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. (Heart Failure Long-Term Registry)
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 / C.J. Kapelios, M. Lainscak, G. Savarese, C. Laroche, P. Seferovic, F. Ruschitzka, A. Coats, S.D. Anker, M.G. Crespo-Leiro, G. Filippatos, M.F. Piepoli, G. Rosano, L. Zanolla, C. Aguiar, J. Murin, P. Leszek, T. McDonagh, A.P. Maggioni, L.H. Lund, J. Auer, K. Ablasser, F. Fruhwald, T. Dolze, K. Brandner, S. Gstrein, G. Poelzl, D. Moertl, S. Reiter, A. Podczeck-Schweighofer, A. Muslibegovic, M. Vasilj, E. Fazlibegovic, M. Cesko, D. Zelenika, B. Palic, D. Pravdic, D. Cuk, K. Vitlianova, T. Katova, T. Velikov, T. Kurteva, P. Gatzov, D. Kamenova, M. Antova, V. Sirakova, J. Krejci, M. Mikolaskova, J. Spinar, J. Krupicka, F. Malek, M. Hegarova, M. Lazarova, Z. Monhart, M. Hassanein, M. Sobhy, F. El Messiry, A.H. El Shazly, Y. Elrakshy, A. Youssef, A.A. Moneim, M. Noamany, A. Reda, T.K. Abdel Dayem, N. Farag, S. Ibrahim Halawa, M. Abdel Hamid, K. Said, A. Saleh, H. Ebeid, R. Hanna, R. Aziz, O. Louis, M.A. Enen, B.S. Ibrahim, G. Nasr, A. Elbahry, H. Sobhy, M. Ashmawy, M. Gouda, W. Aboleineen, Y. Bernard, P. Luporsi, N. Meneveau, M. Pillot, M. Morel, M.-. Seronde, F. Schiele, F. Briand, F. Delahaye, T. Damy, J.-. Eicher, P. de Groote, M. Fertin, N. Lamblin, R. Isnard, C. Lefol, S. Thevenin, A. Hagege, G. Jondeau, D. Logeart, V. Le Marcis, J.-. Ly, D. Coisne, B. Lequeux, V. Le Moal, S. Mascle, P. Lotton, N. Behar, E. Donal, C. Thebault, C. Ridard, A. Reynaud, A. Basquin, F. Bauer, R. Codjia, M. Galinier, P. Tourikis, M. Stavroula, D. Tousoulis, C. Stefanadis, C. Chrysohoou, I. Kotrogiannis, V. Matzaraki, T. Dimitroula, A. Karavidas, G. Tsitsinakis, C. Kapelios, J. Nanas, H. Kampouri, E. Nana, E. Kaldara, A. Eugenidou, P. Vardas, I. Saloustros, A. Patrianakos, T. Tsaknakis, S. Evangelou, N. Nikoloulis, H. Tziourganou, A. Tsaroucha, A. Papadopoulou, A. Douras, L. Polgar, B. Merkely, A. Kosztin, N. Nyolczas, A. Csaba Nagy, R. Halmosi, J. Elber, I. Alony, A. Shotan, A. Vazan Fuhrmann, O. Amir, S. Romano, S. Marcon, M. Penco, M. Di Mauro, E. Lemme, V. Carubelli, R. Rovetta, M. Metra, M. Bulgari, F. Quinzani, C. Lombardi, S. Bosi, G. Schiavina, A. Squeri, A. Barbieri, G. Di Tano, S. Pirelli, R. Ferrari, A. Fucili, T. Passero, S. Musio, M. Di Biase, M. Correale, G. Salvemini, S. Brognoli, E. Zanelli, A. Giordano, P. Agostoni, G. Italiano, E. Salvioni, S. Copelli, M.G. Modena, L. Reggianini, C. Valenti, A. Olaru, S. Bandino, M. Deidda, G. Mercuro, C. Cadeddu Dessalvi, P.N. Marino, M.V. Di Ruocco, C. Sartori, C. Piccinino, G. Parrinello, G. Licata, D. Torres, S. Giambanco, S. Busalacchi, S. Arrotti, S. Novo, R.M. Inciardi, P. Pieri, P.R. Chirco, M. Ausilia