scholarly journals Efficacy of intravenous ferric carboxymaltose for iron deficiency following acute heart failure (AHF) in patients with previously diagnosed HF: a subgroup analysis of AFFIRM-AHF

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
EA Jankowska ◽  
P Van Der Meer ◽  
M Metra ◽  
G Filippatos ◽  
BA Kirwan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Iron Deficiency ◽  
Acute Heart Failure ◽  
Subgroup Analysis ◽  
Randomised Clinical Trial ◽  
Ferric Carboxymaltose ◽  
Private Company ◽  
Funding Sources ◽  
Death Time ◽  
History Of

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Vifor Pharma OnBehalf The AFFIRM-AHF Investigators Introduction AFFIRM-AHF is the first randomised clinical trial to evaluate the effect of intravenous ferric carboxymaltose (IV FCM) (vs placebo) on morbidity and mortality in patients with an episode of acute heart failure (HF) and concomitant iron deficiency. Purpose To determine the effect of FCM versus placebo on efficacy outcomes in the subgroup of the AFFIRM-AHF cohort with a documented history of HF. Methods This subgroup analysis evaluated patients previously diagnosed with HF. Primary outcome was a composite of total HF hospitalisations and CV death. Secondary outcomes included total HF hospitalisations, CV death, time to first HF hospitalisation or CV death, composite of total CV hospitalisations and CV death, and days lost due to HF hospitalisations or CV death. All outcomes were evaluated up to 52 weeks post-randomisation. Results In AFFIRM-AHF, 73% and 70% of patients randomly assigned to FCM and placebo, respectively, had a documented history of HF. Baseline demographics and clinical characteristics were comparable between treatment groups for this subgroup. There were significantly fewer primary events in patients assigned to FCM compared to placebo: 249 vs 336, respectively (rate ratio [RR] 0.72, 95% CI: 0.55–0.95; p = 0.022). 186 total HF hospitalisations occurred in FCM group and 267 in placebo (RR 0.67, 95% CI: 0.52–0.88; p = 0.004). The composite of first HF hospitalisation or CV death occurred in 149 (37%) assigned FCM and in 179 (44%) patients assigned placebo (hazard ratio [HR] 0·76, 95% CI: 0·61–0·95; p = 0·014). Conclusion   In patients with a documented history of HF and iron deficiency who were stabilised after an episode of AHF, treatment with FCM significantly reduced the risk of a composite of total HF hospitalisation and CV death. Primary and Secondary outcomesFCM (n = 405)Placebo (n = 385)RR or HR (95% CI)P valueNo. of eventsRate per 100 patient-yrNo. of eventsRate per 100 patient-yrPrimary outcomeTotal HF hospitalisations and CV death24971.85336101.3RR: 0.72 (0.55-0.95)0.022Secondary outcomesTotal CV hospitalisationsand CV death30888.87401120.57RR: 0.74 (0.58-0.95)0.020Time to CV death63346.5568332.58HR: 0.91 (0.65-1.29)0.602Total HF hospitalisations18653.6726780.28RR: 0.67 (0.52-0.88)0.004Time to first HF hospitalisation or CV death149291.76179257.93HR: 0.76 (0.61-0.95)0.014Days lost due to HF hospitalisation and CV death4.5*526.328.3*955.55RR: 0.58 (0.38-0.90)0.015*Data point is the mean number of days lost per subject.

FC 021EFFICACY OF INTRAVENOUS FERRIC CARBOXYMALTOSE IN PATIENTS WITH IRON DEFICIENCY FOLLOWING ACUTE HEART FAILURE, ACCORDING TO BASELINE EGFR: A SUBGROUP ANALYSIS OF THE AFFIRM-AHF TRIAL

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Iain Macdougall ◽  
Ewa A Jankowska ◽  
Marco Metra ◽  
Gerasimos Filippatos ◽  
Bridget-Anne Kirwan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Placebo Group ◽  
Iron Deficiency ◽  
Medical History ◽  
Rate Ratio ◽  
Primary Outcome ◽  
Ferric Carboxymaltose ◽  
History Of ◽  
Secondary Outcomes ◽  
Post Randomisation

