Stroke is the second-leading cause of death worldwide after ischemic heart disease.  Narrowing of the blood vessels leading to the brain (carotid stenosis) is an important cause of stroke, and this is often due to the buildup of cholesterol-rich plaques associated with atherosclerosis.  In patients with carotid stenosis, it is often recommended to undergo a procedure called “carotid endarterectomy” in which a surgeon removes the plaque from the carotid artery to reduce the risk of stroke.  Previous studies have shown that medication (statins) that reduces LDL cholesterol has the benefit of reducing stroke, cardiovascular events, and death in patients with carotid stenosis caused by atherosclerosis.  Recent research has demonstrated that the new medication evolocumab not only reduces LDL cholesterol significantly but also lowers the occurrence of cardiovascular disease.  Whether evolocumab therapy will benefit individuals with carotid stenosis is unknown.  Given that individuals with diabetes are at a heightened risk of stroke and death following endarterectomy, the CEA Evolocumab randomized clinical trial has been designed to determine if people with carotid stenosis and diabetes may benefit from evolucumab treatment.  The results of this innovative approach may provide new ways to treat patients with carotid stenosis to reduce the risk of stroke and death. This multi-centre trial is being coordinated through CMS.

The EMPA-HEART (Effects of Empagliflozin on Cardiac Structure in Patients with Type 2 Diabetes) Trial recently demonstrated in individuals with type 2 diabetes and stable coronary artery disease that empagliflozin treatment for 6 months resulted in reduced left ventricular mass (Circulation. 2019 Aug 22. doi: 10.1161/CIRCULATIONAHA.119.042375).

As a follow-up, the EMPA-HEART 2 trial seeks to determine if a similar empagliflozin regime will elicit similar left ventricular mass regression in people without diabetes but with risk factors for left ventricular hypertrophy.  This trial has significant translational potential and may provide critical clinical and scientific insights into the therapeutic use of SGLT2 inhibitors in the absence of overt type 2 diabetes.  The EMPA-HEART 2 trial will enroll participants from several countries and will be coordinated by CMS.