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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Main Authors: Robin Hofmann, Tamrat Befekadu Abebe, Johan Herlitz, Stefan K. James, David Erlinge, Troels Yndigegn, Joakim Alfredsson, Thomas Kellerth, Annica Ravn-Fischer, Sebastian Völz, Jörg Lauermann, Tomas Jernberg, Bertil Lindahl, Sophie Langenskiöld
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-03-01
Series:Frontiers in Cardiovascular Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fcvm.2021.638829/full
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author Robin Hofmann
Tamrat Befekadu Abebe
Johan Herlitz
Stefan K. James
Stefan K. James
David Erlinge
Troels Yndigegn
Joakim Alfredsson
Joakim Alfredsson
Thomas Kellerth
Annica Ravn-Fischer
Annica Ravn-Fischer
Sebastian Völz
Sebastian Völz
Jörg Lauermann
Jörg Lauermann
Tomas Jernberg
Bertil Lindahl
Bertil Lindahl
Sophie Langenskiöld
spellingShingle Robin Hofmann
Tamrat Befekadu Abebe
Johan Herlitz
Stefan K. James
Stefan K. James
David Erlinge
Troels Yndigegn
Joakim Alfredsson
Joakim Alfredsson
Thomas Kellerth
Annica Ravn-Fischer
Annica Ravn-Fischer
Sebastian Völz
Sebastian Völz
Jörg Lauermann
Jörg Lauermann
Tomas Jernberg
Bertil Lindahl
Bertil Lindahl
Sophie Langenskiöld
Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial
Frontiers in Cardiovascular Medicine
myocardial infarction
oxygen therapy
Registry-based randomized clinical trial
secondary prevention
health-realted quality of life
patient reported clinical outcomes
author_facet Robin Hofmann
Tamrat Befekadu Abebe
Johan Herlitz
Stefan K. James
Stefan K. James
David Erlinge
Troels Yndigegn
Joakim Alfredsson
Joakim Alfredsson
Thomas Kellerth
Annica Ravn-Fischer
Annica Ravn-Fischer
Sebastian Völz
Sebastian Völz
Jörg Lauermann
Jörg Lauermann
Tomas Jernberg
Bertil Lindahl
Bertil Lindahl
Sophie Langenskiöld
author_sort Robin Hofmann
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_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_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_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
publisher Frontiers Media S.A.
series Frontiers in Cardiovascular Medicine
issn 2297-055X
publishDate 2021-03-01
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.
topic myocardial infarction
oxygen therapy
Registry-based randomized clinical trial
secondary prevention
health-realted quality of life
patient reported clinical outcomes
url https://www.frontiersin.org/articles/10.3389/fcvm.2021.638829/full
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spelling doaj-2465091543e740f9a5d52c0ce15c5c432021-03-15T12:14:32ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2021-03-01810.3389/fcvm.2021.638829638829Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI TrialRobin Hofmann0Tamrat Befekadu Abebe1Johan Herlitz2Stefan K. James3Stefan K. James4David Erlinge5Troels Yndigegn6Joakim Alfredsson7Joakim Alfredsson8Thomas Kellerth9Annica Ravn-Fischer10Annica Ravn-Fischer11Sebastian Völz12Sebastian Völz13Jörg Lauermann14Jörg Lauermann15Tomas Jernberg16Bertil Lindahl17Bertil Lindahl18Sophie Langenskiöld19Division of Cardiology, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, SwedenDepartment of Medical Sciences, Uppsala University, Uppsala, SwedenDepartment of Health Sciences, University of Borås, Borås, SwedenDepartment of Medical Sciences, Uppsala University, Uppsala, SwedenUppsala Clinical Research Center, Uppsala University, Uppsala, SwedenDepartment of Clinical Sciences, Cardiology, Lund University, Lund, SwedenDepartment of Clinical Sciences, Cardiology, Lund University, Lund, SwedenDepartment of Health, Medicine and Caring Sciences, Linköping University, Linköping, SwedenDepartment of Cardiology, Linköping University Hospital, Linköping, SwedenDepartment of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, SwedenDepartment of Molecular and Clinical Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden0Department of Cardiology, University of Gothenburg, Gothenburg, SwedenDepartment of Molecular and Clinical Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden0Department of Cardiology, University of Gothenburg, Gothenburg, Sweden1Department of Cardiology, Ryhov Hospital, Jönköping, Sweden2Department of Health, Medicine and Caring, Linköping University, Linköping, Sweden3Department of Clinical Sciences, Cardiology, Karolinska Institutet, Danderyd Hospital, Stockholm, SwedenDepartment of Medical Sciences, Uppsala University, Uppsala, SwedenUppsala Clinical Research Center, Uppsala University, Uppsala, SwedenDepartment of Medical Sciences, Uppsala University, Uppsala, SwedenBackground: 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.https://www.frontiersin.org/articles/10.3389/fcvm.2021.638829/fullmyocardial infarctionoxygen therapyRegistry-based randomized clinical trialsecondary preventionhealth-realted quality of lifepatient reported clinical outcomes