Randomized comparison of early supplemental oxygen versus ambient air in patients with confirmed myocardial infarction: Sex-related outcomes from DETO2X-AMI - 26/05/21

Doi : 10.1016/j.ahj.2021.03.001

Joakim Alfredsson, MD, PhD ^a, Stefan K. James, MD, PhD ^b,^c, David Erlinge, MD, PhD ^d, Johan Herlitz, MD, PhD ^e, Ole Fröbert, MD, PhD ^f, Christian Dworeck, MD, PhD ^g, Björn Redfors, MD, PhD ^g, Gabriel Arefalk, MD, PhD ^b, Ollie Östlund, PhD ^c, Tomas Jernberg, MD, PhD ^h, Katarina Mars, MD ⁱ, Urban Haaga, BSc ^j, Bertil Lindahl, MD, PhD ^b,^c, Eva Swahn, MD, PhD ^a, Sofia Sederholm Lawesson, MD, PhD ^a, Robin Hofmann, MD, PhD ^i,^⁎
for the DETO2X-SWEDEHEART Investigators
^a Department of Health, Medicine and Caring Sciences and Department of Cardiology, Linköping University, Linköping, Sweden
^b Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden
^c Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden
^d Department of Clinical Sciences, Cardiology, Lund University, Lund, Sweden
^e Department of Health Sciences, University of Borås, Borås, Sweden
^f Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
^g Department of Molecular and Clinical Medicine and Sahlgrenska University Hospital, Department of Cardiology, University of Gothenburg, Gothenburg, Sweden
^h Department of Clinical Sciences, Cardiology, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden
ⁱ Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet-Södersjukhuset, Stockholm, Sweden
^j Department of Cardiology, Karlstad Central Hospital, Karlstad, Sweden

^⁎Reprint requests: Robin Hofmann, MD, PhD, FESC, Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet-Södersjukhuset, Sjukhusbacken 10, 11883 Stockholm, Sweden.Department of Clinical Science and Education, Division of CardiologyKarolinska Institutet-SödersjukhusetSjukhusbacken 10Stockholm11883Sweden

Résumé

Background

The purpose of this study is to investigate the impact of oxygen therapy on cardiovascular outcomes in relation to sex in patients with confirmed myocardial infarction (MI).

Methods

The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction trial randomized 6,629 patients to oxygen at 6 L/min for 6-12 hours or ambient air. In the present subgroup analysis including 5,010 patients (1,388 women and 3,622 men) with confirmed MI, we report the effect of supplemental oxygen on the composite of all-cause death, rehospitalization with MI, or heart failure at long-term follow-up, stratified according to sex.

Results

Event rate for the composite endpoint was 18.1% in women allocated to oxygen, compared to 21.4% in women allocated to ambient air (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.65-1.05). In men, the incidence was 13.6% in patients allocated to oxygen compared to 13.3% in patients allocated to ambient air (HR 1.03, 95% CI 0.86-1.23). No significant interaction in relation to sex was found (P= .16). Irrespective of allocated treatment, the composite endpoint occurred more often in women compared to men (19.7 vs 13.4%, HR 1.51; 95% CI, 1.30-1.75). After adjustment for age alone, there was no difference between the sexes (HR 1.06, 95% CI 0.91-1.24), which remained consistent after multivariate adjustment.

Conclusion

Oxygen therapy in normoxemic MI patients did not significantly affect all-cause mortality or rehospitalization for MI or heart failure in women or men. The observed worse outcome in women was explained by differences in baseline characteristics, especially age.

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Plan

Outcomes and follow-up

Statistical analysis

Results

Study population

In-hospital procedural data

Clinical outcomes for the complete follow-up adjusted for age-stratified by sex and randomized therapy

Clinical outcomes for the complete follow-up adjusted for age, hypertension, diabetes, previous MI, PCI, HF, and infarct type stratified by sex and randomized therapy

Clinical outcomes for women vs men, crude and adjusted

Discussion

Conclusions

Role of the Funder/Sponsor

Clinical trial registration: NCT01787110.

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Vol 237

P. 13-24 - juillet 2021 Retour au numéro

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Randomized comparison of early supplemental oxygen versus ambient air in patients with confirmed myocardial infarction: Sex-related outcomes from DETO2X-AMI - 26/05/21

Résumé

Background

Methods

Results

Conclusion

Plan

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