In late-breaking clinical trial results presented in a Hot Line Session today at the European Society of Cardiology Congress 2019, investigators from Brigham and Women’s Hospital and Greater Paris University Hospitals — AP-HP/Université de Paris presented the results from The Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS), a clinical trial sponsored by AstraZeneca that evaluated whether adding ticagrelor to aspirin improves outcomes for patients with stable coronary artery disease and diabetes mellitus but without a history of heart attack or stroke. Taking ticagrelor in addition to aspirin reduced the risk of a composite of cardiovascular death, heart attack, or stroke. Patients on this dual-antiplatelet therapy also experienced greater risk of major bleeding. In THEMIS-PCI, a study that specifically looked at THEMIS patients with a history of previous percutaneous coronary intervention (PCI) that includes stenting, versus the overall THEMIS population, investigators found even more favorable results for patients taking ticagrelor plus aspirin. Results of THEMIS are published simultaneously in The New England Journal of Medicine and results from THEMIS-PCI are published simultaneously in The Lancet.
“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.”