Tomas Jernberg1, Bertil Lindahl2,3, Joakim Alfredsson4, Ellinor Berglund5, Olle Bergström6, Anders Engström7, David Erlinge8, Johan Herlitz9,10, Raluca Jumatate11, Thomas Kellerth12, Jorg Lauermann13, Krister Lindmark14, Markus Lingman15,16, Lina Ljung17, Carina Nilsson18, Elmir Omerovic9, J Pernow19, Annica Ravn-Fischer9, David Sparv8, Troels Yndigegn8, Ollie Östlund3, Stefan K James2,3, Robin Hofmann17. 1. Department of Clinical Sciences, Division of Cardiology, Karolinska Institutet,zzm321990Danderyd Hospital, Stockholm, Sweden 2. Department of Medical Sciences, Cardiology, Uppsala University, Sweden. 3. Uppsala Clinical Research Center, Uppsala University, Sweden. 4. Department of Medical and Health Sciences and Department of Cardiology, Linköping University, Sweden 5. Department of Medicine, Solna, Centre for Resuscitation Science, Karolinska Institutet, Stockholm, Sweden 6. Department of Medicine, Växjö Hospital, Sweden 7. Department of Medicine, Division of Cardiology, Kalmar Regional Hospital, Sweden 8. Department of Clinical Sciences, Cardiology, Lund University, Sweden 9. Department of Molecular and Clinical Medicine and Sahlgrenskazzm321990University Hospital, Department of Cardiology, University of Gothenburg,zzm321990Sweden 10. Department of Health Sciences, University of Borås, Sweden 11. Department of Medicine, Kristianstad Hospital, Sweden 12. Department of Cardiology, Örebro University Hospital, Sweden 13. Department of Internal Medicine, Division of Cardiology, Ryhov Hospital, Jönköping, Sweden 14. Department of Public Health and Clinical Medicine, Umeå University, Sweden 15. Department of Medicine, Halland Hospital, Halmstad, Sweden 16. Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden 17. Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden 18. Department of Medicine, Ljungby Hospital, Sweden 19. Department of Medicine, Division of Cardiology, Karolinska Institutet,zzm321990Solna, and Karolinska University Hospital, Stockholm, Sweden
Abstract
Background: In the DETO2X-AMI trial (Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction), we compared supplemental oxygen with ambient air in normoxemic patients presenting with suspected myocardial infarction and found no significant survival benefit at 1 year. However, important secondary end points were not yet available. We now report the prespecified secondary end points cardiovascular death and the composite of all-cause death and hospitalization for heart failure. Methods: In this pragmatic, registry-based randomized clinical trial, we used a nationwide quality registry for coronary care for trial procedures and evaluated end points through the Swedish population registry (mortality), the Swedish inpatient registry (heart failure), and cause of death registry (cardiovascular death). Patients with suspected acute myocardial infarction and oxygen saturation of ≥90% were randomly assigned to receive either supplemental oxygen at 6 L/min for 6 to 12 hours delivered by open face mask or ambient air. Results: A total of 6629 patients were enrolled. Acute heart failure treatment, left ventricular systolic function assessed by echocardiography, and infarct size measured by high-sensitive cardiac troponin T were similar in the 2 groups during the hospitalization period. All-cause death or hospitalization for heart failure within 1 year after randomization occurred in 8.0% of patients assigned to oxygen and in 7.9% of patients assigned to ambient air (hazard ratio, 0.99; 95% CI, 0.84–1.18; P=0.92). During long-term follow-up (median [range], 2.1 [1.0–3.7] years), the composite end point occurred in 11.2% of patients assigned to oxygen and in 10.8% of patients assigned to ambient air (hazard ratio, 1.02; 95% CI, 0.88–1.17; P=0.84), and cardiovascular death occurred in 5.2% of patients assigned to oxygen and in 4.8% assigned to ambient air (hazard ratio, 1.07; 95% CI, 0.87–1.33; P=0.52). The results were consistent across all predefined subgroups. Conclusions: Routine use of supplemental oxygen in normoxemic patients with suspected myocardial infarction was not found to reduce the composite of all-cause mortality and hospitalization for heart failure, or cardiovascular death within 1 year or during long-term follow-up. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01787110.
RCT Entities:
Background: In the DETO2X-AMI trial (Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction), we compared supplemental oxygen with ambient air in normoxemic patients presenting with suspected myocardial infarction and found no significant survival benefit at 1 year. However, important secondary end points were not yet available. We now report the prespecified secondary end points cardiovascular death and the composite of all-cause death and hospitalization for heart failure. Methods: In this pragmatic, registry-based randomized clinical trial, we used a nationwide quality registry for coronary care for trial procedures and evaluated end points through the Swedish population registry (mortality), the Swedish inpatient registry (heart failure), and cause of death registry (cardiovascular death). Patients with suspected acute myocardial infarction and oxygen saturation of ≥90% were randomly assigned to receive either supplemental oxygen at 6 L/min for 6 to 12 hours delivered by open face mask or ambient air. Results: A total of 6629 patients were enrolled. Acute heart failure treatment, left ventricular systolic function assessed by echocardiography, and infarct size measured by high-sensitive cardiac troponin T were similar in the 2 groups during the hospitalization period. All-cause death or hospitalization for heart failure within 1 year after randomization occurred in 8.0% of patients assigned to oxygen and in 7.9% of patients assigned to ambient air (hazard ratio, 0.99; 95% CI, 0.84–1.18; P=0.92). During long-term follow-up (median [range], 2.1 [1.0–3.7] years), the composite end point occurred in 11.2% of patients assigned to oxygen and in 10.8% of patients assigned to ambient air (hazard ratio, 1.02; 95% CI, 0.88–1.17; P=0.84), and cardiovascular death occurred in 5.2% of patients assigned to oxygen and in 4.8% assigned to ambient air (hazard ratio, 1.07; 95% CI, 0.87–1.33; P=0.52). The results were consistent across all predefined subgroups. Conclusions: Routine use of supplemental oxygen in normoxemic patients with suspected myocardial infarction was not found to reduce the composite of all-cause mortality and hospitalization for heart failure, or cardiovascular death within 1 year or during long-term follow-up. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01787110.
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 Journal: Front Cardiovasc Med Date: 2021-03-15
Authors: Robin Hofmann; Tamrat Befekadu Abebe; Johan Herlitz; Stefan K James; David Erlinge; Joakim Alfredsson; Tomas Jernberg; Thomas Kellerth; Annica Ravn-Fischer; Bertil Lindahl; Sophie Langenskiöld Journal: Front Public Health Date: 2022-01-12
Authors: Yue Yu; Ren-Qi Yao; Yu-Feng Zhang; Su-Yu Wang; Wang Xi; Jun-Nan Wang; Xiao-Yi Huang; Yong-Ming Yao; Zhi-Nong Wang Journal: Mil Med Res Date: 2021-07-09