Sex Differences among Patients Receiving Ticagrelor Monotherapy or Aspirin after Coronary Bypass Surgery: A Prespecified Subgroup Analysis of the TiCAB Trial.

Background: There is limited evidence on the association of sex with outcomes among patients undergoing coronary bypass surgery (CABG) and treated with ticagrelor monotherapy or aspirin. Methods: This was a pre-specified sub-analysis of TiCAB, an investigator-initiated placebo-controlled randomized trial. Primary efficacy endpoint was the composite of cardiovascular death, myocardial infarction, stroke, or repeat revascularization 1 year after CABG. Safety endpoint was BARC type 2, 3 or 5 bleeding. Results: A total of 280 (15.0%) women and 1579 (85.0%) men were included. Compared with men, women were older (66.1 +/- 10.2 vs. 70.1 +/- 9.3 years) with more acute presentation (17.0% vs 21.1%). The incidence of the primary endpoint was similar between women and men (9.2% vs. 8.9%, HR 1.08, 95%CI 0.71-1.66, P = 0.71). Cardiovascular death occurred more often in women (2.9% vs 1.0%, adjusted HR 2.87, 95%CI 1.23-6.70, P = 0.02). The incidence of bleeding was similar between the sexes (2.2% vs. 2.5%, HR 0.91, 95% CI 0.51-1.65, P = 0.77). Ticagrelor vs aspirin was associated with a similar risk of the primary endpoint in women (10.6% vs. 7.9%, HR 1.39, 95%CI 0.63-3.05, P = 0.42) and men (9.5% vs. 8.2%, HR 1.15, 95%CI 0.82-1.62, P = 0.41;pinteraction = 0.69), and a similar risk of bleeding in women (2.9% vs. 1.4%, HR 2.09, 95%CI 0.38-11.41, P = 0.40) and men (2.2% vs. 2.8%, HR 0.80, 95%CI 0.42-1.52, P = 0.49;pinteraction = 0.35). Conclusions: Among women and men undergoing CABG, ticagrelor monotherapy was associated with a similar risk of the primary efficacy endpoint and bleeding compared with aspirin. The risk of cardiovascular death was increased in women irrespective of antiplatelet therapy.