An Open-Label, Randomized, Parallel-Group Study of Perioperative Epoetin Alfa Versus Standard of Care for Blood Conservation in Major Elective Spinal Surgery

Abstract

This study documented a higher incidence of deep vein thrombosis and similar rates of other clinically relevant thrombovascular events with epoetin alfa versus standard of care for blood conservation in subjects who did not receive prophylactic anticoagulation before spinal surgery. Antithrombotic prophylaxis should be considered when erythropoietin is used in the surgical setting.

ESAs in Dialysis Patients

“…10 From a safety perspective, there is some rationale for lumping the trials together: The risk of ESA exposure seems insensitive to the patient population. Data from RCTs of patients with CKD, 3,4,5,11,12 patients with cancer, 11,13 healthy individuals who underwent spine surgery, 14 and critically ill patients 15 all point to increased risk with ESA exposure.…”

Foro de debate: seguridad de las alternativas a la transfusión alogénica en el paciente quirúrgico y/o crítico

“…En el contexto quirúrgico, la eritropoyetina humana recombinante (epoetina alfa, rHuEPO) solamente tiene indicación en pacientes de cirugía ortopédica programada con Hb o para facilitar la donación autógena preoperatoria, aunque se ha utilizado en cirugía traumatológica, cardíaca y oncológica 10 . En la indicación aprobada, 2 estudios en cirugía vertebral han reportado un aumento de trombosis venosa en pacientes tratados con rHuEPO y que no recibieron tromboprofilaxis 7,8 . Ante estos datos, la FDA requirió que se incluyese en la ficha técnica de estos productos la advertencia de «considerar la profilaxis de la trombosis venosa profunda durante su uso».…”

Assessment and treatment of preoperative anemia: Continuing Professional Development

“…57 The ability of ESAs to reduce transfusions has been balanced by recent concerns of increased adverse outcomes (thrombosis, cancer progression) associated with ESA therapy in patients undergoing spine surgery and in patients with chronic renal failure and Sources: O'Brien et al 44 Vamvakas et al 43 RBC = red blood cells; HIV = human immunodeficiency virus; HCV = hepatitis C virus; HBV = hepatitis B virus; HTLV = Human T-cell leukemia/lymphoma virus; WNV = West Nile virus cancer. [58][59][60] A recent clinical study has suggested that chronic use of high-dose ESA in patients with renal failure may not necessarily improve quality of life or reduce mortality. In fact, the opposite may be true; ESAs may increase the risk of arterial thrombotic events (stroke) and mortality in these patients.…”

“…57 La capacité des ESA à réduire les transfusions a été contrebalancée en raison d'inquiétudes récentes concernant une augmentation des pronostics défavorables (thrombose, progression du cancer) associés à un traitement à base d'ESA chez les patients subissant une chirurgie du rachis et chez les patients souffrant d'insuffisance rénale chronique et de cancer. [58][59][60] Une étude clinique récente a suggéré que l'utilisation chronique d'ESA à fort dosage chez les patients souffrant d'insuffisance rénale pourrait ne pas forcément améliorer leur qualité de vie ou réduire la mortalité. En fait, ce pourrait être le contraire: les ESA pourraient augmenter le risque d'événements thrombotiques artériels (accidents vasculaires ce´re´braux) et la mortalité chez ces patients.…”