Empagliflozin in Type 2 Diabetes Undergoing On-Pump CABG: The POST-CABGDM Randomized Clinical Trial

Objective: To evaluate the efficacy and safety of empagliflozin in patients with type 2 diabetes mellitus (T2DM) undergoing elective on-pump coronary artery bypass grafting (CABG)

Research Design and Methods: Investigator-initiated, pragmatic, single-center, randomized, open-label trial with blinded outcome adjudication conducted in Brazil. A total of 145 patients with T2DM scheduled for elective on-pump CABG were randomized to receive empagliflozin 25 mg daily plus standard care (n=71) for at least three months, discontinued 72 hours before surgery, or standard care alone (n=74). The primary outcome was postoperative acute kidney injury (AKI) within 7 days of surgery, defined by any creatinine-based criteria (AKIN, RIFLE, or KDIGO). Secondary outcomes included 30-day postoperative atrial fibrillation and type 5 myocardial infarction (MI). Safety outcomes were ketoacidosis, urinary tract infection, hospital-acquired pneumonia, and wound infection within 30 days post-CABG.

Results: AKI occurred in 22.5% of the empagliflozin group versus 39.1% in the control group (relative risk [RR], 0.57; 95% CI, 0.34–0.96; P = .03). Rates of atrial fibrillation (15.4% vs. 13.5%; RR, 1.15; 95% CI, 0.52–2.53; P = .73) and type 5 MI (1.4% vs. 4.1%; RR, 0.35; 95% CI, 0.04–3.26; P = .62) were similar between groups. No statistically significant differences between groups were observed for safety events. Three deaths occurred, all in the control group.

Conclusions: Empagliflozin use before on-pump CABG in patients with T2DM was associated with a reduced incidence of postoperative AKI without an increase in safety events These findings warrant confirmation in larger clinical trials.