Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial.

Spahn DR, Schoenrath F, Spahn GH, et al.
Lancet 2019;393:2201-2212.
NATA Rating :
Review by : B. Froessler
NATA Review

Preoperative anaemia detection and the timely management of deficiencies remain a serious challenge in many health care settings. In this pragmatic RCT by Spahn et al., the trial design attempted to overcome these hurdles, testing a potentially essential treatment approach at the last hour.

This single-centre, randomised, double-blind, parallel-group controlled study enrolled patients undergoing elective cardiac surgery with anaemia (Hb <12 g/dL in women and Hb <13 g/dL in men) or isolated iron deficiency (ferritin <100 µg/L and no anaemia). Participants were randomly assigned (1:1) to receive either placebo or a combination treatment consisting of a slow infusion of 20 mg/kg ferric carboxymaltose, 40 000 IU subcutaneous epoetin alpha, 1 mg subcutaneous vitamin B12 and 5 mg oral folic acid on the day before surgery. The primary outcome was the number of RBC transfusions during the first 7 days. The cocktail driving erythropoiesis was administered on the day prior to cardiac surgery or on Friday for participants to be operated on Monday. It is impossible to tease out which treatment component from the administered bundle led to the demonstrated changes. This combination treatment reduced RBC transfusions from 1 unit (IQR 0–3) to 0 unit (0–2; Mann-Whitney test p=0.036) during the first 7 days. Combination treatment also reduced RBC transfusions until postoperative day 90 (p=0.018) but led to an increased overall cost in the treatment group. No increased adverse events were seen in the treatment arm, but only larger studies can reliably underpin safety. In addition to already available evidence from smaller RCTs (Keeler et al., Froessler et al.), the results from large RCTs currently awaited (PREVENTT) or underway (ITACS) will allow additional judgement on the effect of IV iron treatment alone. This will shed more light on the question whether the more ‘heavy-handed’ approach from this study can be justified or should indeed be promoted. Cardiac, cancer and emergency surgery patients may require such a strategy as there is often little time to optimise existing or newly diagnosed deficiencies.

Regardless, this study from Donat Spahn’s group adds to the growing evidence that withholding treatment for anaemic or iron-deficient patients (often reflected in standard care) is not an option. Further subgroup analyses from this study will be awaited with interest.

– Bernd Froessler