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
Por:
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, Queiros, C, Lourenco, 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, Moura, B, Leite, S, Campelo, M, Silva-Cardoso, J, 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, Hagglund, E, Stenberg, A, Lindahl, IM, Asserlund, B, Olsson, L, Dahlstrom, U, Afzelius, M, Karlstrom, P, Tengvall, L, Wiklund, PA, Olsson, B, Kalayci, S, Temizhan, A, Cavusoglu, Y, Gencer, E, Yilmaz, MB, Gunes, H, Heart Failure Long-Term Registry
Publicada:
1 nov 2019
Resumen:
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.
Filiaciones:
Kapelios, CJ:
Laikon Gen Hosp, Dept Cardiol, Athens, Greece
Lainscak, M:
Dept Cardiol, Murska Sobota, Murska Sobota, Slovenia
Univ Ljubljana, Fac Med, Ljubljana, Slovenia
Savarese, G:
Karolinska Inst, Div Cardiol, Dept Med, Stockholm, Sweden
Karolinska Univ Hosp, Heart & Vasc Theme, Stockholm, Sweden
Laroche, C:
European Soc Cardiol, EURObservat Res Programme, Sophia Antipolis, France
Seferovic, P:
Univ Belgrade, Clin Ctr Serbia, Cardiol 2, Dept Heart Failure, Belgrade, Serbia
Ruschitzka, F:
Univ Heart Ctr Zurich, Dept Cardiol Heart Failure Clin & Transplantat, Zurich, Switzerland
Coats, A:
IRCCS San Raffaele, Rome, Italy
Anker, SD:
Charite Univ Med Berlin, Div Cardiol & Metab, German Ctr Cardiovasc Res DZHK, Partner Site Berlin,Dept Cardiol CVK, Berlin, Germany
Charite Univ Med Berlin, Berlin Brandenburg Ctr Regenerat Therapies BCRT, German Ctr Cardiovasc Res DZHK, Partner Site Berlin, Berlin, Germany
UMG, Dept Cardiol & Pneumol, Gottingen, Germany
Crespo-Leiro, MG:
Complexo Hosp Univ A Coruna, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, La Coruna, Spain
Filippatos, G:
Univ Hosp Attikon, Dept Cardiol, Heart Failure Unit, Athens, Greece
Piepoli, MF:
Guglielmo da Saliceto Hosp, Heart Failure Unit, Dept Cardiac, Piacenza, Italy
Rosano, G:
IRCCS San Raffaele, Rome, Italy
St Georges Hosp NHS Trust Univ London, Cardiovasc Clin Acad Grp, Cranmer Terrace, London, England
Zanolla, L:
Osped Civile, Verona, Italy
Aguiar, C:
Hosp Santa Cruz, Unidade Insuficiencia Cardiaca Avancada & Transpl, Carnaxide, Portugal
Murin, J:
Univ Hosp Bratislava, Bratislava, Slovakia
Leszek, P:
Cardinal Stefan Wyszynski Inst Cardiol, Warsaw, Poland
McDonagh, T:
Kings Coll Hosp London, London, England
Maggioni, AP:
European Soc Cardiol, EURObservat Res Programme, Sophia Antipolis, France
Heart Care Fdn, ANMCO Res Ctr, Florence, Italy
Lund, LH:
Karolinska Inst, Div Cardiol, Dept Med, Stockholm, Sweden
Karolinska Univ Hosp, Heart & Vasc Theme, Stockholm, Sweden
Kapelios, C:
Laikon Gen Hosp, Dept Cardiol, Athens, Greece
Zanolla, L:
Osped Civile, Verona, Italy
Leszek, P:
Cardinal Stefan Wyszynski Inst Cardiol, Warsaw, Poland
Murin, J:
Univ Hosp Bratislava, Bratislava, Slovakia
Crespo-Leiro, M:
Complexo Hosp Univ A Coruna, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, La Coruna, Spain
Bronze
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