Amiodarone Reduction in Coronary Heart Trial - ARCH
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.
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.
Patients Enrolled: 300
Mean Follow Up: One month
Mean Patient Age: Mean of 64
Mean Ejection Fraction: Mean 45%
Patients undergoing standard open heart surgery; concurrent digoxin, beta-blockers, or calcium channel blockers for reasons other than any cardiac arrhythmia were allowed.
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
Incidence of atrial fibrillation requiring any treatment, and length of hospital stay
Time to first episode of atrial fibrillation, major morbidity and mortality, and cost of hospital stay
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.
All patients had temporary atrial and ventricular pacing wires.
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).
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.
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.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention
Keywords: Digoxin, Intention to Treat Analysis, Hospital Charges, Blood Pressure, Cardiac Surgical Procedures, Calcium Channel Blockers, Postoperative Period, Length of Stay
< Back to Listings