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.  

PIVOTAL results released at late breaking trial session at #KidneyWk and simultaneously on @NEJM https://t.co/TZ1JLUAWRe

— Anna Burgner MD MEHP (@anna_burgner) October 26, 2018

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). 

It’s landed! #PIVOTAL – the largest UK-only renal trial, published in @NEJM to coincide with #kidneywk. Congratulations to Iain Macdougall, @CharlieTomson, @DavidWheeler2 and the rest of the authors. Spot me and @drmatthall in supplementary appendix 34b. https://t.co/yTnzh930i3

— Jim Moriarty (@HotKidneyAction) October 26, 2018

We are delighted the results of the #PIVOTAL trial examining the use of higher doses of intravenous (IV) iron to manage anaemia in people on haemodialysis have been published in the New England Journal of Medicine. Read it here: https://t.co/5NAhWLyUrA
More detail shortly. pic.twitter.com/AiUnj8sgBb

— Kidney Research UK (@Kidney_Research) October 29, 2018

“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.” 

Including info on #PIVOTAL – the largest UK only #renal trial published in @nejm – thank you @drpaddymark for cramming the wealth of activity into 3mins! https://t.co/YZy5pxZQcn https://t.co/BHSXmp8gfo

— NHS Research Scotland (@NHSResearchScot) October 30, 2018

More Iron -> less ESA, #PIVOTAL trial, @NEJM https://t.co/Tx2BAmwjoo

— Irene Ma (@IM_POCUS) October 28, 2018

Sources: New England Journal of Medicine