AVOIDANCE OF ALLOGENEIC BLOOD-TRANSFUSIONS BY TREATMENT WITH EPOETIN-BETA (RECOMBINANT-HUMAN-ERYTHROPOIETIN) IN PATIENTS UNDERGOING OPEN-HEART-SURGERY

In a double-blind, randomized, placebo-controlled trial, we evaluated the ability of epoetin beta (recombinant human erythropoietin) to avoi d allogeneic blood transfusions (ABT) and the associated risks in pati ents undergoing primary elective open-heart surgery and in whom autolo gous blood donation (ABD) was contraindicated. Seventy-six patients ov erall were enrolled onto the trial and were randomly assigned to the t wo treatment groups, 5 x 500 U/kg body weight (BW) epoetin beta or pla cebo intravenously over 14 days preoperatively. All patients received 300 mg Fe2+ orally per day during the treatment period. Preoperatively , the mean hemoglobin increase was 1.50 g/dL greater in epoetin beta p atients than in placebo patients (95% confidence interval, 1.10 to 1.9 0 g/dL), allowing a rapid return to the baseline value by the seventh postoperative day in most epoetin beta patients. The mean Volume of bl ood collected by intraoperative isovolemic hemodilution was 562 mL (re d blood cell mass, 274 mL) in the epoetin beta group and 218 mL (red b lood cell mass, 94 mL) in the placebo group, respectively. Only four p atients (11%) in the epoetin beta group received an ABT, compared with 19 (53%) in the placebo group (P = .0003). Epoetin beta was most usef ul in patients with a perioperative blood loss greater than 750 mt, in those with a baseline hematocrit value less than 0.42, and in those a ged greater than or equal to 60 years. The iron supplementation proved adequate despite the fact that a significant decrease in ferritin (me dian, 48.1%) and transferrin saturation (median, 40.5%) was observed i n epoetin beta patients preoperatively. No influence of epoetin beta t herapy on blood pressure, laboratory safety variables, or the frequenc y of specific adverse events was observed. Intravenous epoetin beta tr eatment of 5 x 500 U/kg BW in combination with 300 mg Fe2+ orally per day administered over 14 days preoperatively is an adequate therapy fo r increasing mean hemoglobin levels by approximately 1.50 g/dL and red ucing the allogeneic blood requirement in patients undergoing elective open-heart surgery and in whom ABD is contraindicated. (C) 1997 by Th e American Society of Hematology.