Sex- and age-related differences in the management and outcomes of chronic heart failure: an analysis of patients from the ESC HFA EORP Heart Failure Long-Term Registry

Aims: This study aimed to assess age- and sex-related differences in management and 1-year risk for all-cause mortality and hospitalization in chronic heart failure (HF) patients. Methods and results: Of 16 354 patients included in the European Society of Cardiology Heart Failure Long-Term Registry, 9428 chronic HF patients were analysed [median age: 66 years; 28.5% women; mean left ventricular ejection fraction (LVEF) 37%]. Rates of use of guideline-directed medical therapy (GDMT) were high (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, beta-blockers and mineralocorticoid receptor antagonists: 85.7%, 88.7% and 58.8%, respectively). Crude GDMT utilization rates were lower in women than in men (all differences: P\ua0 64 0.001), and GDMT use became lower with ageing in both sexes, at baseline and at 1-year follow-up. Sex was not an independent predictor of GDMT prescription; however, age >75 years was a significant predictor of GDMT underutilization. Rates of all-cause mortality were lower in women than in men (7.1% vs. 8.7%; P\ua0=\ua00.015), as were rates of all-cause hospitalization (21.9% vs. 27.3%; P\ua075 years. Conclusions: There was a decline in GDMT use with advanced age in both sexes. Sex was not an independent predictor of GDMT or adverse outcomes. However, age >75 years independently predicted lower GDMT use and higher all-cause mortality in patients with LVEF 6445%

Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Baseline characteristics of patients in the reduction of events with darbepoetin alfa in heart failure trial (RED-HF)

<p>Aims: This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes.</p> <p>Methods and results: Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate <60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106–117) g/L.</p> <p>Conclusion: The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity.</p&gt

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Acute heart failure congestion and perfusion status – impact of the clinical classification on in-hospital and long-term outcomes; insights from the ESC-EORP-HFA Heart Failure Long-Term Registry

