Recent results from a clinical trial that evaluated the addition of a drug called ‘ticagrelor’ to aspirin were shown to improve clinical outcomes for patients with stable coronary artery disease and diabetes mellitus. These patients in the study had no history of heart attack or stroke.
Findings from the clinical trial known as ‘The Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS), explained how the usage of ticagrelor with aspirin formed a dual-antiplatelet therapy that has reduced the risk of cardiovascular death, heart attack, and stroke. However, the study did show that patients on the dual therapy also experienced a greater risk of a major bleed and intracranial hemorrhage, particularly through an increased number of non-procedural subdural bleeds, in comparison to those who were on the placebo.
"With prolonged dual-antiplatelet therapy, we need to be thoughtful in considering which patients are most suited to taking the regimen -- that is, those at high ischemic risk and low bleeding risk," said THEMIS co-chair Deepak L. Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at the Brigham and professor of medicine at Harvard Medical School. "Our findings show that the greatest benefit occurred in those patients with diabetes and stable coronary artery disease with a history of prior stenting for whom ticagrelor, when added to aspirin, reduced important cardiovascular events, such as heart attacks, strokes and amputations."
THEMIS is the largest clinical trial study involving diabetic patients to date with more than 19,000 participants who have stable coronary artery disease and diabetes that were randomly selected to receive either ticagrelor plus aspirin (the dual antiplatelet therapy) or a placebo plus aspirin. These patients were studied over the course of three years
"The THEMIS population is a critically important one in which to understand the potential benefits of taking ticagrelor in addition to aspirin. As the number of people with diabetes continues to rise globally, we need to evaluate ways of improving long-term outcomes and preventing cardiovascular and ischemic events,” says THEMIS co-chair Philippe Gabriel Steg, MD, Chief of Cardiology at Hôpital Bichat, Greater Paris University Hospitals.
Learn more about the heart disease-diabetes connection:
"Our results indicate that among those with diabetes and stable coronary artery disease, we should focus on ticagrelor for patients with a history of prior stenting. This is an easily identifiable, logical sub-group," said Bhatt. "Studies currently support using long-term dual antiplatelet therapy for patients with the acute coronary syndrome who are at high ischemic risk but low bleeding risk. Our work suggests that a much broader population of patients with stable coronary artery disease and diabetes stand to benefit substantially."
Source: Science Daily