Mineralocorticoid receptor antagonists for heart failure

a real-life observational study

Noemi Bruno, Gianfranco Sinagra, Stefania Paolillo, Alice Bonomi, Ugo Corrà, Massimo Piepoli, Fabrizio Veglia, Elisabetta Salvioni, Rocco Lagioia, Marco Metra, Giuseppe Limongelli, Gaia Cattadori, Angela B. Scardovi, Valentina Carubelli, Domenico Scrutino, Roberto Badagliacca, Marco Guazzi, Rosa Raimondo, Piero Gentile, Damiano Magrì & 27 others Michele Correale, Gianfranco Parati, Federica Re, Mariantonietta Cicoira, Maria Frigerio, Maurizio Bussotti, Carlo Vignati, Fabrizio Oliva, Alessandro Mezzani, Giuseppe Vergaro, Andrea Di Lenarda, Claudio Passino, Susanna Sciomer, Giuseppe Pacileo, Roberto Ricci, Mauro Contini, Anna Apostolo, Pietro Palermo, Massimo Mapelli, Cosimo Carriere, Francesco Clemenza, Simone Binno, Romualdo Belardinelli, Carlo Lombardi, Pasquale Perrone Filardi, Michele Emdin, Piergiuseppe Agostoni

Research output: Contribution to journalArticle

Abstract

Aims: Mineralocorticoid receptor antagonists (MRAs) have been demonstrated to improve outcomes in reduced ejection fraction heart failure (HFrEF) patients. However, MRAs added to conventional treatment may lead to worsening of renal function and hyperkalaemia. We investigated, in a population-based analysis, the long-term effects of MRA treatment in HFrEF patients. Methods and results: We analysed data of 6046 patients included in the Metabolic Exercise Cardiac Kidney Index score dataset. Analysis was performed in patients treated (n = 3163) and not treated (n = 2883) with MRA. The study endpoint was a composite of cardiovascular death, urgent heart transplantation, or left ventricular assist device implantation. Ten years' survival was analysed through Kaplan–Meier, compared by log-rank test and propensity score matching. At 10 years' follow-up, the MRA-untreated group had a significantly lower number of events than the MRA-treated group (P < 0.001). MRA-treated patients had more severe heart failure (higher New York Heart Association class and lower left ventricular ejection fraction, kidney function, and peak VO2). At a propensity-score-matching analysis performed on 1587 patients, MRA-treated and MRA-untreated patients showed similar study endpoint values. Conclusions: In conclusion, MRA treatment does not affect the composite of cardiovascular death, urgent heart transplantation or left ventricular assist device implantation in a real-life setting. A meticulous patient follow-up, as performed in trials, is likely needed to match the positive MRA-related benefits observed in clinical trials.

Original languageEnglish
Pages (from-to)267-274
Number of pages8
JournalESC heart failure
Volume5
Issue number3
DOIs
Publication statusPublished - Jan 1 2018

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Mineralocorticoid Receptor Antagonists
Observational Studies
Heart Failure
Propensity Score
Heart-Assist Devices
Heart Transplantation
Kidney
Hyperkalemia
Stroke Volume
Therapeutics

Keywords

  • Heart failure
  • Hyperkalaemia
  • Mineralocorticoid receptor antagonists
  • Worsening renal function

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Mineralocorticoid receptor antagonists for heart failure : a real-life observational study. / Bruno, Noemi; Sinagra, Gianfranco; Paolillo, Stefania; Bonomi, Alice; Corrà, Ugo; Piepoli, Massimo; Veglia, Fabrizio; Salvioni, Elisabetta; Lagioia, Rocco; Metra, Marco; Limongelli, Giuseppe; Cattadori, Gaia; Scardovi, Angela B.; Carubelli, Valentina; Scrutino, Domenico; Badagliacca, Roberto; Guazzi, Marco; Raimondo, Rosa; Gentile, Piero; Magrì, Damiano; Correale, Michele; Parati, Gianfranco; Re, Federica; Cicoira, Mariantonietta; Frigerio, Maria; Bussotti, Maurizio; Vignati, Carlo; Oliva, Fabrizio; Mezzani, Alessandro; Vergaro, Giuseppe; Di Lenarda, Andrea; Passino, Claudio; Sciomer, Susanna; Pacileo, Giuseppe; Ricci, Roberto; Contini, Mauro; Apostolo, Anna; Palermo, Pietro; Mapelli, Massimo; Carriere, Cosimo; Clemenza, Francesco; Binno, Simone; Belardinelli, Romualdo; Lombardi, Carlo; Perrone Filardi, Pasquale; Emdin, Michele; Agostoni, Piergiuseppe.

