Empagliflozin in Patients With Type 2 Diabetes Undergoing On-Pump CABG: The POST-CABGDM Randomized Clinical Trial
Fábio Grunspun Pitta, Eduardo Gomes Lima, Caio de Assis Moura Tavares, Eduardo Bello Martins, Fabiana Hanna Rached, Eduardo Martelli Moreira, Bruno Mahler Mioto, Simão Augusto Lottenberg, Paula Mathias Paulino Bolta, Larissa Justino, Desidério Favarato, Letícia Neves Solon Carvalho, Henrique Trombini Pinesi, Camila Talita Machado Barbosa, Luís Alberto Oliveira Dallan, Luís Roberto Palma Dallan, Marcelo Henrique Moreira Barbosa, Roberto Kalil Filho, James A. de Lemos, Carlos Serrano
Abstract
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 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. RESULTS: 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. 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.