Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial

Ponikowski, Piotr; Kirwan, Bridget‐Anne; Anker, Stefan D.; Fabien, Vincent; Filippatos, Gerasimos; Göhring, Udo Michael; Keren, Andre; Kragten, Hans; Martínez, Felipe A.; Nicolau, José Carlos; Parkhomenko, Alexander; Pascual-Figal, Domingo; Ruschitzka, Frank; Skouri, Hadi; Lewis, Basil S.; Comín‐Colet, Josep; Haehling, Stephan von; Cohen‐Solal, Alain; Danchin, Nicolás; Doehner, Wolfram; Dargie, Henry J.; Motro, Michael; Butler, Javed; Friede, Tim; Jensen, Klaus H.; Pocock, Stuart J.; Jankowska, Ewa A.; Azize, Guillermo Moisés; Fernández, Anna Mollar; Zapata, GO; Pacho, P. García; Glenny, Anne Marie; Pacora, F Ferre; Parody, ML; Bono, Joseph de; Beltrano, C; Hershson, Alejandro; Vita, Néstor A.; Ha, Luquez; Cestari, HG; Fernández, H.; Prado, Armando Pérez de; Berli, Mario A.; Durán, R García; Thierer, Jorge; Díez, Mirta; Márquez, Lobo; Borelli, RR; Hominal, Má; Metra, Marco; Ameri, Pietro; Agostoni, Piergiuseppe; Salvioni, Alessandra; Fattore, Luciano; Gronda, Edoardo; Ghio, Stefano; Turrini, Fabrizio; Uguccioni, Mariagrazia; Biase, M Di; Piepoli, Massimo F; Savonitto, Stefano; Mortara, Andrea; Terrosu, Pierfranco; Fucili, Alessandro; Boriani, Giuseppe; Midi, Paolo; Passamonti, Enrico; Cosmi, Franco; Meer, Peter van der; Bergen, P. Van; Wetering, M van de; Al-Windy, N. Y. Y.; Tanis, Wilco; Meijs, M. F. L.; Groutars, R.; Kietselaer, Bas; Kesteren, Ham van; Beelen, Dpw; Heymeriks, Jan; Wal, Ruud van de; Schaap, Jeroen; Emans, Mireille E.; Westendorp, Paul H.; Nierop, P R; Nijmeijer, Rian M.; Manintveld, Olivier C.; Dorobanţu, Maria; Darabantiu, DA; Zdrenghea, Dumitru; Toader, DM; Petrescu, L; Militaru, Constantin; Crișu, Daniela; MC, Tomescu; Stanciulescu, G; Dan, A.; Iosipescu, LC; Serban, DL; Dróżdż, Jarosław; Szachniewicz, Joanna; Bronisz, Marek; Tycińska, Agnieszka; Wożakowska−Kapłon, Beata; Mirek-Bryniarska, Ewa; Gruchała, Marcin; Nessler, Jadwiga; Straburzyńska‐Migaj, Ewa; Mizia‐Stec, Katarzyna; Szełemej, Roman; Gil, Robert; Gasior, Maria; Gotsman, Israel; Halabi, Majdi; Shochat, Michael; Shechter, Michael; Witzling, Valentin; Zukermann, Robert; Arbel, Yaron; Flugelman, Moshe Y.; Ben‐Gal, Tuvia; Zvi, V; Kinany, Wadi; Weinstein, JM; Atar, Shaul; Goland, Sorel; Miličić, Davor; Horvat, Darko; Tušek, S; Udovičić, Mario; Šutalo, Krešimir; Samodol, Ante; Pesek, K; Artuković, M; Ružić, Alen; Šikić, Jakov; McDonagh, Theresa A.; Trevelyan, Jasper; Wong, Y.W. James; Gorog, Diana A.; Ray, Robin; Pettit, Shirley; Sharma, Sohan Kumar; Kabir, Ali; Hamdan, H. F.; Tilling, Lindsey; Baracioli, Luciano Moreira; Maia, Lília Nigro; Dutra, Óscar Pereira; Reis, Gilmar; Filho, P. Pimentel; Saraiva, J. Kerr; Kormann, Adrian; Santos, FR dos; Bodanese, Luiz Carlos; Almeida, Dirceu Rodrigues; Précoma, Dalton Bertolim; Rassi, Salvador; Costa, Francesco; Kabbani, Sarah; Abdelbaki, Khaled; Abdallah, Chadi G.; Arnaout, Jean-Paul; Azar, Rania; Chaaban, Said; Raed, O; Kiwan, Ghassan S.; Hassouna, Bassel; Bardajı́, Alfredo; Zamorano, Jaime; Prado, Susana del; Juanatey, J González; Ojeda, FI Ga Bosa; Bueno, Manuel; Bd, Molina; Figal, DA Pascual; Sim, David Kheng Leng; Yeo, Tee Joo; Loh, Sy; Soon, Dinna; Ohlsson, Marcus; Smith, J. G.; Gerward, Sofia; Khintibidze, Irakli; Lominadze, Zurabi; Chapidze, G; Emukhvari, N.; Khabeishvili, Georgy; Chumburidze, Vakhtang; Paposhvili, K; Shaburishvili, Tamaz; Parhomenko, O. V.; Крайз, И. Г.; Koval, O; Золотайкина, Виктория Игоревна; Malynovsky, Yaroslav; Vakaliuk, Ihor; Rudenko, Larisa; Tseluyko, V. I.; Stanislavchuk, Mykola

