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 Sept. 1 in the New England Journal of Medicine.

P. Gabriel Steg, M.D., 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 versus 8.5 percent; hazard ratio [HR], 0.90; 95 percent confidence interval [CI], 0.81 to 0.99; P = 0.04) but a higher incidence of Thrombolysis in Myocardial Infarction major bleeding (2.2 versus 1.0 percent; HR, 2.32; 95 percent CI, 1.82 to 2.94; P < 0.001) and intracranial hemorrhage (0.7 versus 0.5 percent; HR, 1.71; 95 percent CI, 1.18 to 2.48; P = 0.005). The incidence of fatal bleeding did not differ significantly between the groups (0.2 versus 0.1 percent; HR, 1.90; 95 percent 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 versus 10.8 percent; HR, 0.93; 95 percent 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.

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