Abstract | OBJECTIVES: BACKGROUND: 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).
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Authors | 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, PIVOTAL Investigators and Committees |
Journal | JACC. Heart failure
(JACC Heart Fail)
Vol. 9
Issue 7
Pg. 518-527
(07 2021)
ISSN: 2213-1787 [Electronic] United States |
PMID | 34119470
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021. Published by Elsevier Inc. |
Chemical References |
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Topics |
- Administration, Intravenous
- Adult
- Heart Failure
- Hospitalization
- Humans
- Iron
- Renal Dialysis
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