Effects of serelaxin on the outcome of patients with or without substantial peripheral edema

A subgroup analysis from the RELAX-AHF trial

Claudio Gimpelewicz, Marco Metra, John G.F. Cleland, Peter Szecsödy, Chuan Chuan Chang Wun, Leandro Boer-Martins, Gad Cotter, Beth A. Davison, Gary Michael Felker, Gerasimos Filippatos, Barry H. Greenberg, Peter Pang, Piotr Ponikowski, Thomas Severin, Adrian A. Voors, John R. Teerlink

Research output: Contribution to journalArticle

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Abstract

Background Acute heart failure (AHF) is a heterogeneous disorder, with most of the patients presenting with breathlessness along with varying degrees of peripheral edema. The presence of peripheral edema suggests that volume overload is the cause of decompensation leading to AHF, whereas breathlessness in the absence of edema may reflect a “vascular phenotype.” This analysis investigated the characteristics, therapeutic response, and outcome of patients with AHF, with and without overt peripheral edema in the RELAX-AHF trial. Methods Physician-assessed edema scores at baseline were used to categorize the population into those with no/mild edema (score 0 or 1+) and moderate/severe edema (score 2+ or 3+). The effect of serelaxin vs placebo was assessed within each subgroup. Results Patients with moderate/severe edema (n = 583; 50.5%) were more likely to have severe dyspnea, orthopnea (>30°), rales (≥1/3), and elevated jugular venous pressure (>6 cm) than the patients with little or no peripheral edema (n=571; 49.5%). The relative benefits of serelaxin in terms of reduction in breathlessness, lower diuretic requirements, decreased length of initial hospital stay and days in intensive care unit/cardiac care unit, and improved prognosis (180-day cardiovascular and all-cause mortality) were generally similar for patients with or without peripheral edema. However, because patients with moderate/severe peripheral edema had worse outcomes, the absolute benefit was generally greater than in patients with no/mild edema. Conclusions Overall, patients with AHF and moderate/severe peripheral edema have a worse prognosis but appear to receive similar relative benefit and perhaps greater absolute benefit from serelaxin administration.

Original languageEnglish (US)
Pages (from-to)113-122
Number of pages10
JournalAmerican Heart Journal
Volume190
DOIs
StatePublished - Aug 1 2017

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Edema
Heart Failure
Dyspnea
Venous Pressure
Respiratory Sounds
Diuretics
Blood Vessels
Intensive Care Units
Length of Stay
Neck
Placebos
Physicians
Phenotype
Mortality

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Gimpelewicz, C., Metra, M., Cleland, J. G. F., Szecsödy, P., Chang Wun, C. C., Boer-Martins, L., ... Teerlink, J. R. (2017). Effects of serelaxin on the outcome of patients with or without substantial peripheral edema: A subgroup analysis from the RELAX-AHF trial. American Heart Journal, 190, 113-122. https://doi.org/10.1016/j.ahj.2017.05.012

Effects of serelaxin on the outcome of patients with or without substantial peripheral edema : A subgroup analysis from the RELAX-AHF trial. / Gimpelewicz, Claudio; Metra, Marco; Cleland, John G.F.; Szecsödy, Peter; Chang Wun, Chuan Chuan; Boer-Martins, Leandro; Cotter, Gad; Davison, Beth A.; Felker, Gary Michael; Filippatos, Gerasimos; Greenberg, Barry H.; Pang, Peter; Ponikowski, Piotr; Severin, Thomas; Voors, Adrian A.; Teerlink, John R.

In: American Heart Journal, Vol. 190, 01.08.2017, p. 113-122.

Research output: Contribution to journalArticle

Gimpelewicz, C, Metra, M, Cleland, JGF, Szecsödy, P, Chang Wun, CC, Boer-Martins, L, Cotter, G, Davison, BA, Felker, GM, Filippatos, G, Greenberg, BH, Pang, P, Ponikowski, P, Severin, T, Voors, AA & Teerlink, JR 2017, 'Effects of serelaxin on the outcome of patients with or without substantial peripheral edema: A subgroup analysis from the RELAX-AHF trial', American Heart Journal, vol. 190, pp. 113-122. https://doi.org/10.1016/j.ahj.2017.05.012
Gimpelewicz, Claudio ; Metra, Marco ; Cleland, John G.F. ; Szecsödy, Peter ; Chang Wun, Chuan Chuan ; Boer-Martins, Leandro ; Cotter, Gad ; Davison, Beth A. ; Felker, Gary Michael ; Filippatos, Gerasimos ; Greenberg, Barry H. ; Pang, Peter ; Ponikowski, Piotr ; Severin, Thomas ; Voors, Adrian A. ; Teerlink, John R. / Effects of serelaxin on the outcome of patients with or without substantial peripheral edema : A subgroup analysis from the RELAX-AHF trial. In: American Heart Journal. 2017 ; Vol. 190. pp. 113-122.
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abstract = "Background Acute heart failure (AHF) is a heterogeneous disorder, with most of the patients presenting with breathlessness along with varying degrees of peripheral edema. The presence of peripheral edema suggests that volume overload is the cause of decompensation leading to AHF, whereas breathlessness in the absence of edema may reflect a “vascular phenotype.” This analysis investigated the characteristics, therapeutic response, and outcome of patients with AHF, with and without overt peripheral edema in the RELAX-AHF trial. Methods Physician-assessed edema scores at baseline were used to categorize the population into those with no/mild edema (score 0 or 1+) and moderate/severe edema (score 2+ or 3+). The effect of serelaxin vs placebo was assessed within each subgroup. Results Patients with moderate/severe edema (n = 583; 50.5{\%}) were more likely to have severe dyspnea, orthopnea (>30°), rales (≥1/3), and elevated jugular venous pressure (>6 cm) than the patients with little or no peripheral edema (n=571; 49.5{\%}). The relative benefits of serelaxin in terms of reduction in breathlessness, lower diuretic requirements, decreased length of initial hospital stay and days in intensive care unit/cardiac care unit, and improved prognosis (180-day cardiovascular and all-cause mortality) were generally similar for patients with or without peripheral edema. However, because patients with moderate/severe peripheral edema had worse outcomes, the absolute benefit was generally greater than in patients with no/mild edema. Conclusions Overall, patients with AHF and moderate/severe peripheral edema have a worse prognosis but appear to receive similar relative benefit and perhaps greater absolute benefit from serelaxin administration.",
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T1 - Effects of serelaxin on the outcome of patients with or without substantial peripheral edema

