Atrial Fibrillation, Cardiac Surgery
Conditions
Keywords
Cardiac Surgery, Atrial Fibrillation
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
Interventions
DRUGLandiolol
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.
DRUGAmiodarone
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
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
Countries
France
Contacts
Primary ContactEdouard Caspersen, MD
Backup ContactMarc-Olivier Fischer, MD-PhD
Outcome results
None listed