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Long-Term Effects of Oxygen Therapy on Death or Hospitalization for Heart Failure in Patients With Suspected Acute Myocardial Infarction
Circulation. 2018 Dec 11;138(24):2754-2762
Authors: Jernberg T, Lindahl B, Alfredsson J, Berglund E, Bergström O, Engström A, Erlinge D, Herlitz J, Jumatate R, Kellerth T, Lauermann J, Lindmark K, Lingman M, Ljung L, Nilsson C, Omerovic E, Pernow J, Ravn-Fischer A, Sparv D, Yndigegn T, Östlund O, James SK, Hofmann R, DETO2X-SWEDEHEART Investigators
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.
PMID: 30767504 [PubMed - as supplied by publisher]