Efficacy and Safety of Ticagrelor Over Time in Patients with Prior MI in PEGASUS-TIMI 54
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Ticagrelor lowers ischemia risk in patients who have had a previous heart attack (MI). It's uncertain whether the risks of ischemic stroke and the advantages of long-term P2Y12 inhibition in this cohort are stable over time. The goal of the trial was to see how ischemia risk changed over time and if the efficacy and safety of ticagrelor were the same early and late after randomization. The PEGASUS-TIMI (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis In Myocardial Infarction) 54 trial randomised patients with a prior MI (median 1.7 years prior) to ticagrelor 90 mg, ticagrelor 60 mg, or placebo on an aspirin background. At yearly checkpoints, the rates of CV death, MI, and stroke, as well as TIMI significant haemorrhage, were examined (years 1, 2, and 3). A total of 21,162 individuals were randomised and observed for 33 months (median), with 28% of patients still suffering from MI five years after the trial ended. The risk of CV mortality, MI, or stroke in the placebo arm remained essentially stable at a 3% annualised rate throughout the trial. At each succeeding milestone, the benefit of ticagrelor 60 mg was consistent (year 1 hazard ratio [HR]: 0.82; 95 percent confidence interval [CI]: 0.67 to 0.99; year 2 HR: 0.90; 95 percent CI: 0.74 to 1.11; and year 3 HR: 0.79; 95 percent CI: 0.62 to 1.00). At each milestone, ticagrelor 60 mg increased TIMI major bleeding, with the greatest risk in the first year (year 1 HR: 3.22; year 2 HR: 2.07; year 3 HR: 1.65). Even after more than 5 years, patients with past MI who are more than 1-year post-event are still at risk of repeat atherothrombotic events with no signs of declining risk. Ticagrelor reduced ischemia risk in patients who had previously had a MI, with consistent efficacy early and late and a trend toward less bleeding excess with time. These findings support the idea of continuing treatment in patients who tolerate the medicine well. Disclaimer: Lupin makes no representation or warranty of any kind, expressed or implied, regarding the accuracy, adequacy, validity, reliability, availability, or completeness of any scientific information shared by the HCP on the STAR UPDATE podcast. You should not allow the contents of this to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.