Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery
- Registration Number
- NCT04223739
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
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
Randomized clinical study comparing landiolol and amiodarone for treatment of atrial fibrillation following cardiac surgery
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 380
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amiodarone Amiodarone Amiodarone bolus of 5-7 mg/kg in 1 hour, followed by an infusion of 1g/day until conversion to sinus rhythm. Landiolol Landiolol 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.
- Primary Outcome Measures
Name Time Method 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 Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery
- Secondary Outcome Measures
Name Time Method Severe hemorrhagic complications due to anticoagulant therapy, as defined by the Haute Autorité de Santé 2 months postsurgery and 1 year postsurgery 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
Quality of life evaluated by the EQ 5D 3L questionnaire 2 months postsurgery and 1 year postsurgery Quality of life as evaluated by the EQ 5D 3L questionnaire
Rate of atrial fibrillation recurrence 2 months postsurgery and 1 year postsurgery Percentage of patients having a recurrence of atrial fibrillation after the initial conversion to sinus rythm in the postoperative period
Length of hospital stay Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days Length of stay in the hospital from randomisation to hospital discharge
Rate of thrombo-embolic events 2 months postsugery and 1 year postsurgery Rate of stroke or ischemic embolism
Haemodynamic side effects (hypotension, bradycardia) Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days Haemodynamic side effects (hypotension, bradycardia)
Trial Locations
- Locations (1)
Caen University Hospital
🇫🇷Caen, Calvados, France