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ARNI initiation during hospitalization in real-world HFrEF patients is safe

onlinelibrary.wiley.com
Literature - López-Azor JC, Vicent L, Valero-Masa MJ et al., - ESC Heart Fail. 2019. doi: 10.1002/ehf2.12527.

Introduction and methods

Compared to enalapril treatment, sacubitril/valsartan treatment for HF with reduced ejection fraction (HFrEF) more effectively reduces CV mortality and hospital admission when started in a stable phase in outpatients [1]. In addition, sacubitril/valsartan treatment has been shown to be safe when initiated during admission, predicting its extended use in inpatients [2, 3]. However, generalizability of these findings is limited because patients included in clinical trials often do not represent real-life patients.

The present study compares the clinical profile of a non-selected cohort of inpatients who initiated sacubitril/valsartan treatment during admission (n=100), with the clinical profile of patients included in the PIONEER-HF trial (n=440) (Comparison of Sacubitril-Valsartan versus Enalapril on Effect on N-terminal pro-B type natriuretic peptide in Patients Stabilized from an Acute Heart Failure Episode) [2]. Also, the safety and tolerance of sacubitril/valsartan treatment is compared between the inpatient cohort (n=100) and an outpatient cohort (n=427). A register with prospective follow-up was performed, enrolling patients from 17 Spanish hospitals with indication of initiated treatment based on HFrEF, Functional Class ≥ II, and systolic blood pressure ≥ 100 mmHg and with serum potassium ≤ 5.4 mmol/L. Follow-up outcome measures included functional class, left ventricular ejection fraction, treatment changes and titration, de-escalation or removal of sacubitril/valsartan, potential adverse effects attributed to sacubitril/valsartan (symptomatic hypotension, renal failure, hyperkalaemia, and angioedema), unexpected hospital admissions, and all-cause death.

Main results

  • Compared to patients in the PIONEER-HF trial, overall inpatients had a higher risk profile. They were older (inpatients, 71±12 vs. trial patients, 61±14 years; P<0.001), had more frequently Functional Class II (inpatients [41.0%] vs. trial patients [22.7%]; P <0.001) although less frequently Functional Class III (inpatients [45.0%] vs. trial patients [64.3%]; P <0.001), higher levels of N-terminal pro-B type natriuretic peptide (inpatients, 4044 [1630–8680] vs. trial patients, 2883 [1610–5403] ng/mL; P <0.001), and received angiotensin-converting enzyme inhibitors/angiotensin receptor blockers more frequently (inpatients [92.0%] vs. trial patients [47.3%]; P <0.001).
  • Compared to non-selected outpatients, inpatients had a higher risk profile. They were older (inpatients, 71±12 vs. outpatients, 68±12 years; P=0.02), had more frequent Functional Class III (inpatients [45.0%] vs. outpatients [27.0%]; P<0.001) and Functional Class IV (inpatients [13.0%] vs. outpatients [3.3%]; P <0.001), had higher levels of N-terminal pro-B type natriuretic peptide (inpatients, 4044 [1630–8680] vs. outpatients, 2013 (1002–4132) ng/mL; P <0.001), were receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers target dose less frequently (inpatients [55.0%] vs. outpatients [78.5%]; P <0.001), and started sacubitril/valsartan with a low dose (50 mg/12h) more frequently (inpatients [80.0%] vs. outpatients [48.8%]; P <0.001).
  • In addition, the initiation of sacubitril/valsartan in outpatients was an independent predictor of high-dose use, 100 or 200 mg b.i.d. (OR 3.1; 95% CI, 1.7–5.6; P <0.001).
  • The follow-up time in the inpatient and outpatient cohorts, including all patients enrolled, was similar (inpatients, 7.0 ± 0.1 vs. outpatients, 7.2 ± 2.6 months; P=0.72). All-cause admissions during follow-up were more frequent in inpatients (inpatients [28.9%] vs. outpatients [11.4%]; P=0.001), with no relevant differences in all-cause mortality or CV death. There was no significant difference in sacubitril/valsartan withdrawal rate (inpatients [17.0%] vs. outpatients [11.5%]; P=0.13). The incidence of adverse effects was also similar: hypotension (inpatients [16.0%] vs. outpatients [16.7%]; P=0.88), worsening renal function (inpatients [7.0%] vs. outpatients [6.8%]; P=0.94), and hyperkalaemia (inpatients [1.0%] vs. outpatients [4.9%]; P=0.09).

Conclusion

Sacubitril/valsartan treatment initiation in hospitalized HFrEF patients in daily clinical practice is safe. Inpatients more frequently receive low starting doses of sacubitril/valsartan as compared to outpatients.

References

1. Mc Murray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med 2014; 371: 993–1004.

2. Velazquez EJ, Morrow DA, DeVore AD, Duffy CI, Ambrosy AP, McCague K, Rocha R, Braunwald E. Angiotensinneprilysin inhibition in acute decompensated heart failure. N Engl J Med 2019; 380: 539–548.

3. Wachter R, Senni M, Belohlavek J, Butylin D, Noe A, Pascual-Figal D. TRANSITION study Investigators. Initiation of sacubitril/valsartan in hospitalized patients with heart failure with reduced ejection fraction after hemodynamic stabilization: primary results of the TRANSITION study. Eur Heart J 2018; 39: 1.

Find this article online at ESC Heart Failure

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