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Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure.

Artikel i vetenskaplig tidskrift
Författare Scott D Solomon
Muthiah Vaduganathan
Brian L Claggett
Milton Packer
Michael Zile
Karl Swedberg
Jean Rouleau
Marc A Pfeffer
Akshay Desai
Lars H Lund
Lars Koeber
Inder Anand
Nancy K Sweitzer
Gerard Linssen
Bela Merkely
Juan Luis Arango
Dragos Vinereanu
Chen-Huan Chen
Michele Senni
Antonio Sibulo
Sergey Boytsov
Victor Shi
Adel Rizkala
Martin Lefkowitz
John J V McMurray
Publicerad i Circulation
Volym 141
Nummer/häfte 5
Sidor 352-361
ISSN 0009-7322
Publiceringsår 2020
Publicerad vid Institutionen för medicin, avdelningen för molekylär och klinisk medicin
Sidor 352-361
Språk en
Länkar dx.doi.org/10.1161/CIRCULATIONAHA.1...
www.ncbi.nlm.nih.gov/entrez/query.f...
Ämnesord clinical efficacy, heart failure, sacubitril/valsartan, ventricular ejection fraction
Ämneskategorier Kardiologi

Sammanfattning

Background: While disease modifying therapies exist for heart failure (HF) with reduced left ventricular ejection fraction (LVEF), few options are available for patients in the higher range of LVEF (>40%). Sacubitril/valsartan has been compared with a renin-angiotensin- system (RAS) inhibitor alone in two similarly designed clinical trials of patients with reduced and preserved LVEF, permitting examination of its effects across the full spectrum of LVEF. Methods: We combined data from PARADIGM-HF (LVEF eligibility≤40%; n=8,399) and PARAGON-HF (LVEF eligibility≥45%; n=4,796) in a prespecified pooled analysis. We divided randomized patients into LVEF categories:≤22.5% (n=1269), >22.5% to 32.5% (n=3987), >32.5% to 42.5% (n=3143), > 42.5% to 52.5% (n=1427), > 52.5% to 62.5% (n=2166), >62.5% (n=1202). We assessed time to first cardiovascular death and HF hospitalization, its components, and total heart failure hospitlizations, all-cause mortality and non-cardiovascular mortality. Incidence rates and treatment effects were examined across categories of LVEF. Results: Among 13,195 randomized patients, we observed lower rates of cardiovascular death and HF hospitalization, but similar rates of non-cardiovascular death, among patients in the highest vs. lowest groups. Overall sacubitril/valsartan was superior to RAS inhibition for first cardiovascular death or heart failure hospitalization (HR 0.84, 95% CI 0.78, 0.90), cardiovascular death (HR 0.84, 95% CI 0.76, 0.92), heart failure hospitalization (HR 0.84, 95% CI 0.77, 0.91), and all-cause mortality (HR 0.88, 95% CI 0.81, 0.96). The effect of sacubitril/valsartan was modified by LVEF (treatment-by-continuous LVEF interaction p=0.02), and benefit appeared to be present for individuals with EF primarily below the normal range, although the treatment benefit for cardiovascular death diminished at a lower ejection fraction. We observed effect modification by LVEF on the efficacy of sacubitril/valsartan in both men and women with respect to composite total HF hospitalizations and cardiovascular death, although women derived benefit to higher ejection fractions. Conclusions:The therapeutic effects of sacubitril/valsartan, compared with a RAS inhibitor alone, vary by LVEF, with treatment benefits, particularly for heart failure hospitalization, that appear to extend to patients with heart failure and mildly reduced ejection fraction. These therapeutic benefits appeared to extend to a higher LVEF range in women compared with men. Clinical Trial Registration: URL: https://clinicaltrials.gov PARAGON-HF Unique Identifier: NCT01920711. PARADIGM-HF Unique Identifier: NCT01035255.

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