The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery (CAFE)

What this Trial Is About

Researchers are evaluating a new comprehensive method to prevent paroxysms of atrial fibrillation in patients undergoing cardiac surgery, specifically coronary artery bypass grafting (CABG). This observational, cohort, prospective study aims to assess risk factors influencing atrial fibrillation development in the early postoperative period and to compare different therapies to reduce this risk. The study includes 140 patients diagnosed with coronary artery disease who will be treated according to current clinical guidelines. The study involves two groups: one group of 70 patients will receive pericardial fenestration during CABG using an original surgical technique and be prescribed colchicine (Colchicum-dispert) starting 4 hours before surgery and continuing twice daily for 10 days post-surgery. The other 70 patients will undergo standard CABG without pericardial fenestration and receive non-steroidal anti-inflammatory drugs (NSAIDs), specifically diclofenac at 100 mg daily, postoperatively. The colchicine prescription is decided by a medical council due to its off-label use for this purpose. Participants will be observed during the hospital postoperative period, ranging from 10 days to 4 weeks after surgery. Researchers will monitor the incidence of atrial fibrillation paroxysms as the primary outcome, along with secondary outcomes such as pneumonia, mediastinitis, levels of inflammatory and liver markers, kidney function, fluid volumes in the pericardium and pleura, and gastrointestinal disorders. Safety will be evaluated through standard treatment endpoints, and statistical analysis will be conducted to compare results between groups.

The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery