Added value of therapy with sucrosomial iron (SI) on top on ferricarboxymaltose (FCM) for the treatment of iron deficiency anemia (IDA) after cardiac surgery (CS): preliminary data

Abstract

Abstract Background The FCM is the gold standard for IDA therapy in heart failure. Moreover short-term treatment of IDA after CS using FMC or SI showed a significant similar improvement of key hematological parameters (HP) and in functional capacity (1). The aim of the present study was to evaluate whether the use of both therapies had an additional positive effect on the same parameters. Methods 26 consecutive IDA patients, (normal ventricular function, mean age 71,5 ± 8y), after the admission in Cardiac Rehabilitation were all treated with FCM (group A) and a part (group B , n 13) also with SI. The study design included a single dose of 1000 mg of FCM at T1 (at 8-10 days from CS) and after a dose of 60 mg of SI per day from T1 to T2 (the day of discharge 10 days after ) until T3 , 15 days after. Measures of efficacy included changes from baseline in HP, natriuretic peptides (NP), and the 6-minute-walking-test (6MWT). The choice of SI dose was based on a study (2) that demonstrated its effectiveness in reducing transfusion requirements in patients undergoing elective CS. Results The data are shown in the Table. The statistical analysis was conducted with the Mann Whitney test (non-parametric). At baseline there were no differences in Vit B12, folate and reticulocytes. Hb and other HP increased significantly, with no differences between the two groups. The increase in Transferrin Saturation (Tsat) was greater (but not significant) in group B with lower baseline level. The ferritin (F) level was much higher in group A; the delta is also significant. Therefore in group treated with FCM and SI the F remains stable, while in the other it doubles (+94%). No significant differences were observed in others parameters. Only the NP level was lower at T3 in group B; but the data does not appear to be clinically relevant, considering the different baseline values. Conclusions The high levels of F are a consequence of the inflammatory state following CS. On the other hand, it is known that FCM can induce a further increase in F may be due to a low-grade pro-inflammatory effect correlated to the high level of iron deposition in macrophages. The SI can mitigate this effect, with significant effectiveness already in a preliminary case study. Also relevant is the positive impact on TSAT with the possibility of reaching the guidelines-level more quickly. The increase in the number of cases will allow us to achieve more certain results.