Abstract Background and Aims In the AFFIRM-AHF trial, treatment with intravenous (IV) ferric carboxymaltose (FCM) reduced the risk of heart failure (HF) hospitalisations vs placebo in patients with iron deficiency after an episode of acute HF. Of these patients, 41% had a medical history of chronic kidney disease (CKD). This prespecified subanalysis of AFFIRM-AHF data was performed to investigate the effect of renal function on FCM efficacy. Methods In AFFIRM-AHF, patients stabilised following hospitalisation for acute HF with concomitant iron deficiency (defined as ferritin <100 μg/L, or 100–299 μg/L with transferrin saturation <20%) were randomised to receive either IV FCM or placebo before discharge for the index hospitalisation. In this analysis, patients who had received at least one dose of the study drug, and who had at least one post-randomisation data point and a baseline value for estimated glomerular filtration rate (eGFR; calculated using the CKD-EPI formula and baseline creatinine value), were stratified into tertiles according to baseline eGFR. The primary outcome was a composite of total HF hospitalisations and CV death. Secondary outcomes included total HF hospitalisations, CV death, time to first HF hospitalisation or CV death, composite of total CV hospitalisations and CV death, and days lost due to HF hospitalisations or CV death. All outcomes were evaluated up to 52 weeks post-randomisation. Results Of the 1,108 patients included in primary AFFIRM-AHF analyses, 967 (FCM: 487; placebo: 480) had a baseline eGFR value and were included in this analysis. In both groups, 60% of patients had an eGFR <60 mL/min/1.73 m2 following the index acute HF episode. Patients were divided into eGFR tertiles 1, 2 and 3, with corresponding respective baseline eGFR values of <42.96, 42.96 to <64.32, and ≥64.32 mL/min/1.73 m2. At baseline, the mean age, proportion of females, and proportions of patients with ischaemic HF aetiology, a documented history of HF, and a medical history of percutaneous coronary intervention, coronary artery bypass graft and/or cardiac resynchronisation therapy, were highest in eGFR tertile 1 and lowest in eGFR tertile 3. In eGFR tertiles 1, 2 and 3, the number of total HF hospitalisations and CV deaths in the FCM group vs placebo group were, respectively, 115 vs 152, 76 vs 83, and 56 vs 79, with respective annualised rate ratios (95% confidence interval [CI]) of 0.76 (0.50, 1.16), 0.76 (0.48, 1.22) and 0.69 (0.42, 1.12) (Figure). In eGFR tertile 3, the total number of CV hospitalisations and CV deaths was significantly lower in the FCM group vs the placebo group (69 vs 107; rate ratio [95% CI] 0.60 [0.39, 0.93]), with a nominally lower number of total HF hospitalisations with FCM vs placebo (44 vs 66; rate ratio [95% CI] 0.62 [0.38, 1.01]). In the time to first event analysis, FCM significantly reduced HF hospitalisation or CV death vs placebo in eGFR tertile 3 (hazard ratio [95% CI] 0.64 [0.42, 0.98]). In eGFR tertiles 1 and 2, differences between FCM and placebo arms for secondary endpoints did not reach statistical significance. The p-trend for treatment by baseline eGFR subgroup was non-significant for the primary outcome (0.941) and also for the secondary outcomes specified here. Conclusion In patients with iron deficiency who were stabilised after an episode of acute HF, numerically fewer primary and secondary events, endpoints or outcomes were consistently observed with FCM vs placebo across the eGFR tertiles. In addition, no significant interaction between kidney function and FCM efficacy was noted. Given that this analysis was limited by small patient numbers following subgroup stratification, further studies in larger cohorts with CKD may help to clarify the effect of IV FCM in this patient population.

Iron deficiency and safety of ferric carboxymaltose in patients with acute heart failure. AHF‐ID study

2020 ◽  
Vol 74 (10) ◽  
Author(s):  
Javier Jacob ◽  
Òscar Miró ◽  
Carles Ferre ◽  
Carmen Borraz‐Ordás ◽  
Guillermo Llopis‐García ◽  
...  
Keyword(s):  
Heart Failure ◽  
Iron Deficiency ◽  
Acute Heart Failure ◽  
Ferric Carboxymaltose

scholarly journals IV Sodium Ferric Gluconate Complex in Patients Hospitalized Due to Acute Decompensated Heart Failure and Iron Deficiency

