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Sex Differences Among Patients With High Risk Receiving Ticagrelor With or Without Aspirin After Percutaneous
Birgit Vogel1, Usman Baber1,2, David J Cohen3,4
1The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Insights
Shortened dual antiplatelet therapy with ticagrelor monotherapy reduces bleeding events after PCI. Early aspirin withdrawal is safe and effective for both men and women, with comparable benefits across sexes.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) increases bleeding risk.
- Shortened DAPT followed by P2Y12 inhibitor monotherapy is a strategy to reduce bleeding events.
- Sex differences in cardiovascular outcomes and treatment responses require further investigation.
Purpose of the Study:
- To investigate sex-specific outcomes in patients treated with ticagrelor monotherapy versus ticagrelor plus aspirin after PCI.
- To evaluate the association of sex with bleeding and ischemic events in the TWILIGHT trial.
Main Methods:
- Secondary analysis of the TWILIGHT randomized clinical trial (NCT02270242).
- Included high-risk patients who underwent successful PCI with drug-eluting stents.
- Patients received ticagrelor plus aspirin, then randomized to ticagrelor monotherapy or ticagrelor plus aspirin for 12 months.
Main Results:
- Women were older and had a higher prevalence of chronic kidney disease than men.
- Initially, women had a higher risk of bleeding, but this difference was not significant after adjustment.
- Ticagrelor monotherapy significantly reduced bleeding events in both women and men compared to ticagrelor plus aspirin, with similar efficacy in both sexes.
- Ischemic event rates were comparable between sexes and treatment groups.
Conclusions:
- Higher bleeding risk in women was primarily due to baseline differences, not sex itself.
- Early aspirin withdrawal with ticagrelor monotherapy is effective in reducing bleeding without increasing ischemic events in high-risk PCI patients.
- The benefits of ticagrelor monotherapy are comparable between men and women, supporting its use in both populations.
Importance:
Shortened dual antiplatelet therapy followed by potent P2Y12 receptor inhibitor monotherapy reduces bleeding without increasing ischemic events after percutaneous coronary intervention (PCI).
Objective:
To explore sex differences and evaluate the association of sex with outcomes among patients treated with ticagrelor monotherapy vs ticagrelor plus aspirin.
Design, Setting, And Participants:
This was a prespecified secondary analysis of TWILIGHT, an investigator-initiated, placebo-controlled randomized clinical trial conducted at 187 sites across 11 countries. Study participants included patients who underwent successful PCI with drug-eluting stents, were planned for discharge with ticagrelor plus aspirin, and who had at least 1 clinical and at least 1 angiographic feature associated with high risk of ischemic or bleeding events. Data were analyzed from May to July 2020.
Interventions:
At 3 months after PCI, patients adherent to ticagrelor and aspirin without major adverse event were randomized to either aspirin or placebo for an additional 12 months along with ticagrelor.
Main Outcomes And Measures:
The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding at 12 months after randomization. The primary ischemic end point was a composite of death, myocardial infarction, or stroke.
Results:
Of 9006 enrolled patients, 7119 underwent randomization (mean [SD] age, 63.9 [10.2] years; 5421 [76.1%] men). Women were older (mean [SD] age, 65.5 [9.6] years in women vs 63.4 [10.3] years in men) with higher prevalence of chronic kidney disease (347 women [21.2%] vs 764 men [14.7%]). The primary bleeding end point occurred more often in women than men (hazard ratio [HR], 1.32; 95% CI, 1.06-1.64; P = .01). After multivariate adjustment, incremental bleeding risk associated with female sex was no longer significant (adjusted HR, 1.20; 95% CI, 0.95-1.52; P = .12). Ischemic end points were similar between sexes. Ticagrelor plus placebo vs ticagrelor plus aspirin was associated with lower risk of BARC type 2, 3, or 5 bleeding in women (adjusted HR, 0.62; 95% CI, 0.42-0.92; P = .02) and men (adjusted HR, 0.57; 95% CI, 0.44-0.73; P < .001; P for interaction = .69). Ischemic end points were similar between treatment groups in both sexes.
Conclusions And Relevance:
These findings suggest that the higher bleeding risk in women compared with men was mostly attributable to baseline differences, whereas ischemic events were similar between sexes. In this high-risk PCI population, the benefits of early aspirin withdrawal with continuation of ticagrelor were generally comparable in women and men.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02270242.
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