Taking ticagrelor plus 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.
The results from The Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS)—which evaluated whether adding ticagrelor to aspirin improves outcomes for patients with stable coronary artery disease (CAD) and diabetes mellitus but without a history of heart attack or stroke—were presented September 1 at the 2019 European Society of Cardiology Congress.
In THEMIS-PCI, a study specifically examining THEMIS patients with a history of previous percutaneous coronary intervention (PCI) that includes stenting, compared with the overall THEMIS population, investigators found even more favorable results for patients taking ticagrelor plus aspirin. The results from THEMIS are published in The New England Journal of Medicine and results from THEMIS-PCI, in The Lancet.
In THEMIS, the largest trial of patients with diabetes to date, more than 19,000 patients with stable CAD and diabetes were randomized to receive either ticagrelor plus aspirin or a placebo plus aspirin. Patients were followed for an average of more than three years. During that time, 736 of 9,619 patients (7.7%) taking ticagrelor plus aspirin experienced cardiovascular death, myocardial infarction, or stroke compared with 818 of 9,601 patients (8.5%) taking placebo plus aspirin—a 10% reduction.
Like other antiplatelet medications, ticagrelor increased the risk of major bleeding and intracranial hemorrhage compared with placebo. The difference in intracranial hemorrhages was driven by an increased number of traumatic bleeds, most of them subdural, and not by spontaneous or procedural bleeding.
In participants with prior PCI, risk reductions outweighed increased bleeding risks. Patients who had received PCI accounted for the majority of the total THEMIS population. Among those patients in THEMIS-PCI, 7.3% of participants taking ticagrelor plus aspirin experienced cardiovascular death, myocardial infarction, or stroke, compared with 8.6% of participants taking placebo plus aspirin—a 15% reduction.
Major bleeding occurred in 2.0% of patients receiving ticagrelor and in 1.1% of patients receiving placebo. The risk for intracranial bleeding was similar between ticagrelor and placebo (33 vs. 31 patients, respectively). Ticagrelor provided a very favorable balance of benefit versus risk—more than in patients without a history of PCI.
"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," said THEMIS co-chair Deepak L. Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at the Brigham and Women’s Hospital and professor of medicine at Harvard Medical School.
Studies currently support the use of long-term dual antiplatelet therapy for patients with acute coronary syndrome who are at high ischemic risk but low bleeding risk. But according to Dr. Bhatt, the THEMIS results “suggest that a much broader population of patients with stable CAD and diabetes stand to benefit substantially.”
Source: MedicalXpress, September 1, 2019