PIONEER-HF 临床试验人群在因心力衰竭和射血分数降低而住院的患者中的代表性。
Representativeness of the PIONEER-HF Clinical Trial Population in Patients Hospitalized With Heart Failure and Reduced Ejection Fraction.
机构信息
Duke Clinical Research Institute, Durham, NC (M.F., S.S., A.F.H., A.D.D.).
Division of Cardiology, Duke University Medical Center, Durham, NC (M.F., A.F.H., A.D.D.).
出版信息
Circ Heart Fail. 2020 Apr;13(4):e006645. doi: 10.1161/CIRCHEARTFAILURE.119.006645. Epub 2020 Apr 6.
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.
背景
在 PIONEER-HF（比较沙库巴曲缬沙坦与依那普利对急性心力衰竭发作后 NT-proBNP 的影响）研究中，住院治疗急性失代偿性心力衰竭（ADHF）的患者早期起始沙库巴曲缬沙坦是安全的，并且可以改善预后。我们旨在使用真实世界的数据来确定 PIONEER-HF 试验在 ADHF 住院患者中的代表性。
方法
研究人群来自 2006 年至 2018 年 Get With The Guidelines-HF 登记处所有因 ADHF 出院存活的患者，其中包括射血分数降低的心力衰竭（HFrEF；所有因 ADHF 导致的 HFrEF）。然后，我们确定符合 PIONEER-HF 入选标准（PIONEER-HF 合格）和符合一组有限入选标准（可操作队列）的患者比例。使用链接的医疗保险索赔数据，比较所有 HFrEF 合并 ADHF、PIONEER-HF 合格和可操作队列的心力衰竭再入院率和全因死亡率。
结果
Get With The Guidelines-HF 中有 99767 例 HFrEF 患者因 ADHF 住院。71633 例（71.8%）患者符合 PIONEER-HF 纳入标准，20704 例（20.8%）患者同时符合纳入和排除标准。此外，68739 例（68.9%）患者符合可操作队列的标准。在与医疗保险和医疗补助相关的患者中，所有 HFrEF 合并 ADHF 患者的 1 年心力衰竭再住院率为 35.1%（95%CI，34.5-35.8），PIONEER-HF 合格队列为 32.6%（95%CI，31.3-33.9），可操作队列为 33.1%（95%CI，32.3-33.9）。所有 HFrEF 合并 ADHF 患者的 1 年全因死亡率为 36.7%（95%CI，36.1-7.4），PIONEER-HF 合格队列为 31.6%（95%CI，30.3-32.9），可操作队列为 32.2%（95%CI，31.4-33.0）。
结论
与常规实践中遇到的患者相比，仅符合 PIONEER-HF 标准的患者特征和临床结局差异不大，这表明对于因 ADHF 住院的 HFrEF 患者，应常规考虑早期起始沙库巴曲缬沙坦治疗。
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