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Short-term outcomes of ticagrelor monotherapy after primary percutaneous coronary intervention for ST-elevation
Eva C I Woelders1, Bahram Yosofi1, Denise A M Peeters1
1Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.
Insights
Ticagrelor monotherapy after primary PCI showed similar ischemic event rates compared to dual antiplatelet therapy (DAPT) in STEMI patients. Bleeding events were numerically lower with ticagrelor monotherapy, but safety requires further study.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Dual antiplatelet therapy (DAPT) is standard after percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI).
- Ticagrelor monotherapy is being explored as an alternative to reduce bleeding risk.
- Assessing the safety and efficacy of ticagrelor monotherapy post-PCI is crucial.
Purpose of the Study:
- To evaluate the safety of ticagrelor monotherapy versus DAPT in STEMI patients undergoing primary PCI.
- To compare major adverse cardiac and cerebral events (MACCE) and bleeding events between the two strategies.
Main Methods:
- A randomized, multicenter, open-label pilot study.
- 200 STEMI patients were randomized to ticagrelor monotherapy or DAPT after primary PCI.
- Outcomes assessed included MACCE, clinically relevant bleeding, and clinically relevant non-access site bleeding at three months.
Main Results:
- No significant difference in MACCE between ticagrelor monotherapy (3.1%) and DAPT (2.0%) groups.
- Clinically relevant bleeding was lower in the ticagrelor monotherapy group (4.2%) compared to DAPT (8.9%).
- Clinically relevant non-access site bleeding was significantly lower with ticagrelor monotherapy (2.0%) versus DAPT (7.9%).
Conclusions:
- Ticagrelor monotherapy did not show a significant difference in ischemic events compared to DAPT in STEMI patients.
- A trend towards reduced bleeding events, particularly non-access site bleeding, was observed with ticagrelor monotherapy.
- Larger studies are needed to confirm the safety and efficacy of ticagrelor monotherapy due to the small number of events in this pilot study.
Background:
Ticagrelor monotherapy after a short period of dual antiplatelet therapy (DAPT) has shown to be safe and effective after percutaneous coronary intervention (PCI), including primary PCI in ST-elevation myocardial infarction (STEMI). However, direct omission of aspirin could further reduce bleeding risk. We aimed to assess the safety of ticagrelor monotherapy directly after primary PCI regarding ischemic events, and to investigate the effect on clinical bleeding events.
Methods:
In this multicenter open-label pilot study, 200 STEMI patients were 1:1 randomized to ticagrelor monotherapy versus ticagrelor plus aspirin, directly after primary PCI. Major adverse cardiac and cerebral events (MACCE) and bleeding were assessed at 3 months.
Results:
At 3 months, major adverse cardiac and cerebral events occurred in 3.1% of the experimental group (n = 99) vs 2.0% in the control group (n = 101) (HR: 1.54; 95% CI: 0.26-9.24), clinically relevant bleeding was observed in 4.2% vs 8.9% (HR: 0.46, 95% CI: 0.14-1.48), and clinically relevant non-access site bleeding in 2.0% vs 7.9% (HR: 0.25, 95% CI: 0.05-1.19).
Conclusions:
Although no significant difference in ischemic events was observed between the novel concept of ticagrelor monotherapy and DAPT, safety cannot be confirmed given the small number of events. Additionally, there was a tendency for a reduction in clinically relevant non-access site bleeding events.
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