- NEWS . 28 Oct 2019
Patients with stable coronary disease and diabetes taking ticagrelor have lower incidence of ischaemic cardiovascular events compared with placebo plus aspirin
In patients with stable coronary artery disease and diabetes without a history of myocardial infarction or stroke, those who received ticagrelor plus aspirin had a lower incidence of ischaemic cardiovascular events but a higher incidence of major bleeding than those who received placebo plus aspirin.
The findings come from the randomized, double-blind trial called The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS), where a total of 20,108 patients were enrolled. Of these, 19,220 patients underwent randomization to receive either ticagrelor plus aspirin or placebo plus aspirin.
The incidence of ischaemic cardiovascular events (the primary efficacy outcome) was lower in the ticagrelor group than in the placebo group (7.7% vs 8.5%; hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.81–0.99; p=0.04), whereas the incidence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding was higher (2.2% vs 1.0%; HR, 2.32; 95% CI, 1.82–2.94; p<0.001), as was the incidence of intracranial haemorrhage (0.7% vs 0.5%; HR, 1.71; 95% CI, 1.18–2.48; p=0.005).
There was no significant difference in the incidence of fatal bleeding (0.2% vs 0.1%; HR, 1.90; 95% CI, 0.87–4.15; p= 0.11). The incidence of an exploratory composite outcome of irreversible harm (death from any cause, myocardial infarction, stroke, fatal bleeding or intracranial haemorrhage) was similar in the ticagrelor group.
Steg PG, et al. Ticagrelor in patients with stable coronary disease and diabetes. N Engl J Med 2019;381:1309-1320.