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

Data de publicação: 01/11/2019

Autores da FMUP

• Brenda Eugénia Carvalho De Moura Cardoso

  Autor

• José Carlos De Magalhães Silva Cardoso

  Autor

Participantes de fora da FMUP

• Kapelios, CJ
• Lainscak, M
• Savarese, G
• Laroche, C
• Seferovic, P
• Ruschitzka, F
• Coats, A
• Anker, SD
• Crespo-Leiro, MG
• Filippatos, G
• Piepoli, MF
• Rosano, G
• Zanolla, L
• Aguiar, C
• Murin, J
• Leszek, P
• McDonagh, T
• Maggioni, AP
• Lund, LH
• 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, AH
• Elrakshy, Y
• Youssef, A
• Moneim, AA
• Noamany, M
• Reda, A
• Dayem, TKA
• Farag, N
• Halawa, SI
• Hamid, MA
• Said, K
• Saleh, A
• Ebeid, H
• Hanna, R
• Aziz, R
• Louis, O
• Enen, MA
• Ibrahim, BS
• Nasr, G
• Elbahry, A
• Sobhy, H
• Ashmawy, M
• Gouda, M
• Aboleineen, W
• Bernard, Y
• Luporsi, P
• Meneveau, N
• Pillot, M
• Morel, M
• Seronde, MF
• Schiele, F
• Briand, F
• Delahaye, F
• Damy, T
• Eicher, JC
• de Groote, P
• Fertin, M
• Lamblin, N
• Isnard, R
• Lefol, C
• Thevenin, S
• Hagege, A
• Jondeau, G
• Logeart, D
• Le Marcis, V
• Ly, JF
• 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, AC
• Halmosi, R
• Elber, J
• Alony, I
• Shotan, A
• Fuhrmann, AV
• 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, MG
• Reggianini, L
• Valenti, C
• Olaru, A
• Bandino, S
• Deidda, M
• Mercuro, G
• Dessalvi, CC
• Marino, PN
• Di Ruocco, MV
• Sartori, C
• Piccinino, C
• Parrinello, G
• Licata, G
• Torres, D
• Giambanco, S
• Busalacchi, S
• Arrotti, S
• Novo, S
• Inciardi, RM
• Pieri, P
• Chirco, PR
• Galifi, MA
• Teresi, G
• Buccheri, D
• Minacapelli, A
• Veniani, M
• Frisinghelli, A
• Priori, SG
• 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, FG
• 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, JD
• Michalak, L
• Soska, KW
• 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, AF
• 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, RJ
• Mozenska, O
• Byczkowska, K
• Gil, K
• Pawlak, A
• Michalek, A
• Krzesinski, P
• Piotrowicz, K
• Uzieblo-Zyczkowska, B
• Stanczyk, A
• Skrobowski, A
• Ponikowski, P
• Jankowska, E
• Rozentryt, P
• Polonski, L
• Gadula-Gacek, E
• Nowalany-Kozielska, E
• Kuczaj, A
• Kalarus, Z
• Szulik, M
• Przybylska, K
• Klys, J
• Prokop-Lewicka, G
• Kleinrok, A
• Aguiar, CT
• Ventosa, A
• Pereira, S
• Faria, R
• Chin, J
• De Jesus, I
• Santos, R
• Silva, P
• Moreno, N
• Queirós, C
• Lourenço, C
• Pereira, A
• Castro, A
• Andrade, A
• Guimaraes, TO
• Martins, S
• Placido, R
• Lima, G
• Brito, D
• Francisco, AR
• Cardiga, R
• Proenca, M
• Araujo, I
• Marques, F
• Fonseca, C
• Leite, S
• Campelo, M
• Rodrigues, J
• Rangel, I
• Martins, E
• Correia, AS
• Peres, M
• Marta, L
• da Silva, GF
• Severino, D
• Durao, D
• Leao, S
• Magalhaes, P
• Moreira, I
• Cordeiro, AF
• Ferreira, C
• Araujo, C
• Ferreira, A
• Baptista, A
• Radoi, M
• Bicescu, G
• Vinereanu, D
• Sinescu, CJ
• Macarie, C
• Popescu, R
• Daha, I
• Dan, GA
• Stanescu, C
• Dan, A
• Craiu, E
• Nechita, E
