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. 2022 May 18;7(8):1793-1801.
doi: 10.1016/j.ekir.2022.05.008. eCollection 2022 Aug.

An Analysis of Vascular Access Thrombosis Events From the Proactive IV irOn Therapy in hemodiALysis Patients Trial

Peter C Thomson  1 , Patrick B Mark  2 , Michele Robertson  3 , Claire White  4 , Stefan D Anker  5 , Sunil Bhandari  6 , Kenneth Farrington  7 , Alan G Jardine  2 , Philip A Kalra  8 , John McMurray  2 , Donal Reddan  9 , David C Wheeler  10 , Christopher G Winearls  11 , Ian Ford  3 , Iain C Macdougall  4 ; PIVOTAL Investigators and Committees
Collaborators, Affiliations

An Analysis of Vascular Access Thrombosis Events From the Proactive IV irOn Therapy in hemodiALysis Patients Trial

Peter C Thomson et al. Kidney Int Rep. .

Abstract

Introduction: Treatment of anemia in dialysis patients has been associated with increased risk of vascular access thrombosis (VAT). Proactive IV irOn Therapy in hemodiALysis Patients (PIVOTAL) was a clinical trial of proactive compared with reactive i.v. iron therapy in patients requiring hemodialysis. We analyzed the trial data to determine whether randomized treatment arm, alongside other clinical and laboratory variables, independently associated with VAT.

Methods: In PIVOTAL, 2141 adult patients were randomized. The type of vascular access (arteriovenous fistula [AVF], arteriovenous graft [AVG], or central venous catheter [CVC]) was recorded at baseline and every month after randomization. The associations between clinical and laboratory data and first VAT were evaluated in a multivariate analysis.

Results: A total of 480 (22.4%) participants experienced VAT in a median of 2.1 years of follow-up. In multivariable analyses, treatment arm (proactive vs. reactive) was not an independent predictor of VAT (hazard ratio [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 1 quarter of participants in a median of just >2 years. In this post hoc analysis, randomization to proactive i.v. iron treatment arms did not increase the risk of VAT.

Keywords: anemia; hemodialysis; iron; thrombosis; vascular access.

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Figures

None
Graphical abstract
Figure 1
Figure 1
Cumulative incidence curves of vascular access thrombosis events within each of the randomized treatment arms of proactive and reactive iron dosing.
See this image and copyright information in PMC

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