The Effects of Normal as Compared With Low Hematocrit Values in Patients With Cardiac Disease Who Are Receiving Hemodialysis and Epoetin

N Engl J Med. 1998 Aug 27;339(9):584-90. doi: 10.1056/NEJM199808273390903.

Abstract

Background: In patients with end-stage renal disease, anemia develops as a result of erythropoietin deficiency, and recombinant human erythropoietin (epoetin) is prescribed to correct the anemia partially. We examined the risks and benefits of normalizing the hematocrit in patients with cardiac disease who were undergoing hemodialysis.

Methods: We studied 1233 patients with clinical evidence of congestive heart failure or ischemic heart disease who were undergoing hemodialysis: 618 patients were assigned to receive increasing doses of epoetin to achieve and maintain a hematocrit of 42 percent, and 615 were assigned to receive doses of epoetin sufficient to maintain a hematocrit of 30 percent throughout the study. The median duration of treatment was 14 months. The primary end point was the length of time to death or a first nonfatal myocardial infarction.

Results: After 29 months, there were 183 deaths and 19 first nonfatal myocardial infarctions among the patients in the normal-hematocrit group and 150 deaths and 14 nonfatal myocardial infarctions among those in the low-hematocrit group (risk ratio for the normal-hematocrit group as compared with the low-hematocrit group, 1.3; 95 percent confidence interval, 0.9 to 1.9). Although the difference in event-free survival between the two groups did not reach the prespecified statistical stopping boundary, the study was halted. The causes of death in the two groups were similar. The mortality rates decreased with increasing hematocrit values in both groups. The patients in the normal-hematocrit group had a decline in the adequacy of dialysis and received intravenous iron dextran more often than those in the low-hematocrit group.

Conclusions: In patients with clinically evident congestive heart failure or ischemic heart disease who are receiving hemodialysis, administration of epoetin to raise their hematocrit to 42 percent is not recommended.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anemia / blood
  • Anemia / complications
  • Anemia / drug therapy*
  • Epoetin Alfa
  • Erythropoietin / therapeutic use*
  • Female
  • Heart Failure / blood*
  • Heart Failure / complications
  • Hematocrit*
  • Humans
  • Iron / therapeutic use
  • Kidney Failure, Chronic / blood
  • Kidney Failure, Chronic / complications
  • Kidney Failure, Chronic / mortality
  • Kidney Failure, Chronic / therapy*
  • Male
  • Middle Aged
  • Myocardial Infarction / epidemiology
  • Myocardial Ischemia / blood*
  • Myocardial Ischemia / complications
  • Prospective Studies
  • Recombinant Proteins
  • Renal Dialysis*

Substances

  • Recombinant Proteins
  • Erythropoietin
  • Epoetin Alfa
  • Iron