Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, California; Division of Research, Kaiser Permanente Northern California, Oakland, California.
TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Department of Medicine, Harvard Medical School, Boston, Massachusetts.
J Am Coll Cardiol. 2020 Sep 1;76(9):1034-1048. doi: 10.1016/j.jacc.2020.06.073.
The PIONEER-HF (comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode) trial demonstrated the efficacy and safety of sacubitril/valsartan (S/V) in stabilized patients with acute decompensated heart failure (HF) and reduced ejection fraction.
The study sought to determine whether and how prior HF history and treatment with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) affected the results.
The PIONEER-HF trial was a prospective, multicenter, double-blind, randomized clinical trial enrolling 881 patients with an ejection fraction ≤40%. Patients were randomly assigned 1:1 to in-hospital initiation of S/V (n = 440) versus enalapril (n = 441). Pre-specified subgroup analyses were performed based on prior HF history (i.e., de novo HF vs. worsening chronic HF) and treatment with an ACE inhibitor or ARB (i.e., ACE inhibitor or ARB-yes vs. ACE inhibitor or ARB-no) at admission.
At enrollment, 303 (34%) patients presented with de novo HF and 576 (66%) patients with worsening chronic HF. A total of 421 (48%) patients had been treated with an ACE inhibitor or ARB, while 458 (52%) had not been treated with an ACE inhibitor or ARB. N-terminal pro-B-type natriuretic peptide declined significantly in all 4 subgroups (p < 0.001), with greater decreases in the S/V versus the enalapril arm (p < 0.001). There was no interaction between prior HF history (p = 0.350) or ACE inhibitor or ARB treatment (p = 0.880) and the effect of S/V versus enalapril on cardiovascular death or rehospitalization for HF. The incidences of adverse events were comparable between S/V and enalapril across all 4 subgroups.
Among patients admitted for acute decompensated HF, S/V was safe and well tolerated, led to a significantly greater reduction in N-terminal pro-B-type natriuretic peptide, and improved clinical outcomes compared with enalapril irrespective of previous HF history or ACE inhibitor or ARB treatment. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect of NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).
PIONEER-HF（比较沙库巴曲缬沙坦与依那普利对急性心力衰竭患者 NT-proBNP 的影响）试验表明，沙库巴曲缬沙坦（S/V）在急性失代偿性心力衰竭（HF）和射血分数降低的稳定患者中的疗效和安全性。
本研究旨在确定既往 HF 病史和血管紧张素转换酶（ACE）抑制剂或血管紧张素受体阻滞剂（ARB）治疗对结果的影响。
PIONEER-HF 试验是一项前瞻性、多中心、双盲、随机临床试验，纳入 881 名射血分数≤40%的患者。患者被随机分配 1:1 接受住院期间开始 S/V（n=440）或依那普利（n=441）治疗。根据既往 HF 病史（新发 HF 与慢性 HF 恶化）和入院时 ACE 抑制剂或 ARB 治疗（ACE 抑制剂或 ARB-是与 ACE 抑制剂或 ARB-否）进行了预先指定的亚组分析。
入组时，303 例（34%）患者为新发 HF，576 例（66%）患者为慢性 HF 恶化。共有 421 例（48%）患者接受 ACE 抑制剂或 ARB 治疗，458 例（52%）患者未接受 ACE 抑制剂或 ARB 治疗。所有 4 个亚组的 N 末端 B 型利钠肽前体均显著下降（p<0.001），与依那普利相比，S/V 组下降更大（p<0.001）。既往 HF 病史（p=0.350）或 ACE 抑制剂或 ARB 治疗（p=0.880）与 S/V 与依那普利对心血管死亡或 HF 再住院的影响之间无交互作用。S/V 和依那普利在所有 4 个亚组的不良事件发生率相似。
在因急性失代偿性 HF 入院的患者中，与依那普利相比，S/V 安全且耐受良好，可显著降低 N 末端 B 型利钠肽前体，改善临床结局，无论既往 HF 病史或 ACE 抑制剂或 ARB 治疗如何。（比较沙库巴曲缬沙坦与依那普利对急性心力衰竭患者 NT-proBNP 的影响[PIONEER-HF]；NCT02554890）。
