Adding the blood thinning drug ticagrelor to aspirin reduces the risk of heart attack or stroke caused by blood vessel blockage, but increased the risks of hemorrhage and bleeding, in people with type 2 diabetes.
The trial has investigated combining ticagrelor and aspirin and compared cardiovascular events with people that took aspirin alone.
The findings of the Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS) were unveiled at the European Society of Cardiology Congress 2019.
The study co-chair Dr Philippe Gabriel Steg, Chief of Cardiology at Hôpital Bichat, Greater Paris University Hospitals, said: 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.”
Cardiovascular events are problems that affect the heart and blood vessels throughout the body. Ischemic events are problems caused by blockages in blood vessels. Heart and blood vessels problems are common complications of diabetes.
More than 19,000 people were recruited into the research trial from 42 countries. They were all aged over 50, had type 2 diabetes and stable coronary artery disease, meaning they had not previously had a heart disease event such as heart attack or stroke.
They were randomly allocated to take either aspirin and ticagrelor or to take aspirin and a placebo. Participants were not informed whether they were taking ticagrelor or the placebo.
Senior author Professor Deepak L. Bhatt of Brigham and Women’s Hospital and Harvard Medical School, Bosto, said: “In the overall population studied in THEMIS, the reduction in important ischemic events was somewhat counterbalanced by the increase in bleeding. Therefore, it remains critical to identify which patients are at high ischemic risk, but low bleeding risk, who could benefit from ticagrelor and aspirin.
“There was a significant reduction in the primary endpoint of cardiovascular death, heart attack, and stroke with ticagrelor versus placebo. In addition to heart attack and stroke, acute limb ischemia and major amputations were also reduced with ticagrelor. Major bleeding was significantly increased.”
The findings of the THEMIS trial are published in the New England Journal of Medicine.
Similar results to the THEMIS trial were found in another trial, published in The Lancet journal that included people with diabetes that had previously had a stent put in. A stent is a metal or plastic tube inserted into a blood vessel to keep the blood vessel open.