BACKGROUND The appropriate duration of treatment with beta-blocker drugs after a myocardial infarction is unknown. Data are needed on the safety and efficacy of the interruption of long-term beta-blocker treatment to reduce side effects and improve quality of life in patients with a history of uncomplicated myocardial infarction. METHODS In a multicenter, open label, randomized, noninferiority trial conducted at 49 sites in France, we randomly assigned patients with a history of myocardial infarction, in a 1:1 ratio, to interruption or continuation of beta-blocker treatment. All the patients had a left ventricular ejection fraction of at least 40% while receiving long-term beta-blocker treatment and had no history of a cardiovascular event in the previous 6 months. The primary end point was a composite of death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for cardiovascular reasons at the longest follow-up (minimum, 1 year), according to an analysis of noninferiority (defined as a between-group difference of <3 percentage points for the upper boundary of the two-sided 95% confidence interval). The main secondary end point was the change in quality of life as measured by the European Quality of Life-5 Dimensions questionnaire. RESULTS A total of 3698 patients underwent randomization: 1846 to the interruption group and 1852 to the continuation group. The median time between the last myocardial infarction and randomization was 2.9 years (interquartile range, 1.2 to 6.4), and the median follow-up was 3.0 years (interquartile range, 2.0 to 4.0). A primary-outcome event occurred in 432 of 1812 patients (23.8%) in the interruption group and in 384 of 1821 patients (21.1%) in the continuation group (risk difference, 2.8 percentage points; 95% confidence interval [CI], <0.1 to 5.5), for a hazard ratio of 1.16 (95% CI, 1.01 to 1.33; P = 0.44 for noninferiority). Beta-blocker interruption did not seem to improve the patients' quality of life. CONCLUSIONS In patients with a history of myocardial infarction, interruption of long-term beta-blocker treatment was not found to be noninferior to a strategy of beta-blocker continuation. (Funded by the French Ministry of Health and ACTION Study Group; ABYSS ClinicalTrials.gov number, NCT03498066; EudraCT number, 2017-003903-23.).

中文翻译：

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心肌梗死后 β 受体阻滞剂中断或继续治疗。


背景 心肌梗死后 β 受体阻滞剂药物治疗的适当持续时间尚不清楚。需要关于中断长期 β 受体阻滞剂治疗的安全性和有效性的数据，以减少无并发症心肌梗死病史患者的副作用并改善生活质量。方法 在法国 49 个地点进行的一项多中心、开放标签、随机、非劣效性试验中，我们以 1：1 的比例将有心肌梗死病史的患者随机分配到中断或继续 β 受体阻滞剂治疗组。所有患者在接受长期 β 受体阻滞剂治疗时左心室射血分数至少为 40%，并且在过去 6 个月内没有心血管事件史。根据非劣效性分析（定义为双侧 95% 置信区间上限的组间差异 <3 个百分点），主要终点是最长随访时间（最短 1 年）死亡、非致死性心肌梗死、非致死性中风或因心血管原因住院的复合终点。主要的次要终点是通过欧洲生活质量 5 维度问卷测量的生活质量变化。结果 共有 3698 例患者接受了随机分组： 中断组 1846 例，继续组 1852 例。末次心肌梗死与随机分组之间的中位时间为 2.9 年 （四分位距，1.2 至 6.4），中位随访时间为 3.0 年 （四分位距，2.0 至 4.0）。中断组 1812 例患者中有 432 例 （23.8%） 发生主要结局事件，延续组 1821 例患者中有 384 例 （21.1%） 发生主要结局事件 （风险差异，2.8 个百分点;95% 置信区间 [CI]，<0.1 至 5.5），风险比为 1.16 （95% CI，1.01 至 1.33;非劣效性 P = 0.44）。β 受体阻滞剂中断似乎并未改善患者的生活质量。结论 在有心肌梗死病史的患者中，未发现中断长期 β 受体阻滞剂治疗不劣于 β 受体阻滞剂继续使用策略。（由法国卫生部和 ACTION 研究小组资助;ABYSS ClinicalTrials.gov 编号，NCT03498066;EudraCT 编号，2017-003903-23。