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Ticagrelor monotherapy in patients at high bleeding risk undergoing percutaneous coronary intervention: TWILIGHT-HBR
Javier Escaned1, Davide Cao2, Usman Baber3
1Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid 28040, Spain.
Insights
For patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI), stopping aspirin after 3 months of dual antiplatelet therapy (DAPT) and continuing ticagrelor monotherapy significantly reduced bleeding events without increasing ischemic risks.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- High bleeding risk (HBR) is common in patients undergoing percutaneous coronary intervention (PCI).
- Early aspirin discontinuation after short dual antiplatelet therapy (DAPT) is a strategy to reduce bleeding in HBR patients.
- Ticagrelor monotherapy is being explored as an alternative to DAPT to balance efficacy and safety.
Purpose of the Study:
- To evaluate the efficacy and safety of ticagrelor monotherapy versus ticagrelor plus aspirin in HBR patients after 3-month DAPT.
- To assess the impact of early aspirin withdrawal on bleeding and ischemic events in HBR patients post-PCI.
- To compare the absolute and relative risk reductions of bleeding between HBR and non-HBR populations.
Main Methods:
- Prespecified analysis of the TWILIGHT trial data.
- Inclusion of patients meeting Academic Research Consortium (ARC) high bleeding risk criteria.
- Randomization of event-free patients to 12 months of ticagrelor plus aspirin or ticagrelor monotherapy after initial 3-month DAPT.
Main Results:
- Ticagrelor monotherapy significantly reduced BARC 2, 3, or 5 bleeding in HBR patients (6.3% vs. 11.4%; HR 0.53).
- A trend towards greater absolute risk reduction in major bleeding was observed in HBR patients compared to non-HBR patients.
- No significant differences in death, myocardial infarction, or stroke were found between treatment arms, regardless of HBR status.
Conclusions:
- Aspirin discontinuation followed by ticagrelor monotherapy is a safe and effective strategy for HBR patients post-PCI, reducing bleeding without compromising ischemic protection.
- The findings support a tailored antiplatelet strategy for HBR patients to minimize bleeding complications.
- Ticagrelor monotherapy offers a favorable risk-benefit profile in HBR patients completing initial DAPT.
Aims:
Patients at high bleeding risk (HBR) represent a prevalent subgroup among those undergoing percutaneous coronary intervention (PCI). Early aspirin discontinuation after a short course of dual antiplatelet therapy (DAPT) has emerged as a bleeding avoidance strategy. The aim of this study was to assess the effects of ticagrelor monotherapy after 3-month DAPT in a contemporary HBR population.
Methods And Results:
This prespecified analysis of the TWILIGHT trial evaluated the treatment effects of early aspirin withdrawal followed by ticagrelor monotherapy in HBR patients undergoing PCI with drug-eluting stents. After 3 months of ticagrelor plus aspirin, event-free patients were randomized to 12 months of aspirin or placebo in addition to ticagrelor. A total of 1064 (17.2%) met the Academic Research Consortium definition for HBR. Ticagrelor monotherapy reduced the incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding compared with ticagrelor plus aspirin in HBR (6.3% vs. 11.4%; hazard ratio (HR) 0.53, 95% confidence interval (CI) 0.35-0.82) and non-HBR patients (3.5% vs. 5.9%; HR 0.59, 95% CI 0.46-0.77) with similar relative (Pinteraction = 0.67) but a trend towards greater absolute risk reduction in the former [-5.1% vs. -2.3%; difference in absolute risk differences (ARDs) -2.8%, 95% CI -6.4% to 0.8%, P = 0.130]. A similar pattern was observed for more severe BARC 3 or 5 bleeding with a larger absolute risk reduction in HBR patients (-3.5% vs. -0.5%; difference in ARDs -3.0%, 95% CI -5.2% to -0.8%, P = 0.008). There was no significant difference in the key secondary endpoint of death, myocardial infarction, or stroke between treatment arms, irrespective of HBR status.
Conclusions:
Among HBR patients undergoing PCI who completed 3-month DAPT without experiencing major adverse events, aspirin discontinuation followed by ticagrelor monotherapy significantly reduced bleeding without increasing ischaemic events, compared with ticagrelor plus aspirin. The absolute risk reduction in major bleeding was larger in HBR than non-HBR patients.
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