In: ESC heart failure, Vol. 5, No. 3, 01.01.2018, p. 267-274.

Research output: Contribution to journalArticle

Bruno, N, Sinagra, G, Paolillo, S, Bonomi, A, Corrà, U, Piepoli, M, Veglia, F, Salvioni, E, Lagioia, R, Metra, M, Limongelli, G, Cattadori, G, Scardovi, AB, Carubelli, V, Scrutino, D, Badagliacca, R, Guazzi, M, Raimondo, R, Gentile, P, Magrì, D, Correale, M, Parati, G, Re, F, Cicoira, M, Frigerio, M, Bussotti, M, Vignati, C, Oliva, F, Mezzani, A, Vergaro, G, Di Lenarda, A, Passino, C, Sciomer, S, Pacileo, G, Ricci, R, Contini, M, Apostolo, A, Palermo, P, Mapelli, M, Carriere, C, Clemenza, F, Binno, S, Belardinelli, R, Lombardi, C, Perrone Filardi, P, Emdin, M & Agostoni, P 2018, 'Mineralocorticoid receptor antagonists for heart failure: a real-life observational study', ESC heart failure, vol. 5, no. 3, pp. 267-274. https://doi.org/10.1002/ehf2.12244
Bruno, Noemi ; Sinagra, Gianfranco ; Paolillo, Stefania ; Bonomi, Alice ; Corrà, Ugo ; Piepoli, Massimo ; Veglia, Fabrizio ; Salvioni, Elisabetta ; Lagioia, Rocco ; Metra, Marco ; Limongelli, Giuseppe ; Cattadori, Gaia ; Scardovi, Angela B. ; Carubelli, Valentina ; Scrutino, Domenico ; Badagliacca, Roberto ; Guazzi, Marco ; Raimondo, Rosa ; Gentile, Piero ; Magrì, Damiano ; Correale, Michele ; Parati, Gianfranco ; Re, Federica ; Cicoira, Mariantonietta ; Frigerio, Maria ; Bussotti, Maurizio ; Vignati, Carlo ; Oliva, Fabrizio ; Mezzani, Alessandro ; Vergaro, Giuseppe ; Di Lenarda, Andrea ; Passino, Claudio ; Sciomer, Susanna ; Pacileo, Giuseppe ; Ricci, Roberto ; Contini, Mauro ; Apostolo, Anna ; Palermo, Pietro ; Mapelli, Massimo ; Carriere, Cosimo ; Clemenza, Francesco ; Binno, Simone ; Belardinelli, Romualdo ; Lombardi, Carlo ; Perrone Filardi, Pasquale ; Emdin, Michele ; Agostoni, Piergiuseppe. / Mineralocorticoid receptor antagonists for heart failure : a real-life observational study. In: ESC heart failure. 2018 ; Vol. 5, No. 3. pp. 267-274.
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abstract = "Aims: Mineralocorticoid receptor antagonists (MRAs) have been demonstrated to improve outcomes in reduced ejection fraction heart failure (HFrEF) patients. However, MRAs added to conventional treatment may lead to worsening of renal function and hyperkalaemia. We investigated, in a population-based analysis, the long-term effects of MRA treatment in HFrEF patients. Methods and results: We analysed data of 6046 patients included in the Metabolic Exercise Cardiac Kidney Index score dataset. Analysis was performed in patients treated (n = 3163) and not treated (n = 2883) with MRA. The study endpoint was a composite of cardiovascular death, urgent heart transplantation, or left ventricular assist device implantation. Ten years' survival was analysed through Kaplan–Meier, compared by log-rank test and propensity score matching. At 10 years' follow-up, the MRA-untreated group had a significantly lower number of events than the MRA-treated group (P < 0.001). MRA-treated patients had more severe heart failure (higher New York Heart Association class and lower left ventricular ejection fraction, kidney function, and peak VO2). At a propensity-score-matching analysis performed on 1587 patients, MRA-treated and MRA-untreated patients showed similar study endpoint values. Conclusions: In conclusion, MRA treatment does not affect the composite of cardiovascular death, urgent heart transplantation or left ventricular assist device implantation in a real-life setting. A meticulous patient follow-up, as performed in trials, is likely needed to match the positive MRA-related benefits observed in clinical trials.",
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T1 - Mineralocorticoid receptor antagonists for heart failure

T2 - a real-life observational study

AU - Bruno, Noemi

AU - Sinagra, Gianfranco

AU - Paolillo, Stefania

AU - Bonomi, Alice

AU - Corrà, Ugo

AU - Piepoli, Massimo

AU - Veglia, Fabrizio

AU - Salvioni, Elisabetta

AU - Lagioia, Rocco

AU - Metra, Marco

AU - Limongelli, Giuseppe

AU - Cattadori, Gaia

AU - Scardovi, Angela B.

