PIVOTAL: High-dose Iron in Hemodialysis Noninferior to Low-dose Regimen

Results from the new PIVOTAL study suggest that a high-dose intravenous iron regimen in patients undergoing hemodialysis was noninferior to a low-dose regimen. 

The authors randomized a total of 2,141 patients undergoing maintenance hemodialysis and assigned them to receive either high-dose iron sucrose (400 mg monthly) or low-dose iron sucrose (0 to 400 mg monthly). The composite study endpoint consisted of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death. Media follow-up was 2.1 years.  

According to the results, a total of 333 patients in the high-risk group experienced a primary endpoint event, compared to 343 in the low-dose group (HR=0.88; 95% CI, 0.76 to 1.03; P<0.001 for noninferiority). 

“This trial showed that, among patients undergoing hemodialysis, the use of a high-dose regimen of intravenous iron administered proactively resulted in a significantly lower dose of erythropoiesis-stimulating agent and a lower incidence of blood transfusion than the use of a low-dose regimen administered reactively,” the researchers wrote in their conclusion. “Mortality and the incidence of nonfatal cardiovascular events and infections did not differ significantly between the two treatment groups.” 

Sources: New England Journal of Medicine