Service of Cardiology, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.
Service of Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.
ESC Heart Fail. 2020 Jun;7(3):1282-1290. doi: 10.1002/ehf2.12676. Epub 2020 Mar 13.
Large-scale clinical trials have demonstrated clinical benefits of sacubitril-valsartan in symptomatic heart failure with reduced ejection fraction patients (PARADIGM-HF), with potential benefits in patients hospitalized for acute decompensated heart failure (ADHF) (PIONEER-HF) and fewer benefits in patients with heart failure with preserved ejection fraction (PARAGON-HF). The aim of this study was to evaluate eligibility for sacubitril-valsartan using criteria described in PIONNER-HF in non-selected patients hospitalized for ADHF.
Between November 2014 and May 2019, 799 patients were recruited in a prospective registry of acute heart failure at the University Hospitals of Geneva (ClinicalTrials.gov: NCT02444416). The cohort consists of consecutive patients admitted to the Department of Medicine with ADHF. Eligibility for sacubitril-valsartan was determined using criteria described in PIONEER-HF, including left ventricular ejection fraction, clinical parameters, and co-morbidities. Of 799 patients, 123 (15.39%) were eligible for sacubitril-valsartan treatment. Clinical outcomes including all-cause mortality and readmission were similar in eligible and non-eligible groups, hazard ratio 1.02 (95% confidence interval 0.81-1.29, P = 083).
Using current criteria from randomized controlled trials, only 15% of non-selected patients admitted for ADHF are theoretically eligible for sacubitril-valsartan. Eligibility for sacubitril-valsartan using published criteria is not associated with worse outcome, suggesting that further evaluation of benefits of sacubitril-valsartan in heart failure patients based on parameters other than left ventricular ejection fraction may be of interest.
大规模临床试验已经证明沙库巴曲缬沙坦在射血分数降低的有症状心力衰竭患者（PARADIGM-HF）中的临床益处，在因急性失代偿性心力衰竭（ADHF）住院的患者（PIONEER-HF）中可能具有潜在益处，而在射血分数保留的心力衰竭患者（PARAGON-HF）中益处较少。本研究的目的是使用 PIONEER-HF 中描述的标准评估非选择 ADHF 住院患者使用沙库巴曲缬沙坦的资格。
2014 年 11 月至 2019 年 5 月，在日内瓦大学附属医院进行了一项急性心力衰竭前瞻性登记研究，共招募了 799 例患者（ClinicalTrials.gov：NCT02444416）。该队列由因 ADHF 收入内科的连续患者组成。使用 PIONEER-HF 中描述的标准确定沙库巴曲缬沙坦的资格，包括左心室射血分数、临床参数和合并症。在 799 例患者中，有 123 例（15.39%）符合沙库巴曲缬沙坦治疗条件。在符合条件和不符合条件的组中，全因死亡率和再入院率相似，风险比为 1.02（95%置信区间 0.81-1.29，P=0.83）。
使用当前随机对照试验的标准，只有 15%的非选择 ADHF 住院患者理论上符合沙库巴曲缬沙坦的条件。使用已发表的标准评估沙库巴曲缬沙坦的资格与不良结局无关，这表明基于左心室射血分数以外的参数进一步评估沙库巴曲缬沙坦在心力衰竭患者中的获益可能是有意义的。