AU - Carubelli, Valentina

AU - Scrutino, Domenico

AU - Badagliacca, Roberto

AU - Guazzi, Marco

AU - Raimondo, Rosa

AU - Gentile, Piero

AU - Magrì, Damiano

AU - Correale, Michele

AU - Parati, Gianfranco

AU - Re, Federica

AU - Cicoira, Mariantonietta

AU - Frigerio, Maria

AU - Bussotti, Maurizio

AU - Vignati, Carlo

AU - Oliva, Fabrizio

AU - Mezzani, Alessandro

AU - Vergaro, Giuseppe

AU - Di Lenarda, Andrea

AU - Passino, Claudio

AU - Sciomer, Susanna

AU - Pacileo, Giuseppe

AU - Ricci, Roberto

AU - Contini, Mauro

AU - Apostolo, Anna

AU - Palermo, Pietro

AU - Mapelli, Massimo

AU - Carriere, Cosimo

AU - Clemenza, Francesco

AU - Binno, Simone

AU - Belardinelli, Romualdo

AU - Lombardi, Carlo

AU - Perrone Filardi, Pasquale

AU - Emdin, Michele

AU - Agostoni, Piergiuseppe

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Aims: Mineralocorticoid receptor antagonists (MRAs) have been demonstrated to improve outcomes in reduced ejection fraction heart failure (HFrEF) patients. However, MRAs added to conventional treatment may lead to worsening of renal function and hyperkalaemia. We investigated, in a population-based analysis, the long-term effects of MRA treatment in HFrEF patients. Methods and results: We analysed data of 6046 patients included in the Metabolic Exercise Cardiac Kidney Index score dataset. Analysis was performed in patients treated (n = 3163) and not treated (n = 2883) with MRA. The study endpoint was a composite of cardiovascular death, urgent heart transplantation, or left ventricular assist device implantation. Ten years' survival was analysed through Kaplan–Meier, compared by log-rank test and propensity score matching. At 10 years' follow-up, the MRA-untreated group had a significantly lower number of events than the MRA-treated group (P < 0.001). MRA-treated patients had more severe heart failure (higher New York Heart Association class and lower left ventricular ejection fraction, kidney function, and peak VO2). At a propensity-score-matching analysis performed on 1587 patients, MRA-treated and MRA-untreated patients showed similar study endpoint values. Conclusions: In conclusion, MRA treatment does not affect the composite of cardiovascular death, urgent heart transplantation or left ventricular assist device implantation in a real-life setting. A meticulous patient follow-up, as performed in trials, is likely needed to match the positive MRA-related benefits observed in clinical trials.

AB - Aims: Mineralocorticoid receptor antagonists (MRAs) have been demonstrated to improve outcomes in reduced ejection fraction heart failure (HFrEF) patients. However, MRAs added to conventional treatment may lead to worsening of renal function and hyperkalaemia. We investigated, in a population-based analysis, the long-term effects of MRA treatment in HFrEF patients. Methods and results: We analysed data of 6046 patients included in the Metabolic Exercise Cardiac Kidney Index score dataset. Analysis was performed in patients treated (n = 3163) and not treated (n = 2883) with MRA. The study endpoint was a composite of cardiovascular death, urgent heart transplantation, or left ventricular assist device implantation. Ten years' survival was analysed through Kaplan–Meier, compared by log-rank test and propensity score matching. At 10 years' follow-up, the MRA-untreated group had a significantly lower number of events than the MRA-treated group (P < 0.001). MRA-treated patients had more severe heart failure (higher New York Heart Association class and lower left ventricular ejection fraction, kidney function, and peak VO2). At a propensity-score-matching analysis performed on 1587 patients, MRA-treated and MRA-untreated patients showed similar study endpoint values. Conclusions: In conclusion, MRA treatment does not affect the composite of cardiovascular death, urgent heart transplantation or left ventricular assist device implantation in a real-life setting. A meticulous patient follow-up, as performed in trials, is likely needed to match the positive MRA-related benefits observed in clinical trials.

KW - Heart failure

KW - Hyperkalaemia

KW - Mineralocorticoid receptor antagonists

KW - Worsening renal function

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