Robin Hofmann1, Stefan K James1, Tomas Jernberg1, Bertil Lindahl1, David Erlinge1, Nils Witt1, Gabriel Arefalk1, Mats Frick1, Joakim Alfredsson1, Lennart Nilsson1, Annica Ravn-Fischer1, Elmir Omerovic1, Thomas Kellerth1, David Sparv1, Ulf Ekelund1, Rickard Linder1, Mattias Ekström1, Jörg Lauermann1, Urban Haaga1, John Pernow1, Ollie Östlund1, Johan Herlitz1, Leif Svensson1. 1. From the Department of Clinical Science and Education, Division of Cardiology (R.H., N.W., M.F.), and Center for Resuscitation Science (L.S.), Karolinska Institutet, Södersjukhuset, and the Department of Clinical Sciences, Cardiology, Danderyd Hospital, Karolinska Institutet (T.J., R.L., M.E.), Stockholm, the Department of Medical Sciences, Cardiology (S.K.J., B.L., G.A.), and Uppsala Clinical Research Center (S.K.J., O.Ö.), Uppsala University, Uppsala, the Department of Clinical Sciences, Cardiology (D.E., D.S.), and Department of Clinical Sciences, Emergency Medicine (U.E.), Lund University, Lund, the Department of Medical and Health Sciences and Department of Cardiology, Linköping University, Linköping (J.A., L.N.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (A.R.-F., E.O., J.H.), the Department of Cardiology, Örebro University Hospital, Örebro (T.K.), the Department of Internal Medicine, Division of Cardiology, Ryhov Hospital, Jönköping (J.L.), the Department of Cardiology, Karlstad Central Hospital, Karlstad (U.H.), the Department of Cardiology, Karolinska University Hospital (J.P.), and the Department of Medicine, Karolinska Institutet (J.P., L.S.), Solna, and the Department of Health Sciences, University of Borås, Borås (J.H.) - all in Sweden.
Abstract
BACKGROUND: The clinical effect of routine oxygen therapy in patients with suspected acute myocardial infarction who do not have hypoxemia at baseline is uncertain. METHODS: In this registry-based randomized clinical trial, we used nationwide Swedish registries for patient enrollment and data collection. Patients with suspected myocardial infarction and an oxygen saturation of 90% or higher were randomly assigned to receive either supplemental oxygen (6 liters per minute for 6 to 12 hours, delivered through an open face mask) or ambient air. RESULTS: A total of 6629 patients were enrolled. The median duration of oxygen therapy was 11.6 hours, and the median oxygen saturation at the end of the treatment period was 99% among patients assigned to oxygen and 97% among patients assigned to ambient air. Hypoxemia developed in 62 patients (1.9%) in the oxygen group, as compared with 254 patients (7.7%) in the ambient-air group. The median of the highest troponin level during hospitalization was 946.5 ng per liter in the oxygen group and 983.0 ng per liter in the ambient-air group. The primary end point of death from any cause within 1 year after randomization occurred in 5.0% of patients (166 of 3311) assigned to oxygen and in 5.1% of patients (168 of 3318) assigned to ambient air (hazard ratio, 0.97; 95% confidence interval [CI], 0.79 to 1.21; P=0.80). Rehospitalization with myocardial infarction within 1 year occurred in 126 patients (3.8%) assigned to oxygen and in 111 patients (3.3%) assigned to ambient air (hazard ratio, 1.13; 95% CI, 0.88 to 1.46; P=0.33). The results were consistent across all predefined subgroups. CONCLUSIONS: Routine use of supplemental oxygen in patients with suspected myocardial infarction who did not have hypoxemia was not found to reduce 1-year all-cause mortality. (Funded by the Swedish Heart-Lung Foundation and others; DETO2X-AMI ClinicalTrials.gov number, NCT01787110 .).
RCT Entities:
BACKGROUND: The clinical effect of routine oxygen therapy in patients with suspected acute myocardial infarction who do not have hypoxemia at baseline is uncertain. METHODS: In this registry-based randomized clinical trial, we used nationwide Swedish registries for patient enrollment and data collection. Patients with suspected myocardial infarction and an oxygen saturation of 90% or higher were randomly assigned to receive either supplemental oxygen (6 liters per minute for 6 to 12 hours, delivered through an open face mask) or ambient air. RESULTS: A total of 6629 patients were enrolled. The median duration of oxygen therapy was 11.6 hours, and the median oxygen saturation at the end of the treatment period was 99% among patients assigned to oxygen and 97% among patients assigned to ambient air. Hypoxemia developed in 62 patients (1.9%) in the oxygen group, as compared with 254 patients (7.7%) in the ambient-air group. The median of the highest troponin level during hospitalization was 946.5 ng per liter in the oxygen group and 983.0 ng per liter in the ambient-air group. The primary end point of death from any cause within 1 year after randomization occurred in 5.0% of patients (166 of 3311) assigned to oxygen and in 5.1% of patients (168 of 3318) assigned to ambient air (hazard ratio, 0.97; 95% confidence interval [CI], 0.79 to 1.21; P=0.80). Rehospitalization with myocardial infarction within 1 year occurred in 126 patients (3.8%) assigned to oxygen and in 111 patients (3.3%) assigned to ambient air (hazard ratio, 1.13; 95% CI, 0.88 to 1.46; P=0.33). The results were consistent across all predefined subgroups. CONCLUSIONS: Routine use of supplemental oxygen in patients with suspected myocardial infarction who did not have hypoxemia was not found to reduce 1-year all-cause mortality. (Funded by the Swedish Heart-Lung Foundation and others; DETO2X-AMI ClinicalTrials.gov number, NCT01787110 .).
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