Objectives: Amiodarone administration is presently considered in the prevention of new-onset postoperative atrial fibrillation (PAF) after cardiac operations, but relapse of PAF requiring anticoagulation therapy at ho...Objectives: Amiodarone administration is presently considered in the prevention of new-onset postoperative atrial fibrillation (PAF) after cardiac operations, but relapse of PAF requiring anticoagulation therapy at hospital discharge is prevalent despite amiodarone prophylaxis. PAF is also associated with increased morbidity and mortality including complications resulting from long-term anticoagulation therapy. Currently, the most effective therapy to prevent PAF after cardiac surgery remains undetermined. Inflammatory mechanisms may be partly responsible for PAF. Minocycline, a tetracycline antibiotic, has specifically an atrial myocytes anti-apoptotic effect, decreases right atrial tissue inflammation and oxidative stress activity. These observations led to this trial’s hypothesis that the addition of minocycline to amiodarone may favorably affect suppression of PAF. Methods: This trial compares the efficacy and safety of minocycline plus amiodarone versus amiodarone alone, in the prevention of PAF among adult patients undergoing cardiac procedures. All patients receive Beta-blocker agent. The primary outcome is PAF occurrence. Secondary outcomes include thromboembolic stroke, need for pharmacologic or electric cardioversion, mediastinal exploration for sepsis or for anticoagulation-related bleeding, serious drug side effects, length of hospital stay and 30-day mortality from cardiovascular causes. Results: This is an ongoing prospective single center randomized controlled clinical trial. Conclusion: The trial provides information on the comparative effectiveness of this low-risk prevention therapy of PAF that could be integrated in clinical practice. (Clinicaltrials.gov number, NCT 01422148).展开更多
文摘Objectives: Amiodarone administration is presently considered in the prevention of new-onset postoperative atrial fibrillation (PAF) after cardiac operations, but relapse of PAF requiring anticoagulation therapy at hospital discharge is prevalent despite amiodarone prophylaxis. PAF is also associated with increased morbidity and mortality including complications resulting from long-term anticoagulation therapy. Currently, the most effective therapy to prevent PAF after cardiac surgery remains undetermined. Inflammatory mechanisms may be partly responsible for PAF. Minocycline, a tetracycline antibiotic, has specifically an atrial myocytes anti-apoptotic effect, decreases right atrial tissue inflammation and oxidative stress activity. These observations led to this trial’s hypothesis that the addition of minocycline to amiodarone may favorably affect suppression of PAF. Methods: This trial compares the efficacy and safety of minocycline plus amiodarone versus amiodarone alone, in the prevention of PAF among adult patients undergoing cardiac procedures. All patients receive Beta-blocker agent. The primary outcome is PAF occurrence. Secondary outcomes include thromboembolic stroke, need for pharmacologic or electric cardioversion, mediastinal exploration for sepsis or for anticoagulation-related bleeding, serious drug side effects, length of hospital stay and 30-day mortality from cardiovascular causes. Results: This is an ongoing prospective single center randomized controlled clinical trial. Conclusion: The trial provides information on the comparative effectiveness of this low-risk prevention therapy of PAF that could be integrated in clinical practice. (Clinicaltrials.gov number, NCT 01422148).
