title: Effect of online hemodiafiltration on all-cause mortality and cardiovascular outcomes.
abstract: In patients with ESRD, the effects of online hemodiafiltration on all-cause mortality and cardiovascular events are unclear. In this prospective study, we randomly assigned 714 chronic hemodialysis patients to online postdilution hemodiafiltration (n=358) or to continue low-flux hemodialysis (n=356). The primary outcome measure was all-cause mortality. The main secondary endpoint was a composite of major cardiovascular events, including death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, therapeutic coronary intervention, therapeutic carotid intervention, vascular intervention, or amputation. After a mean 3.0 years of follow-up (range, 0.4-6.6 years), we did not detect a significant difference between treatment groups with regard to all-cause mortality (121 versus 127 deaths per 1000 person-years in the online hemodiafiltration and low-flux hemodialysis groups, respectively; hazard ratio, 0.95; 95% confidence interval, 0.75-1.20). The incidences of cardiovascular events were 127 and 116 per 1000 person-years, respectively (hazard ratio, 1.07; 95% confidence interval, 0.83-1.39). Receiving high-volume hemodiafiltration during the trial associated with lower all-cause mortality, a finding that persisted after adjusting for potential confounders and dialysis facility. In conclusion, this trial did not detect a beneficial effect of hemodiafiltration on all-cause mortality and cardiovascular events compared with low-flux hemodialysis. On-treatment analysis suggests the possibility of a survival benefit among patients who receive high-volume hemodiafiltration, although this subgroup finding requires confirmation.
authors.affiliation: Department of Nephrology, University Medical Center Utrecht, Utrecht, The Netherlands. P.J.Blankestijn@umcutrecht.nl
authors.forename: Muriel P C
authors.initials: MP
authors.lastname: Grooteman
authors.forename: Marinus A
authors.initials: MA
authors.lastname: van den Dorpel
authors.forename: Michiel L
authors.initials: ML
authors.lastname: Bots
authors.forename: E Lars
authors.initials: EL
authors.lastname: Penne
authors.forename: Neelke C
authors.initials: NC
authors.lastname: van der Weerd
authors.forename: Albert H A
authors.initials: AH
authors.lastname: Mazairac
authors.forename: Claire H
authors.initials: CH
authors.lastname: den Hoedt
authors.forename: Ingeborg
authors.initials: I
authors.lastname: van der Tweel
authors.forename: Renée
authors.initials: R
authors.lastname: Lévesque
authors.forename: Menso J
authors.initials: MJ
authors.lastname: Nubé
authors.forename: Piet M
authors.initials: PM
authors.lastname: ter Wee
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Blankestijn
mesh_terms: D000367:Age Factors; D002170:Canada; D002318:Cardiovascular Diseases / Q000209:etiology* / Q000401:mortality* / Q000503:physiopathology; D002423:Cause of Death; D005260:Female; D017583:Hemodiafiltration / Q000009:adverse effects / Q000401:mortality; D006436:Hemodialysis Units, Hospital; D006801:Humans; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D009426:Netherlands; D009664:Norway; D011379:Prognosis; D006435:Renal Dialysis / Q000009:adverse effects / Q000401:mortality*; D018570:Risk Assessment; D012737:Sex Factors; D016037:Single-Blind Method; D016019:Survival Analysis; D016896:Treatment Outcome