Abstract
To investigate the effect of high-dose iron vs. low-dose intravenous (IV) iron on myocardial infarction (MI) in patients on maintenance haemodialysis. This was a pre-specified analysis of secondary endpoints of the Proactive IV Iron Therapy in Hemodialysis Patients trial (PIVOTAL) randomized, controlled clinical trial. Adults who had started haemodialysis within the previous year, who had a ferritin concentration <400 μg per litre and a transferrin saturation <30% were randomized to high-dose or low-dose IV iron. The main outcome measure for this analysis was fatal or non-fatal MI. Over a median of 2.1 years of follow-up, 8.4% experienced a MI. Rates of type 1 MIs (3.2/100 patient-years) were 2.5 times higher than type 2 MIs (1.3/100 patient-years). Non-ST-elevation MIs (3.3/100 patient-years) were 6 times more common than ST-elevation MIs (0.5/100 patient-years). Mortality was high after non-fatal MI (1- and 2-year mortality of 40% and 60%, respectively). In time-to-first event analyses, proactive high-dose IV iron reduced the composite endpoint of non-fatal and fatal MI [hazard ratio (HR) 0.69, 95% confidence interval (CI) 0.52-0.93, P = 0.01] and non-fatal MI (HR 0.69, 95% CI 0.51-0.93; P = 0.01) when compared with reactive low-dose IV iron. There was less effect of high-dose IV iron on recurrent MI events than on the time-to-first event analysis. In total, 8.4% of patients on maintenance haemodialysis had an MI over 2 years. High-dose compared to low-dose IV iron reduced MI in patients receiving haemodialysis. 2013-002267-25.
Highlights
Contemporary data on the incidence and outcomes of myocardial infarction (MI) in patients on maintenance haemodialysis are sparse
8.4% of patients on maintenance haemodialysis had an MI over 2 years
High dose v low dose intravenous iron myocardial infarcƟon (HR 0.69, 95% confidence interval (CI) 0.52-0.93, p=0.01)
Summary
Contemporary data on the incidence and outcomes of myocardial infarction (MI) in patients on maintenance haemodialysis are sparse. Concerns have been expressed that intravenous (IV) iron could increase the prevalence or severity of coronary artery disease, and even increase coronary artery events These concerns have emerged from observational studies in humans, animal studies, and small mechanistic studies.[1,2,3,4] Others have suggested that IV iron may not increase coronary events[5] but there are no data to suggest that IV iron might reduce MIs. In the Proactive IV Iron Therapy in Hemodialysis Patients trial (PIVOTAL), we compared a regimen of IV iron administered proactively in a highdose regimen, with a low-dose regimen, administered reactively.[6] MI was an adjudicated outcome [type 1, type 2, ST-elevation MI (STEMI), nonST-elevation MI (NSTEMI)] and was a pre-specified secondary endpoint in the trial. We describe the rates and prognostic significance of MI in patients on maintenance haemodialysis and the effect of the high- vs. low-dose IV iron therapy regimens on MIs
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