Integrated analysis of thrombotic/vascular event occurrence in epoetin alfa-treated patients undergoing major,...

Data from four prospective, multicenter, randomized studies involving 869 major, elective orthopedic surgery patients were examined by means of a retrospective integrated analysis to evaluate whether perioperative Epoetin alfa use was associated with the occurrence of thrombotic/vascular events. The incidence of thrombotic/vascular events was similar between 619 patients treated with Epoetin alfa and 250 patients receiving placebo (7.4% versus 8.0%, respectively). Regression analyses identified age, cardiac history, hypertension, and cardiac medications, but not Epoetin alfa, as risk factors for thrombotic/vascular events. The analysis did not implicate an increase in the rate of rise in hematocrit or maximum hematocrit obtained prior to surgery as contributors to thrombotic events. Thus, Epoetin alfa, which enhances preoperative erythropoiesis and increases hematocrit, did not affect the probability of thrombotic/vascular events.