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Safety and Cumulative Incidence of Major Cardiovascular Events with Ticagrelor in Taiwanese Patients with
Guang-Yuan Mar1,2, Wilhelm Ridderstråle3, Jianxin Wei3
1Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan.
Insights
Ticagrelor demonstrated good safety and tolerability in Taiwanese patients with non-ST-segment elevation myocardial infarction (NSTEMI). The study found low rates of major bleeding and cardiovascular events over one year.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- Ticagrelor is a direct-acting, reversible P2Y12 receptor antagonist used to inhibit platelet aggregation.
- Non-ST-segment elevation myocardial infarction (NSTEMI) is a critical cardiovascular condition requiring effective antiplatelet therapy.
Purpose of the Study:
- To evaluate the safety and tolerability of ticagrelor in Taiwanese patients diagnosed with NSTEMI.
- To assess the incidence of bleeding events and major cardiovascular events over a 1-year follow-up period.
Main Methods:
- A phase IV, single-arm study involving 108 Taiwanese patients with NSTEMI.
- Patients received ticagrelor (180 mg loading, 90 mg twice daily) plus aspirin (100 mg/day) for up to 1 year.
- Safety was assessed via adverse events, serious adverse events, and PLATO-defined bleeding events; major cardiovascular events were also tracked.
Main Results:
- 32% of patients experienced at least one PLATO-defined bleeding event; major bleeding occurred in 6.5% of patients.
- No fatal bleeding events were reported. Serious adverse events occurred in 21.3% of patients.
- Six patients (5.6%) experienced major cardiovascular events, with a Kaplan-Meier estimated risk of 5.6%.
Conclusions:
- Ticagrelor, when used for up to one year in Taiwanese NSTEMI patients, showed a low rate of major bleeding and major cardiovascular events.
- The safety profile observed in this study aligns with the established safety profile of ticagrelor.
Background:
Ticagrelor, an oral, direct-acting, and reversible P2Y12 receptor antagonist, inhibits platelet activation and aggregation. This phase IV, single-arm study analyzed the safety and tolerability of ticagrelor in Taiwanese patients with non-ST-segment elevation myocardial infarction (NSTEMI) during 1 year of follow-up.
Methods:
Patients aged ≥ 20 years with an index event of NSTEMI received ticagrelor (180 mg loading and 90 mg doses twice daily thereafter) plus low-dose aspirin (100 mg/day) for up to 1 year. Safety was evaluated according to adverse events (AEs), serious AEs (SAEs), and PLATO-defined bleeding events. The cumulative incidence of major cardiovascular (CV) events including CV death, myocardial infarction, and stroke was also evaluated.
Results:
The safety population included 108 patients across 13 centers in Taiwan. During treatment, 32 (29.6%) patients had ≥ one PLATO-defined bleeding event. Major bleeding events occurred in seven (6.5%) patients with a Kaplan-Meier (KM) estimated event risk [95% confidence interval (CI)] of 7.1% (3.4%-14.4%), including life-threatening bleeding [four (3.7%) patients] and other major bleeding [three (2.8%) patients]. No PLATO-defined fatal bleeding was observed. SAEs were reported in 23 (21.3%) patients. Six (5.6%) patients experienced major CV events during the 1-year follow-up period, with a KM-estimated event risk (95% CI) of 5.6% (2.6%-12.0%).
Conclusions:
Ticagrelor for up to 1 year was associated with a low rate of major bleeding events and a low incidence of major CV events in Taiwanese patients with NSTEMI. The overall safety of ticagrelor was in accordance with the known safety profile of ticagrelor.
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