none614siAims: Classification of acute heart failure (AHF) patients into four clinical profiles defined by evidence of congestion and perfusion is advocated by the 2016 European Society of Cardiology (ESC)guidelines. Based on the ESC-EORP-HFA Heart Failure Long-Term Registry, we compared differences in baseline characteristics, in-hospital management and outcomes among congestion/perfusion profiles using this classification. Methods and results: We included 7865 AHF patients classified at admission as: ‘dry-warm’ (9.9%), ‘wet-warm’ (69.9%), ‘wet-cold’ (19.8%) and ‘dry-cold’ (0.4%). These groups differed significantly in terms of baseline characteristics, in-hospital management and outcomes. In-hospital mortality was 2.0% in ‘dry-warm’, 3.8% in ‘wet-warm’, 9.1% in ‘dry-cold’ and 12.1% in ‘wet-cold’ patients. Based on clinical classification at admission, the adjusted hazard ratios (95% confidence interval) for 1-year mortality were: ‘wet-warm’ vs. ‘dry-warm’ 1.78 (1.43–2.21) and ‘wet-cold’ vs. ‘wet-warm’ 1.33 (1.19–1.48). For profiles resulting from discharge classification, the adjusted hazard ratios (95% confidence interval) for 1-year mortality were: ‘wet-warm’ vs. ‘dry-warm’ 1.46 (1.31–1.63) and ‘wet-cold’ vs. ‘wet-warm’ 2.20 (1.89–2.56). Among patients discharged alive, 30.9% had residual congestion, and these patients had higher 1-year mortality compared to patients discharged without congestion (28.0 vs. 18.5%). Tricuspid regurgitation, diabetes, anaemia and high New York Heart Association class were independently associated with higher risk of congestion at discharge, while beta-blockers at admission, de novo heart failure, or any cardiovascular procedure during hospitalization were associated with lower risk of residual congestion. Conclusion: Classification based on congestion/perfusion status provides clinically relevant information at hospital admission and discharge. 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Kleinrok A.; Aguiar C.T.; Ventosa A.; Pereira S.; Faria R.; Chin J.; De Jesus I.; Santos R.; Silva P.; Moreno N.; Queiros C.; Lourenco C.; Pereira A.; Castro A.; Andrade A.; Guimaraes T.O.; Martins S.; Placido R.; Lima G.; Brito D.; Francisco A.R.; Cardiga R.; Proenca M.; Araujo I.; Marques F.; Fonseca C.; Moura B.; Leite S.; Campelo M.; Silva-Cardoso J.; Rodrigues J.; Rangel I.; Martins E.; Correia A.S.; Peres M.; Marta L.; da Silva G.F.; Severino D.; Durao D.; Leao S.; Magalhaes P.; Moreira I.; Cordeiro A.F.; Ferreira C.; Araujo C.; Ferreira A.; Baptista A.; Radoi M.; Bicescu G.; Vinereanu D.; Sinescu C.-J.; Macarie C.; Popescu R.; Daha I.; Dan G.-A.; Stanescu C.; Dan A.; Craiu E.; Nechita E.; Aursulesei V.; Christodorescu R.; Otasevic P.; Seferovic P.M.; Simeunovic D.; Ristic A.D.; Celic V.; Pavlovic-Kleut M.; Lazic J.S.; Stojcevski B.; Pencic B.; Stevanovic A.; Andric A.; Iric-Cupic V.; Jovic M.; Davidovic G.; Milanov S.; Mitic V.; Atanaskovic V.; Antic S.; Pavlovic M.; Stanojevic D.; 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Cerdena I.L.; Baldomero I.F.H.; Padron A.L.; Rosillo S.O.; Gonzalez-Gallarza R.D.; Montanes O.S.; Manjavacas A.M.I.; Conde A.C.; Araujo A.; Soria T.; Garcia-Pavia P.; Gomez-Bueno M.; Cobo-Marcos M.; Alonso-Pulpon L.; Cubero J.S.; Sayago I.; Gonzalez-Segovia A.; Briceno A.; Subias P.E.; Hernandez M.V.; Cano M.J.R.; Sanchez M.A.G.; Jimenez J.F.D.; Garrido-Lestache E.B.; Pinilla J.M.G.; de la Villa B.G.; Sahuquillo A.; Marques R.B.; Calvo F.T.; Perez-Martinez M.T.; Gracia-Rodenas M.R.; Garrido-Bravo I.P.; Pastor-Perez F.; Pascual-Figal D.A.; Molina B.D.; Orus J.; Gonzalo F.E.; Bertomeu V.; Valero R.; Martinez-Abellan R.; Quiles J.; Rodrigez-Ortega J.A.; Mateo I.; ElAmrani A.; Fernandez-Vivancos C.; Valero D.B.; Almenar-Bonet L.; Sanchez-Lazaro I.J.; Marques-Sule E.; Facila-Rubio L.; Perez-Silvestre J.; Garcia-Gonzalez P.; Ridocci-Soriano F.; Garcia-Escriva D.; Pellicer-Cabo A.; de la Fuente Galan L.; Diaz J.L.; Platero A.R.; Arias J.C.; Blasco-Peiro T.; Julve M.S.; Sanchez-Insa E.; Aured-Guallar C.; Portoles-Ocampo A.; Melin M.; Hagglund E.; Stenberg A.; Lindahl I.-M.; Asserlund B.; Olsson L.; Dahlstrom U.; Afzelius M.; Karlstrom P.; Tengvall L.; Wiklund P.