TY - JOUR
T1 - A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur
T2 - an interim blinded analysis
AU - Musa, Ahmad Farouk
AU - Dillon, Jeswant
AU - Md Taib, Mohamed Ezani
AU - Yunus, Alwi Mohamed
AU - Sanusi, Abdul Rais
AU - Nordin, Mohd Nazeri
AU - Smith, Julian A.
N1 - Funding Information:
The authors would like to extend their heartfelt gratitude to Dr Mohd Zahid Kamaruddin, Cardiothoracic Trainee, National Heart Institute, for his assiduous and untiring effort; Madam Irni Yusnida Mohd Rashid, Senior Study Coordinator, Clinical Research Department; the Clinical Research nurses; and our dedicated research assistants namely Mohd Ikhmal Othman, Anisah Zahirah Nor Aripin, and Ahmad Muziru Idham Adnan for making this study possible.
Funding Information:
This project was funded by HOVID Berhad: MMRD-MS-1801 and Malaysian Palm Oil Berhad (MPOB): MMRD-MS-2001. However, the funders had no role in the design of the project nor the preparation of this manuscript.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/11/24
Y1 - 2021/11/24
N2 - Introduction: Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. Aims: The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay. Methods: This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life. Results: Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045). Conclusion: A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037.
AB - Introduction: Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. Aims: The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay. Methods: This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life. Results: Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045). Conclusion: A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037.
KW - CABG
KW - Health-related quality of life (HRQoL)
KW - Length of hospital stay (LoHS)
KW - Morbidity
KW - Mortality
KW - Post-operative atrial fibrillation (POAF)
KW - Tocovid
UR - http://www.scopus.com/inward/record.url?scp=85119892265&partnerID=8YFLogxK
U2 - 10.1186/s13019-021-01721-6
DO - 10.1186/s13019-021-01721-6
M3 - Article
C2 - 34819126
AN - SCOPUS:85119892265
SN - 1749-8090
VL - 16
JO - Journal of Cardiothoracic Surgery
JF - Journal of Cardiothoracic Surgery
IS - 1
M1 - 340
ER -