Effects of FCM on recurrent HF hospitalizations: an individual participant data meta-analysis

Presented at the ESC congress 2023 by: Piotr Ponikowski, MD, PhD - Wroclaw, Poland

Introduction and methods

Beneficial effects of intravenous ferric carboxymaltose (FCM) on exercise capacity and quality of life have been shown in HF patients with iron deficiency. However, there is still uncertainty as to whether this treatment also reduces their risk of clinical events.

In this meta-analysis, individual-participant data were pooled from 3 placebo-controlled RCTs with long-term follow- up (≥12 months) investigating the efficacy of intravenous FCM versus placebo in a total of 4475 patients with HF (HFrEF or HFmrEF) and iron deficiency: the CONFIRM-HF, AFFIRM-AHF, and HEART-FID trials.

The 2 prespecified primary efficacy endpoints were: (1) composite outcome of total CV hospitalizations or CV death at 52 weeks; and (2) composite outcome of total HF hospitalizations or CV death at 52 weeks. In addition, there were 9 key secondary efficacy endpoints, including the individual components of the composite endpoints. Safety was also assessed.

Main results

• The incidence of the coprimary composite endpoint of total CV hospitalizations or CV death was lower in patients treated with FCM compared with those treated with placebo (27.6% vs. 30.5%; rate ratio (RR): 0.86; 95%CI: 0.75–0.98; P=0.029).
• There was no statistically significant difference in the incidence of the other coprimary composite endpoint of total HF hospitalizations or CV death (22.5% vs. 25.2%; RR: 0.87; 95%CI: 0.75–1.01; P=0.076).
• FCM reduced the risks of total CV hospitalizations (852 vs. 1015 events; RR: 0.83; 95%CI: 0.73–0.96; P=0.009), total HF hospitalizations (604 vs. 734 events; RR: 0.84; 95%CI: 0.71–0.98; P=0.025), and total all-cause hospitalizations (997 vs. 1138 events; RR: 0.87; 95%CI: 0.76–0.99; P=0.029) compared with placebo.
• However, FCM did not have a beneficial effect on mortality.
• Subgroup analyses showed the beneficial effect of FCM on the coprimary composite endpoint of total CV hospitalizations or CV death was greater in patients in the lowest transferrin saturation (TSAT) tertile at baseline (<15%) compared with those with a higher baseline TSAT (P for interaction=0.019).

Conclusion

In this largest pooled analysis of FCM trials to date, intravenous FCM reduced the risk of the coprimary composite endpoint of total CV hospitalizations or CV death by 14% in patients with HFrEF/HFmrEF and iron deficiency. However, there was no significant effect of FCM on the other coprimary composite endpoint of total HF hospitalizations or CV death, nor on mortality alone.

• Our reporting is based on the information provided at the ESC Congress -

Watch a video on this meta-analysis by Piotr Ponikowski