-A.; Olsson B.; Kalayci S.; Temizhan A.; Cavusoglu Y.; Gencer E.; Yilmaz M.B.; Gunes H.Chioncel, O.; Mebazaa, A.; Maggioni, A. P.; Harjola, V. -P.; Rosano, G.; Laroche, C.; Piepoli, M. F.; Crespo-Leiro, M. G.; Lainscak, M.; Ponikowski, P.; Filippatos, G.; Ruschitzka, F.; Seferovic, P.; Coats, A. J. S.; Lund, L. H.; Auer, J.; Ablasser, K.; Fruhwald, F.; Dolze, T.; Brandner, K.; Gstrein, S.; Poelzl, G.; Moertl, D.; Reiter, S.; Podczeck-Schweighofer, A.; Muslibegovic, A.; Vasilj, M.; Fazlibegovic, E.; Cesko, M.; Zelenika, D.; Palic, B.; Pravdic, D.; Cuk, D.; Vitlianova, K.; Katova, T.; Velikov, T.; Kurteva, T.; Gatzov, P.; Kamenova, D.; Antova, M.; Sirakova, V.; Krejci, J.; Mikolaskova, M.; Spinar, J.; Krupicka, J.; Malek, F.; Hegarova, M.; Lazarova, M.; Monhart, Z.; Hassanein, M.; Sobhy, M.; El Messiry, F.; El Shazly, A. H.; Elrakshy, Y.; Youssef, A.; Moneim, A. A.; Noamany, M.; Reda, A.; Dayem, T. K. A.; Farag, N.; Halawa, S. I.; Hamid, M. A.; Said, K.; Saleh, A.; Ebeid, H.; Hanna, R.; Aziz, R.; Louis, O.; Enen, M. A.; Ibrahim, B. S.; Nasr, G.; Elbahry, A.; Sobhy, H.; Ashmawy, M.; Gouda, M.; Aboleineen, W.; Bernard, Y.; Luporsi, P.; Meneveau, N.; Pillot, M.; Morel, M.; Seronde, M. -F.; Schiele, F.; Briand, F.; Delahaye, F.; Damy, T.; Eicher, J. -C.; de Groote, P.; Fertin, M.; Lamblin, N.; Isnard, R.; Lefol, C.; Thevenin, S.; Hagege, A.; Jondeau, G.; Logeart, D.; Le Marcis, V.; Ly, J. -F.; Coisne, D.; Lequeux, B.; Le Moal, V.; Mascle, S.; Lotton, P.; Behar, N.; Donal, E.; Thebault, C.; Ridard, C.; Reynaud, A.; Basquin, A.; Bauer, F.; Codjia, R.; Galinier, M.; Tourikis, P.; Stavroula, M.; Tousoulis, D.; Stefanadis, C.; Chrysohoou, C.; Kotrogiannis, I.; Matzaraki, V.; Dimitroula, T.; Karavidas, A.; Tsitsinakis, G.; Kapelios, C.; Nanas, J.; Kampouri, H.; Nana, E.; Kaldara, E.; Eugenidou, A.; Vardas, P.; Saloustros, I.; Patrianakos, A.; Tsaknakis, T.; Evangelou, S.; Nikoloulis, N.; Tziourganou, H.; Tsaroucha, A.; Papadopoulou, A.; Douras, A.; Polgar, L.; Merkely, B.; Kosztin, A.; Nyolczas, N.; Nagy, A. C.; Halmosi, R.; Elber, J.; Alony, I.; Shotan, A.; Fuhrmann, A. V.; Amir, O.; Romano, S.; Marcon, S.; Penco, M.; Di Mauro, M.; Lemme, E.; Carubelli, V.; Rovetta, R.; Metra, M.; Bulgari, M.; Quinzani, F.; Lombardi, C.; Bosi, S.; Schiavina, G.; Squeri, A.; Barbieri, A.; Di Tano, G.; Pirelli, S.; Ferrari, R.; Fucili, A.; Passero, T.; Musio, S.; Di Biase, M.; Correale, M.; Salvemini, G.; Brognoli, S.; Zanelli, E.; Giordano, A.; Agostoni, P.; Italiano, G.; Salvioni, E.; Copelli, S.; Modena, M. G.; Reggianini, L.; Valenti, C.; Olaru, A.; Bandino, S.; Deidda, M.; Mercuro, G.; Dessalvi, C. C.; Marino, P. N.; Di Ruocco, M. V.; Sartori, C.; Piccinino, C.; Parrinello, G.; Licata, G.; Torres, D.; Giambanco, S.; Busalacchi, S.; Arrotti, S.; Novo, S.; Inciardi, R. M.; Pieri, P.; Chirco, P. R.; Galifi, M. A.; Teresi, G.; Buccheri, D.; Minacapelli, A.; Veniani, M.; Frisinghelli, A.; Priori, S. G.; Cattaneo, S.; Opasich, C.; Gualco, A.; Pagliaro, M.; Mancone, M.; Fedele, F.; Cinque, A.; Vellini, M.; Scarfo, I.; Romeo, F.; Ferraiuolo, F.; Sergi, D.; Anselmi, M.; Melandri, F.; Leci, E.; Iori, E.; Bovolo, V.; Pidello, S.; Frea, S.; Bergerone, S.; Botta, M.; Canavosio, F. G.; Gaita, F.; Merlo, M.; Cinquetti, M.; Sinagra, G.; Ramani, F.; Fabris, E.; Stolfo, D.; Artico, J.; Miani, D.; Fresco, C.; Daneluzzi, C.; Proclemer, A.; Cicoira, M.; Zanolla, L.; Marchese, G.; Torelli, F.; Vassanelli, C.; Voronina, N.; Erglis, A.; Tamakauskas, V.; Smalinskas, V.; Karaliute, R.; Petraskiene, I.; Kazakauskaite, E.; Rumbinaite, E.; Kavoliuniene, A.; Vysniauskas, V.; Brazyte-Ramanauskiene, R.; Petraskiene, D.; Stankala, S.; Switala, P.; Juszczyk, Z.; Sinkiewicz, W.; Gilewski, W.; Pietrzak, J.; Orzel, T.; Kasztelowicz, P.; Kardaszewicz, P.; Lazorko-Piega, M.; Gabryel, J.; Mosakowska, K.; Bellwon, J.; Rynkiewicz, A.; Raczak, G.; Lewicka, E.; Dabrowska-Kugacka, A.; Bartkowiak, R.; Sosnowska-Pasiarska, B.; Wozakowska-Kaplon, B.; Krzeminski, A.; Zabojszcz, M.; Mirek-Bryniarska, E.; Grzegorzko, A.; Bury, K.; Nessler, J.; Zalewski, J.; Furman, A.; Broncel, M.; Poliwczak, A.; Bala, A.; Zycinski, P.; Rudzinska, M.; Jankowski, L.; Kasprzak, J. D.; Michalak, L.; Soska, K. W.; Drozdz, J.; Huziuk, I.; Retwinski, A.; Flis, P.; Weglarz, J.; Bodys, A.; Grajek, S.; Kaluzna-Oleksy, M.; Straburzynska-Migaj, E.; Dankowski, R.; Szymanowska, K.; Grabia, J.; Szyszka, A.; Nowicka, A.; Samcik, M.; Wolniewicz, L.; Baczynska, K.; Komorowska, K.; Poprawa, I.; Komorowska, E.; Sajnaga, D.; Zolbach, A.; Dudzik-Plocica, A.; Abdulkarim, A. -F.; Lauko-Rachocka, A.; Kaminski, L.; Kostka, A.; Cichy, A.; Ruszkowski, P.; Splawski, M.; Fitas, G.; Szymczyk, A.; Serwicka, A.; Fiega, A.; Zysko, D.; Krysiak, W.; Szabowski, S.; Skorek, E.; Pruszczyk, P.; Bienias, P.; Ciurzynski, M.; Welnicki, M.; Mamcarz, A.; Folga, A.; Zielinski, T.; Rywik, T.; Leszek, P.; Sobieszczanska-Malek, M.; Piotrowska, M.; Kozar-Kaminska, K.; Komuda, K.; Wisniewska, J.; Tarnowska, A.; Balsam, P.; Marchel, M.; Opolski, G.; Kaplon-Cieslicka, A.; Gil, R. 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Unravelling the interplay between hyperkalaemia, renin\u2013angiotensin\u2013aldosterone inhibitor use and clinical outcomes. Data from 9222 chronic heart failure patients of the ESC-HFA-EORP Heart Failure Long-Term Registry

