Key result
Routine oxygen therapy provided to normoxemic patients with acute myocardial infarction did not significantly improve the EQ-5D index at 6-10 weeks compared to ambient air (MD -0.01).
Why the study?
Recent guidelines restrict routine oxygen in acute MI due to lack of efficacy on clinical outcomes in normoxemic patients, but its effect on health-related quality of life was unknown.
Does routine oxygen therapy improve health-related quality of life in normoxemic patients with acute myocardial infarction?
RCT (n=3,086)
Open-label
1:1
Yes
Does routine oxygen therapy improve health-related quality of life in normoxemic patients with acute myocardial infarction?
Routine oxygen therapy in normoxemic patients with acute myocardial infarction does not improve health-related quality of life, supporting current restrictive oxygen guidelines.
No QoL benefit from oxygen in normoxemic AMI; reinforces restrictive guidelines and confirms RCT evidence.
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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Hofmann et al. (2021) conducted an RCT in Acute Myocardial Infarction (n=3,086). Oxygen therapy vs. Ambient air was evaluated on EQ-5D index at 6-10 weeks (MD -0.01, 95% CI -0.03-0.01, p=0.23). Routine oxygen therapy provided to normoxemic patients with acute myocardial infarction did not significantly improve the EQ-5D index at 6-10 weeks compared to ambient air (MD -0.01).
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