TY - JOUR
T1 - Characteristics and outcomes in patients with a prior myocardial infarction treated with extended dual antiplatelet therapy with ticagrelor 60 mg
T2 - findings from ALETHEIA, a multi-country observational study
AU - Bonaca, M. P.
AU - Lesén, E.
AU - Giannitsis, E.
AU - Hedberg, J.
AU - Jernberg, T.
AU - Lambrelli, D.
AU - Duong, M.
AU - Maggioni, A. P.
AU - Ariza-Solé, A.
AU - ten Berg, J.
AU - Storey, R. F.
N1 - Funding Information:
ALETHEIA was sponsored by AstraZeneca.
Funding Information:
Dr. Bonaca receives support from the AHA SFRN under award numbers 18SFRN3390085 (BWH-DH SFRN Center) and 18SFRN33960262 (BWH-DH Clinical Project).
Funding Information:
The authors thank Dr Narinder Bhalla and Dr Christopher Hewitt for providing guidance on the design of the ALETHEIA study. This study is based in part on data from the Clinical Practice Research Datalink obtained under licence from the UK Medicines and Healthcare products Regulatory Agency. The data are provided by patients and collected by the NHS as part of their care and support. The interpretation and conclusions contained in this study are those of the authors alone. The authors would also like to thank the Ingress team and the ReS team, for data acquisition and analyses using the AOK Plus databases and ReS databases, as well as the rest of the Evidera team (Anna Ramond, Javier Cid, Christina Chebili, Brian Murphy, Charlotte Pettersson, Sharon MacLachlan, Rachel Armstrong, and Jason Simeone) for data acquisition and analyses using Medicare, Optum, the Swedish Prescribed Drug Register, and CPRD and study conduct oversight in all countries.
Publisher Copyright:
© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background Guidelines recommend extended dual antiplatelet therapy, 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 ischaemic outcomes associated with long-term ticagrelor 60 mg in routine clinical practice have not been well described. Methods Register and claims data from the USA (Optum Clinformatics, IBM MarketScan, and Medicare) and Europe (Sweden, Italy, UK, and Germany) were extracted. Patients initiating ticagrelor 60 mg =12 months after MI, meeting eligibility criteria for 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 45) 54 trial, were included. The cumulative incidence of the composite of MI, stroke, or all-cause mortality and that of bleeding requiring hospitalization were calculated. Meta-analyses were performed to combine estimates from each source. Results A total of 7035 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% confidence interval (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 ischaemic events and bleeding generally align with those in the pivotal trials, support the established safety profile of ticagrelor, and highlight the significant residual ischaemic risk in this population.
AB - Background Guidelines recommend extended dual antiplatelet therapy, 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 ischaemic outcomes associated with long-term ticagrelor 60 mg in routine clinical practice have not been well described. Methods Register and claims data from the USA (Optum Clinformatics, IBM MarketScan, and Medicare) and Europe (Sweden, Italy, UK, and Germany) were extracted. Patients initiating ticagrelor 60 mg =12 months after MI, meeting eligibility criteria for 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 45) 54 trial, were included. The cumulative incidence of the composite of MI, stroke, or all-cause mortality and that of bleeding requiring hospitalization were calculated. Meta-analyses were performed to combine estimates from each source. Results A total of 7035 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% confidence interval (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 ischaemic events and bleeding generally align with those in the pivotal trials, support the established safety profile of ticagrelor, and highlight the significant residual ischaemic risk in this population.
KW - Long-term ticagrelor
KW - Myocardial infarction
KW - Real-world evidence
U2 - 10.1093/ehjcvp/pvad062
DO - 10.1093/ehjcvp/pvad062
M3 - Article
SN - 2055-6837
VL - 9
SP - 701
EP - 708
JO - European Heart Journal-Cardiovascular Pharmacotherapy
JF - European Heart Journal-Cardiovascular Pharmacotherapy
IS - 8
ER -