Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study

Introduction: Clinical guidelines recommend extended treatment with dual antiplatelet therapy (DAPT) with ticagrelor 60 mg (twice daily) beyond 12 months in high-risk patients with a history of myocardial infarction (MI) who have previously tolerated DAPT and are not at heightened bleeding risk. How...

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Autores: Lesén, Eva, Hewitt, Christopher, Giannitsis, Evangelos, Hedberg, Jonatan, Jernberg, Tomas, Lambrelli, Dimitra, Maggioni, Aldo P., Simeone, Jason C., Ariza Solé, Albert, Storey, Robert F., Berg, Jurrien, Bonaca, Marc, Aletheia Study Team
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/179945
Acceso en línea:https://hdl.handle.net/2445/179945
Access Level:acceso abierto
Palabra clave:Infart de miocardi
Vasodilatadors
Myocardial infarction
Vasodilators
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spelling Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational studyLesén, EvaHewitt, ChristopherGiannitsis, EvangelosHedberg, JonatanJernberg, TomasLambrelli, DimitraMaggioni, Aldo P.Simeone, Jason C.Ariza Solé, AlbertStorey, Robert F.Berg, JurrienBonaca, MarcAletheia Study TeamInfart de miocardiVasodilatadorsMyocardial infarctionVasodilatorsIntroduction: Clinical guidelines recommend extended treatment with dual antiplatelet therapy (DAPT) with ticagrelor 60 mg (twice daily) beyond 12 months in high-risk patients with a history of myocardial infarction (MI) who have previously tolerated DAPT and are not at heightened bleeding risk. However, evidence on patterns of use and associated clinical outcomes in routine clinical practice is limited. Methods: ALETHEIA is an observational, multi-country study, designed to describe characteristics, treatment persistence, and bleeding and cardiovascular (CV) outcomes in post-MI patients who initiate ticagrelor 60 mg in routine clinical practice (NCT04568083). The study will include electronic health data in the United States (US; Medicare, commercial claims) and Europe (Sweden, Italy, United Kingdom, Germany). Characteristics will be described among patients with and without ticagrelor 60 mg ≥1 year post-MI. Assuming an a priori threshold of 5000 person-years on-treatment is met, to ensure sufficient precision, clinical outcomes (bleeding and CV events) among patients treated with ticagrelor 60 mg will be assessed. Risk factors for clinical outcomes and treatment discontinuation will be assessed in patients with ticagrelor 60 mg and meta-analysis used to combine estimates across databases. Cohort selection will initiate from the ticagrelor 60 mg US and European approval dates and end February 2020. An estimated total of 7250 patients prescribed ticagrelor 60 mg are expected to be included. Discussion: An increased understanding of patterns of ticagrelor 60 mg use and associated clinical outcomes among high-risk patients with a prior MI is needed. The a priori specified stepwise approach adapted in this observational study is expected to generate useful evidence for clinical decision-making and treatment optimization.Wiley2021202120212021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion12 p.application/pdfhttps://hdl.handle.net/2445/179945Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1002/clc.23702Clinical Cardiology, 2021, vol. 44https://doi.org/10.1002/clc.23702cc by (c) Lesén, Eva et al, 2021http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/1799452026-05-29T05:05:01Z
dc.title.none.fl_str_mv Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study
title Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study
spellingShingle Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study
Lesén, Eva
Infart de miocardi
Vasodilatadors
Myocardial infarction
Vasodilators
title_short Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study
title_full Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study
title_fullStr Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study
title_full_unstemmed Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study
title_sort Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA , a multi‐country observational study
dc.creator.none.fl_str_mv Lesén, Eva
Hewitt, Christopher
Giannitsis, Evangelos
Hedberg, Jonatan
Jernberg, Tomas
Lambrelli, Dimitra
Maggioni, Aldo P.
Simeone, Jason C.
Ariza Solé, Albert
Storey, Robert F.
Berg, Jurrien
Bonaca, Marc
Aletheia Study Team
author Lesén, Eva
author_facet Lesén, Eva
Hewitt, Christopher
Giannitsis, Evangelos
Hedberg, Jonatan
Jernberg, Tomas
Lambrelli, Dimitra
Maggioni, Aldo P.
Simeone, Jason C.
Ariza Solé, Albert
Storey, Robert F.
Berg, Jurrien
Bonaca, Marc
Aletheia Study Team
author_role author
author2 Hewitt, Christopher
Giannitsis, Evangelos
Hedberg, Jonatan
Jernberg, Tomas
Lambrelli, Dimitra
Maggioni, Aldo P.
Simeone, Jason C.
Ariza Solé, Albert
Storey, Robert F.
Berg, Jurrien
Bonaca, Marc
Aletheia Study Team
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Infart de miocardi
Vasodilatadors
Myocardial infarction
Vasodilators
topic Infart de miocardi
Vasodilatadors
Myocardial infarction
Vasodilators
description Introduction: Clinical guidelines recommend extended treatment with dual antiplatelet therapy (DAPT) with ticagrelor 60 mg (twice daily) beyond 12 months in high-risk patients with a history of myocardial infarction (MI) who have previously tolerated DAPT and are not at heightened bleeding risk. However, evidence on patterns of use and associated clinical outcomes in routine clinical practice is limited. Methods: ALETHEIA is an observational, multi-country study, designed to describe characteristics, treatment persistence, and bleeding and cardiovascular (CV) outcomes in post-MI patients who initiate ticagrelor 60 mg in routine clinical practice (NCT04568083). The study will include electronic health data in the United States (US; Medicare, commercial claims) and Europe (Sweden, Italy, United Kingdom, Germany). Characteristics will be described among patients with and without ticagrelor 60 mg ≥1 year post-MI. Assuming an a priori threshold of 5000 person-years on-treatment is met, to ensure sufficient precision, clinical outcomes (bleeding and CV events) among patients treated with ticagrelor 60 mg will be assessed. Risk factors for clinical outcomes and treatment discontinuation will be assessed in patients with ticagrelor 60 mg and meta-analysis used to combine estimates across databases. Cohort selection will initiate from the ticagrelor 60 mg US and European approval dates and end February 2020. An estimated total of 7250 patients prescribed ticagrelor 60 mg are expected to be included. Discussion: An increased understanding of patterns of ticagrelor 60 mg use and associated clinical outcomes among high-risk patients with a prior MI is needed. The a priori specified stepwise approach adapted in this observational study is expected to generate useful evidence for clinical decision-making and treatment optimization.
publishDate 2021
dc.date.none.fl_str_mv 2021
2021
2021
2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/179945
url https://hdl.handle.net/2445/179945
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1002/clc.23702
Clinical Cardiology, 2021, vol. 44
https://doi.org/10.1002/clc.23702
dc.rights.none.fl_str_mv cc by (c) Lesén, Eva et al, 2021
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Lesén, Eva et al, 2021
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 12 p.
application/pdf
dc.publisher.none.fl_str_mv Wiley
publisher.none.fl_str_mv Wiley
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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