The Journal of thoracic and cardiovascular surgery · 2025
Propofol-supplemented cardioplegia: A multicenter blinded 3-group randomized trial (Propofol for Myocardial Protection Trial 2: ProMPT2).
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Angelini Gianni D, Smartt Helena J M, Joyce Katherine, Heys Rachael, Maishman Rachel, Culliford Lucy, de Jesus Samantha E, Fitzgerald Beth M, Suleiman M Saadeh, Punjabi Prakash, Nwaejike Nnamdi, Downes Richard, Gibbison Ben, Rogers Chris A
Аннотация
OBJECTIVE: Coronary artery bypass grafting using cardiopulmonary bypass and cardioplegic arrest is an effective treatment for coronary artery disease. Research suggests supplementing the cardioplegia solution with propofol may be cardioprotective. Our aim was to compare the safety and efficacy of supplementing the cardioplegia solution with different doses of propofol in adults undergoing first-time surgery.
METHODS: A blinded, parallel group randomized controlled trial conducted in 3 hospitals in the United Kingdom compared a cardioplegia solution supplemented with high-dose propofol (concentration 12 μg/mL), low-dose propofol (concentration 6 μg/mL), and placebo (saline). Primary outcome was cardiac troponin T measurements over the first 48 hours after surgery. Participants were followed for 12 months.
RESULTS: In total, 240 participants, median age 66 years, 90% male, were randomly allocated: 78 to high-dose propofol, 80 to low-dose propofol, and 82 to placebo. In total, 239 participants were included in the primary analysis. Geometric mean cardiac troponin release at 48 hours (95% confidence interval) was 145 ng/L (125-168), 162 ng/L (138-191), and 150 ng/L (125-180) in the high-dose propofol, low-dose propofol, and placebo groups, respectively (adjusted geometric mean ratio 1.06; 95% confidence interval, 0.97-1.15; P = .20, for pairwise comparisons between high- and low-dose propofol and between low-dose propofol and placebo). A total of 96 adverse events that prolonged the hospital stay or were life-threatening were reported (33, 26, and 37 in the high-dose propofol, low-dose propofol, and placebo groups, respectively), as well as 4 deaths (1 low-dose propofol group, 3 placebo group).
CONCLUSIONS: Propofol supplementation of warm blood cardioplegia at both the lower and higher concentrations is safe, but there is no evidence to suggest either dose is cardioprotective.
METHODS: A blinded, parallel group randomized controlled trial conducted in 3 hospitals in the United Kingdom compared a cardioplegia solution supplemented with high-dose propofol (concentration 12 μg/mL), low-dose propofol (concentration 6 μg/mL), and placebo (saline). Primary outcome was cardiac troponin T measurements over the first 48 hours after surgery. Participants were followed for 12 months.
RESULTS: In total, 240 participants, median age 66 years, 90% male, were randomly allocated: 78 to high-dose propofol, 80 to low-dose propofol, and 82 to placebo. In total, 239 participants were included in the primary analysis. Geometric mean cardiac troponin release at 48 hours (95% confidence interval) was 145 ng/L (125-168), 162 ng/L (138-191), and 150 ng/L (125-180) in the high-dose propofol, low-dose propofol, and placebo groups, respectively (adjusted geometric mean ratio 1.06; 95% confidence interval, 0.97-1.15; P = .20, for pairwise comparisons between high- and low-dose propofol and between low-dose propofol and placebo). A total of 96 adverse events that prolonged the hospital stay or were life-threatening were reported (33, 26, and 37 in the high-dose propofol, low-dose propofol, and placebo groups, respectively), as well as 4 deaths (1 low-dose propofol group, 3 placebo group).
CONCLUSIONS: Propofol supplementation of warm blood cardioplegia at both the lower and higher concentrations is safe, but there is no evidence to suggest either dose is cardioprotective.