PIVOTAL
Proactive IV Iron Therapy in Haemodialysis Patients
Patient / Population Intervention / Exposure Comparison Outcome
In 2,141 incident haemodialysis patients, proactive high-dose intravenous iron reduced death and cardiovascular events compared with a reactive low-dose regimen.
N
2,141
Design
Open-label RCT
Endpoint
Composite of death, MI, stroke or HF hospitalisation
Relevance
2
Result29.3% vs 32.3%; HR 0.85 (95% CI 0.73–1.00; p=0.04), also lowering the ESA dose.
Macdougall IC, et al. N Engl J Med. 2019;380(5):447-458. 10.1056/NEJMoa1810742
Discussion & critique
Higher iron dosing proved safe and effective without an excess infection signal.