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Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial

Background: After decades of ubiquitous oxygen therapy in all patients with acute myocardial infarction (MI), recent guidelines are more restrictive based on lack of efficacy in contemporary trials evaluating hard clinical outcomes in patients without hypoxemia at baseline. However, no evidence rega...

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Autores principales: Hofmann, Robin, Befekadu Abebe, Tamrat, Herlitz, Johan, James, Stefan K., Erlinge, David, Yndigegn, Troels, Alfredsson, Joakim, Kellerth, Thomas, Ravn-Fischer, Annica, Völz, Sebastian, Lauermann, Jörg, Jernberg, Tomas, Lindahl, Bertil, Langenskiöld, Sophie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006541/
https://www.ncbi.nlm.nih.gov/pubmed/33791349
http://dx.doi.org/10.3389/fcvm.2021.638829
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author Hofmann, Robin
Befekadu Abebe, Tamrat
Herlitz, Johan
James, Stefan K.
Erlinge, David
Yndigegn, Troels
Alfredsson, Joakim
Kellerth, Thomas
Ravn-Fischer, Annica
Völz, Sebastian
Lauermann, Jörg
Jernberg, Tomas
Lindahl, Bertil
Langenskiöld, Sophie
author_facet Hofmann, Robin
Befekadu Abebe, Tamrat
Herlitz, Johan
James, Stefan K.
Erlinge, David
Yndigegn, Troels
Alfredsson, Joakim
Kellerth, Thomas
Ravn-Fischer, Annica
Völz, Sebastian
Lauermann, Jörg
Jernberg, Tomas
Lindahl, Bertil
Langenskiöld, Sophie
author_sort Hofmann, Robin
collection PubMed
description Background: After decades of ubiquitous oxygen therapy in all patients with acute myocardial infarction (MI), recent guidelines are more restrictive based on lack of efficacy in contemporary trials evaluating hard clinical outcomes in patients without hypoxemia at baseline. However, no evidence regarding treatment effects on health-related quality of life (HRQoL) exists. In this study, we investigated the impact of routine oxygen supplementation on HRQoL 6–8 weeks after hospitalization with acute MI. Secondary objectives included analyses of MI subtypes, further adjustment for infarct size, and oxygen saturation at baseline and 1-year follow-up. Methods: In the DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6–12 h or ambient air. In this prespecified analysis, patients younger than 75 years of age with confirmed MI who had available HRQoL data by European Quality of Life Five Dimensions questionnaire (EQ-5D) in the national registry were included. Primary endpoint was the EQ-5D index assessed by multivariate linear regression at 6–10 weeks after MI occurrence. Results: A total of 3,086 patients (median age 64, 22% female) were eligible, 1,518 allocated to oxygen and 1,568 to ambient air. We found no statistically significant effect of oxygen therapy on EQ-5D index (−0.01; 95% CI: −0.03–0.01; p = 0.23) or EQ-VAS score (−0.57; 95% CI: −1.88–0.75; p = 0.40) compared to ambient air after 6–10 weeks. Furthermore, no significant difference was observed between the treatment groups in EQ-5D dimensions. Results remained consistent across MI subtypes and at 1-year follow-up, including further adjustment for infarct size or oxygen saturation at baseline. Conclusions: Routine oxygen therapy provided to normoxemic patients with acute MI did not improve HRQoL up to 1 year after MI occurrence. Clinical Trial Registration: ClinicalTrials.gov number, NCT01787110.
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spelling pubmed-80065412021-03-30 Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial Hofmann, Robin Befekadu Abebe, Tamrat Herlitz, Johan James, Stefan K. Erlinge, David Yndigegn, Troels Alfredsson, Joakim Kellerth, Thomas Ravn-Fischer, Annica Völz, Sebastian Lauermann, Jörg Jernberg, Tomas Lindahl, Bertil Langenskiöld, Sophie Front Cardiovasc Med Cardiovascular Medicine Background: After decades of ubiquitous oxygen therapy in all patients with acute myocardial infarction (MI), recent guidelines are more restrictive based on lack of efficacy in contemporary trials evaluating hard clinical outcomes in patients without hypoxemia at baseline. However, no evidence regarding treatment effects on health-related quality of life (HRQoL) exists. In this study, we investigated the impact of routine oxygen supplementation on HRQoL 6–8 weeks after hospitalization with acute MI. Secondary objectives included analyses of MI subtypes, further adjustment for infarct size, and oxygen saturation at baseline and 1-year follow-up. Methods: In the DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6–12 h or ambient air. In this prespecified analysis, patients younger than 75 years of age with confirmed MI who had available HRQoL data by European Quality of Life Five Dimensions questionnaire (EQ-5D) in the national registry were included. Primary endpoint was the EQ-5D index assessed by multivariate linear regression at 6–10 weeks after MI occurrence. Results: A total of 3,086 patients (median age 64, 22% female) were eligible, 1,518 allocated to oxygen and 1,568 to ambient air. We found no statistically significant effect of oxygen therapy on EQ-5D index (−0.01; 95% CI: −0.03–0.01; p = 0.23) or EQ-VAS score (−0.57; 95% CI: −1.88–0.75; p = 0.40) compared to ambient air after 6–10 weeks. Furthermore, no significant difference was observed between the treatment groups in EQ-5D dimensions. Results remained consistent across MI subtypes and at 1-year follow-up, including further adjustment for infarct size or oxygen saturation at baseline. Conclusions: Routine oxygen therapy provided to normoxemic patients with acute MI did not improve HRQoL up to 1 year after MI occurrence. Clinical Trial Registration: ClinicalTrials.gov number, NCT01787110. Frontiers Media S.A. 2021-03-15 /pmc/articles/PMC8006541/ /pubmed/33791349 http://dx.doi.org/10.3389/fcvm.2021.638829 Text en Copyright © 2021 Hofmann, Befekadu Abebe, Herlitz, James, Erlinge, Yndigegn, Alfredsson, Kellerth, Ravn-Fischer, Völz, Lauermann, Jernberg, Lindahl and Langenskiöld. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Cardiovascular Medicine
Hofmann, Robin
Befekadu Abebe, Tamrat
Herlitz, Johan
James, Stefan K.
Erlinge, David
Yndigegn, Troels
Alfredsson, Joakim
Kellerth, Thomas
Ravn-Fischer, Annica
Völz, Sebastian
Lauermann, Jörg
Jernberg, Tomas
Lindahl, Bertil
Langenskiöld, Sophie
Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial
title Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial
title_full Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial
title_fullStr Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial
title_full_unstemmed Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial
title_short Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial
title_sort routine oxygen therapy does not improve health-related quality of life in patients with acute myocardial infarction—insights from the randomized deto2x-ami trial
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006541/
https://www.ncbi.nlm.nih.gov/pubmed/33791349
http://dx.doi.org/10.3389/fcvm.2021.638829
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