Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis: A Prespecified Secondary Analysis of the PIVOTAL Trial.
Aged
Arteriovenous Shunt, Surgical
/ adverse effects
Cardiovascular Diseases
/ epidemiology
Catheter-Related Infections
/ epidemiology
Cause of Death
Cross Infection
/ epidemiology
Dose-Response Relationship, Drug
Female
Hospitalization
Humans
Infections
/ epidemiology
Infusions, Intravenous
Iron
/ administration & dosage
Male
Middle Aged
Proportional Hazards Models
Renal Dialysis
/ adverse effects
Survival Analysis
chronic kidney disease
hemodialysis
infections
intravenous iron
randomized controlled trial
Journal
Journal of the American Society of Nephrology : JASN
ISSN: 1533-3450
Titre abrégé: J Am Soc Nephrol
Pays: United States
ID NLM: 9013836
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
26
09
2019
accepted:
19
02
2020
pubmed:
8
4
2020
medline:
29
12
2020
entrez:
8
4
2020
Statut:
ppublish
Résumé
Experimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance hemodialysis, might increase the risk of infections. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure. Comparison of infection rates between the two groups was a prespecified secondary analysis. Secondary end points included any infection, hospitalization for infection, and death from infection; we calculated cumulative event rates for these end points. We also interrogated the interaction between iron dose and vascular access (fistula versus catheter). We found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ. We did find a significant association between risk of a first cardiovascular event and any infection in the previous 30 days. Compared with patients undergoing dialysis with an arteriovenous fistula, those doing so The high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.
Sections du résumé
BACKGROUND
Experimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance hemodialysis, might increase the risk of infections. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure. Comparison of infection rates between the two groups was a prespecified secondary analysis.
METHODS
Secondary end points included any infection, hospitalization for infection, and death from infection; we calculated cumulative event rates for these end points. We also interrogated the interaction between iron dose and vascular access (fistula versus catheter).
RESULTS
We found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ. We did find a significant association between risk of a first cardiovascular event and any infection in the previous 30 days. Compared with patients undergoing dialysis with an arteriovenous fistula, those doing so
CONCLUSIONS
The high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.
Identifiants
pubmed: 32253271
pii: ASN.2019090972
doi: 10.1681/ASN.2019090972
pmc: PMC7217408
doi:
Substances chimiques
Iron
E1UOL152H7
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1118-1127Investigateurs
G Winnett
(G)
H Akbani
(H)
C Winearls
(C)
J Wessels
(J)
W Ayub
(W)
A Connor
(A)
A Brown
(A)
J Moriarty
(J)
P Chowdury
(P)
M Griffiths
(M)
I Dasgupta
(I)
S Bhandari
(S)
T Doulton
(T)
I Macdougall
(I)
J Barratt
(J)
E Vilar
(E)
S Mitra
(S)
B Ramakrishna
(B)
J Nicholas
(J)
C Ross
(C)
A Khwaja
(A)
M Hall
(M)
A Kirk
(A)
S Smith
(S)
M Jesky
(M)
C Day
(C)
B Alchi
(B)
J Stratton
(J)
H Clarke
(H)
S Walsh
(S)
R Brown
(R)
K McCafferty
(K)
L Solomon
(L)
S Ramadoss
(S)
B Ramakrishna
(B)
K Basanyake
(K)
S Lawman
(S)
P Kalra
(P)
G Balasubramaniam
(G)
A Power
(A)
D Banerjee
(D)
P Swift
(P)
M Wellberry-Smith
(M)
C Goldsmith
(C)
T Ledson
(T)
A Mikhail
(A)
R Benzimra
(R)
S Bell
(S)
A Severn
(A)
J Neary
(J)
A Doyle
(A)
P Thomson
(P)
G Shivashankar
(G)
S Bolton
(S)
M Quinn
(M)
P Maxwell
(P)
J Harty
(J)
I Ford
(I)
S Anker
(S)
K Farrington
(K)
J McMurray
(J)
C Tomson
(C)
D Wheeler
(D)
E Connolly
(E)
P Jhund
(P)
M MacDonald
(M)
P Mark
(P)
M Petrie
(M)
M Walters
(M)
A Jardine
(A)
J Peacock
(J)
C Isles
(C)
D Reddan
(D)
H Murray
(H)
K Wetherall
(K)
S Kean
(S)
C Kerr
(C)
S Boyle
(S)
R Wilson
(R)
J Aziz
(J)
E Dinnett
(E)
A Reid
(A)
C Burton
(C)
R Clarke
(R)
N Hillen
(N)
C White
(C)
C Reid
(C)
S Andani
(S)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2020 by the American Society of Nephrology.
Références
Kidney Int. 2016 Oct;90(4):897-904
pubmed: 27591084
Blood. 2011 Apr 28;117(17):4425-33
pubmed: 21346250
Am J Nephrol. 2018;48(4):260-268
pubmed: 30304714
Clin J Am Soc Nephrol. 2011 Jul;6(7):1708-13
pubmed: 21566109
BMJ. 2013 Aug 15;347:f4822
pubmed: 23950195
J Am Soc Nephrol. 2013 Feb;24(3):465-73
pubmed: 23431075
Clin Kidney J. 2016 Apr;9(2):260-7
pubmed: 26985378
Clin J Am Soc Nephrol. 2019 May 7;14(5):728-737
pubmed: 30988164
Nephrol Dial Transplant. 2013 Oct;28(10):2570-9
pubmed: 24078642
Eur Heart J. 2016 Jul 14;37(27):2129-2200
pubmed: 27206819
Kidney Int. 2003 Aug;64(2):728-36
pubmed: 12846772
J Am Soc Nephrol. 2013 Jun;24(7):1151-8
pubmed: 23787911
N Engl J Med. 2019 Jan 10;380(2):171-176
pubmed: 30625066
Kidney Int. 2016 Jan;89(1):28-39
pubmed: 26759045
N Engl J Med. 2019 Jan 31;380(5):447-458
pubmed: 30365356
Clin J Am Soc Nephrol. 2018 Mar 7;13(3):457-467
pubmed: 29463597
Nephrol Dial Transplant. 2015 Apr;30(4):667-75
pubmed: 25366328
J Am Heart Assoc. 2018 Nov 20;7(22):e009683
pubmed: 30571501