1.
An Analysis of Vascular Access Thrombosis Events From the Proactive IV irOn Therapy in hemodiALysis Patients Trial
Thomson PC, Mark PB, Robertson M, White C, Anker SD, Bhandari S, Farrington K, Jardine AG, Kalra PA, McMurray J, et al
Kidney international reports. 2022;7(8):1793-1801
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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.
PICO Summary
Population
Adult patients requiring haemodialysis enrolled in the PIVOTAL trial, in 50 sites across the UK (n= 2,141).
Intervention
High-dose of intravenous iron administered proactively (n= 1,093).
Comparison
Low-dose of intravenous iron administered reactively (n= 1,048).
Outcome
The associations between clinical and laboratory data and first vascular access thrombosis (VAT) were evaluated. 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). Diabetic kidney disease (HR 1.45), arteriovenous graft (AVG) use (HR 2.29), digoxin use (HR 2.48), diuretic use (HR 1.25), female sex (HR 1.33), and previous/current smoker (HR 1.47) were independently associated with a higher risk of VAT. Angiotensin receptor blocker use (HR 0.66) was independently associated with a lower risk of VAT.
2.
Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy
Jhund PS, Petrie MC, Robertson M, Mark PB, MacDonald MR, Connolly E, Anker SD, Bhandari S, Farrington K, Kalra PA, et al
JACC. Heart failure. 2021
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Abstract
OBJECTIVES The 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. CONCLUSION 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).
PICO Summary
Population
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.