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IV Ferric Carboxymaltose and QoL in Iron-Deficient Acute HF
Quick Take
- In iron-deficient HFrEF patients, who had stabilized after an episode of acute HF, treatment with IV ferric carboxymaltose, compared with placebo, results in clinically meaningful beneficial effects on quality of life.
Study Questions:
What is the effect of intravenous (IV) ferric carboxymaltose (FCM), compared with placebo, administered just prior to discharge in patients with acute heart failure (HF) and iron deficiency, on health-related quality of life (HRQoL), as determined by the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), overall summary score (OSS), and clinical summary score (CSS) up to 52 weeks after randomization?
Methods:
The study cohort was comprised of patients enrolled in the AFFIRM-AHF study (a randomized, double-blind, placebo-controlled trial comparing the effect of IV FCM on hospitalizations and mortality in iron-deficient patients admitted for acute HF). Baseline KCCQ-12 was administered just prior to randomization during the index hospitalization. During follow-up, the KCCQ-12 was completed by patients at weeks 2, 4, 6, 12, 24, 36, and 52. For each visit as described, the KCCQ OSS and KCCQ CSS were calculated. The actual values and change from baseline in these two summary scores were descriptively summarized at each visit. The treatment difference in KCCQ-12 scores (one model for each summary score) at weeks 2, 4, 6, 12, 24, 36, and 52 were analyzed by comparing the model-adjusted means of the respective visits based on a repeated-measures model adjusted for corresponding baseline KCCQ-12 value, gender, age at randomization (<70 years/≥70 years). Responder analyses were performed, examining the proportion of patients with a deterioration or an improvement in KCCQ-12 during subsequent study visits.
Results:
Among the 1,108 patients included in the modified intention-to-treat AFFIRM-AHF analysis, a baseline KCCQ-12 was completed for 1,058 (95%) patients (535 and 523 in the FCM and placebo groups, respectively). Overall, the KCCQ-12 completion rate decreased from 96% at week 2 to 73% at week 52. The baseline KCCQ-12 OSS mean ± standard error was 38.7 ± 0.9 (FCM group) and 37.1 ± 0.8 (placebo group); corresponding values for the CSS were 40.9 ± 0.9 and 40.1 ± 0.9. At week 2, changes in OSS and CSS were similar for FCM and placebo. From weeks 4–24, patients assigned to FCM had significantly greater improvements in OSS and CSS scores versus placebo (adjusted mean difference [95% confidence interval (CI)] at week 4: 2.9 [0.5–5.3, p = 0.018] for OSS and 2.8 [0.3–5.3, p = 0.029] for CSS; adjusted mean difference [95% CI] at week 24: 3.0 [0.3–5.6, p = 0.028] for OSS and 2.9 [0.2–5.6, p = 0.035] for CSS). At week 52, the treatment effect had attenuated but remained in favor of FCM.
Conclusions:
The study authors concluded that in iron-deficient patients with HF and left ventricular ejection fraction (EF) <50% who had stabilized after an episode of acute HF, treatment with IV FCM, compared with placebo, results in clinically meaningful beneficial effects on HRQoL as early as 4 weeks after treatment initiation, lasting up to week 24.
Perspective:
While we clinicians focus on guideline-directed medical therapy in HF with reduced EF (HFrEF) patients, improving symptoms, function, and QoL are also important targets of therapy. This study suggests that replacing iron in patients who are iron deficient has important effects, particularly on their QoL. This trial underscores, in HFrEF patients with iron deficiency, the importance of replenishing with IV iron.
Clinical Topics: Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure
Keywords: Anemia, Iron-Deficiency, Cardiomyopathies, Ferric Compounds, Geriatrics, Heart Failure, Iron, Maltose, Metabolic Syndrome, Patient Discharge, Quality of Life, Secondary Prevention, Stroke Volume, Ventricular Function, Left
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