Aims: We assessed the interplay between hyperkalaemia (HK) and renin\u2013angiotensin\u2013aldosterone system inhibitor (RAASi) use, dose and discontinuation, and their association with all-cause or cardiovascular death in patients with chronic heart failure (HF). We hypothesized that HK-associated increased death may be related to RAASi withdrawal. Methods and results: The ESC-HFA-EORP Heart Failure Long-Term Registry was used. Among 9222 outpatients (HF with reduced ejection fraction: 60.6%, HF with mid-range ejection fraction: 22.9%, HF with preserved ejection fraction: 16.5%) from 31 countries, 16.6% had HK ( 655.0 mmol/L) at baseline. Angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) was used in 88.3%, a mineralocorticoid receptor antagonist (MRA) in 58.7%, or a combination in 53.2%; of these, at 6550% of target dose in ACEi: 61.8%; ARB: 64.7%; and MRA: 90.3%. At a median follow-up of 12.2 months, there were 789 deaths (8.6%). Both hypokalaemia and HK were independently. associated with higher mortality, and ACEi/ARB prescription at baseline with lower mortality. MRA prescription was not retained in the model. In multivariable analyses, HK at baseline was independently associated with MRA non-prescription at baseline and subsequent discontinuation. When considering subsequent discontinuation of RAASi (instead of baseline use), HK was no longer found associated with all-cause deaths. Importantly, all RAASi (ACEi, ARB, or MRA) discontinuations were strongly associated with mortality. Conclusions: In HF, hyper- and hypokalaemia were associated with mortality. However, when adjusting for RAASi discontinuation, HK was no longer associated with mortality, suggesting that HK may be a risk marker for RAASi discontinuation rather than a risk factor for worse outcomes

Sacubitril/valsartan eligibility and outcomes in the ESC-EORP-HFA Heart Failure Long-Term Registry: bridging between European Medicines Agency/Food and Drug Administration label, the PARADIGM-HF trial, ESC guidelines, and real world

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