β受体阻滞剂对心肌梗死且左心室功能保留患者生活质量和幸福感的影响——REDUCE-AMI研究的一项预先设定的亚组研究
Effects of beta-blockers on quality of life and well-being in patients with myocardial infarction and preserved left ventricular function-a prespecified substudy from REDUCE-AMI.
作者信息
Mars Katarina, Humphries Sophia, Leissner Philip, Jonsson Martin, Karlström Patric, Lauermann Jörg, Alfredsson Joakim, Kellerth Thomas, Ravn-Fischer Annica, Erlinge David, Lindahl Bertil, Yndigegn Troels, Jernberg Tomas, Held Claes, Olsson Erik M G, Hofmann Robin
机构信息
Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sjukhusbacken 10, 188 83, Sweden.
Department of Women's and Children's Health, Uppsala University, Uppsala 751 85, Sweden.
出版信息
Eur Heart J Cardiovasc Pharmacother. 2025 Jan 11;10(8):708-718. doi: 10.1093/ehjcvp/pvae062.
AIMS
In the Randomized Evaluation of Decreased Usage of Beta-Blockers after Acute Myocardial Infarction (REDUCE-AMI) study, long-term beta-blocker use in patients after acute myocardial infarction (AMI) with preserved left ventricular ejection fraction demonstrated no effect on death or cardiovascular outcomes. The aim of this prespecified substudy was to investigate effects of beta-blockers on self-reported quality of life and well-being.
METHODS AND RESULTS
From this parallel-group, open-label, registry-based randomized clinical trial, EQ-5D, and World Health Organization well-being index-5 (WHO-5) questionnaires were obtained at 6-10 weeks and 11-13 months after AMI in 4080 and 806 patients, respectively. We report results from intention-to-treat and on-treatment analyses for the overall population and relevant subgroups using Wilcoxon rank sum test and adjusted ordinal regression analyses. Of the 4080 individuals reporting EQ-5D (median age 64 years, 22% female), 2023 were randomized to beta-blockers. The main outcome, median EQ-5D index score, was 0.94 [interquartile range (IQR) 0.88, 0.97] in the beta-blocker group, and 0.94 (IQR 0.88, 0.97) in the no-beta-blocker group 6-10 weeks after AMI, OR 1.00 [95% CI 0.89-1.13; P > 0.9]. After 11-13 months, results remained unchanged. Findings were robust in on-treatment analyses and across relevant subgroups. Secondary outcomes, EQ-VAS and WHO-5 index score, confirmed these results.
CONCLUSION
Among patients after AMI with preserved left ventricular ejection fraction, self-reported quality of life and well-being was not significantly different in individuals randomized to routine long-term beta-blocker therapy as compared to individuals with no beta-blocker use. These results appear consistent regardless of adherence to randomized treatment and across subgroups which emphasizes the need for a careful individual risk-benefit evaluation prior to initiation of beta-blocker treatment.
目的
在急性心肌梗死后β受体阻滞剂使用减少的随机评估（REDUCE-AMI）研究中，对左心室射血分数保留的急性心肌梗死（AMI）患者长期使用β受体阻滞剂，未显示出对死亡或心血管结局有影响。这项预先设定的亚研究旨在调查β受体阻滞剂对自我报告的生活质量和幸福感的影响。
方法和结果
在这项平行组、开放标签、基于注册登记的随机临床试验中，分别在AMI后6 - 10周和11 - 13个月，从4080例和806例患者中获取了欧洲五维度健康量表（EQ-5D）和世界卫生组织幸福感指数-5（WHO-5）问卷。我们使用Wilcoxon秩和检验以及调整后的有序回归分析，报告了总体人群和相关亚组的意向性分析和治疗中分析结果。在4080例报告了EQ-5D的个体（中位年龄64岁，22%为女性）中，2023例被随机分配至β受体阻滞剂组。主要结局指标，即EQ-5D指数中位数得分，在AMI后6 - 10周时，β受体阻滞剂组为0.94[四分位数间距（IQR）0.88，0.97]，非β受体阻滞剂组为0.94（IQR 0.88，0.97），比值比（OR）为1.00[95%置信区间（CI）0.89 - 1.13；P > 0.9]。11 - 13个月后，结果保持不变。在治疗中分析以及各相关亚组中，研究结果均较为稳健。次要结局指标，即EQ视觉模拟量表（EQ-VAS）和WHO-5指数得分，证实了这些结果。
结论
在左心室射血分数保留的AMI患者中，与未使用β受体阻滞剂的个体相比，随机接受常规长期β受体阻滞剂治疗的个体自我报告的生活质量和幸福感无显著差异。无论是否坚持随机治疗以及在各个亚组中，这些结果似乎都是一致的，这强调了在开始β受体阻滞剂治疗前，需要仔细进行个体风险效益评估。
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