doi:10.1016/s0140-6736(20)32339-4

Cited by 453 publications

(443 citation statements)

References 25 publications

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“…AFFIRM-AHF enrolled patients who were initially hospitalized with acute heart failure, while other trials enrolled chronic ambulatory heart failure patients. 11 This could have led to some heterogeneity. Second, given the size of the AFFIRM-HF study the results of this meta-analysis were mainly driven by this study.…”

Section: Discussionmentioning

confidence: 99%

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Ferric carboxymaltose for the treatment of iron‐deficient heart failure patients: a systematic review and meta‐analysis

et al. 2020

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Aims Intravenous ferric carboxymaltose (FCM) has been shown to improve functional capacity and quality of life in iron deficient heart failure patients. However, FCM's effect on hospitalizations and mortality remains unclear as previous randomized controlled trials (RCTs) and their meta‐analyses have been underpowered to detect significant differences. We sought to conduct an updated meta‐analysis using recently published RCT data. Methods and results Online databases were searched from inception until November 2020 for RCTs evaluating the effects of FCM on clinical outcomes in iron‐deficient heart failure patients. Outcomes of interest included heart failure hospitalizations, all‐cause mortality, and cardiovascular mortality. Meta‐analysis was performed using a fixed‐effect model and estimates were reported as odds ratios (ORs), hazard ratios, or rate ratios (RRs) along with corresponding 95% confidence intervals (CIs). A total of 1947 patients (n = 1062 in the FCM group; n = 885 in the placebo group) were included. FCM, compared with placebo, significantly reduced the risk of the composite endpoint of time to first heart failure hospitalization or cardiovascular death (hazard ratio = 0.76; 95% CI = 0.63–0.90; I2 = 55%). FCM also significantly reduced the risk of recurrent heart failure hospitalizations (RR = 0.68; 95% CI = 0.54–0.85; I2 = 71%) and recurrent cardiovascular hospitalizations (RR = 0.71; 95% CI = 0.59–0.86; I2 = 56%). However, FCM had no significant effect on the risk of all‐cause (OR = 0.97; 95% CI = 0.73–1.28; I2 = 0%) or cardiovascular mortality (OR = 0.93; 95% CI = 0.69–1.27; I2 = 0%). Conclusions Ferric carboxymaltose reduces heart failure hospitalizations and cardiovascular hospitalizations with no beneficial effect on all‐cause and cardiovascular mortality in iron‐deficient heart failure patients. These findings reinforce the role of FCM as a therapeutic option in heart failure patients.

