Secondary analysis
Association Between Hemoglobin Levels and Efficacy of Intravenous Ferric Carboxymaltose in Patients With Acute Heart Failure and Iron Deficiency: An AFFIRM-AHF Subgroup Analysis
- Secondary analysis of the AFFIRM-AHF randomised trial
- prespecified subgroup analysis
- multicentre
- double-blind
- placebo-controlled
Authors' conclusion
The effects of intravenous FCM on outcomes in iron-deficient patients stabilized after an AHF episode, including improvements in iron parameters over time, did not differ between patients with hemoglobin levels <12 and ≥12 g/dL.
Study context
- Population
- Iron-deficient patients hospitalised for acute heart failure (HF), stabilised after the episodeof 1108 AFFIRM-AHF patients
- Participants
- 1,107 patients
- Comparison
- Ferric carboxymaltose (FCM) vs placebo, by baseline hemoglobin
- Primary endpoint
- Primary composite of:
- Total hHF and CV death
- By baseline hemoglobin subgroup (<12 vs ≥12 g/dL)
- Follow-up
- Week 52
Primary result
As reported in the abstract
Primary composite (total hHF and CV death), annualized event rates per 100 patient-years
FCM
71.1 per 100 patient-years
Hemoglobin <12 g/dL · Hemoglobin ≥12 g/dL 48.5 per 100 patient-years
Placebo
73.6 per 100 patient-years
Hemoglobin <12 g/dL · Hemoglobin ≥12 g/dL 72.9 per 100 patient-years
FCM vs PlaceboEstimate (95% CI)
hemoglobin <12 g/dL
rate ratio 0.97(0.66–1.41)
hemoglobin ≥12 g/dL
RR 0.67(0.48–0.93)
Secondary outcomes
Secondary outcomes, by hemoglobin subgroup
- No significant interactions between hemoglobin subgroup and treatment effect
Change in hemoglobin, serum ferritin and transferrin saturation · weeks 6 to 52
- Significantly greater with FCM vs placebo in both subgroups
Sensitivity analysis with WHO anemia definition
- Findings similar
Original publication
Association Between Hemoglobin Levels and Efficacy of Intravenous Ferric Carboxymaltose in Patients With Acute Heart Failure and Iron Deficiency: An AFFIRM-AHF Subgroup Analysis. Circulation. Published 13 April 2023. doi:10.1161/circulationaha.122.060757
Summarised from the published abstract; every number is checked against it