THE EFFECTS OF NORMAL AS COMPARED WITH LOW HEMATOCRIT VALUES IN PATIENTS WITH CARDIAC DISEASE WHO ARE RECEIVING HEMODIALYSIS AND EPOETIN

Background In patients with end-stage renal disease, anemia develops a s a result of erythropoietin deficiency, and recombinant human erythro poietin (epoetin) is prescribed to correct the anemia partially. We ex amined the risks and benefits of normalizing the hematocrit in patient s with cardiac disease who were undergoing hemodialysis. Methods We st udied 1233 patients with clinical evidence of congestive heart failure or ischemic heart disease who were undergoing hemodialysis: 618 patie nts were assigned to receive increasing doses of epoetin to achieve an d maintain a hematocrit of 42 percent, and 615 were assigned to receiv e doses of epoetin sufficient to maintain a hematocrit of 30 percent t hroughout the study. The median duration of treatment was 14 months. T he primary end point was the length of time to death or a first nonfat al myocardial infarction. Results After 29 months, there were 183 deat hs 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 th e normal-hematocrit group as compared with the low-hematocrit group, 1 .3; 95 percent confidence interval, 0.9 to 1.9). Although the differen ce in event-free survival between the two groups did not reach the pre specified statistical stopping boundary, the study was halted. The cau ses of death in the two groups were similar. The mortality rates decre ased 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 lo w-hematocrit group. Conclusions In patients with clinically evident co ngestive heart failure or ischemic heart disease who are receiving hem odialysis, administration of epoetin to raise their hematocrit to 42 p ercent is not recommended. (N Engl J Med 1998;339:584-90.) (C) 1998, M assachusetts Medical Society.