo (7.6 days vs. 8.2 days, p=0.34).
Interpretation:
In this trial of postoperative IV amiodarone for the prevention of atrial fibrillation, treatment with amiodarone was generally well-tolerated and was associated with a decreased incidence of atrial fibrillation, but no difference in length of hospital stay. In the amiodarone-treated group, atrial fibrillation occurred soon after discontinuing the infusion, suggesting that preoperative treatment, higher doses, or continuing therapy for a longer period of time could potentially further affect the incidence of atrial fibrillation.
References:
Guarnieri T, Nolan S, Gottlieb SO, Dudek A, Lowry DR. Intravenous amiodarone for the prevention of atrial fibrillation after open heart surgery: the Amiodarone Reduction in Coronary Heart (ARCH) trial. J Am Coll Cardiol 1999;34:343-7.
Keywords: Digoxin, Intention to Treat Analysis, Hospital Charges, Blood Pressure, Cardiac Surgical Procedures, Calcium Channel Blockers, Postoperative Period, Length of Stay
< Back to Listings
