Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery

Study Overview
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Brief Summary
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Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone. Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias. Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study. The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.

Detailed Description
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Randomized clinical study comparing landiolol and amiodarone for treatment of atrial fibrillation following cardiac surgery

Official Title
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Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery : a Randomized Multicenter Clinical Trial

Conditions
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Atrial Fibrillation, Cardiac Surgery

Intervention / Treatment
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* Drug: Landiolol
* Drug: Amiodarone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients hospitalized in the cardiac ICU after having undergone cardiac surgery (CABG, aortic valve or ascending aortic root replacement or a combination of both) New onset of atrial fibrillation lasting more than 30 minutes in the postoperative period after cardiac surgery French speaking patients Written consent Patients with social security insurance Exclusion Criteria: Hemodynamic instability requiring electrical cardioversion of atrial fibrillation Sepsis Bradyarrythmia (< 90/min) Patients requiring inotropes in the postoperative period Patient with pre-existing atrial fibrillation Patient with anticoagulant therapy before surgery Contraindication to amiodarone or beta-blockers Urgent surgery (< 24h), ventricular assist device, heart transplant, TAVR, mechanical valve, mitral or tricuspid valve replacement. No written consent Pregnant women, Underaged patients (<18 years old) Patients not able to give consent (curators, patients deprived of public rights)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Landiolol<br>Landiolol infusion starting at 2.5 µg/kg/min and titrating up to 80µg/kg/min with a heart rate goal of under 90 bpm. | Drug: Landiolol<br>* Landiolol infusion with incremental doses (range from 2,5µg/kg/min to 80 µg/kg/min) with go of heart rate < 90 bpm. Doses are modified every 10 minutes if necessary. Once heart rate goal is obtained, switch to an oral dose of Bisoprolol.<br>* Other names: Rapibloc;|
| Active Comparator: Amiodarone<br>Amiodarone bolus of 5-7 mg/kg in 1 hour, followed by an infusion of 1g/day until conversion to sinus rhythm. | Drug: Amiodarone<br>* Amiodarone loading dose of 5-7 mg/kg in 1 hour followed by an infusion of 1 g/day until conversion to sinus rhythm. Once sinus rhythm is obtained, switch to an oral dose of 200mg/day<br>* Other names: Cordarone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery | Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery | Day 2 after onset of atrial fibrillation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic side effects (hypotension, bradycardia) | Haemodynamic side effects (hypotension, bradycardia) | Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days | 
| Length of hospital stay | Length of stay in the hospital from randomisation to hospital discharge | Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days | 
| Rate of thrombo-embolic events | Rate of stroke or ischemic embolism | 2 months postsugery and 1 year postsurgery | 
| Quality of life evaluated by the EQ 5D 3L questionnaire | Quality of life as evaluated by the EQ 5D 3L questionnaire | 2 months postsurgery and 1 year postsurgery | 
| Rate of atrial fibrillation recurrence | Percentage of patients having a recurrence of atrial fibrillation after the initial conversion to sinus rythm in the postoperative period | 2 months postsurgery and 1 year postsurgery | 
| Severe hemorrhagic complications due to anticoagulant therapy, as defined by the Haute Autorité de Santé | Hemorrhagic complications requiring surgery or interventional radiology Hemorrhagic complications responsible of hemodynamic instability (Systolic Arterial Pressure < 90 mmHg, or drop of more than 40 mmHg or Mean Arterial Pressure < 65 mmHg or signs of shock) Life threatening hemorrhagic complications (intracerebral, intramedullar or intraocular hemorrhage, hemothorax, abdominal hemorrhage, deep muscular hemorrhage | 2 months postsurgery and 1 year postsurgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Atrial Fibrillation