BACKGROUND Mineralocorticoid receptor antagonists have been shown to reduce mortality in patients after myocardial infarction with congestive heart failure. Whether routine use of spironolactone is beneficial after myocardial infarction is uncertain. METHODS In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients with myocardial infarction who had undergone percutaneous coronary intervention to receive either spironolactone or placebo and either colchicine or placebo. The results of the spironolactone trial are reported here. The two primary outcomes were a composite of death from cardiovascular causes or new or worsening heart failure, evaluated as the total number of events; and a composite of the first occurrence of myocardial infarction, stroke, new or worsening heart failure, or death from cardiovascular causes. Safety was also assessed. RESULTS We enrolled 7062 patients at 104 centers in 14 countries; 3537 patients were assigned to receive spironolactone and 3525 to receive placebo. At the time of our analyses, the vital status was unknown for 45 patients (0.6%). For the first primary outcome, there were 183 events (1.7 per 100 patient-years) in the spironolactone group as compared with 220 events (2.1 per 100 patient-years) in the placebo group over a median follow-up period of 3 years (hazard ratio adjusted for competing risk of death from noncardiovascular causes, 0.91; 95% confidence interval [CI], 0.69 to 1.21; P = 0.51). With respect to the second primary outcome, an event occurred in 280 of 3537 patients (7.9%) in the spironolactone group and 294 of 3525 patients (8.3%) in the placebo group (hazard ratio adjusted for competing risk, 0.96; 95% CI, 0.81 to 1.13; P = 0.60). Serious adverse events were reported in 255 patients (7.2%) in the spironolactone group and 241 (6.8%) in the placebo group. CONCLUSIONS Among patients with myocardial infarction, spironolactone did not reduce the incidence of death from cardiovascular causes or new or worsening heart failure or the incidence of a composite of death from cardiovascular causes, myocardial infarction, stroke, or new or worsening heart failure. (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.).

中文翻译：

---

急性心肌梗死中的常规螺内酯。


背景盐皮质激素受体拮抗剂已被证明可以降低充血性心力衰竭心肌梗死后患者的死亡率。心肌梗死后常规使用螺内酯是否有益尚不确定。方法 在这项采用 2×2 析因设计的多中心试验中，我们随机分配接受经皮冠状动脉介入治疗的心肌梗死患者接受螺内酯或安慰剂以及秋水仙碱或安慰剂。螺内酯试验的结果见此处。两个主要结局是心血管原因导致的死亡或新发或恶化的心力衰竭的复合结局，评估为事件总数;以及首次出现心肌梗死、中风、新发或恶化的心力衰竭或心血管原因导致的死亡的复合症状。还评估了安全性。结果我们在 14 个国家的 104 个中心招募了 7062 名患者;3537 例患者被分配接受螺内酯治疗，3525 例患者接受安慰剂治疗。在我们分析时，45 名患者 （0.6%） 的生命状态未知。对于第一个主要结局，螺内酯组有 183 个事件（每 100 个患者年 1.7 个），而安慰剂组有 220 个事件（每 100 个患者年 2.1 个）（根据非心血管原因导致的竞争性死亡风险调整的风险比，0.91;95% 置信区间 [CI]，0.69 至 1.21;P = 0.51）。关于第二个主要结局，螺内酯组 3537 名患者中有 280 名 （7.9%） 发生事件，安慰剂组 3525 名患者中有 294 名 （8.3%） 发生事件（根据竞争风险调整后的风险比，0.96;95% CI，0.81 至 1.13;P = 0.60）。255 例患者报告了严重不良事件 （7.螺内酯组为 2%），安慰剂组为 241 例 （6.8%）。结论 在心肌梗死患者中，螺内酯并未降低心血管原因死亡或新发或恶化心力衰竭的发生率，或降低心血管原因死亡、心肌梗死、中风或新发或恶化的心力衰竭复合发生率。（由加拿大卫生研究院和其他机构资助;清除 ClinicalTrials.gov 号码，NCT03048825.）。