Faculty of Medicine, University of Oslo, Oslo, Norway. Department of Cardiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway. KG Jebsen Center for Cardiac Research and Center for Heart Failure Research, University of Oslo, Oslo, Norway. Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.
AIMS: The aim of this trial was to evaluate whether intravenous iron could provide benefit beyond transcatheter aortic valve implantation (TAVI) in iron deficient patients with severe aortic stenosis. METHODS AND RESULTS In this randomised, placebo-controlled, double-blinded, single-centre trial, we enrolled patients with severe aortic stenosis and iron deficiency (defined as ferritin < 100 μg/L, or 100-299 μg/L with a transferrin saturation < 20 %) who were evaluated for TAVI. Patients were randomly assigned (1:1) to receive i.v. ferric derisomaltose or placebo approximately three months before TAVI. The primary endpoint was the between-group, baseline-adjusted six-minute walk distance measured three months after TAVI. Secondary outcomes included quality of life, iron stores, handgrip strength, NYHA class, and safety. Between January 2020 and September 2021, we randomised 74 patients to ferric derisomaltose and 75 patients to placebo. The modified intention-to-treat population comprised the 104 patients who completed the six-minute walk test at baseline and three months after successful TAVI. Iron stores were restored in 76 % of the patients allocated to iron and 13 % of the patients allocated to placebo (p < 0.001). There was no difference in the baseline-adjusted six-minute walk distance between the two treatment arms (p = 0.82). The number of serious adverse events, quality of life, handgrip strength, and NYHA class did not differ between the treatment arms. CONCLUSION Treatment with intravenous iron did not
provide clinical benefit beyond TAVI in iron deficient patients with severe aortic stenosis.