(HealthDay News) — Ticagrelor plus aspirin compared with placebo plus aspirin is associated with a lower incidence of ischemic cardiovascular events but a higher incidence of major bleeding among patients with stable coronary artery disease and type 2 diabetes, according to a study published online in the New England Journal of Medicine. The research was published to coincide with the European Society of Cardiology Congress 2019, held from Aug. 31 to Sept. 4 in Paris.
P. Gabriel Steg, MD, from the Université de Paris, and colleagues randomly assigned 19,220 patients age 50 years or older who had stable coronary artery disease and type 2 diabetes mellitus to receive either ticagrelor plus aspirin or placebo plus aspirin. Patients with previous stroke or myocardial infarction were excluded.
The researchers found that the ticagrelor group had a lower incidence of ischemic cardiovascular events than the placebo group (7.7 vs 8.5%; hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.81 to 0.99; P=0.04) but a higher incidence of Thrombolysis in Myocardial Infarction major bleeding (2.2 vs 1.0%; HR, 2.32; 95% CI, 1.82 to 2.94; P<0.001) and intracranial hemorrhage (0.7 vs 0.5%; HR, 1.71; 95% CI, 1.18 to 2.48; P=0.005). The incidence of fatal bleeding did not differ significantly between the groups (0.2 vs 0.1%; HR, 1.90; 95% CI, 0.87 to 4.15; P=0.11). There was also no significant difference between the groups in the incidence of an exploratory composite outcome of irreversible harm (10.1 vs 10.8%; HR, 0.93; 95% CI, 0.86 to 1.02).
“The risk of a composite outcome of net irreversible harm was not significantly lower in the ticagrelor group than in the placebo group, which suggests that ticagrelor therapy does not have a favorable risk-benefit ratio in this trial population,” the authors write.
The study was funded by AstraZeneca, the manufacturer of ticagrelor.