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Observational Study
. 2018 Jun;5(3):267-274.
doi: 10.1002/ehf2.12244. Epub 2018 Feb 4.

Mineralocorticoid receptor antagonists for heart failure: a real-life observational study

Noemi Bruno  1 , Gianfranco Sinagra  2 , Stefania Paolillo  3 , Alice Bonomi  1 , Ugo Corrà  4 , Massimo Piepoli  5 , Fabrizio Veglia  1 , Elisabetta Salvioni  1 , Rocco Lagioia  6 , Marco Metra  7 , Giuseppe Limongelli  8 , Gaia Cattadori  9 , Angela B Scardovi  10 , Valentina Carubelli  7 , Domenico Scrutino  6 , Roberto Badagliacca  11 , Marco Guazzi  12 , Rosa Raimondo  13 , Piero Gentile  2 , Damiano Magrì  14 , Michele Correale  15 , Gianfranco Parati  16   17 , Federica Re  18 , Mariantonietta Cicoira  19 , Maria Frigerio  20 , Maurizio Bussotti  21 , Carlo Vignati  1 , Fabrizio Oliva  20 , Alessandro Mezzani  4 , Giuseppe Vergaro  22 , Andrea Di Lenarda  23 , Claudio Passino  22   24 , Susanna Sciomer  11 , Giuseppe Pacileo  8 , Roberto Ricci  10 , Mauro Contini  1 , Anna Apostolo  1 , Pietro Palermo  1 , Massimo Mapelli  1 , Cosimo Carriere  2 , Francesco Clemenza  25 , Simone Binno  5 , Romualdo Belardinelli  26 , Carlo Lombardi  7 , Pasquale Perrone Filardi  27 , Michele Emdin  22   24 , Piergiuseppe Agostoni  1   28
Affiliations
Observational Study

Mineralocorticoid receptor antagonists for heart failure: a real-life observational study

Noemi Bruno et al. ESC Heart Fail. 2018 Jun.

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.

Keywords: Heart failure; Hyperkalaemia; Mineralocorticoid receptor antagonists; Worsening renal function.

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Figures

Figure 1
Figure 1
Study population and data analysis. From the whole population of 6112 patients, we selected those with complete treatment information as regards presence or not of mineralocorticoid receptor antagonist (MRA) treatment (n = 6110). Afterwards, we excluded patients with contraindication to MRA due to estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2. The final analysed population was composed of 6046 subjects, including 2883 MRA‐untreated and 3163 MRA‐treated patients.
Figure 2
Figure 2
Kaplan–Meier analyses of study endpoint (cardiovascular death, urgent heart transplant, or left ventricular assist device implantation) of the mineralocorticoid receptor antagonist (MRA)‐treated (MRA+) and MRA‐untreated (MRA−) patients: at 10 years' follow‐up the MRA− group had significantly higher survival than the MRA+ group (P < 0.001). HR, hazard ratio.
Figure 3
Figure 3
Kaplan–Meier analyses of study endpoint (cardiovascular death, urgent heart transplant, or left ventricular assist device implantation)of the mineralocorticoid receptor antagonist (MRA)‐treated (MRA+) and MRA‐untreated (MRA−) patients after propensity‐score‐matching analysis: at 10 years' follow‐up, survival differences between MRA+ and MRA− patients reduced and statistical significance was lost (P = 0.12). HR, hazard ratio.
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