Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation

Background Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear. Methods In an international trial with a two-by-two factorial design, we randomly assigned patients with at...

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Autores: Lopes, RD, Heizer, G, Aronson, R, Vora, AN, Massaro, T, Mehran, R, Goodman, SG, Windecker, S, Darius, H, Li, J, Averkov, O, Bahit, MC, Berwanger, O, Budaj, A, Hijazi, Z, Parkhomenko, A, Sinnaeve, P, Storey, RF, Thiele, H, Vinereanu, D, Granger, CB, Alexander, JH, AUGUSTUS Investigators
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p3691
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/3691
Access Level:acceso abierto
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spelling Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial FibrillationLopes, RDHeizer, GAronson, RVora, ANMassaro, TMehran, RGoodman, SGWindecker, SDarius, HLi, JAverkov, OBahit, MCBerwanger, OBudaj, AHijazi, ZParkhomenko, ASinnaeve, PStorey, RFThiele, HVinereanu, DGranger, CBAlexander, JHAUGUSTUS InvestigatorsBackground Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear. Methods In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y(12) inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events. Results Enrollment included 4614 patients from 33 countries. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001). Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P=0.002) and a similar incidence of ischemic events. Patients in the aspirin group had an incidence of death or hospitalization and of ischemic events that was similar to that in the placebo group. Conclusions In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y(12) inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both. (Funded by Bristol-Myers Squibb and Pfizer; AUGUSTUS ClinicalTrials.gov number, NCT02415400.)MASSACHUSETTS MEDICAL SOC2019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/3691NEW ENGLAND JOURNAL OF MEDICINEISSN: 00284793ISSNe: 15334406reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p36912026-06-07T16:35:31Z
dc.title.none.fl_str_mv Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
title Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
spellingShingle Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
Lopes, RD
title_short Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
title_full Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
title_fullStr Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
title_full_unstemmed Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
title_sort Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
dc.creator.none.fl_str_mv Lopes, RD
Heizer, G
Aronson, R
Vora, AN
Massaro, T
Mehran, R
Goodman, SG
Windecker, S
Darius, H
Li, J
Averkov, O
Bahit, MC
Berwanger, O
Budaj, A
Hijazi, Z
Parkhomenko, A
Sinnaeve, P
Storey, RF
Thiele, H
Vinereanu, D
Granger, CB
Alexander, JH
AUGUSTUS Investigators
author Lopes, RD
author_facet Lopes, RD
Heizer, G
Aronson, R
Vora, AN
Massaro, T
Mehran, R
Goodman, SG
Windecker, S
Darius, H
Li, J
Averkov, O
Bahit, MC
Berwanger, O
Budaj, A
Hijazi, Z
Parkhomenko, A
Sinnaeve, P
Storey, RF
Thiele, H
Vinereanu, D
Granger, CB
Alexander, JH
AUGUSTUS Investigators
author_role author
author2 Heizer, G
Aronson, R
Vora, AN
Massaro, T
Mehran, R
Goodman, SG
Windecker, S
Darius, H
Li, J
Averkov, O
Bahit, MC
Berwanger, O
Budaj, A
Hijazi, Z
Parkhomenko, A
Sinnaeve, P
Storey, RF
Thiele, H
Vinereanu, D
Granger, CB
Alexander, JH
AUGUSTUS Investigators
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
description Background Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear. Methods In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y(12) inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events. Results Enrollment included 4614 patients from 33 countries. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001). Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P=0.002) and a similar incidence of ischemic events. Patients in the aspirin group had an incidence of death or hospitalization and of ischemic events that was similar to that in the placebo group. Conclusions In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y(12) inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both. (Funded by Bristol-Myers Squibb and Pfizer; AUGUSTUS ClinicalTrials.gov number, NCT02415400.)
publishDate 2019
dc.date.none.fl_str_mv 2019
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://incliva.portalinvestigacion.com/publicaciones/3691
url https://incliva.portalinvestigacion.com/publicaciones/3691
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv MASSACHUSETTS MEDICAL SOC
publisher.none.fl_str_mv MASSACHUSETTS MEDICAL SOC
dc.source.none.fl_str_mv NEW ENGLAND JOURNAL OF MEDICINE
ISSN: 00284793
ISSNe: 15334406
reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
instname:INCLIVA
instname_str INCLIVA
reponame_str r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
collection r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
repository.name.fl_str_mv
repository.mail.fl_str_mv
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