Findings from the Evaluating Lixisenatide in Acute Coronary Syndrome (ELIXA) trial showed that protein biomarkers including NT-proBNP could independently predict cardiovascular outcomes among patients with type 2 diabetes post-acute coronary syndrome (ACS).
The ELIXA data, presented in a late-breaking session at the American Diabetes Association (ADA) 2022 Scientific Sessions by Dr. Hertzel Gerstein, professor of medicine at McMaster University, showed increased NT-proBNP was associated with a 54% increased risk of major adverse cardiovascular events (MACE) per standard deviation in patients with type 2 diabetes after ACS (hazard ratio [HR], 1.54; 95% CI, 1.41 – 1.68). The increased biomarker was also associated with two-fold increased risk of death per standard deviation in the same patients (HR, 2.01; 95% CI, 1.78-2.29).
In an interview with HCPLive During ADA 2022, Gerstein reviewed the impact of the new ELIXA findings as they relate to assessing cardiovascular risk in patients with type 2 diabetes.
HCPLive: What is the understood risk of cardiovascular outcomes and mortality among patients with type 2 diabetes and ACS? What is its burden, relative to other high-risk cardiometabolic patient populations?
Gerstein: Diabetes is an independent risk factor for cardiovascular events. Regardless of background health status, people with diabetes are 1.5 to 3 times more likely to have a cardiovascular event compared with people without diabetes.
Could you provide a brief background of the proteins identified in the trial?
The ELIXA biomarker study showed 2 things:
- It provides further validation for a previously validated panel of 10 protein biomarkers for cardiovascular outcomes and 15 for death in people with diabetes. The degree to which these are causally related to cardiovascular disease or are markers of higher risk because of linkage with other causal factors remains unclear.
- It shows that in people with diabetes and prior ACS, the addition of only 1 protein alone, NT-proBNP, to routinely measured clinical risk factors differentiates those who will and will not develop a cardiovascular event to an extent that is similar to NT-proBNP plus other proteins. This supports routine measurement of NT-proBNP in people with type 2 diabetes as a prognostic marker for cardiovascular events and death.
What is the current value of NT-proBNP in assessing cardiovascular event or disease risk in patients? What is the status of its assessment in clinical practice—are we utilizing it enough?
NT-proBNP is typically used as part of the assessment of heart failure. The ELIXA biomarker study and other biomarker studies show that its prognostic utility extends to cardiovascular events and death.
What further research into cardiovascular outcome biomarkers is your team interested in on the basis of these findings?
Once biomarkers are identified, it is important to tease out which are causal and which are not, which can lead to therapeutic insights.
The study, “Cardiovascular Outcomes in People with Type 2 Diabetes and Acute Coronary Syndrome—The ELIXA Biomarker Study,” was presented at ADA 2022.