An analysis of vascular access thrombosis events from the Proactive IV Iron Therapy in Hemodialysis Patients (PIVOTAL) trial

Thomson, P. C. et al. (2022) An analysis of vascular access thrombosis events from the Proactive IV Iron Therapy in Hemodialysis Patients (PIVOTAL) trial. Kidney International Reports, 7(8), pp. 1793-1801. (doi: 10.1016/j.ekir.2022.05.008) (PMID:35967105) (PMCID:PMC9366296)

Abstract

Introduction: Treatment of anaemia in dialysis patients has been associated with increased risk of vascular access thrombosis (VAT). PIVOTAL was a clinical trial of proactive compared to reactive intravenous iron therapy in patients requiring haemodialysis. We analysed the trial data to determine whether randomised treatment arm, alongside other clinical and laboratory variables, independently associated with VAT. Methods: In PIVOTAL, 2141 adult patients were randomised. The type of vascular access (AVF, AVG or CVC) was recorded at baseline and every month after randomization. The associations between clinical and laboratory data and first VAT were examined in a multivariate analysis. Results: 480 (22.4%) participants experienced VAT over a median 2.1 years follow up. In multivariable analyses, treatment arm (Proactive v Reactive) was not an independent predictor of VAT (HR 1.13, p=0.18). Diabetic kidney disease (HR 1.45, p<0.001), AVG use (HR 2.29, p<0.001), digoxin use (HR 2.48, p<0.001), diuretic use (HR 1.25, p=0.02), female sex (HR 1.33, p=0.002) and previous/current smoker (HR 1.47, p=0.004) were independently associated with a higher risk of VAT. Angiotensin receptor blocker (ARB) use (HR 0.66, p=0.01) was independently associated with a lower risk of VAT. Conclusion: In PIVOTAL VAT occurred in nearly one-quarter of participants over a median of just over 2 years. In this post hoc analysis, randomisation to proactive intravenous iron treatment arms did not increase the risk of VAT.

• 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: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Robertson, Mrs Michele and Thomson, Dr Peter and Mark, Professor Patrick and Ford, Professor Ian and McMurray, Professor John and Jardine, Professor Alan
• Authors: Thomson, P. C., Mark, P. B., Robertson, M., White, C., Anker, S. D., Bhandari, S., Farrington, K., Jardine, A. G., Kalra, P. A., McMurray, J., Reddan, D., Wheeler, D. C., Winearls, C. G., Ford, I., and Macdougall, I. C.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: Kidney International Reports
• Publisher: Elsevier
• ISSN: 2468-0249
• ISSN (Online): 2468-0249
• Published Online: 18 May 2022
• Copyright Holders: Copyright © 2022 Elsevier
• First Published: First published in Kidney International Reports 7(8): 1793-1801
• Publisher Policy: Reproduced under a Creative Commons License