None listed
Conditions
Brief summary
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.
Interventions
Empagliflozin orally at 10mg daily for nine months.
Empagliflozin is to be commenced within 7 days of coronary stent procedure (as diabetic medications should be witheld peri-operatively)
Adherence will be assessed through laboratory test (HbA1c) and interview.
Sponsors
Northern Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Stable angina or non-culprit lesions in acute coronary syndrome • Planned for coronary stenting with a drug-eluting stent (everolimus-based) with distal reference vessel of at least 2.5 mm and estimated length of at most 48 mm • Diabetes on metformin without pre-treatment of SGLT2i • HbA1c below 10% • Adults (above 18 years old) who can provide informed consent
Exclusion criteria
• Culprit lesions in acute coronary syndrome • Patient with left main coronary artery stenosis • Patients with cardiogenic shock • Distal reference vessel < 2.5 mm • History of severe urosepsis • Concurrent pregnancy • eGFR < 45 ml/min
Outcome results
None listed