2022 ◽  
Vol 27 ◽  
pp. 107424842110556
Author(s):  
Itay Borreda ◽  
Robert Zukermann ◽  
Danny Epstein ◽  
Erez Marcusohn
Keyword(s):  
Heart Failure ◽  
Iron Deficiency ◽  
Ejection Fraction ◽  
Acute Decompensated Heart Failure ◽  
High Risk Patient ◽  
Decompensated Heart Failure ◽  
Ferric Carboxymaltose ◽  
Reduced Ejection Fraction ◽  
Standard Medical Therapy ◽  
History Of

Background: Patients suffering from heart failure (HF) and iron deficiency (ID) have worse outcomes. Treatment with intra-venous (IV) ferric carboxymaltose has been shown to reduce HF rehospitalizations and to improve functional capacity and symptoms in patients with HF and reduced ejection fraction (HFrEF). However, IV ferric carboxymaltose is significantly more expensive than IV sodium ferric gluconate complex (SFGC) limiting its availability to most HF patients around the globe. Methods: A retrospective analysis comparing patients admitted to internal medicine or cardiology departments between January 2013 to December 2018 due to acute decompensated HF (ADHF) and treated with or without IV SFGC on top of standard medical therapy. Results: During the study period, a total of 1863 patients were hospitalized due to ADHF with either HFrEF or HF with preserved ejection fraction (HFpEF). Among them, 840 patients had laboratory evidence of iron deficiency (absolute or functional) and met the inclusion criteria. One hundred twenty-two of them (14.5%) were treated with IV SFGC during the index hospitalization. Patients treated with IV iron were more likely to have history of ischemic heart disease, atrial fibrillation, and chronic kidney disease. The rate of readmissions due to ADHF was similar between the groups at 30 days, 3 months, and 1 year. Conclusion: High risk patient hospitalized to ADHF and treated with IV SFGC showed comparable ADHF readmission rates, compared to those who did not receive iron supplementation.

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

The Lancet ◽  
2020 ◽  
Vol 396 (10266) ◽  
pp. 1895-1904 ◽  
Author(s):  
Piotr Ponikowski ◽  
Bridget-Anne Kirwan ◽  
Stefan D Anker ◽  
Theresa McDonagh ◽  
Maria Dorobantu ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomised Controlled Trial ◽  
Iron Deficiency ◽  
Acute Heart Failure ◽  
Controlled Trial ◽  
Ferric Carboxymaltose ◽  
Double Blind ◽  
Randomised Controlled

Predictors Factors of Onset de Novo Heart failure after STEMI

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
S Abouradi ◽  
H Choukrani ◽  
A Maaroufi ◽  
A Drighil ◽  
R Habbal
Keyword(s):  
Heart Failure ◽  
De Novo ◽  
Microvascular Disease ◽  
Prior History ◽  
Killip Class ◽  
Funding Sources ◽  
Significant Difference ◽  
Primary Coronary Angioplasty ◽  
History Of ◽  
Predictor Factors

Abstract Funding Acknowledgements Type of funding sources: None. INTRODUCTION STEMI gets complicated very often by a heart failure (HF), which it is important to know associated factors. The aim of this study  was to determinate the predictor factors of onset of de novo HF after STEMI in patients with no prior history of heart failure recorded at baseline. METHODS A retrospective, descriptive study from 1 center in Morocco, including 210 patients hospitalized in a cardiology intensive care unit for STEMI from September 2019 to November 2020. The main outcomes were HF Killip class at hospital presentation and intra-hospital mortality. RESULTS The main age was 59.3 ± 7.02 and Sex ratio: 2, 86. The incidence of de novo HF at admission was higher in women (40, 4% vs. 29.5%, [OR 1, 61; 95%, [CI] 0, 83-3, 11). Forty-nine point eight percent were in Killip≥ 2. The method of early revascularization was Thrombolysis in 82, 3% compared to primary coronary angioplasty without significant difference in onset of the novo HF. There was no association of age, comorbidities, delay to hospital presentation and coronary involvement with incidence of onset of de novo HF.  Women had higher mortality than men with the novo HF (28, 6% vs. 20.5%; OR: 1, 55; 95%). CONCLUSION  Gender has appeared associated to onset of de novo HF after STEMI with a superiority of the female sex after controlling for others factors described in the literature. Anterior studies have related this to the increased prevalence of microvascular disease in women predisposing them to heart failure after STEMI.

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