Chris J Kapelios1, Mitja Lainscak2, Gianluigi Savarese3, Cécile Laroche4, Petar Seferovic5, Frank Ruschitzka6, Andrew Coats7, Stefan D Anker8, Maria G Crespo-Leiro9, Gerasimos Filippatos10, Massimo F Piepoli11, Giuseppe Rosano12, Luisa Zanolla13, Carlos Aguiar14, Jan Murin15, Przemyslaw Leszek16, Theresa McDonagh17, Aldo P Maggioni4,18, Lars H Lund3. 1. Department of Cardiology, Laiko General Hospital, Athens, Greece. 2. Division of Cardiology, Murska Sobota, Murska Sobota and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. 3. Division of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden. 4. EURObservational Research Programme, European Society of Cardiology, Sophia-Antipolis, France. 5. Clinical Center of Serbia, Cardiology II, Department for Heart Failure, University of Belgrade, Belgrade, Serbia. 6. Department of Cardiology, Heart Failure Clinic and Transplantation, University Heart Centre Zurich, Zurich, Switzerland. 7. IRCCS San Raffaele, Rome, Italy. 8. Division of Cardiology and Metabolism; Department of Cardiology (CVK); and Berlin-Brandenburg Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany & Department of Cardiology and Pneumology, University Medicine Göttingen (UMG), Göttingen, Germany. 9. Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Complexo Hospitalario Universitario A Coruna, La Coruna, Spain. 10. Heart Failure Unit, Department of Cardiology, University Hospital Attikon, Athens, Greece. 11. Heart Failure Unit, Cardiac Department, Guglielmo da Saliceto Hospital, Piacenza, Italy. 12. Cardiovascular Clinical Academic Group St George's Hospitals NHS Trust University of London, Cranmer Terrace, London, IRCCS San Raffaele, Rome, Italy. 13. Ospedale Civile Maggiore, Verona, Italy. 14. Unidade de Insuficiência Cardíaca Avançada e Transplantação Cardíaca, Hospital de Santa Cruz, Carnaxide, Portugal. 15. University Hospital Bratislava, Bratislava, Slovakia. 16. The Cardinal Stefan Wyszynski Institute of Cardiology, Warsaw, Poland. 17. King's College Hospital, London, UK. 18. ANMCO Research Centre, Heart Care Foundation, Florence, Italy.
Abstract
AIMS: To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM-HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes. METHODS AND RESULTS: Outpatients with HFrEF in the ESC-EORP-HFA Long-Term Heart Failure (HF-LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM-HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM-HF and guideline criteria, respectively. Absent PARADIGM-HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub-optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%) and sub-optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM-HF and guidelines. One-year heart failure hospitalization was higher (12% and 17% vs. 12%) and all-cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM-HF. CONCLUSIONS: Among outpatients with HFrEF in the ESC-EORP-HFA HF-LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM-HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM-HF enalapril group.
AIMS: To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM-HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes. METHODS AND RESULTS: Outpatients with HFrEF in the ESC-EORP-HFA Long-Term Heart Failure (HF-LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM-HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM-HF and guideline criteria, respectively. Absent PARADIGM-HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub-optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%) and sub-optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM-HF and guidelines. One-year heart failure hospitalization was higher (12% and 17% vs. 12%) and all-cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM-HF. CONCLUSIONS: Among outpatients with HFrEF in the ESC-EORP-HFA HF-LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM-HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM-HF enalapril group.
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