Evaluating the limited impact of therapy with empagliflozin on primary PCI patients' outcomes: the ELITE-PCI trial

Objectives: Empagliflozin, a sodium-glucose co-transporter 2(SGLT2) inhibitor, has demonstrated cardiovascular benefits in various patient groups. However, its effects on patients undergoing primary percutaneous coronary intervention (PCI) have not been extensively studied. This research aims to assess the impact of empagliflozin on clinical outcomes for participants in the ELITE-PCI trial. Methods: The ELITE-PCI trial was a prospective, single-center, randomized, triple-blind, placebo-controlled study conducted from June 8, 2023, to May 25, 2024. It included 110 patients with acute myocardial infarction (AMI) undergoing primary PCI, who were assigned to receive either 10 mg of empagliflozin or a placebo. Clinical outcomes, including major adverse cardiovascular events (MACE) and rehospitalization rates, were assessed at 12 weeks post-intervention. Results: The study included 110 participants, with 55 in each group. The mean age was 59.9 years (±10.7) for the empagliflozin group and 58.1 years (±11.9) for the placebo group (p = 0.392). Both groups had a consistent sex distribution (90.9% male, p > 0.999). Baseline characteristics, including BMI, GFR, blood pressure, and left ventricular ejection fraction, showed no significant differences. Diabetes prevalence was 47.3% in the empagliflozin group and 43.6% in the placebo group (p = 0.702). At 12 weeks, MACE was absent, while the empagliflozin group had a 7.2% readmission rate, primarily due to pulmonary edema, compared to 5.4% in the placebo group(p=0.405). Conclusions: The findings of the ELITE-PCI trial suggest that short-term empagliflozin therapy does not have a significant impact on clinical outcomes in patients undergoing primary PCI. Nevertheless, these results highlight the necessity for further research to clarify the role of SGLT2 inhibitors within this patient population.