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.
Clinical trial reg. no. NCT04523064, clinicaltrials.gov
This article contains supplementary material online at https://doi.org/10.2337/figshare.28655303.
