The GLORIOUS trial, presented at the American Heart Association's Scientific Sessions 2024 in Chicago, found that using exenatide during heart surgeries involving cardiopulmonary bypass did not provide significant benefits in reducing complications or mortality rates. The study involved approximately 1,400 adult patients undergoing coronary bypass grafting and/or surgical aortic valve replacement at a heart center in Denmark between 2016 and 2021. Participants were randomly assigned to receive either a six-hour and 15-minute infusion of exenatide or a placebo prior to surgery in a double-blind trial design.
Dr. Sebastian Wiberg, the lead investigator and an anesthesiologist at The Heart Centre, Copenhagen University Hospital Rigshospitalet, emphasized the importance of the study, stating, "There is a large unmet need for clinical trials investigating strategies to optimize treatment and reduce the risk of complications, such as organ injury, inflammation and the formation of blood clots." The findings, based on an average follow-up period of nearly six years, showed no significant differences in outcomes between the exenatide and placebo groups. Key results included a 14% mortality rate in the exenatide group versus 13% in the placebo group, 5.8% stroke incidence in the exenatide group compared to 4.8% in the placebo group, 9.8% new or worsening heart failure in the exenatide group versus 10% in the placebo group, and 4.8% acute kidney injury during initial hospitalization in the exenatide group compared to 5.3% in the placebo group.
These results suggest that the administration of exenatide in this context does not offer the organ-protective effects that were initially hypothesized. Dr. Wiberg noted, "We had hoped exenatide might protect patients from developing heart failure or other common complications after heart bypass surgery, however, the results suggest that this GLP-1 analog does not offer significant benefits." The study's findings are particularly relevant given the widespread use of cardiopulmonary bypass in heart surgeries. This technique, while crucial for many procedures, carries inherent risks including death, stroke, kidney failure, and new or worsening heart failure. The search for methods to mitigate these risks remains an important area of research in cardiac medicine.
It's important to note that the trial assessed the effects of a single treatment with exenatide over a relatively brief administration period at one heart center in Denmark. Dr. Wiberg cautioned that the results may not be generalizable to other medications or patient populations. He suggested that different GLP-1 analogs, longer administration periods, or larger doses might potentially yield different results. The GLORIOUS trial provides valuable insights into the complexities of perioperative care in cardiac surgery. While the results did not show the hoped-for benefits of exenatide, they underscore the critical need for continued research in this field. As Dr. Wiberg stated, "There is still a big gap in knowledge about how to best support patients on bypass during surgery, and there is an urgent need for more clinical trials to find ways to optimize patient health during and after bypass surgery." This study contributes to the growing body of evidence guiding best practices in cardiac surgery and highlights the importance of rigorous clinical trials in advancing patient care.
