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

Abstract

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). 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 3 months, which was discontinued 72 h before surgery, or to received standard care alone (n = 74). The primary outcome was postoperative acute kidney injury (AKI) within 7 days of surgery, defined by creatinine-based criteria (namely, Acute Kidney Injury Network; Risk, Injury, Failure, Loss of Kidney Function, and End-Stage Kidney Disease; or Kidney Disease: Improving Global Outcomes). 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 after CABG. AKI occurred in 22.5% of the empagliflozin group vs. 39.1% in the control group (relative risk [RR] 0.57 [95% CI 0.34-0.96]; P = 0.03). Rates of atrial fibrillation (15.4% vs. 13.5%; RR 1.15 [95% CI 0.52-2.53]; P = 0.73) and type 5 MI (1.4% vs. 4.1%; RR 0.35 [95% CI 0.04-3.26]; P = 0.62) were similar between groups. No statistically significant differences between groups were observed for safety events. Three deaths occurred, all in the control group. 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.