EMPRESS Trial: Assessing the efficacy of EMPagliflozin in REducing Coronary Stent ReStenosis Rates in Type 2 Diabetes

Diabetic patients are at higher risk of stent failure and heart attacks following percutaneous coronary intervention (PCI). Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are second-line therapy in diabetes and certain SGLT2i (empagliflozin) have been shown to reduce cardiovascular events. Observational data have suggested reduced coronary restenosis rates with SGLT2i following PCI, regardless of glycaemic control. An animal model study demonstrated the plaque-stabilising effects of SGLT2i through the reduction in lipid core and increasing fibrous cap thickness. This study explores the role of empagliflozin in reducing the risk of coronary stent restenosis in diabetic patients. Diabetic patients undergoing PCI in a non-emergency setting will be randomised to either empagliflozin or standard of care (non-SGLT2 inhibitor treatments for diabetes). All patients will receive intravascular imaging at baseline and at 9 months following PCI. The primary outcome of this study is the degree of lumen loss at follow-up, a marker of stent restenosis. Other markers that will be examined include strut coverage, stent mal-apposition and neo-intimal growth. In the world’s first study, we will also examine the impact of empagliflozin on coronary plaque morphology such as fibrous cap thickness, lipid plaque volume and plaque regression over time. This will provide additional knowledge on the impact of SGLT2i on vascular healing and plaque stabilisation.