Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy
Haemodialysis patients enrolled in the PIVOTAL trial (n= 2,141).
INTERVENTION:Intravenous iron administered proactively in a high-dose regimen (n= 1,093).
COMPARISON:Low-dose regimen administered reactively (n= 1,048).
OUTCOME: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. 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. Most patients presented with pulmonary oedema and were mainly treated by mechanical removal of fluid. History of heart failure and diabetes were independent predictors of a heart failure event.
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 |
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MESH HEADINGS: | Administration, Intravenous; Adult; Heart Failure; Hospitalization; Humans; Iron; Renal Dialysis |
Study Design: | Randomised Controlled Trial |
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Language: | eng |
Credits: | Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine |