Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after Coronary Artery Bypass Graft Surgery [PACeS]

Evaluation of the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.

Inova Schar Heart and Vascular
Inova Fairfax Medical Campus
3300 Gallows Road
Falls Church, VA 22042

• Patients of age ≥18 years who undergo isolated CABG for coronary artery disease
• POAF that persists for >60 minutes or is recurrent (more than one episode) within 7 days after the original CABG surgery

• Clinical history of either permanent, persistent or paroxysmal atrial fibrillation
• Any pre-existing clinical indication for long-term OAC
• Any absolute contraindication to OAC
• Planned use of post-operative dual antiplatelet therapy (DAPT)*
• Cardiogenic shock
• Major perioperative complication** occurring between CABG and randomization
• Concomitant left atrial appendage closure during CABG
• Concomitant valve surgery during CABG (including aortic, mitral, tricuspid or pulmonary)
• Concomitant surgery for AF during CABG
• Closure of an atrial septal defect or of a patent foramen ovale during CABG
• Stage IV or V chronic kidney disease (estimated glomerular filtration rate [eGFR]< 30 mL/min/1.73m2)
• Liver cirrhosis or Child-Pugh Class C chronic liver disease
• Pharmacologic therapy with an investigational drug or device within 30-days prior to randomization or plan to enroll patient in an investigational drug or device trial during participation in this trial
• Pregnancy at the time of randomization
• Unable or unwilling to provide informed consent
• Unable or unwilling to comply with the study treatment and follow-up
• Existence of underlying disease that limits life expectancy to less than one year

* This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent.

** Including stroke, TIA, MI, major bleeding (BARC type 4 bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperation due to bleeding (e.g. pericardial tamponade).