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Section: Discussionmentioning

confidence: 99%

“…The primary outcomes within each of the trials differed. Only AFFIRM‐AHF had a clinical primary endpoint, that is, composite of recurrent heart failure hospitalizations and cardiovascular death 11 . The primary outcomes of other trials were based on quality of life and functional capacity.…”

Section: Methodsmentioning

confidence: 99%

Ferric carboxymaltose for the treatment of iron‐deficient heart failure patients: a systematic review and meta‐analysis

et al. 2020

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“…One randomized study and one individual-patient metaanalysis showed a reduction in HF hospitalizations and a reduced composite outcome of recurrent cardiovascular hospitalizations and cardiovascular mortality, respectively [34,38]. A recent outcomes study has generated further evidence on the benefits of intravenous iron supplementation in patients with iron deficiency and LVEF <50% who are stabilized after an episode of acute HF; reporting a reduction in the risk of subsequent HF hospitalizations but with no apparent effect on the risk of cardiovascular death [39].…”

Section: When Should Iron Therapy Be Used In Inflammatory Bowel Disease?mentioning

confidence: 99%

Questions and answers on iron deficiency treatment selection and the use of intravenous iron in routine clinical practice

et al. 2021

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Iron deficiency is a common cause of morbidity and can arise as a consequence or complication from many diseases. The use of intravenous iron has increased significantly in the last decade, but concerns remain about indications and administration. Modern intravenous iron preparations can facilitate rapid iron repletion in one or two doses, both for absolute iron deficiency and, in the presence of inflammation, functional iron deficiency, where oral iron therapy is ineffective or has not worked. A multidisciplinary team of experts experienced in iron deficiency undertook a consensus review to support healthcare professionals with practical advice on managing iron deficiency in gastrointestinal, renal and cardiac disease, as well as; pregnancy, heavy menstrual bleeding, and surgery. We explain how intravenous iron may work where oral iron has not. We provide context on how and when intravenous iron should be administered, and informed opinion on potential benefits balanced with potential side-effects. We propose how intravenous iron side-effects can be anticipated in terms of what they may be and when they may occur. The aim of this consensus is to provide a practical basis for educating and preparing staff and patients on when and how iron infusions can be administered safely and efficiently. KEY MESSAGES Iron deficiency treatment selection is driven by several factors, including the presence of inflammation, the time available for iron replenishment, and the anticipated risk of sideeffects or intolerance. Intravenous iron preparations are indicated for the treatment of iron deficiency when oral preparations are ineffective or cannot be used, and therefore have applicability in a wide range of clinical contexts, including chronic inflammatory conditions, perioperative settings, and disorders associated with chronic blood loss. Adverse events occurring with intravenous iron can be anticipated according to when they typically occur, which provides a basis for educating and preparing staff and patients on how iron infusions can be administered safely and efficiently.

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“…Independientemente de la presencia o no de anemia, la deficiencia de hierro (DH) se presenta con una prevalencia del 50% en pacientes ambulatorios con IC (15) . El estudio AFFIRM-AHF (16) demostró la eficacia y seguridad del uso de carboximaltosa férrica intravenosa en pacientes con hospitalización por IC una vez estabilizado el cuadro, que además tenga DH (ferritina<100 ng/mL o ferritina 100-200 ng/mL con saturación de transferrina <20%) y FEVI <50%. El beneficio en hospitalizaciones por IC y muerte CV tuvo un resultado limítrofe con un RR de 0,79 (IC 0,62-1,01, p=0,059).…”

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Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial

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Cited by 453 publications

References 25 publications

Ferric carboxymaltose for the treatment of iron‐deficient heart failure patients: a systematic review and meta‐analysis

Ferric carboxymaltose for the treatment of iron‐deficient heart failure patients: a systematic review and meta‐analysis

Questions and answers on iron deficiency treatment selection and the use of intravenous iron in routine clinical practice

Lo mejor del 2020: Estudios que marcarán nuestra práctica clínica

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