A Randomised, Double-blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Subjects Admitted for Acute Heart Failure (AFFIRM-AHF), an industry-promoted multicentre trial, investigated the effect of ferric carboxymaltose or placebo on total heart failure (HF) hospitalizations and cardiovascular (CV) death up to 52 weeks of follow-up (primary endpoint) in stabilized patients with acute HF and iron deficiency. • The randomized population included 1132 eligible patients hospitalized for acute HF with iron deficiency (defined as ferritin <100 lg/L, or 100–299 lg/L with transferrin saturation <20%), and left ventricular ejection fraction <50%. Shortly before hospital discharge, participants received intravenous ferric carboxymaltose or placebo and the second dose was administered at Week 6 (repletion doses). The subsequent doses of study treatment (maintenance doses) were given at Weeks 12 and 24, only to patients in whom iron deficiency persisted and for whom haemoglobin was 8–15 g/dL. A total of 1000 patients (500 per treatment group) were required to detect a rate ratio (RR) of 0.75 for the primary composite endpoint with 80% power. • 293 primary events (57.2 per 100 patient-years) occurred in 558 patients in the ferric carboxymaltose group and 372 (72.5 per 100 patientyears) occurred in 550 patients in the placebo group [RR 0.79, 95% confidence interval (CI) 0.62–1.01; P ¼ 0.059], a difference that falls just short of conventional 5% statistical significance. The incidence of CV death was 14% in both groups [hazard ratio (HR) 0.96, 95% CI 0.70– 1.32; P ¼ 0.81]. Ferric carboxymaltose had statistically significant treatment benefits on several secondary endpoints, including first HF hospitalization or CV death (HR 0.80, 95% CI 0.66–0.98; P ¼ 0.030) and total HF hospitalizations (RR 0.74, 95% CI 0.58–0.94; P ¼ 0.013).
Iron heart / Volpe, M.; Patrono, C.. - In: EUROPEAN HEART JOURNAL. - ISSN 1522-9645. - 42:8(2021), pp. 809-810. [10.1093/eurheartj/ehaa1099]
|Data di pubblicazione:||2021|
|Citazione:||Iron heart / Volpe, M.; Patrono, C.. - In: EUROPEAN HEART JOURNAL. - ISSN 1522-9645. - 42:8(2021), pp. 809-810. [10.1093/eurheartj/ehaa1099]|
|Appartiene alla tipologia:||01b Commento, Erratum, Replica e simili|