Galifi, G. Teresi, D. Buccheri, A. Minacapelli, M. Veniani, A. Frisinghelli, S.G. Priori, S. Cattaneo, C. Opasich, A. Gualco, M. Pagliaro, M. Mancone, F. Fedele, A. Cinque, M. Vellini, I. Scarfo, F. Romeo, F. Ferraiuolo, D. Sergi, M. Anselmi, F. Melandri, E. Leci, E. Iori, V. Bovolo, S. Pidello, S. Frea, S. Bergerone, M. Botta, F.G. Canavosio, F. Gaita, M. Merlo, M. Cinquetti, G. Sinagra, F. Ramani, E. Fabris, D. Stolfo, J. Artico, D. Miani, C. Fresco, C. Daneluzzi, A. Proclemer, M. Cicoira, L. Zanolla, G. Marchese, F. Torelli, C. Vassanelli, N. Voronina, A. Erglis, V. Tamakauskas, V. Smalinskas, R. Karaliute, I. Petraskiene, E. Kazakauskaite, E. Rumbinaite, A. Kavoliuniene, V. Vysniauskas, R. Brazyte-Ramanauskiene, D. Petraskiene, S. Stankala, P. Switala, Z. Juszczyk, W. Sinkiewicz, W. Gilewski, J. Pietrzak, T. Orzel, P. Kasztelowicz, P. Kardaszewicz, M. Lazorko-Piega, J. Gabryel, K. Mosakowska, J. Bellwon, A. Rynkiewicz, G. Raczak, E. Lewicka, A. Dabrowska-Kugacka, R. Bartkowiak, B. Sosnowska-Pasiarska, B. Wozakowska-Kaplon, A. Krzeminski, M. Zabojszcz, E. Mirek-Bryniarska, A. Grzegorzko, K. Bury, J. Nessler, J. Zalewski, A. Furman, M. Broncel, A. Poliwczak, A. Bala, P. Zycinski, M. Rudzinska, L. Jankowski, J.D. Kasprzak, L. Michalak, K. Wojtczak Soska, J. Drozdz, I. Huziuk, A. Retwinski, P. Flis, J. Weglarz, A. Bodys, S. Grajek, M. Kaluzna-Oleksy, E. Straburzynska-Migaj, R. Dankowski, K. Szymanowska, J. Grabia, A. Szyszka, A. Nowicka, M. Samcik, L. Wolniewicz, K. Baczynska, K. Komorowska, I. Poprawa, E. Komorowska, D. Sajnaga, A. Zolbach, A. Dudzik-Plocica, A.-. Abdulkarim, A. Lauko-Rachocka, L. Kaminski, A. Kostka, A. Cichy, P. Ruszkowski, M. Splawski, G. Fitas, A. Szymczyk, A. Serwicka, A. Fiega, D. Zysko, W. Krysiak, S. Szabowski, E. Skorek, P. Pruszczyk, P. Bienias, M. Ciurzynski, M. Welnicki, A. Mamcarz, A. Folga, T. Zielinski, T. Rywik, P. Leszek, M. Sobieszczanska-Malek, M. Piotrowska, K. Kozar-Kaminska, K. Komuda, J. Wisniewska, A. Tarnowska, P. Balsam, M. Marchel, G. Opolski, A. Kaplon-Cieslicka, R.J. Gil, O. Mozenska, K. Byczkowska, K. Gil, A. Pawlak, A. Michalek, P. Krzesinski, K. Piotrowicz, B. Uzieblo-Zyczkowska, A. Stanczyk, A. Skrobowski, P. Ponikowski, E. Jankowska, P. Rozentryt, L. Polonski, E. Gadula-Gacek, E. Nowalany-Kozielska, A. Kuczaj, Z. Kalarus, M. Szulik, K. Przybylska, J. Klys, G. Prokop-Lewicka, A. Kleinrok, C. Tavares Aguiar, A. Ventosa, S. Pereira, R. Faria, J. Chin, I. De Jesus, R. Santos, P. Silva, N. Moreno, C. Queiros, C. Lourenco, A. Pereira, A. Castro, A. Andrade, T. Oliveira Guimaraes, S. Martins, R. Placido, G. Lima, D. Brito, A.R. Francisco, R. Cardiga, M. Proenca, I. Araujo, F. Marques, C. Fonseca, B. Moura, S. Leite, M. Campelo, J. Silva-Cardoso, J. Rodrigues, I. Rangel, E. Martins, A. Sofia Correia, M. Peres, L. Marta, G. Ferreira da Silva, D. Severino, D. Durao, S. Leao, P. Magalhaes, I. Moreira, A. Filipa Cordeiro, C. Ferreira, C. Araujo, A. Ferreira, A. Baptista, M. Radoi, G. Bicescu, D. Vinereanu, C.-. Sinescu, C. Macarie, R. Popescu, I. Daha, G.