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 (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.
Highlights
Oxygen therapy has been used liberally in patients with acute myocardial infarction (MI) across the world [1]
The present study describes a prespecified subgroup analysis in patients who were followed up in clinical routine over 1 year in the Secondary Prevention after Heart Intensive Care Admission (SEPHIA) part of SWEDEHEART where only patients with confirmed MI below the age of 75 are subject for follow-up, comprising 3,086 individuals in our study population
In contrast to clinical practice over the last decades, contemporary randomized clinical trials did not show any prognostic benefit of routine oxygen therapy regarding survival or cardiovascular outcomes compared to ambient air in patients with acute MI without hypoxemia at baseline [10, 11, 33]
Summary
Oxygen therapy has been used liberally in patients with acute myocardial infarction (MI) across the world [1]. Experimental [2, 5,6,7] and clinical [8] evidence showed that high arterial oxygen content may lead to negative cardiovascular effects and potentially detrimental outcomes including increased morbidity and mortality [9]. To elucidate this controversy, the Determination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2XAMI) trial compared routine oxygen therapy with ambient air in 6,629 normoxemic patients with suspected MI. Secondary objectives included analyses of MI subtypes, further adjustment for infarct size, and oxygen saturation at baseline and 1-year follow-up
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