METHODS: We conducted a prospective, randomised, controlled trial. We supplied the treatment group with Tocovid capsules and the control group with placebo containing palm superolein.
RESULTS: Since January 2019, we have recruited the target population of 250 patients. However, the result is still blinded as we are still analysing blood samples for tocotrienol levels. 89.2% of patients completed the study with a 3.6% mortality and a 7.6% attrition rate. 35.2% of the patients developed POAF, the mean time being 46.06 ± 26.96 hours post-CABG. We did not observe any statistically significant difference when we compared left atrial size, New York Heart Association (NYHA) functional class, ejection fraction and premorbid history, besides EuroSCORE II (The European System for Cardiac Operative Risk Evaluation II) status except for older age group, right atrial size, and pleural effusion. There was also no difference in bypass time, cross clamp time or number of anastomoses. However, we noted a significant difference in death (p = 0.01) and renal failure requiring dialysis (p = 0.007) among patients with POAF; those patients also had a longer CICU stay (p = 0.005), HDU stay (p = 0.02), and total hospital stay (p = 0.001).
CONCLUSIONS: POAF is associated with a higher incidence of renal failure and death while it increases CICU, HDU, and total hospital stay. It remains to be seen whether Tocovid reduces POAF and its associated sequelae.
CLINICAL TRIAL REGISTRATION: NCT03807037 (Registered on 16 January 2019).