Benefit, Harm Seen for Ticagrelor Plus Aspirin in Stable CAD With T2DM

Incidence of ischemic cardiovascular events lower but major bleeding increased versus placebo plus aspirin

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TUESDAY, Sept. 3, 2019 (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 Sept. 1 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, 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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