Publisher Information: Linköpings universitet, Avdelningen för kardiovaskulär medicin Linköpings universitet, Medicinska fakulteten Region Östergötland, Kardiologiska kliniken US Karolinska Inst, Sweden Uppsala Univ, Sweden Karolinska Inst, Sweden Vaxjo Hosp, Sweden Kalmar Reg Hosp, Sweden Lund Univ, Sweden Univ Gothenburg, Sweden; Univ Boras, Sweden Kristianstad Hosp, Sweden Orebro Univ Hosp, Sweden Ryhov Hosp, Sweden Umea Univ, Sweden Halland Hosp, Sweden; Univ Gothenburg, Sweden Karolinska Inst, Sweden Ljungby Hosp, Sweden Univ Gothenburg, Sweden Karolinska Inst, Sweden; Karolinska Univ Hosp, Sweden Univ Gothenburg, Sweden Lund Univ, Sweden Lund Univ, Sweden Uppsala Univ, Sweden Uppsala Univ, Sweden Karolinska Inst, Sweden LIPPINCOTT WILLIAMS & WILKINS 2018
نبذة مختصرة : 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 amp;gt;= 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
Funding Agencies|Swedish Research Council [VR20130307]; Swedish Heart-Lung Foundation [HLF20130262, HLF20160688, HLF20170277]; Swedish Foundation for Strategic Research [SFF KF10-0024]
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