Background: Guidelines recommend extended dual antiplatelet therapy (DAPT), including ticagrelor 60 mg twice daily, in high-risk post myocardial infarction (MI) patients who have tolerated 12 months and are not at high bleeding risk. The real-world utilization and bleeding and ischemic outcomes associated with long-term ticagrelor 60 mg in routine clinical practice have not been well described.
Methods: Register and claims data from US (Optum Clinformatics, IBM MarketScan, Medicare) and Europe (Sweden, Italy, UK, Germany) were extracted. Patients initiating ticagrelor 60 mg ≥ 12 months after MI, meeting eligibility criteria for PEGASUS-TIMI 54 trial, were included. The cumulative incidence of the composite of MI, stroke, or all-cause mortality, and of bleeding requiring hospitalization were calculated. Meta-analyses were performed to combine estimates from each source.
Results: 7 035 patients treated with ticagrelor 60 mg met eligibility criteria. Median age was 67 years and 29% were females; 12% had a history of multiple MIs. The majority (95%) had been treated with ticagrelor 90 mg prior to initiating ticagrelor 60 mg. At 12 months from initiation of ticagrelor 60 mg, the cumulative incidence (95% CI) of MI, stroke or mortality was 3.33% (2.73-4.04) and was approximately three-fold the risk of bleeding (0.96%; 0.69-1.33).
Conclusions: This study provides insights into the use of ticagrelor 60 mg in patients with prior MI in clinical practice. Observed event rates for ischemic events and bleeding generally align with those in the pivotal trials, support the established safety profile of ticagrelor, and highlight the significant residual ischemic risk in this population.Clinical Trials.gov Registration NCT04568083.
Keywords: Long-term ticagrelor; Myocardial infarction; Real world evidence.
© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.