Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis: A Prespecified Secondary Analysis of the PIVOTAL Trial

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 u...

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Published inJournal of the American Society of Nephrology Vol. 31; no. 5; pp. 1118 - 1127
Main Authors Macdougall, Iain C., Bhandari, Sunil, White, Claire, Anker, Stefan D., Farrington, Kenneth, Kalra, Philip A., Mark, Patrick B., McMurray, John J. V., Reid, Chante, Robertson, Michele, Tomson, Charles R.V., Wheeler, David C., Winearls, Christopher G., Ford, Ian
Format Journal Article
LanguageEnglish
Published United States American Society of Nephrology 01.05.2020
Subjects
Aged
Arteriovenous Shunt, Surgical - adverse effects
Cardiovascular Diseases - epidemiology
Catheter-Related Infections - epidemiology
Catheter-Related Infections - etiology
Cause of Death
Clinical Research
Cross Infection - epidemiology
Dose-Response Relationship, Drug
Female
Hospitalization
Humans
Infections - epidemiology
Infections - etiology
Infusions, Intravenous
Iron - administration & dosage
Iron - therapeutic use
Male
Middle Aged
Proportional Hazards Models
Renal Dialysis - adverse effects
Renal Dialysis - instrumentation
Survival Analysis
intravenous iron
hemodialysis
infections
chronic kidney disease
randomized controlled trial
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Abstract 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 a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes. 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.
AbstractList 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.BACKGROUNDExperimental 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).METHODSSecondary 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 via a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes.RESULTSWe 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 via a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes.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.CONCLUSIONSThe high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.
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 a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes. 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.
Experimental and observational data have raised concerns that intravenous (IV) iron might increase the risk of infections. In this analysis from the Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial involving 2141 patients on hemodialysis randomly assigned to receive either a high-dose or low-dose IV iron regimen, investigators reported finding no evidence that the two groups differed in incidence of infection, hospitalization for infection, or death from infection. Given the potential cardiovascular benefits of higher-dose IV iron seen in the PIVOTAL trial (due to either a direct effect of the IV iron or a decreased use of erythropoiesis-stimulating agents and thus, less exposure to associated cardiotoxic effects), this analysis provides reassurance for administering higher doses of IV iron than are currently given in many units worldwide.
Author Mark, Patrick B.
Winearls, Christopher G.
Macdougall, Iain C.
Bhandari, Sunil
Anker, Stefan D.
McMurray, John J. V.
Robertson, Michele
Kalra, Philip A.
Reid, Chante
White, Claire
Farrington, Kenneth
Ford, Ian
Wheeler, David C.
Tomson, Charles R.V.
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  organization: Hull University Teaching Hospitals NHS Trust and Hull York Medical School, Hull, United Kingdom
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  organization: Department of Renal Medicine, King's College Hospital, London, United Kingdom
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  givenname: Stefan D.
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  organization: Division of Cardiology and Metabolism, Department of Cardiology, Charité Universitätsmedizin Berlin, Berlin, Germany, Berlin-Brandenburg Center for Regenerative Therapies, Charité Universitätsmedizin Berlin, Berlin, Germany, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany
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  organization: Lister Hospital, Stevenage, United Kingdom, University of Hertfordshire, Hertfordshire, United Kingdom
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  organization: Salford Royal Hospital, Salford, United Kingdom
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  organization: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom
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  organization: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom
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  organization: Department of Renal Medicine, King's College Hospital, London, United Kingdom
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  organization: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom
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  surname: Tomson
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  organization: Freeman Hospital, Newcastle upon Tyne, United Kingdom
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  organization: University College London, London, United Kingdom, George Institute for Global Health, Sydney, New South Wales, Australia
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/32253271$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Contributor Ross, C
Bell, S
Tomson, C
Murray, H
Shivashankar, G
Hall, M
Winearls, C
Wilson, R
Isles, C
Kean, S
McCafferty, K
Swift, P
Reddan, D
Alchi, B
Kerr, C
Mitra, S
Solomon, L
Hillen, N
Macdougall, I
Khwaja, A
Ledson, T
Wellberry-Smith, M
Maxwell, P
Bhandari, S
Kirk, A
Bolton, S
Kalra, P
Mikhail, A
Walters, M
Andani, S
Jardine, A
Akbani, H
Brown, R
Clarke, R
Ramadoss, S
Clarke, H
Connolly, E
Connor, A
Petrie, M
Dinnett, E
Ford, I
Brown, A
Peacock, J
Day, C
Banerjee, D
Vilar, E
Nicholas, J
Power, A
Wetherall, K
Reid, A
Moriarty, J
Balasubramaniam, G
Ayub, W
Smith, S
Benzimra, R
MacDonald, M
Wheeler, D
Doulton, T
Thomson, P
Anker, S
Griffiths, M
Ramakrishna, B
Boyle, S
Winnett, G
Severn, A
Aziz, J
Chowdury, P
White, C
Stratton, J
Harty, J
McMurray, J
Dasgupta, I
Jhund, P
Farrington, K
Burton, C
Reid, C
Neary, J
Wessels, J
Quinn, M
Mark, P
Barratt, J
Lawman, S
Jesky, M
Basanyake, K
Doyle, A
Walsh, S
Goldsmith, C
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Keywords intravenous iron
hemodialysis
infections
chronic kidney disease
randomized controlled trial
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Snippet Experimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance...
Experimental and observational data have raised concerns that intravenous (IV) iron might increase the risk of infections. In this analysis from the Proactive...
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SubjectTerms Aged
Arteriovenous Shunt, Surgical - adverse effects
Cardiovascular Diseases - epidemiology
Catheter-Related Infections - epidemiology
Catheter-Related Infections - etiology
Cause of Death
Clinical Research
Cross Infection - epidemiology
Dose-Response Relationship, Drug
Female
Hospitalization
Humans
Infections - epidemiology
Infections - etiology
Infusions, Intravenous
Iron - administration & dosage
Iron - therapeutic use
Male
Middle Aged
Proportional Hazards Models
Renal Dialysis - adverse effects
Renal Dialysis - instrumentation
Survival Analysis
Title Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis: A Prespecified Secondary Analysis of the PIVOTAL Trial
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Volume 31
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