The results of the AFFIRM-AHF trial demonstrated that addressing iron deficiency in patients with heart failure (HF) can decrease the risk of subsequent hospitalisations following an acute HF event. Although the study narrowly missed its primary endpoint, it did demonstrate that intravenous (IV) iron resulted in a significant 26% drop in HF hospitalisations .
Prof. Piotr Ponikowski (Wroclaw Medical University, Poland) presented the results of the AFFIRM-AHF trial (NCT02937454), which were simultaneously published in The Lancet . AFFIRM-AHF was a multicentre study in 1,132 patients hospitalised for acute HF. The average age was 71 years, 56% were male, and 41% had diabetes. Average LVEF was 33%. All participants had serum ferritin <100 ng/mL (or 100–299 ng/mL and a transferrin saturation <20%) and a left ventricular ejection fraction (LVEF) <50%. Before being discharged, patients randomly received the first IV treatment of either ferric carboxymaltose (n=567) or placebo (n=565). A second treatment was provided at week 6 to patients with persistent iron deficiency. Prof. Ponikowski said that 80% of patients had resolution of their iron deficiency with one or two treatments; the other patients received additional doses at weeks 12 and 24. Dosing regimen of ferric carboxymaltose (500–2,000 mg) was based on weight and haemoglobin level (average dose 1,350 mg). Follow-up was 52 weeks. The combined primary endpoint was total hospitalisations and CV death.
After 52 weeks, the combined primary endpoint occurred in 52.5% of the ferric carboxymaltose group compared with 67.6% of the placebo group (P=0.059). The difference failed to reach significance, although the total number of events was numerically lower in the experimental group (RR 0.79; 95% CI 0.62–1.01). The incidence of CV death was 13.8% in the ferric carboxymaltose group compared with 14.2% of the placebo group (P=0.89). The incidence of total HF hospitalisations was significantly lower in the treatment group: 48.9% versus 53.5%, respectively (P=0.013). Moreover, a time-to-first-event analysis revealed a significant reduction in the secondary endpoint of risk of first HF hospitalisation or CV death: HR 0.80 (95% CI 0.66–0.98). There were no apparent differences between adverse events in the different groups, and IV ferric carboxymaltose was well tolerated.
Prof. Ponikowski concluded by recommending ferric carboxymaltose for the prevention of recurrent HF hospitalisation in patients with iron deficiency, LVEF <50%, and who are stabilised after an episode of acute HF.
- Ponikowski P, et al. AFFIRM-AHF: IV Iron Supplementation Linked to Fewer Repeat Hospitalisations for HF. LBS.01, AHA Scientific Sessions 2020, 13–17 Nov.
- Ponikowski P, et al. Lancet. 2020;396(10266):1895–1904.
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