Hofmann Robin, Befekadu Abebe Tamrat, Herlitz Johan, James Stefan K, Erlinge David, Yndigegn Troels, Alfredsson Joakim, Kellerth Thomas, Ravn-Fischer Annica, Völz Sebastian, Lauermann Jörg, Jernberg Tomas, Lindahl Bertil, Langenskiöld Sophie
Division of Cardiology, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.
Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Front Cardiovasc Med. 2021 Mar 15;8:638829. doi: 10.3389/fcvm.2021.638829. eCollection 2021.
After decades of ubiquitous oxygen therapy in all patients with acute myocardial infarction (MI), recent guidelines are more restrictive based on lack of efficacy in contemporary trials evaluating hard clinical outcomes in patients without hypoxemia at baseline. However, no evidence regarding treatment effects on health-related quality of life (HRQoL) exists. In this study, we investigated the impact of routine oxygen supplementation on HRQoL 6-8 weeks after hospitalization with acute MI. Secondary objectives included analyses of MI subtypes, further adjustment for infarct size, and oxygen saturation at baseline and 1-year follow-up. In the DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6-12 h or ambient air. In this prespecified analysis, patients younger than 75 years of age with confirmed MI who had available HRQoL data by European Quality of Life Five Dimensions questionnaire (EQ-5D) in the national registry were included. Primary endpoint was the EQ-5D index assessed by multivariate linear regression at 6-10 weeks after MI occurrence. A total of 3,086 patients (median age 64, 22% female) were eligible, 1,518 allocated to oxygen and 1,568 to ambient air. We found no statistically significant effect of oxygen therapy on EQ-5D index (-0.01; 95% CI: -0.03-0.01; = 0.23) or EQ-VAS score (-0.57; 95% CI: -1.88-0.75; = 0.40) compared to ambient air after 6-10 weeks. Furthermore, no significant difference was observed between the treatment groups in EQ-5D dimensions. Results remained consistent across MI subtypes and at 1-year follow-up, including further adjustment for infarct size or oxygen saturation at baseline. Routine oxygen therapy provided to normoxemic patients with acute MI did not improve HRQoL up to 1 year after MI occurrence. ClinicalTrials.gov number, NCT01787110.
在对所有急性心肌梗死（MI）患者进行了数十年的普遍氧疗之后，近期的指南基于在评估基线时无低氧血症患者的硬临床结局的当代试验中缺乏疗效而更加严格。然而，尚无关于治疗对健康相关生活质量（HRQoL）影响的证据。在本研究中，我们调查了急性心肌梗死后住院6至8周时常规氧补充对HRQoL的影响。次要目标包括分析心肌梗死亚型、对梗死面积进行进一步校正，以及分析基线和1年随访时的氧饱和度。在“确定氧气在疑似急性心肌梗死中的作用（DETO2X-AMI）”试验中，6629例疑似心肌梗死的血氧正常患者被随机分为接受6 L/min的氧气治疗6至12小时或接受室内空气治疗。在这项预先设定的分析中，纳入了年龄小于75岁、确诊心肌梗死且在国家登记处有通过欧洲生活质量五维度问卷（EQ-5D）获得的HRQoL数据的患者。主要终点是心肌梗死发生后6至10周通过多变量线性回归评估的EQ-5D指数。共有3086例患者（中位年龄64岁，22%为女性）符合条件，1518例被分配接受氧气治疗，1568例被分配接受室内空气治疗。我们发现，与室内空气相比，6至10周后氧疗对EQ-5D指数（-0.01；95%CI：-0.03至0.01；P = 0.23）或EQ视觉模拟量表（VAS）评分（-0.57；95%CI：-1.88至0.75；P = 0.40）没有统计学上的显著影响。此外，治疗组在EQ-5D维度上未观察到显著差异。在心肌梗死亚型以及1年随访中，包括对梗死面积或基线氧饱和度进行进一步校正后，结果仍然一致。对急性心肌梗死的血氧正常患者进行的常规氧疗在心肌梗死后长达1年的时间里并未改善HRQoL。临床试验注册号，NCT01787110。
