Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy

PIVOTAL investigators and committees; Pardeep S Jhund; Mark C Petrie; Michele Robertson; Patrick B Mark; Michael R MacDonald; Eugene Connolly; Stefan D Anker; Sunil Bhandari; Kenneth Farrington; Philip A Kalra; David C Wheeler; Charles R V Tomson; Ian Ford; John J V McMurray; Iain C Macdougall

doi:10.1016/j.jchf.2021.04.005

Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy

PIVOTAL investigators and committees, Pardeep S Jhund, Mark C Petrie, Michele Robertson, Patrick B Mark, Michael R MacDonald, Eugene Connolly, Stefan D Anker, Sunil Bhandari, Kenneth Farrington, Philip A Kalra, David C Wheeler, Charles R V Tomson, Ian Ford, John J V McMurray, Iain C Macdougall

School of Life and Medical Sciences

Research output: Contribution to journal › Article › peer-review

Abstract

Objectives: This study sought to examine the effect of intravenous iron on heart failure events in hemodialysis patients.

Background: Heart failure is a common and deadly complication in patients receiving hemodialysis and is difficult to diagnose and treat.

Methods: The study analyzed heart failure events in the PIVOTAL (Proactive IV Iron Therapy in Hemodialysis Patients) trial, which compared intravenous iron administered proactively in a high-dose regimen with a low-dose regimen administered reactively. Heart failure hospitalization was an adjudicated outcome, a component of the primary composite outcome, and a prespecified secondary endpoint in the trial.

Results: Overall, 2,141 participants were followed for a median of 2.1 years. A first fatal or nonfatal heart failure event occurred in 51 (4.7%) of 1,093 patients in the high-dose iron group and in 70 (6.7%) of 1,048 patients in the low-dose group (HR: 0.66; 95% CI: 0.46–0.94; P = 0.023). There was a total of 63 heart failure events (including first and recurrent events) in the high-dose iron group and 98 in the low-dose group, giving a rate ratio of 0.59 (95% CI: 0.40–0.87; P = 0.0084). Most patients presented with pulmonary edema and were mainly treated by mechanical removal of fluid. History of heart failure and diabetes were independent predictors of a heart failure event.

Conclusions: Compared with a lower-dose regimen, high-dose intravenous iron decreased the occurrence of first and recurrent heart failure events in patients undergoing hemodialysis, with large relative and absolute risk reductions. (UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients; 2013-002267-25).

Original language	English
Pages (from-to)	518-527
Number of pages	10
Journal	JACC: Heart Failure
Volume	9
Issue number	7
Early online date	9 Jun 2021
DOIs	https://doi.org/10.1016/j.jchf.2021.04.005
Publication status	Published - 1 Jul 2021

Keywords

anemia
dialysis
heart failure
iron
kidney disease

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PIVOTAL investigators and committees, Jhund, P. S., Petrie, M. C., Robertson, M., Mark, P. B., MacDonald, M. R., Connolly, E., Anker, S. D., Bhandari, S., Farrington, K., Kalra, P. A., Wheeler, D. C., Tomson, C. R. V., Ford, I., McMurray, J. J. V., & Macdougall, I. C. (2021). Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy. JACC: Heart Failure, 9(7), 518-527. https://doi.org/10.1016/j.jchf.2021.04.005

@article{26ee9efb7df74b79b792035776183cef,

title = "Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy",

abstract = "Objectives: This study sought to examine the effect of intravenous iron on heart failure events in hemodialysis patients. Background: Heart failure is a common and deadly complication in patients receiving hemodialysis and is difficult to diagnose and treat. Methods: The study analyzed heart failure events in the PIVOTAL (Proactive IV Iron Therapy in Hemodialysis Patients) trial, which compared intravenous iron administered proactively in a high-dose regimen with a low-dose regimen administered reactively. Heart failure hospitalization was an adjudicated outcome, a component of the primary composite outcome, and a prespecified secondary endpoint in the trial. Results: Overall, 2,141 participants were followed for a median of 2.1 years. A first fatal or nonfatal heart failure event occurred in 51 (4.7%) of 1,093 patients in the high-dose iron group and in 70 (6.7%) of 1,048 patients in the low-dose group (HR: 0.66; 95% CI: 0.46–0.94; P = 0.023). There was a total of 63 heart failure events (including first and recurrent events) in the high-dose iron group and 98 in the low-dose group, giving a rate ratio of 0.59 (95% CI: 0.40–0.87; P = 0.0084). Most patients presented with pulmonary edema and were mainly treated by mechanical removal of fluid. History of heart failure and diabetes were independent predictors of a heart failure event. Conclusions: Compared with a lower-dose regimen, high-dose intravenous iron decreased the occurrence of first and recurrent heart failure events in patients undergoing hemodialysis, with large relative and absolute risk reductions. (UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients; 2013-002267-25).",

keywords = "anemia, dialysis, heart failure, iron, kidney disease",

author = "{PIVOTAL investigators and committees} and Jhund, {Pardeep S} and Petrie, {Mark C} and Michele Robertson and Mark, {Patrick B} and MacDonald, {Michael R} and Eugene Connolly and Anker, {Stefan D} and Sunil Bhandari and Kenneth Farrington and Kalra, {Philip A} and Wheeler, {David C} and Tomson, {Charles R V} and Ian Ford and McMurray, {John J V} and Macdougall, {Iain C}",

