- In patients with stable coronary artery disease (CAD) and diabetes mellitus without a history of myocardial infarction (MI) or stroke, ticagrelor plus aspirin was associated with a lower incidence of ischaemic cardiovascular (CV) events but was associated with a higher incidence of major bleeding compared with placebo plus aspirin.
Why this matters
- The benefits of dual antiplatelet therapy with ticagrelor plus aspirin in patients with stable CAD and diabetes mellitus and without a history of MI or stroke remain unclear.
- The Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS) including 19,220 patients with CAD and diabetes mellitus who were randomly assigned to receive ticagrelor (n=9619) and placebo (n=9601) was conducted.
- Primary outcomes were divided into 2 types:
- efficacy: composite of CV death, MI, or stroke.
- safety: major bleeding events defined by the Thrombolysis in MI (TIMI) criteria.
- Exploratory composite outcome of irreversible harm (death from any cause, MI, stroke, fatal bleeding, or intracranial haemorrhage).
- Funding: AstraZeneca.
- Ticagrelor was effective for primary efficacy outcome vs placebo (HR, 0.90; 95% CI, 0.81-0.99; P=.04).
- Incidence of TIMI major bleeding (HR, 2.32; 95% CI, 1.82-2.94; P<.001 was higher and intracranial haemorrhage ci p=".005)" more frequent in ticagrelor vs placebo groups.>
- No significant difference was observed in the incidence of fatal bleeding (HR, 1.90; 95% CI, 0.87-4.15; P=.11).
- The incidence of an exploratory composite outcome of irreversible harm did not differ between the ticagrelor and placebo groups (HR, 0.93; 95% CI, 0.84-1.02).
- Permanent treatment discontinuation was more frequent in the ticagrelor vs placebo groups (34.5% vs 25.4%).