Intravenous Ferric Carboxymaltose in Heart Failure With Iron Deficiency

作者：Stefan D. Anker, Tim Friede, Javed Butler, Khawaja M. Talha, Marius Placzek, Monika Diek, Anna Nosko, Adriane Stas, Stefan Kluge, Dominik Jarczak, Geraldine deHeer, Meike Rybczynski, Antoni Bayés‐Genís, Michael Böhm, Andrew J.S. Coats, Frank T. Edelmann, Gerasimos Filippatos, Gerd Hasenfuß, Wilhelm Haverkamp, Mitja Lainščak, Ulf Landmesser, Iain C. Macdougall, Béla Merkely, Burkert Pieske, Fausto J. Pinto, Tienush Rassaf, Jennifer K. Visser‐Rogers, Giuseppe Rosano, Maurizio Volterrani, Stephan von Haehling, Markus S. Anker, Wolfram Doehner, Hüseyin İnce, Friedrich Koehler, Gianluigi Savarese, Muhammad Shahzeb Khan, Ursula Rauch‐Kröhnert, Tommaso Gori, Teresa Trenkwalder, Ibrahim Akin, Christina Paitazoglou, Iwona Kobielusz‐Gembala, Luca Kuthi, Norbert Frey, Manuela Licka, Stefan Kääb, Karl‐Ludwig Laugwitz, Piotr Ponikowski, Mahir Karakas · 发表于：JAMA · 年份：2025 · DOI：10.1001/jama.2025.3833 · 被引用次数：64 · 研究领域：Erythropoietin and Anemia Treatment、Iron Metabolism and Disorders、Hemoglobinopathies and Related Disorders

Importance: Uncertainty remains about the efficacy of intravenous iron in patients with heart failure and iron deficiency. Objective: To assess the efficacy and safety of ferric carboxymaltose in patients with heart failure and iron deficiency. Design, Setting, and Participants: This multicenter, randomized clinical trial enrolled 1105 patients with heart failure (defined as having a left ventricular ejection fraction of ≤45%) and iron deficiency (serum ferritin level <100 ng/mL; or if transferrin saturation was <20%, a serum ferritin level between 100 ng/mL and 299 ng/mL) at 70 clinic sites in 6 European countries from March 2017 to November 2023. The median follow-up was 16.6 months (IQR, 7.9-29.9 months). Intervention: Administration of ferric carboxymaltose (n = 558) initially given at an intravenous dose of up to 2000 mg that was followed by 500 mg every 4 months (unless stopping criteria were met) vs a saline placebo (n = 547). Main Outcomes and Measures: The primary end point events were (1) time to cardiovascular death or first heart failure hospitalization, (2) total heart failure hospitalizations, and (3) time to cardiovascular death or first heart failure hospitalization in patients with a transferrin saturation less than 20%. All end point events were measured through follow-up. The end points would be considered statistically significant if they fulfilled at least 1 of the following conditions: (1) P ≤ .05 for all 3 of the end point comparisons, (2) P ≤ .025 for ...