Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial
International audience Background: Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials.Objectives: The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly pati...
Published in: | American Journal of Cardiovascular Drugs |
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Main Authors: | , , , , , , , , , , , , , , , , , , , |
Other Authors: | , , , , , , , , , , , , , , , , , , , , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
HAL CCSD
2021
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Subjects: | |
Online Access: | https://hal.archives-ouvertes.fr/hal-03633900 https://doi.org/10.1007/s40256-021-00468-8 |
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Inserm: HAL (Institut national de la santé et de la recherche médicale) |
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language |
English |
topic |
MESH: Acute Coronary Syndrome MESH: Aged 80 and over MESH: Hemorrhage MESH: Humans MESH: Risk Factors MESH: Treatment Outcome [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology |
spellingShingle |
MESH: Acute Coronary Syndrome MESH: Aged 80 and over MESH: Hemorrhage MESH: Humans MESH: Risk Factors MESH: Treatment Outcome [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology Lattuca, Benoit Cayla, Guillaume Silvain, Johanne Cuisset, Thomas Leclercq, Florence Manzo-Silberman, Stephane Saint-Etienne, Christophe Delarche, Nicolas El Mahmoud, Rami Carrié, Didier Souteyrand, Géraud Kerneis, Mathieu Hauguel-Moreau, Marie Zeitouni, Michel Guedeney, Paul Diallo, Abdourahmane Collet, Jean-Philippe Vicaut, Eric Montalescot, Gilles Group, Action Study Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial |
topic_facet |
MESH: Acute Coronary Syndrome MESH: Aged 80 and over MESH: Hemorrhage MESH: Humans MESH: Risk Factors MESH: Treatment Outcome [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology |
description |
International audience Background: Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials.Objectives: The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention.Methods: From the 877 patients aged ≥ 75 years included in the ANTARCTIC randomized trial, data on Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke, were collected over 1 year.Results: Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = 181) at 1 year, of which, one third occurred in the first month. Anemia (adjusted hazard ratio [adj.HR] 3.98, 95% confidence interval [CI] 1.41-11.22; p = 0.009), severe chronic renal failure (adj.HR 1.83, 95% CI 1.12-2.98; p = 0.015), and femoral access (adj.HR 2.54, 95% CI 1.71-3.77; p < 0.001) were independently associated with clinically relevant bleeding events, while age > 85 years (adj.HR 2.22, 95% CI 1.14-4.30; p = 0.018) was independently associated with major bleeding events (BARC types 3 or 5). Patients with a clinically relevant bleeding event had a higher rate of MACE at 1 year (adj.HR 2.04, 95% CI 1.24-3.38; p = 0.005), with a particularly strong effect on stroke (adj.HR 5.55, 95% CI 2.04-15.06; p < 0.001).Conclusions: Clinically relevant bleeding events were observed in one out of five elderly patients undergoing stenting for an ACS and were strongly associated with further stroke occurrence. Rather than the antiplatelet therapy, comorbidities and an age > 85 years predicted bleeding outcomes in this elderly population.Clinical trial registration: Clinicaltrials.gov identifier: NCT01538446. https://www.clinicaltrials.gov . |
author2 |
Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases IHU ICAN Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition CHU Pitié Salpêtrière (IHU ICAN) CHU Pitié-Salpêtrière AP-HP Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière AP-HP Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) Initial MAnagement and prevention of acute orGan failures IN critically ill patiEnts (IMAGINE) Université de Montpellier (UM) Institut de cardiologie CHU Pitié-Salpêtrière Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) Hôpital de la Timone CHU - APHM (TIMONE) Nutrition, obésité et risque thrombotique (NORT) Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM) Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN) Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier) Hôpital Lariboisière-Fernand-Widal APHP Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) Centre hospitalier de Pau Hôpital Ambroise Paré AP-HP CHU Toulouse Toulouse CHU Gabriel Montpied Clermont-Ferrand CHU Clermont-Ferrand |
format |
Article in Journal/Newspaper |
author |
Lattuca, Benoit Cayla, Guillaume Silvain, Johanne Cuisset, Thomas Leclercq, Florence Manzo-Silberman, Stephane Saint-Etienne, Christophe Delarche, Nicolas El Mahmoud, Rami Carrié, Didier Souteyrand, Géraud Kerneis, Mathieu Hauguel-Moreau, Marie Zeitouni, Michel Guedeney, Paul Diallo, Abdourahmane Collet, Jean-Philippe Vicaut, Eric Montalescot, Gilles Group, Action Study |
author_facet |
Lattuca, Benoit Cayla, Guillaume Silvain, Johanne Cuisset, Thomas Leclercq, Florence Manzo-Silberman, Stephane Saint-Etienne, Christophe Delarche, Nicolas El Mahmoud, Rami Carrié, Didier Souteyrand, Géraud Kerneis, Mathieu Hauguel-Moreau, Marie Zeitouni, Michel Guedeney, Paul Diallo, Abdourahmane Collet, Jean-Philippe Vicaut, Eric Montalescot, Gilles Group, Action Study |
author_sort |
Lattuca, Benoit |
title |
Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial |
title_short |
Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial |
title_full |
Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial |
title_fullStr |
Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial |
title_full_unstemmed |
Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial |
title_sort |
bleeding in the elderly: risk factors and impact on clinical outcomes after an acute coronary syndrome, a sub-study of the randomized antarctic trial |
publisher |
HAL CCSD |
publishDate |
2021 |
url |
https://hal.archives-ouvertes.fr/hal-03633900 https://doi.org/10.1007/s40256-021-00468-8 |
long_lat |
ENVELOPE(155.883,155.883,-81.417,-81.417) |
geographic |
Antarctic Mace The Antarctic |
geographic_facet |
Antarctic Mace The Antarctic |
genre |
Antarc* Antarctic |
genre_facet |
Antarc* Antarctic |
op_source |
ISSN: 1175-3277 American Journal of Cardiovascular Drugs https://hal.archives-ouvertes.fr/hal-03633900 American Journal of Cardiovascular Drugs, Springer Verlag, 2021, 21 (6), pp.681-691. ⟨10.1007/s40256-021-00468-8⟩ |
op_relation |
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op_doi |
https://doi.org/10.1007/s40256-021-00468-8 |
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American Journal of Cardiovascular Drugs |
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21 |
container_issue |
6 |
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681 |
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spelling |
ftinserm:oai:HAL:hal-03633900v1 2023-05-15T13:45:35+02:00 Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial Lattuca, Benoit Cayla, Guillaume Silvain, Johanne Cuisset, Thomas Leclercq, Florence Manzo-Silberman, Stephane Saint-Etienne, Christophe Delarche, Nicolas El Mahmoud, Rami Carrié, Didier Souteyrand, Géraud Kerneis, Mathieu Hauguel-Moreau, Marie Zeitouni, Michel Guedeney, Paul Diallo, Abdourahmane Collet, Jean-Philippe Vicaut, Eric Montalescot, Gilles Group, Action Study Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases IHU ICAN Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition CHU Pitié Salpêtrière (IHU ICAN) CHU Pitié-Salpêtrière AP-HP Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière AP-HP Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) Initial MAnagement and prevention of acute orGan failures IN critically ill patiEnts (IMAGINE) Université de Montpellier (UM) Institut de cardiologie CHU Pitié-Salpêtrière Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) Hôpital de la Timone CHU - APHM (TIMONE) Nutrition, obésité et risque thrombotique (NORT) Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM) Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN) Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier) Hôpital Lariboisière-Fernand-Widal APHP Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) Centre hospitalier de Pau Hôpital Ambroise Paré AP-HP CHU Toulouse Toulouse CHU Gabriel Montpied Clermont-Ferrand CHU Clermont-Ferrand 2021-11 https://hal.archives-ouvertes.fr/hal-03633900 https://doi.org/10.1007/s40256-021-00468-8 en eng HAL CCSD Springer Verlag info:eu-repo/semantics/altIdentifier/doi/10.1007/s40256-021-00468-8 info:eu-repo/semantics/altIdentifier/pmid/34191259 hal-03633900 https://hal.archives-ouvertes.fr/hal-03633900 doi:10.1007/s40256-021-00468-8 PUBMED: 34191259 WOS: 000668429000001 ISSN: 1175-3277 American Journal of Cardiovascular Drugs https://hal.archives-ouvertes.fr/hal-03633900 American Journal of Cardiovascular Drugs, Springer Verlag, 2021, 21 (6), pp.681-691. ⟨10.1007/s40256-021-00468-8⟩ MESH: Acute Coronary Syndrome MESH: Aged 80 and over MESH: Hemorrhage MESH: Humans MESH: Risk Factors MESH: Treatment Outcome [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology info:eu-repo/semantics/article Journal articles 2021 ftinserm https://doi.org/10.1007/s40256-021-00468-8 2022-06-23T21:02:50Z International audience Background: Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials.Objectives: The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention.Methods: From the 877 patients aged ≥ 75 years included in the ANTARCTIC randomized trial, data on Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke, were collected over 1 year.Results: Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = 181) at 1 year, of which, one third occurred in the first month. Anemia (adjusted hazard ratio [adj.HR] 3.98, 95% confidence interval [CI] 1.41-11.22; p = 0.009), severe chronic renal failure (adj.HR 1.83, 95% CI 1.12-2.98; p = 0.015), and femoral access (adj.HR 2.54, 95% CI 1.71-3.77; p < 0.001) were independently associated with clinically relevant bleeding events, while age > 85 years (adj.HR 2.22, 95% CI 1.14-4.30; p = 0.018) was independently associated with major bleeding events (BARC types 3 or 5). Patients with a clinically relevant bleeding event had a higher rate of MACE at 1 year (adj.HR 2.04, 95% CI 1.24-3.38; p = 0.005), with a particularly strong effect on stroke (adj.HR 5.55, 95% CI 2.04-15.06; p < 0.001).Conclusions: Clinically relevant bleeding events were observed in one out of five elderly patients undergoing stenting for an ACS and were strongly associated with further stroke occurrence. Rather than the antiplatelet therapy, comorbidities and an age > 85 years predicted bleeding outcomes in this elderly population.Clinical trial registration: Clinicaltrials.gov identifier: NCT01538446. https://www.clinicaltrials.gov . Article in Journal/Newspaper Antarc* Antarctic Inserm: HAL (Institut national de la santé et de la recherche médicale) Antarctic Mace ENVELOPE(155.883,155.883,-81.417,-81.417) The Antarctic American Journal of Cardiovascular Drugs 21 6 681 691 |