In patients with preoperative anemia and isolated iron deficiency, a combination treatment comprised of intravenous iron, subcutaneous erythropoietin alpha, vitamin B12, and oral folic acid is associated with reduced red blood cell and total allogeneic blood product transfusions when administered prior to elective cardiac surgery, according to a study published in the Lancet.
The study enrolled patients with anemia (n=253) and isolated iron deficiency (n=252) who were scheduled to undergo elective cardiac surgery at the University Hospital of Zürich in Switzerland (ClinicalTrials.gov identifier: NCT02031289). Patients with anemia had a hemoglobin concentration of <120 g/L in women and <130 g/L in men, and those with isolated iron deficiency had a ferritin level of <100 mcg/L.
Investigators randomly assigned (1:1) patients to either placebo (n=241) or a combination regimen comprised of a slow intravenous infusion of 20 mg/kg ferric carboxymaltose, 40,000 U subcutaneous erythropoietin alpha, 1 mg subcutaneous vitamin B12, and 5 mg oral folic acid or placebo (n=243) on the day prior to intervention. The primary outcome included the number of red blood cell transfusions during the first 7 days of treatment.
Treatment with the combination regimen was associated with a significant reduction in red blood cell transfusions (median, 1 unit in placebo group vs 0 units in treatment group; odds ratio, 0.70; 95% CI, 0.50-0.98] for each threshold of number of red blood cell transfusions; P =.036). The combination group also experienced a significant reduction in red blood cell transfusions until postoperative day 90 (P =.018).
Relative to the placebo group, patients in the treatment group had higher hemoglobin levels, higher reticulocyte counts, and a higher reticulocyte hemoglobin content during the first 7 days (P ≤.001). The treatment group also had fewer combined allogeneic transfusions compared with the placebo group during the first 7 days (0 vs 1, respectively; P =.038) and until 90 days after surgery (P =.019).
Limitations of the study were the inclusion of patients from a single center as well as the small sample size.
“Finally, by study design a combination treatment was given and therefore it was not possible to assess the individual contribution of each of the four drugs administered,” the researchers added. “Future studies might be needed to answer this question.”
Disclosure: The study was in part funded by a grant from Vifor Pharma. Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Spahn DR, Schoenrath F, Spahn GH, et al. Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial [published online April 26, 2019]. Lancet. doi:10.1016/S0140-6736(18)32555-8