João Pedro Ferreira1,2, Patrick Rossignol1, Jean-Loup Machu1, Abhinav Sharma3,4, Nicolas Girerd1, Stefan D Anker5, John G Cleland6, Kenneth Dickstein7,8, Gerasimos Filippatos9, Hans L Hillege10, Chim C Lang11, Jozine M Ter Maaten10,12, Marco Metra13, Leong Ng14, Piotr Ponikowski15, Nilesh J Samani16, Dirk J van Veldhuisen10, Aeilko H Zwinderman17, Adriaan Voors10, Faiez Zannad1. 1. INSERM, Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine, CHRU de Nancy and F-CRIN INI-CRCT, Nancy, France. 2. Cardiovascular Research and Development Unit, Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine, University of Porto, Porto, Portugal. 3. Duke Clinical Research Institute, Duke University, Durham, NC, USA. 4. Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada. 5. Department of Innovative Clinical Trials, University Medical Centre Göttingen (UMG), Robert-Koch-Straße, D-37075, Göttingen, Germany. 6. Robertson Centre for Biostatistics and Glasgow Clinical Trials Unit, Glasgow, UK. 7. University of Bergen, Bergen, Norway. 8. Stavanger University Hospital, Stavanger, Norway. 9. National and Kopodistrian University of Athens, School of Medicine, Heart Failure Unit, Department of Cardiology, Athens University Hospital Attikon, Rimini 1, Athens, 12462, Greece. 10. Department of Cardiology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713, GZ, Groningen, The Netherlands. 11. Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK. 12. Program of Applied Translational Research, Yale University, New Haven, CT, USA. 13. University of Brescia, Brescia, Italy. 14. Department of Cardiovascular Sciences, University of Leicester, Leicester, UK and NIHR Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK. 15. Department of Cardiology, Centre for Heart Diseases, 4th Military Hospital, Wroclaw, Poland and Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland. 16. Department of Cardiovascular Sciences, University of Leicester, BHF Cardiovascular Research Centre, Glenfield Hospital, Groby Rd, Leicester, LE3 9QP, UK. 17. Academic Medical Center, Clinical Epidemiology Biostatistics and Bioinformatics, Amsterdam, The Netherlands.
Abstract
AIMS: Mineralocorticoid receptor antagonists (MRAs) are recommended (unless contraindicated) to all patients with heart failure with reduced ejection fraction (HFrEF). However, MRAs are still largely underused in routine clinical practice. This study aims to describe the determinants and pattern of use of MRAs in HFrEF. METHODS AND RESULTS: BIOSTAT-CHF is a European multicentre, prospective study which enrolled patients suboptimally treated with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARBs) and/or beta-blockers, with the aim of optimizing guideline-based use of these agents. From the original 2516 subjects, this retrospective post hoc analysis included the 1325 patients with an indication for MRA therapy (i.e. left ventricular ejection fraction ≤35%, estimated glomerular filtration rate ≥30 mL/min/1.73 m2 , K+ ≤5.0 mmol/L). The mean age was 66.1 ± 12.2 years. At baseline an MRA was prescribed to 741 (56%) patients. Patients who were prescribed MRAs at baseline were younger, more often male, had higher body mass index, lower sodium, higher proportion of hypertension history and ACEi/ARB prescription (all P < 0.05). Of the 1049 patients who completed the baseline plus the 9 month visit, 585 (56%) had an MRA prescribed at baseline and 662 (63%) had an MRA prescribed at 9 months. Among the 585 patients with MRA at baseline, 91 (16%) had discontinued therapy and among the 461 (44%) patients without MRA at baseline 168 (36%) had initiated therapy subsequently. MRA discontinuation was more likely in subjects with higher left ventricular ejection fraction and NYHA class III/IV (P < 0.05 for both). MRA prescription both at baseline and 9 months was not associated with the outcome of death or heart failure hospitalization (adjusted hazard ratio 1.02, 95% confidence interval 0.66-1.58; P = 0.93). CONCLUSIONS: In this prospective observational study across Europe, MRAs were largely under-prescribed and frequently discontinued. Owing to these dynamic changes, outcome inferences are inconclusive.
AIMS: Mineralocorticoid receptor antagonists (MRAs) are recommended (unless contraindicated) to all patients with heart failure with reduced ejection fraction (HFrEF). However, MRAs are still largely underused in routine clinical practice. This study aims to describe the determinants and pattern of use of MRAs in HFrEF. METHODS AND RESULTS:BIOSTAT-CHF is a European multicentre, prospective study which enrolled patients suboptimally treated with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARBs) and/or beta-blockers, with the aim of optimizing guideline-based use of these agents. From the original 2516 subjects, this retrospective post hoc analysis included the 1325 patients with an indication for MRA therapy (i.e. left ventricular ejection fraction ≤35%, estimated glomerular filtration rate ≥30 mL/min/1.73 m2 , K+ ≤5.0 mmol/L). The mean age was 66.1 ± 12.2 years. At baseline an MRA was prescribed to 741 (56%) patients. Patients who were prescribed MRAs at baseline were younger, more often male, had higher body mass index, lower sodium, higher proportion of hypertension history and ACEi/ARB prescription (all P < 0.05). Of the 1049 patients who completed the baseline plus the 9 month visit, 585 (56%) had an MRA prescribed at baseline and 662 (63%) had an MRA prescribed at 9 months. Among the 585 patients with MRA at baseline, 91 (16%) had discontinued therapy and among the 461 (44%) patients without MRA at baseline 168 (36%) had initiated therapy subsequently. MRA discontinuation was more likely in subjects with higher left ventricular ejection fraction and NYHA class III/IV (P < 0.05 for both). MRA prescription both at baseline and 9 months was not associated with the outcome of death or heart failure hospitalization (adjusted hazard ratio 1.02, 95% confidence interval 0.66-1.58; P = 0.93). CONCLUSIONS: In this prospective observational study across Europe, MRAs were largely under-prescribed and frequently discontinued. Owing to these dynamic changes, outcome inferences are inconclusive.
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