Abstract：
BACKGROUND: In the Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) trial, omecamtiv mecarbil, compared with placebo, reduced the risk of worsening heart failure (HF) events, or cardiovascular death in patients with HF and reduced ejection fraction. The primary aim of this prespecified analysis was to evaluate the safety and efficacy of omecamtiv mecarbil by randomization setting, that is, whether participants were enrolled as outpatients or inpatients.
RESULTS: Patients were randomized either during a HF hospitalization or as an outpatient, within one year of a worsening HF event (hospitalization or emergency department visit). The primary outcome was a composite of worsening HF event (HF hospitalization or an urgent emergency department or clinic visit) or cardiovascular death. Of the 8232 patients analyzed, 2084 (25%) were hospitalized at randomization. Hospitalized patients had higher N-terminal prohormone of B-type natriuretic peptide concentrations, lower systolic blood pressure, reported more symptoms, and were less frequently treated with a renin-angiotensin system blocker or a beta-blocker than outpatients. The rate (per 100 person-years) of the primary outcome was higher in hospitalized patients (placebo group = 38.3/100 person-years) than in outpatients (23.1/100 person-years); adjusted hazard ratio 1.21 (95% confidence interval 1.12-1.31). The effect of omecamtiv mecarbil versus placebo on the primary outcome was similar in hospitalized patients (hazard ratio 0.89, 95% confidence interval 0.78-1.01) and outpatients (hazard ratio 0.94, 95% confidence interval 0.86-1.02) (interaction P = .51).
CONCLUSIONS: Hospitalized patients with HF with reduced ejection fraction had a higher rate of the primary outcome than outpatients. Omecamtiv mecarbil decreased the risk of the primary outcome both when initiated in hospitalized patients and in outpatients.
RESULTS: Patients were randomized either during a HF hospitalization or as an outpatient, within one year of a worsening HF event (hospitalization or emergency department visit). The primary outcome was a composite of worsening HF event (HF hospitalization or an urgent emergency department or clinic visit) or cardiovascular death. Of the 8232 patients analyzed, 2084 (25%) were hospitalized at randomization. Hospitalized patients had higher N-terminal prohormone of B-type natriuretic peptide concentrations, lower systolic blood pressure, reported more symptoms, and were less frequently treated with a renin-angiotensin system blocker or a beta-blocker than outpatients. The rate (per 100 person-years) of the primary outcome was higher in hospitalized patients (placebo group = 38.3/100 person-years) than in outpatients (23.1/100 person-years); adjusted hazard ratio 1.21 (95% confidence interval 1.12-1.31). The effect of omecamtiv mecarbil versus placebo on the primary outcome was similar in hospitalized patients (hazard ratio 0.89, 95% confidence interval 0.78-1.01) and outpatients (hazard ratio 0.94, 95% confidence interval 0.86-1.02) (interaction P = .51).
CONCLUSIONS: Hospitalized patients with HF with reduced ejection fraction had a higher rate of the primary outcome than outpatients. Omecamtiv mecarbil decreased the risk of the primary outcome both when initiated in hospitalized patients and in outpatients.
摘要：
背景：在通过改善心力衰竭（GALACTIC-HF）的收缩力来降低不良心脏结果的全球方法中，omecamtivmecarbil,与安慰剂相比，降低心力衰竭（HF）事件恶化或心血管病死亡的风险和射血分数（HFrEF）降低的患者。本预设分析的主要目的是通过随机化设置评估omecamtivmecarbil的安全性和有效性，即参与者是作为门诊患者还是住院患者入组.
结果：患者在HF住院期间或作为门诊病人被随机分组，在HF事件恶化的一年内（住院或急诊科[ED]访视）。主要结局是恶化的HF事件（HF住院或紧急ED或门诊就诊）或心血管死亡的复合。在分析的8232名患者中，2084（25％）在随机分组时住院。住院患者NT-proBNP浓度较高，降低收缩压,与门诊患者相比,肾素-血管紧张素系统阻滞剂或β-受体阻滞剂的症状较多,治疗频率较低.住院患者（安慰剂组=38.3/100PY）的主要结局发生率（每100人年[PY]）高于门诊患者（23.1/100PY）；校正风险比（HR）1.21（95CI1.12，1.31）。omecamtivmecarbil与安慰剂对主要结局的影响在住院患者（HR0.89，95CI0.78，1.01）和门诊患者（HR0.94，95CI0.86，1.02）中相似（相互作用P=0.51）。
结论：住院HFrEF患者的主要转归率高于门诊患者。Omecamtivmecarbil在住院患者和门诊患者中开始时都降低了主要结局的风险。
结果：患者在HF住院期间或作为门诊病人被随机分组，在HF事件恶化的一年内（住院或急诊科[ED]访视）。主要结局是恶化的HF事件（HF住院或紧急ED或门诊就诊）或心血管死亡的复合。在分析的8232名患者中，2084（25％）在随机分组时住院。住院患者NT-proBNP浓度较高，降低收缩压,与门诊患者相比,肾素-血管紧张素系统阻滞剂或β-受体阻滞剂的症状较多,治疗频率较低.住院患者（安慰剂组=38.3/100PY）的主要结局发生率（每100人年[PY]）高于门诊患者（23.1/100PY）；校正风险比（HR）1.21（95CI1.12，1.31）。omecamtivmecarbil与安慰剂对主要结局的影响在住院患者（HR0.89，95CI0.78，1.01）和门诊患者（HR0.94，95CI0.86，1.02）中相似（相互作用P=0.51）。
结论：住院HFrEF患者的主要转归率高于门诊患者。Omecamtivmecarbil在住院患者和门诊患者中开始时都降低了主要结局的风险。
