Amiodarone to Prevent Post-Operative Arrhythmias

Condition(s) targeted: Atrial Fibrillation

Intervention: amiodarone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Calgary

Official(s) and/or principal investigator(s):
L. Brent Mitchell, MD, Principal Investigator, Affiliation: University of Calgary

Rapid heart rhythms originating from the upper heart chambers (atrial tachyarrhythmias) are very common after open-heart surgery. The hypothesis of the PAPABEAR study is that a brief (13 day) peri-operative course of oral amiodarone therapy would be effective and safe for the prevention of these post-operative atrial tachyarrhythmias.

Official title: Prophylactic Amiodarone for the Prevention of Arrhythmias That Begin Early After Revascularization, Valve Replacement, or Repair - PAPABEAR

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

more than 5 minutes of post-operative atrial tachyarrhythmia

ventricular response rate of atrial tachyarrhythmias

burden of post-operate atrial tachyarrhythmias

length of hospital stay

Secondary outcome:

withdrawal of full-dose blinded therapy

non-fatal post-operative complications

hospital mortality

Detailed description: Six hundred and one patients who were about to undergo non-emergent open-heart surgery were randomized to receive oral amiodarone (10 mg/kg/day) or its matching placebo from six days before surgery through 6 days after surgery. The major outcome tracked was the incidence of more than 5 minutes of an atrial tachyarrhythmia that prompted therapy by the sixth post-operative day. Safety was assessed by the incidence of dosage reduction of blinded therapy, non-fatal post-operative complications, and in-hospital mortality. The randomization scheme was stratified to permit separate analysis of patients less than versus more than or equal to 65 years of age, patients having coronary artery bypass surgery alone versus those having valve surgery with or without concomitant bypass surgery, and patients also receiving versus not also receiving concomitant therapy with a beta-blocker medication.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- non-emergent coronary artery bypass surgery or valve replacement or repair

- informed consent

Exclusion Criteria:

- any heart rhythm other than sinus

- myocardial infarction within two weeks

- Class IV congestive Heart Failure

- requirement for antiarrhythmic drug therapy

- history of sustained atrial tachyarrhythmias

- treatment with amiodarone within 3 months

- sinus bradycardia (less than 50 bpm) while awake

- advanced conduction system disease

- prolonged QT interval

- clinical hypo- or hyperthyroidism

- women of child bearing potential

Libin Cardiovascular Institute / University of Calgary, Calgary, Alberta T2N 2T9, Canada

Starting date: February 1999
Ending date: September 2004
Last updated: May 4, 2006