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;p interaction = 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;p interaction = 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.