Ticagrelor With or Without Aspirin in High-Risk Patients With Anemia Undergoing Percutaneous Coronary Intervention: a subgroup analysis of the TWILIGHT trial

Aim: The aim of this study was to assess the effect of ticagrelor monotherapy among high-risk patients with anemia undergoing percutaneous coronary intervention (PCI). Methods and results: In the TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention), after 3 months of ticagrelor plus aspirin, high-risk patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. Anemia was defined as hemoglobin <13 g/dL for men and <12 g/dL for women. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding. The key secondary endpoint was a composite of all-cause death, myocardial infarction, or stroke.Out of 6 828 patients, 1 329 (19.5%) had anemia and were more likely to have comorbidities, multivessel disease, and to experience bleeding or ischemic complications than non-anemic patients. Among anemic patients, BARC 2, 3, or 5 bleeding occurred less frequently with ticagrelor monotherapy than with ticagrelor plus aspirin (6.4% vs. 10.7%; HR 0.60; 95% CI 0.41 to 0.88; p = 0.009); the rate of the key secondary endpoint was similar in the two arms (5.2% vs. 4.8%; HR 1.07; 95% CI 0.66 to 1.74; p = 0.779). These effects were consistent in patients without anemia (interaction p-value 0.671 and 0.835, respectively). Conclusions: In high-risk patients undergoing PCI, ticagrelor monotherapy after 3 months of ticagrelor-based DAPT was associated with a reduced risk of clinically relevant bleeding without any increase in ischemic events irrespective of anemia status. (TWILIGHT: NCT02270242).