Clinical Outcomes in Women on Ticagrelor Monotherapy After PCI for ACS

Women have a greater risk for bleeding and ischemia and consequent net adverse clinical events (NACE) than men after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS), but this risk can be reduced via ticagrelor monotherapy following 3 months of dual-antiplatelet therapy (DAPT). These findings were published in Arteriosclerosis, Thrombosis, and Vascular Biology.

A post hoc analysis of the Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus-Eluting Stent for Acute Coronary Syndrome (TICO) trial was conducted to evaluate the effects of sex differences on clinical outcomes in patients with ACS treated with ticagrelor monotherapy following 3-month vs 12-month ticagrelor-based dual-antiplatelet therapy (DAPT).

The cohort of 3056 patients with ACS from TICO were classified into 2 groups based on sex. The primary outcome was NACE, which was defined as a composite of major bleeding events and major adverse cardiac and cerebrovascular events (MACCE; a composite of all-cause death, myocardial infarction [MI], stent thrombosis, stroke, and target-vessel revascularization) within 3 to 12 months after an index PCI.

Among the participants, 628 were women (mean age, 67.0±9.5 years) and 2428 were men (mean age, 59.4±10.5 years). The women had a greater risk of comorbidities, including hypertension, diabetes, chronic kidney disease, current smoking status, anemia, history of stroke, MI, PCI, or coronary bypass surgery, vs men.

Women had an increased risk for NACE (hazard ratio [HR], 1.89; 95% CI, 1.34-2.67; P <.001), MACCE (HR, 1.69; 95% CI, 1.07-2.68; P =.026), and major bleeding (HR, 2.04; 95% CI, 1.25-3.35; P =.005), compared with men. Women treated with ticagrelor-based 12-month DAPT consistently had a higher rate of the primary and key secondary outcomes among the groups after multivariate adjustment.

The risk for NACE was significantly decreased among women who received ticagrelor monotherapy after 3-month DAPT vs those treated with ticagrelor-based 12-month DAPT (HR, 0.47; 95% CI, 0.26-0.85), although it was comparable between men in the 2 treatment groups (HR, 0.77; 95% CI, 0.52-1.14). Ticagrelor monotherapy after 3-month DAPT was consistently associated with a favorable trend for MACCE risk in women and men. In addition, the trend in favor of ticagrelor monotherapy after 3-month DAPT for decreasing the bleeding risk consistently occurred in women (2.5% vs 5.2%; HR, 0.47; 95% CI, 0.20-1.10) and men (1.4% vs 2.4%; HR, 0.60; 95% CI, 0.33-1.09).

No significant interactions were observed between sexes and DAPT strategies for NACE, MACCE, or major bleeding events. Ticagrelor monotherapy vs ticagrelor-based 12-month DAPT had consistent treatment effects in both sexes in the propensity score-matched populations.

Ticagrelor-based 12-month DAPT was significantly associated with NACE in women and patients with chronic kidney disease in multivariable regression analyses.

Among several limitations, results from the sex-specific subgroups were not sufficiently powered to determine clear conclusions on the effect of ticagrelor monotherapy vs ticagrelor-based 12-month DAPT, and it remains to be determined whether the primary results of TICO are generally applicable to women. Also, because the treatment outcome by sex was not prespecified in TICO, the current findings are susceptible to type I error owing to multiple testing. Furthermore, the impact of residual confounders cannot be excluded.

“Among patients with ACS undergoing drug-eluting stent implantation, women demonstrated relatively higher risks of major bleeding and MACCE, resulting in a significantly higher risk of NACE than men,” wrote the researchers. “There was no significant heterogeneity in the impact of ticagrelor monotherapy after 3-month DAPT, compared with ticagrelor-based 12-month DAPT on NACE, major bleeding, and MACCE between both sexes. Ticagrelor monotherapy after 3-month DAPT was significantly associated with a lower risk of primary outcomes in women than ticagrelor-based 12-month DAPT.”

Disclosure: This study was funded by Biotronik. Please see the original reference for a full list of disclosures.