Stroke in hemodialysis patients randomized to different intravenous iron strategies: a prespecified analysis from the PIVOTAL trial

Mark, P. B. et al. (2021) Stroke in hemodialysis patients randomized to different intravenous iron strategies: a prespecified analysis from the PIVOTAL trial. Kidney360, (doi: 10.34067/KID.0004272021) (Early Online Publication)

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Publisher's URL: https://doi.org/10.34067/KID.0004272021

Abstract

Background: People with kidney failure treated with hemodialysis (HD) are at increased risk of stroke compared to similarly aged people with normal kidney function. One concern is that treatment of renal anemia might increase stroke risk. We studied risk factors for stroke in a prespecified secondary analysis of a randomized controlled trial of intravenous iron treatment strategies in HD. Methods: We analyzed data from the Proactive IV IrOn Therapy in HaemodiALysis Patients (PIVOTAL) trial focusing on variables associated with risk of stroke. The trial randomized 2,141 adults, who had started hemodialysis <12 months earlier and who were receiving an erythropoiesis-stimulating agent (ESA), to high-dose IV iron administered proactively or low-dose IV iron administered reactively in a 1:1 ratio. Possible stroke events were independently adjudicated. We performed analyses to identify variables associated with stroke during follow-up and assessed survival following stroke. Results: During a median 2.1 years follow-up, 69 (3.2%) patients experienced a first post randomization stroke. 57 (82.6%) were ischemic strokes and 12 (17.4%) hemorrhagic strokes. There were 34 post randomization strokes in the proactive arm and 35 in the reactive arm (hazard ratio (95% confidence interval): 0.90 (0.56, 1.44), p=0.66). In multivariable models, female gender, diabetes, history of prior stroke at baseline, higher baseline systolic blood pressure, lower serum albumin and higher C-reactive protein were independently associated with stroke events during follow up. Hemoglobin, total iron or ESA dose were not associated with risk of stroke. 58% of patients with a stroke event died during follow-up, compared to 23% without a stroke. Conclusions: In hemodialysis patients, stroke risk is broadly associated with risk factors previously described to increase cardiovascular risk in this population. Proactive intravenous iron does not increase stroke risk.

Item Type:Articles
Additional Information:The PIVOTAL trial was funded by Kidney Research UK which was supported by an unrestricted grant from Vifor Fresenius Medical Care Renal Pharma.
Status:Early Online Publication
Refereed:Yes
Glasgow Author(s) Enlighten ID:Mark, Professor Patrick and Jhund, Dr Pardeep and Petrie, Professor Mark and Robertson, Mrs Michele and Connolly, Dr Eugene and McMurray, Professor John and Ford, Professor Ian and Walters, Professor Matthew
Authors: Mark, P. B., Jhund, P. S., Walters, M. R., Petrie, M. C., Power, A., White, C., Robertson, M., Connolly, E., Anker, S. D., Bhandari, S., Farrington, K., Kalra, P. A., Tomson, C. R.V., Wheeler, D. C., Winearls, C. G., McMurray, J. J.V., Macdougall, I. C., and Ford, I.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:Kidney360
Publisher:American Society of Nephrology
ISSN:2641-7650
ISSN (Online):2641-7650
Published Online:16 September 2021
Copyright Holders:Copyright © 2021 American Society of Nephrology
First Published:First published in Kidney360 2021
Publisher Policy:Reproduced in accordance with the publisher copyright policy

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