- Ticagrelor monotherapy was associated with a lower incidence of bleeding than ticagrelor plus aspirin, without leading to ischaemic harm over a period of 1 year among high-risk patients who underwent percutaneous coronary intervention (PCI) and completed 3 months of dual antiplatelet therapy.
Why this matters
- Findings suggest ticagrelor monotherapy may be a suitable strategy to lower bleeding risk and preserving the ischaemic benefit in patients who have undergone PCI.
- In the TWILIGHT trial, patients who had not had a major bleeding event or an ischaemic event (n=7119) at 3 months post-hospital discharge were randomly assigned to receive either aspirin (n=3564) or placebo (n=3555) along with the continuation of ticagrelor for 12 months.
- Primary outcome: first occurrence of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding.
- Secondary outcome: death from any cause, non-fatal myocardial infarction (MI) or non-fatal stroke.
- Funding: AstraZeneca.
- After 12 months, patients who received ticagrelor+placebo vs those who received ticagrelor+aspirin had lower incidence of BARC type 2, 3 or 5 bleeding (4.0% vs 7.1%; HR, 0.56; 95% CI, 0.45-0.68; P<.001 difference percentage points ci to>
- The difference in risk for BARC type 3 or 5 bleeding was similar between the groups (1.0% vs 2.0%; HR, 0.49; 95% CI, 0.33-0.74).
- The incidence of death from any cause, non-fatal MI or non-fatal stroke was 3.9% in both groups (difference, −0.06 percentage points; 95% CI, −0.97 to 0.84; HR, 0.99; 95% CI, 0.78-1.25; P<.001 for non-inferiority>
- Lack of power to detect differences in the risk for rare clinical events.
- Results may not be generalisable.