note = "{\textcopyright} 2021 Published by Elsevier on behalf of the American College of Cardiology Foundation. ",

year = "2021",

month = jul,

day = "1",

doi = "10.1016/j.jchf.2021.04.005",

language = "English",

volume = "9",

pages = "518--527",

journal = "JACC: Heart Failure",

issn = "2213-1779",

publisher = "Elsevier",

number = "7",

}

PIVOTAL investigators and committees, Jhund, PS, Petrie, MC, Robertson, M, Mark, PB, MacDonald, MR, Connolly, E, Anker, SD, Bhandari, S, Farrington, K, Kalra, PA, Wheeler, DC, Tomson, CRV, Ford, I, McMurray, JJV & Macdougall, IC 2021, 'Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy', JACC: Heart Failure, vol. 9, no. 7, pp. 518-527. https://doi.org/10.1016/j.jchf.2021.04.005

TY - JOUR

T1 - Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy

AU - PIVOTAL investigators and committees

AU - Jhund, Pardeep S

AU - Petrie, Mark C

AU - Robertson, Michele

AU - Mark, Patrick B

AU - MacDonald, Michael R

AU - Connolly, Eugene

AU - Anker, Stefan D

AU - Bhandari, Sunil

AU - Farrington, Kenneth

AU - Kalra, Philip A

AU - Wheeler, David C

AU - Tomson, Charles R V

AU - Ford, Ian

AU - McMurray, John J V

AU - Macdougall, Iain C

PY - 2021/7/1

Y1 - 2021/7/1

N2 - Objectives: This study sought to examine the effect of intravenous iron on heart failure events in hemodialysis patients. Background: Heart failure is a common and deadly complication in patients receiving hemodialysis and is difficult to diagnose and treat. Methods: The study analyzed heart failure events in the PIVOTAL (Proactive IV Iron Therapy in Hemodialysis Patients) trial, which compared intravenous iron administered proactively in a high-dose regimen with a low-dose regimen administered reactively. Heart failure hospitalization was an adjudicated outcome, a component of the primary composite outcome, and a prespecified secondary endpoint in the trial. Results: Overall, 2,141 participants were followed for a median of 2.1 years. A first fatal or nonfatal heart failure event occurred in 51 (4.7%) of 1,093 patients in the high-dose iron group and in 70 (6.7%) of 1,048 patients in the low-dose group (HR: 0.66; 95% CI: 0.46–0.94; P = 0.023). There was a total of 63 heart failure events (including first and recurrent events) in the high-dose iron group and 98 in the low-dose group, giving a rate ratio of 0.59 (95% CI: 0.40–0.87; P = 0.0084). Most patients presented with pulmonary edema and were mainly treated by mechanical removal of fluid. History of heart failure and diabetes were independent predictors of a heart failure event. Conclusions: Compared with a lower-dose regimen, high-dose intravenous iron decreased the occurrence of first and recurrent heart failure events in patients undergoing hemodialysis, with large relative and absolute risk reductions. (UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients; 2013-002267-25).

AB - Objectives: This study sought to examine the effect of intravenous iron on heart failure events in hemodialysis patients. Background: Heart failure is a common and deadly complication in patients receiving hemodialysis and is difficult to diagnose and treat. Methods: The study analyzed heart failure events in the PIVOTAL (Proactive IV Iron Therapy in Hemodialysis Patients) trial, which compared intravenous iron administered proactively in a high-dose regimen with a low-dose regimen administered reactively. Heart failure hospitalization was an adjudicated outcome, a component of the primary composite outcome, and a prespecified secondary endpoint in the trial. Results: Overall, 2,141 participants were followed for a median of 2.1 years. A first fatal or nonfatal heart failure event occurred in 51 (4.7%) of 1,093 patients in the high-dose iron group and in 70 (6.7%) of 1,048 patients in the low-dose group (HR: 0.66; 95% CI: 0.46–0.94; P = 0.023). There was a total of 63 heart failure events (including first and recurrent events) in the high-dose iron group and 98 in the low-dose group, giving a rate ratio of 0.59 (95% CI: 0.40–0.87; P = 0.0084). Most patients presented with pulmonary edema and were mainly treated by mechanical removal of fluid. History of heart failure and diabetes were independent predictors of a heart failure event. Conclusions: Compared with a lower-dose regimen, high-dose intravenous iron decreased the occurrence of first and recurrent heart failure events in patients undergoing hemodialysis, with large relative and absolute risk reductions. (UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients; 2013-002267-25).

KW - anemia

KW - dialysis

KW - heart failure

KW - iron

KW - kidney disease

UR - http://www.scopus.com/inward/record.url?scp=85108359264&partnerID=8YFLogxK

U2 - 10.1016/j.jchf.2021.04.005

DO - 10.1016/j.jchf.2021.04.005

M3 - Article

C2 - 34119470

SN - 2213-1779

VL - 9

SP - 518

EP - 527

JO - JACC: Heart Failure

JF - JACC: Heart Failure

IS - 7

ER -

Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy

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Keywords

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