-. Dan, C. Stanescu, A. Dan, E. Craiu, E. Nechita, V. Aursulesei, R. Christodorescu, P. Otasevic, P.M. Seferovic, D. Simeunovic, A.D. Ristic, V. Celic, M. Pavlovic-Kleut, J. Suzic Lazic, B. Stojcevski, B. Pencic, A. Stevanovic, A. Andric, V. Iric-Cupic, M. Jovic, G. Davidovic, S. Milanov, V. Mitic, V. Atanaskovic, S. Antic, M. Pavlovic, D. Stanojevic, V. Stoickov, S. Ilic, M. Deljanin Ilic, D. Petrovic, S. Stojsic, S. Kecojevic, S. Dodic, N. Cemerlic Adic, M. Cankovic, J. Stojiljkovic, B. Mihajlovic, A. Radin, S. Radovanovic, M. Krotin, A. Klabnik, E. Goncalvesova, M. Pernicky, J. Murin, F. Kovar, J. Kmec, H. Semjanova, M. Strasek, M. Savnik Iskra, T. Ravnikar, N. Cernic Suligoj, J. Komel, Z. Fras, B. Jug, T. Glavic, R. Losic, M. Bombek, I. Krajnc, B. Krunic, S. Horvat, D. Kovac, D. Rajtman, V. Cencic, M. Letonja, R. Winkler, M. Valentincic, C. Melihen-Bartolic, A. Bartolic, M. Pusnik Vrckovnik, M. Kladnik, C. Slemenik Pusnik, A. Marolt, J. Klen, B. Drnovsek, B. Leskovar, M.J. Fernandez Anguita, J.C. Gallego Page, F.M. Salmeron Martinez, J. Andres, A. Bayes-Genis, S. Mirabet, A. Mendez, L. Garcia-Cosio, E. Roig, V. Leon, J. Gonzalez-Costello, G. Muntane, A. Garay, V. Alcade-Martinez, S. Lopez Fernandez, R. Rivera-Lopez, M. Puga-Martinez, M. Fernandez-Alvarez, J.L. Serrano-Martinez, Z. Grille-Cancela, R. Marzoa-Rivas, P. Blanco-Canosa, M.J. Paniagua-Martin, E. Barge-Caballero, I. Laynez Cerdena, I. Famara Hernandez Baldomero, A. Lara Padron, S. Ofelia Rosillo, R. Dalmau Gonzalez-Gallarza, O. Salvador Montanes, A.M. Iniesta Manjavacas, A. Castro Conde, A. Araujo, T. Soria, P. Garcia-Pavia, M. Gomez-Bueno, M. Cobo-Marcos, L. Alonso-Pulpon, J. Segovia Cubero, I. Sayago, A. Gonzalez-Segovia, A. Briceno, P. Escribano Subias, M. Vicente Hernandez, M.J. Ruiz Cano, M.A. Gomez Sanchez, J.F. Delgado Jimenez, E. Barrios Garrido-Lestache, J.M. Garcia Pinilla, B. Garcia de la Villa, A. Sahuquillo, R. Bravo Marques, F. Torres Calvo, M.T. Perez-Martinez, M.R. Gracia-Rodenas, I.P. Garrido-Bravo, F. Pastor-Perez, D.A. Pascual-Figal, B. Diaz Molina, J. Orus, F. Epelde Gonzalo, V. Bertomeu, R. Valero, R. Martinez-Abellan, J. Quiles, J.A. Rodrigez-Ortega, I. Mateo, A. ElAmrani, C. Fernandez-Vivancos, D. Bierge Valero, L. Almenar-Bonet, I.J. Sanchez-Lazaro, E. Marques-Sule, L. Facila-Rubio, J. Perez-Silvestre, P. Garcia-Gonzalez, F. Ridocci-Soriano, D. Garcia-Escriva, A. Pellicer-Cabo, L. de la Fuente Galan, J. Lopez Diaz, A. Recio Platero, J.C. Arias, T. Blasco-Peiro, M. Sanz Julve, E. Sanchez-Insa, C. Aured-Guallar, A. Portoles-Ocampo, M. Melin, E. Hagglund, A. Stenberg, I.-. Lindahl, B. Asserlund, L. Olsson, U. Dahlstrom, M. Afzelius, P. Karlstrom, L. Tengvall, P.-. Wiklund, B. Olsson, S. Kalayci, A. Temizhan, Y. Cavusoglu, E. Gencer, M.B. Yilmaz, H. Gunes. - In: EUROPEAN JOURNAL OF HEART FAILURE. - ISSN 1388-9842. - 21:11(2019 Nov), pp. 1383-1397. [10.1002/ejhf.1532]
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
P. AgostoniMembro del Collaboration Group
;
2019
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. (Heart Failure Long-Term Registry)File | Dimensione | Formato | |
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