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Bleeding and Ischemic Risks of Ticagrelor Monotherapy After Coronary Interventions
Guiomar Mendieta1, Shamir Mehta2, Usman Baber3
1National Center of Cardiovascular Investigations Carlos III (CNIC), Madrid, Spain.
Insights
Ticagrelor monotherapy after percutaneous coronary intervention (PCI) reduces bleeding events compared to dual antiplatelet therapy (DAPT). This approach in high-risk patients did not increase ischemic events, offering a safer alternative.
Area of Science:
- Cardiology
- Pharmacology
Background:
- The TWILIGHT trial investigated ticagrelor monotherapy versus dual antiplatelet therapy (DAPT) in high-risk patients post-percutaneous coronary intervention (PCI).
- Previous strategies involved continuing DAPT with aspirin and ticagrelor after an initial course.
Purpose of the Study:
- To evaluate the clinical net benefit of ticagrelor monotherapy compared to DAPT.
- To individually model bleeding benefits and ischemic risks associated with each treatment strategy.
Main Methods:
- Multivariable Cox regression models were used to assess Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 events and major adverse cardiac and cerebrovascular events (MACCE).
- Risk scores for bleeding and ischemia were calculated for each patient based on model coefficients.
- Stepwise forward variable selection was employed in model development.
Main Results:
- In 7,119 patients, ticagrelor monotherapy consistently reduced bleeding events across all risk strata compared to DAPT.
- This reduction in bleeding was not accompanied by an increase in MACCE, even in high-risk patients.
- The interaction P-values for bleeding and ischemic risk strata were 0.54 and 0.11, respectively.
Conclusions:
- Discontinuing aspirin to maintain ticagrelor monotherapy for three months post-PCI reduces bleeding in high-risk patients.
- This strategy offers a significant bleeding reduction benefit without an apparent increase in ischemic risk.
- The findings support ticagrelor monotherapy as a potentially safer option after PCI in selected high-risk populations.
Background:
In TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention), among high-risk patients undergoing percutaneous coronary intervention (PCI), ticagrelor monotherapy vs continuation of dual antiplatelet therapy (DAPT) with aspirin and ticagrelor after completing a 3-month course of DAPT was associated with reduced bleeding, without an increase in ischemic events.
Objectives:
This investigation sought to study the clinical benefit of ticagrelor monotherapy vs DAPT by simultaneously modeling its associated potential bleeding benefits and ischemic harms on an individual patient basis.
Methods:
Multivariable Cox regression models for: 1) Bleeding Academic Research Consortium type 2, 3, or 5 (BARC-2/3/5); and 2) cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke (major adverse cardiac and cerebrovascular event [MACCE]) were developed using stepwise forward variable selection. The coefficients in the BARC-2/3/5 and MACCE models were used to calculate bleeding and ischemic risk scores, respectively, for each patient (excluding the coefficient for randomized treatment).
Results:
In the total study group (N = 7,119), BARC-2/3/5 occurred in 391 (5.5%) patients, and MACCE occurred in 258 (3.6%). There was a consistent reduction in bleeding events associated with ticagrelor monotherapy compared with DAPT across both bleeding and ischemic risk strata (P interaction = 0.54 and 0.11, respectively). Importantly, this benefit associated with ticagrelor monotherapy was not offset by an increase in MACCE at any level of bleeding or ischemic risk.
Conclusions:
Three months after PCI, discontinuing aspirin and maintaining ticagrelor monotherapy reduces bleeding in both higher-bleeding risk and lower-bleeding risk patients compared with continued DAPT. This benefit does not appear to be offset by greater ischemic risk. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).
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