- Question
- Does adding ticagrelor to aspirin reduce cardiovascular events in patients with stable coronary artery disease and type 2 diabetes who have never had a myocardial infarction or stroke?
- Design
- Randomized, double-blind, multinational, placebo-controlled trial with 19220 patients randomized and a median follow-up of 39.9 months.
- Population
- Patients aged 50 years or older with stable coronary artery disease and type 2 diabetes mellitus, excluding those with a previous myocardial infarction or stroke.
- Intervention
- Ticagrelor plus aspirin; according to the registry, the dose was 60 mg twice daily (initially 90 mg, reduced through a protocol amendment).
- Control
- Placebo plus aspirin.
- Primary outcome
- Composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was TIMI major bleeding.
- Results
- The primary efficacy outcome occurred less often with ticagrelor than with placebo (7.7% vs. 8.5%; HR 0.90; 95% CI 0.81 to 0.99; P = 0.04). The exploratory composite of irreversible harm was similar between groups (10.1% vs. 10.8%; HR 0.93; 95% CI 0.86 to 1.02).
- Safety
- TIMI major bleeding was more frequent with ticagrelor (2.2% vs. 1.0%; HR 2.32; 95% CI 1.82 to 2.94; P<0.001), as was intracranial hemorrhage (0.7% vs. 0.5%; HR 1.71; 95% CI 1.18 to 2.48; P = 0.005). Fatal bleeding did not differ significantly (0.2% vs. 0.1%; HR 1.90; 95% CI 0.87 to 4.15; P = 0.11). Permanent discontinuation was more frequent with ticagrelor (34.5% vs. 25.4%).
- Conclusion
- In patients with stable coronary artery disease and diabetes without prior myocardial infarction or stroke, ticagrelor plus aspirin lowered ischemic events but increased major bleeding compared with placebo plus aspirin.
- Why it matters
- The trial showed that, in this high-risk group, the ischemic benefit of prolonged dual antiplatelet therapy comes with a meaningful bleeding cost, requiring individualized decisions that weigh ischemic against hemorrhagic risk.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026