T2 - A subgroup analysis from the RELAX-AHF trial

AU - Gimpelewicz, Claudio

AU - Metra, Marco

AU - Cleland, John G.F.

AU - Szecsödy, Peter

AU - Chang Wun, Chuan Chuan

AU - Boer-Martins, Leandro

AU - Cotter, Gad

AU - Davison, Beth A.

AU - Felker, Gary Michael

AU - Filippatos, Gerasimos

AU - Greenberg, Barry H.

AU - Pang, Peter

AU - Ponikowski, Piotr

AU - Severin, Thomas

AU - Voors, Adrian A.

AU - Teerlink, John R.

PY - 2017/8/1

Y1 - 2017/8/1

N2 - Background Acute heart failure (AHF) is a heterogeneous disorder, with most of the patients presenting with breathlessness along with varying degrees of peripheral edema. The presence of peripheral edema suggests that volume overload is the cause of decompensation leading to AHF, whereas breathlessness in the absence of edema may reflect a “vascular phenotype.” This analysis investigated the characteristics, therapeutic response, and outcome of patients with AHF, with and without overt peripheral edema in the RELAX-AHF trial. Methods Physician-assessed edema scores at baseline were used to categorize the population into those with no/mild edema (score 0 or 1+) and moderate/severe edema (score 2+ or 3+). The effect of serelaxin vs placebo was assessed within each subgroup. Results Patients with moderate/severe edema (n = 583; 50.5%) were more likely to have severe dyspnea, orthopnea (>30°), rales (≥1/3), and elevated jugular venous pressure (>6 cm) than the patients with little or no peripheral edema (n=571; 49.5%). The relative benefits of serelaxin in terms of reduction in breathlessness, lower diuretic requirements, decreased length of initial hospital stay and days in intensive care unit/cardiac care unit, and improved prognosis (180-day cardiovascular and all-cause mortality) were generally similar for patients with or without peripheral edema. However, because patients with moderate/severe peripheral edema had worse outcomes, the absolute benefit was generally greater than in patients with no/mild edema. Conclusions Overall, patients with AHF and moderate/severe peripheral edema have a worse prognosis but appear to receive similar relative benefit and perhaps greater absolute benefit from serelaxin administration.

AB - Background Acute heart failure (AHF) is a heterogeneous disorder, with most of the patients presenting with breathlessness along with varying degrees of peripheral edema. The presence of peripheral edema suggests that volume overload is the cause of decompensation leading to AHF, whereas breathlessness in the absence of edema may reflect a “vascular phenotype.” This analysis investigated the characteristics, therapeutic response, and outcome of patients with AHF, with and without overt peripheral edema in the RELAX-AHF trial. Methods Physician-assessed edema scores at baseline were used to categorize the population into those with no/mild edema (score 0 or 1+) and moderate/severe edema (score 2+ or 3+). The effect of serelaxin vs placebo was assessed within each subgroup. Results Patients with moderate/severe edema (n = 583; 50.5%) were more likely to have severe dyspnea, orthopnea (>30°), rales (≥1/3), and elevated jugular venous pressure (>6 cm) than the patients with little or no peripheral edema (n=571; 49.5%). The relative benefits of serelaxin in terms of reduction in breathlessness, lower diuretic requirements, decreased length of initial hospital stay and days in intensive care unit/cardiac care unit, and improved prognosis (180-day cardiovascular and all-cause mortality) were generally similar for patients with or without peripheral edema. However, because patients with moderate/severe peripheral edema had worse outcomes, the absolute benefit was generally greater than in patients with no/mild edema. Conclusions Overall, patients with AHF and moderate/severe peripheral edema have a worse prognosis but appear to receive similar relative benefit and perhaps greater absolute benefit from serelaxin administration.

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