Long term secondary prevention with ticagrelor reduces CV event rate
Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin (PEGASUS) – Thrombolysis in Myocardial Infarction (TIMI) 54Presented at the ACC Scientific Session 2015 by: Marc Sabatine (Brigham and Women's Hospital, Boston, MA, VS)
BackgroundIt is common practice to take livelong daily aspirin after a myocardial infarction (MI), to prevent a second MI. Previous studies have shown the benefit of addition of a second platelet inhibitor, like the P2Y12 inhibitor ticagrelor. These studies studied this additional treatment only during one year, so the benefit of longer treatment was unclear.
The PEGASUS-TIMIS 54 study therefore evaluated in the long run whether ticagrelor twice daily, in addition to background therapy with aspirin, reduces the number of CV events (CV mortality, MI, stroke), as compared with placebo. Prevention of thrombotic events with ticagrelor 90 mg or 60 mg was examined in a randomised, double blind, placebo-controlled parallel group study in 21162 patients who experienced an MI in the past 1 to 3 years, with at least one extra risk factor. Patients were followed up for on average of almost 3 years.
- 36 months after randomisation the risk of CV events was 5% lower with use of ticagrelor 90 mg (HR: 0.85, 95%CI: 0.75-0.96, P=0.008) and 16% lower in patients on 60 mg (HR: 0.84, 95%CI: 0.74-0.95, P=0.004), as compared with placebo.
- The benefit of ticagrelor was comparable for the individual components of the primary endpoint.
- Patients were followed up for a mean of almost 3 years, in which the event curves of ticagrelor and placebo-treated patients continued to separate.
- Major bleedings were seen to a comparable extent in both treatment arms (TIMI major bleeding: ticagrelor 90 mg: HR: 2.69, 95%CI: 1.96-3.70, ticagrelor 60 mg: HR: 2.32, 95%CI: 1.68-3.21).
Intracranial and fatal bleedings were not more often seen in ticagrelor-treated patients than in the placebo group.
Dyspnoea occurred more often with ticagrelor than with placebo and bleeding and dyspnoea was reason for discontinuation with the study drug in 7 and 5% of ticacrelor-treated patients respectively.
ConclusionLong term addition of ticagrelor twice daily to background therapy with aspirin after a myocardial infarction lowers the risk of death by cardiovascular causes, myocardial infarction or stroke. The event curves suggest that the effect increases with time.
This study was simultaneously published in the New England Journal of Medicine.
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