PMID- 35579454
OWN - NLM
STAT- MEDLINE
DCOM- 20220725
LR  - 20221015
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Print)
IS  - 1388-9842 (Linking)
VI  - 24
IP  - 7
DP  - 2022 Jul
TI  - Intravenous iron supplement for iron deficiency in patients with severe aortic 
      stenosis scheduled for transcatheter aortic valve implantation: results of the 
      IIISAS randomised trial.
PG  - 1269-1279
LID - 10.1002/ejhf.2557 [doi]
AB  - 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-blind, single-centre trial, we enrolled 
      patients with severe aortic stenosis and iron deficiency (defined as ferritin 
      <100 microg/L, or 100-299 microg/L with a transferrin saturation <20%) who were evaluated 
      for TAVI. Patients were randomly assigned (1:1) to receive intravenous ferric 
      derisomaltose or placebo  approximately 3 months before TAVI. The primary endpoint was the 
      between-group, baseline-adjusted 6-min walk distance measured 3 months after 
      TAVI. Secondary outcomes included quality of life, iron stores, hand grip 
      strength, New York Heart Association (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 6-min walk test at baseline and 3 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 6-min walk distance between the two treatment 
      arms (p = 0.82). The number of serious adverse events, quality of life, hand grip 
      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. CLINICAL TRIAL REGISTRATION: 
      ClinicalTrials.gov NCT04206228.
CI  - (c) 2022 The Authors. European Journal of Heart Failure published by John Wiley & 
      Sons Ltd on behalf of European Society of Cardiology.
FAU - Kvaslerud, Anette B
AU  - Kvaslerud AB
AUID- ORCID: 0000-0001-9923-2685
AD  - Faculty of Medicine, University of Oslo, Oslo, Norway.
AD  - Department of Cardiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway.
AD  - KG Jebsen Center for Cardiac Research and Center for Heart Failure Research, 
      University of Oslo, Oslo, Norway.
FAU - Bardan, Sara
AU  - Bardan S
AD  - Faculty of Medicine, University of Oslo, Oslo, Norway.
FAU - Andresen, Kristoffer
AU  - Andresen K
AD  - Faculty of Medicine, University of Oslo, Oslo, Norway.
AD  - Department of Cardiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway.
FAU - Klove, Sophie F
AU  - Klove SF
AD  - Department of Cardiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway.
FAU - Fagerland, Morten W
AU  - Fagerland MW
AD  - Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo 
      University Hospital, Oslo, Norway.
FAU - Edvardsen, Thor
AU  - Edvardsen T
AD  - Faculty of Medicine, University of Oslo, Oslo, Norway.
AD  - Department of Cardiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway.
FAU - Gullestad, Lars
AU  - Gullestad L
AD  - Faculty of Medicine, University of Oslo, Oslo, Norway.
AD  - Department of Cardiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway.
AD  - KG Jebsen Center for Cardiac Research and Center for Heart Failure Research, 
      University of Oslo, Oslo, Norway.
FAU - Broch, Kaspar
AU  - Broch K
AD  - Faculty of Medicine, University of Oslo, Oslo, Norway.
AD  - Department of Cardiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway.
AD  - KG Jebsen Center for Cardiac Research and Center for Heart Failure Research, 
      University of Oslo, Oslo, Norway.
LA  - eng
SI  - ClinicalTrials.gov/NCT04206228
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220603
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
RN  - 0 (Disaccharides)
RN  - 0 (Ferric Compounds)
RN  - AHU547PI9H (ferric derisomaltose)
RN  - E1UOL152H7 (Iron)
SB  - IM
CIN - Eur J Heart Fail. 2022 Jul;24(7):1280-1281. PMID: 35726638
MH  - Aortic Valve/surgery
MH  - *Aortic Valve Stenosis/complications/surgery
MH  - Disaccharides
MH  - Ferric Compounds
MH  - Hand Strength
MH  - *Heart Failure/drug therapy
MH  - Humans
MH  - Iron/therapeutic use
MH  - *Iron Deficiencies
MH  - Quality of Life
MH  - *Transcatheter Aortic Valve Replacement
MH  - Treatment Outcome
PMC - PMC9544901
OTO - NOTNLM
OT  - Aortic stenosis
OT  - Iron deficiency
OT  - Randomized controlled trials
OT  - Safety
EDAT- 2022/05/18 06:00
MHDA- 2022/07/26 06:00
PMCR- 2022/10/07
CRDT- 2022/05/17 09:06
PHST- 2022/05/11 00:00 [revised]
PHST- 2022/05/02 00:00 [received]
PHST- 2022/05/14 00:00 [accepted]
PHST- 2022/05/18 06:00 [pubmed]
PHST- 2022/07/26 06:00 [medline]
PHST- 2022/05/17 09:06 [entrez]
PHST- 2022/10/07 00:00 [pmc-release]
AID - EJHF2557 [pii]
AID - 10.1002/ejhf.2557 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2022 Jul;24(7):1269-1279. doi: 10.1002/ejhf.2557. Epub 2022 Jun 
      3.