• Aursulesei, V
• Christodorescu, R
• Otasevic, P
• Seferovic, PM
• Simeunovic, D
• Ristic, AD
• Celic, V
• Pavlovic-Kleut, M
• Lazic, JS
• 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
• Stoickov, V
• Ilic, S
• Ilic, MD
• Petrovic, D
• Stojsic, S
• Kecojevic, S
• Dodic, S
• Adic, NC
• Cankovic, M
• Stojiljkovic, J
• Mihajlovic, B
• Radin, A
• Radovanovic, S
• Krotin, M
• Klabnik, A
• Goncalvesova, E
• Pernicky, M
• Murin, J
• Kovar, F
• Kmec, J
• Semjanova, H
• Strasek, M
• Iskra, MS
• Ravnikar, T
• Suligoj, NC
• Komel, J
• Fras, Z
• Jug, B
• Glavic, T
• Losic, R
• Bombek, M
• Krajnc, I
• Krunic, B
• Horvat, S
• Kovac, D
• Rajtman, D
• Cencic, V
• Letonja, M
• Winkler, R
• Valentincic, M
• Melihen-Bartolic, C
• Bartolic, A
• Vrckovnik, MP
• Kladnik, M
• Pusnik, CS
• Marolt, A
• Klen, J
• Drnovsek, B
• Leskovar, B
• Anguita, MJF
• Page, JCG
• Martinez, FMS
• Andres, J
• Bayes-Genis, A
• Mirabet, S
• Mendez, A
• Garcia-Cosio, L
• Roig, E
• Leon, V
• Gonzalez-Costello, J
• Muntane, G
• Garay, A
• Alcade-Martinez, V
• Fernandez, SL
• Rivera-Lopez, R
• Puga-Martinez, M
• Fernandez-Alvarez, M
• Serrano-Martinez, JL
• Crespo-Leiro, M
• Grille-Cancela, Z
• Marzoa-Rivas, R
• Blanco-Canosa, P
• Paniagua-Martin, MJ
• Barge-Caballero, E
• Cerdena, IL
• Baldomero, IFH
• Padron, AL
• Rosillo, SO
• Gonzalez-Gallarza, RD
• Montanes, OS
• Manjavacas, AMI
• Conde, AC
• Soria, AAT
• Garcia-Pavia, P
• Gomez-Bueno, M
• Cobo-Marcos, M
• Alonso-Pulpon, L
• Cubero, JS
• Sayago, I
• Gonzalez-Segovia, A
• Briceno, A
• Subias, PE
• Hernandez, MV
• Cano, MJR
• Sanchez, MAG
• Jimenez, JFD
• Garrido-Lestache, EB
• Pinilla, JMG
• de la Villa, BG
• Sahuquillo, A
• Marques, RB
• Calvo, FT
• Perez-Martinez, MT
• Gracia-Rodenas, MR
• Garrido-Bravo, IP
• Pastor-Perez, F
• Pascual-Figal, DA
• Molina, BD
• Orus, J
• Gonzalo, FE
• Bertomeu, V
• Valero, R
• Martinez-Abellan, R
• Quiles, J
• Rodrigez-Ortega, JA
• Mateo, I
• ElAmrani, A
• Fernandez-Vivancos, C
• Valero, DB
• Almenar-Bonet, L
• Sanchez-Lazaro, IJ
• Marques-Sule, E
• Facila-Rubio, L
• Perez-Silvestre, J
• Garcia-Gonzalez, P
• Ridocci-Soriano, F
• Garcia-Escriva, D
• Pellicer-Cabo, A
• Galan, LD
• Diaz, JL
• Platero, AR
• Arias, JC
• Blasco-Peiro, T
• Julve, MS
• Sanchez-Insa, E
• Aured-Guallar, C
• Portoles-Ocampo, A
• Melin, M
• Hägglund, E
• Stenberg, A
• Lindahl, IM
• Asserlund, B
• Olsson, L
• Dahlström, U
• Afzelius, M
• Karlström, P
• Tengvall, L
• Wiklund, PA
• Olsson, B
• Kalayci, S
• Temizhan, A
• Cavusoglu, Y
• Gencer, E
• Yilmaz, MB
• Gunes, H
• Heart Failure Long-Term Registry

Unidades de investigação

• Medicina

• RISE-Health

  

  Investigador

  Fernando Carlos De Landér Schmitt

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 >= 10mg 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 >= 10mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM-HF enalapril group.

Keywords

• Sacubitril/valsartan; LCZ696; Angiotensin receptor; neprilysin inhibitor; Eligibility; Registry; Prognosis