Background:In PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-pro BNP in Patients Stabilized From an Acute Heart Failure Episode), the in-hospital initiation of sacubitril/valsartan in patients hospitalized for acute decompensated heart failure (ADHF) was well-tolerated and led to improved outcomes. We aim to determine the representativeness of the PIONEER-HF trial among patients hospitalized for ADHF using real-world data.Methods:The study population was derived from all patients discharged alive for ADHF in the Get With The Guidelines—HF registry from 2006 to 2018 with HF with reduced ejection fraction (HFrEF; all HFrEF with ADHF). We then determined the proportion of patients meeting PIONEER-HF eligibility criteria (PIONEER-HF eligible) and those meeting a set of limited eligibility criteria (actionable cohort). Rates of HF readmissions and all-cause mortality were then compared between the all HFrEF with ADHF, PIONEER-HF eligible, and actionable cohorts using linked Medicare claims data.Results:A total of 99 767 patients with HFrEF in Get With The Guidelines—HF were hospitalized for ADHF. PIONEER-HF inclusion criteria were met by 71 633 (71.8%) patients, and both inclusion and exclusion criteria were met by 20 704 (20.8%) patients. Further, 68 739 (68.9%) patients met the criteria for the actionable cohort. Among the Centers for Medicare and Medicaid—linked patients, the HF rehospitalization rate at 1 year was 35.1% (95% CI, 34.5–35.8) for all HFrEF with ADHF patients, 32.6% (95% CI, 31.3–33.9) for the PIONEER-HF eligible cohort, and 33.1% (95% CI, 32.3–33.9) for the actionable cohort. The 1-year all-cause mortality was 36.7% (95% CI, 36.1–7.4) for all HFrEF with ADHF patients, 31.6% (95% CI, 30.3–32.9) for the PIONEER-HF eligible cohort, and 32.2% (95% CI, 31.4–33.0) for the actionable cohort.Conclusions:Patient characteristics and clinical outcomes for patients eligible for PIONEER-HF only modestly differ when compared with those encountered in routine practice, suggesting that the in-hospital initiation of sacubitril/valsartan should be routinely considered for patients with HFrEF hospitalized for ADHF.

中文翻译：

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PIONEER-HF 临床试验人群在心力衰竭和射血分数降低住院患者中的代表性。

背景：在 PIONEER-HF（沙库巴曲/缬沙坦与依那普利对急性心力衰竭发作后稳定患者 NT-pro BNP 影响的比较）中，因急性失代偿性心力衰竭住院的患者院内开始使用沙库巴曲/缬沙坦（ ADHF）具有良好的耐受性并导致改善的结果。我们旨在使用真实世界数据确定 PIONEER-HF 试验在因 ADHF 住院的患者中的代表性。方法：研究人群来自 2006 年至 2018 年 Get With The Guidelines-HF 登记中所有因 ADHF 存活出院的患者伴有射血分数降低的 HF（HFrEF；所有 HFrEF 伴有 ADHF）。然后，我们确定了符合 PIONEER-HF 资格标准（PIONEER-HF 合格）和符合一组有限资格标准（可操作队列）的患者比例。然后使用关联的医疗保险索赔数据比较所有 HFrEF 与 ADHF、PIONEER-HF 合格和可操作队列之间的 HF 再入院率和全因死亡率。结果：共有 99 767 名 HFrEF 患者接受指南 - HF因 ADHF 住院。71 633 名（71.8%）患者符合 PIONEER-HF 纳入标准，20 704 名（20.8%）患者符合纳入和排除标准。此外，68 739 名 (68.9%) 患者符合可操作队列的标准。在医疗保险和医疗补助中心相关的患者中，所有 HFrEF 合并 ADHF 患者的 1 年 HF 再住院率为 35.1%（95% CI，34.5-35.8），32.6%（95% CI，31.3-33.9） PIONEER-HF 合格队列，33.1% (95% CI, 32.3–33.9) 可操作队列。1 年全因死亡率为 36.7% (95% CI, 36.1–7.