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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

Hofmann, Robin ; Befekadu Abebe, Tamrat ; Herlitz, Johan ; James, Stefan K. ; Erlinge, David LU orcid ; Yndigegn, Troels LU ; Alfredsson, Joakim ; Kellerth, Thomas ; Ravn-Fischer, Annica and Völz, Sebastian , et al. (2021) In Frontiers in Cardiovascular Medicine 8.
Abstract

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... (More)

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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type
Contribution to journal
publication status
published
subject
keywords
health-realted quality of life, myocardial infarction, oxygen therapy, patient reported clinical outcomes, Registry-based randomized clinical trial, secondary prevention
in
Frontiers in Cardiovascular Medicine
volume
8
article number
638829
publisher
Frontiers Media S. A.
external identifiers
  • scopus:85105914429
  • pmid:33791349
ISSN
2297-055X
DOI
10.3389/fcvm.2021.638829
language
English
LU publication?
yes
additional info
Funding Information: The authors would like to thank the personnel and staff at the participating centers for collaboration in the DETO2X-AMI study. We are grateful for the continuous support from personnel at Uppsala Research Center, Uppsala University, Uppsala, on all aspects of the trial. Funding. This work was supported by the Swedish Heart-Lung Foundation (Grant nos. HLF20160688 and HLF20180187) and the Swedish Research Council (Grant no. VR20130307). RH was supported by the Stockholm County Council (clinical postdoctoral appointment) (Grant no. K 2017-4577) and the Swedish Heart-Lung Foundation (Grant no. HLF20180287).
id
1258d8d1-5445-4651-9144-7c3e8b875c28
date added to LUP
2021-06-02 11:05:53
date last changed
2024-06-15 11:59:57
@article{1258d8d1-5445-4651-9144-7c3e8b875c28,
  abstract     = {{<p>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.</p>}},
  author       = {{Hofmann, Robin and Befekadu Abebe, Tamrat and Herlitz, Johan and James, Stefan K. and Erlinge, David and Yndigegn, Troels and Alfredsson, Joakim and Kellerth, Thomas and Ravn-Fischer, Annica and Völz, Sebastian and Lauermann, Jörg and Jernberg, Tomas and Lindahl, Bertil and Langenskiöld, Sophie}},
  issn         = {{2297-055X}},
  keywords     = {{health-realted quality of life; myocardial infarction; oxygen therapy; patient reported clinical outcomes; Registry-based randomized clinical trial; secondary prevention}},
  language     = {{eng}},
  publisher    = {{Frontiers Media S. A.}},
  series       = {{Frontiers in Cardiovascular Medicine}},
  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}},
  url          = {{http://dx.doi.org/10.3389/fcvm.2021.638829}},
  doi          = {{10.3389/fcvm.2021.638829}},
  volume       = {{8}},
  year         = {{2021}},
}