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| RBT-1, a Pharmacologic Preconditioning Agent, Reduces the Incidence of Anemia, Blood Transfusion, and Use of Supplemental Iron in Patients Undergoing Cardiac Surgery |
| Ashish K Khanna1,2, Kevin W Lobdell3, Rakesh C Arora4,5, Stacey Ruiz6, Jeannette Rodriguez6, Ayrn D O'Connor6, Bhupinder Singh6, Andre Lamy7 1Department of Anesthesiology, Section on Critical Care Medicine, Perioperative Outcomes and Informatics Collaborative (POIC), Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, NC, United States 2Outcomes Research Consortium, Cleveland, OH, United States 3Sanger Heart & Vascular Institute, Atrium Health, Charlotte, NC, United States 4Harrington Heart and Vascular Institute, University Hospitals - Cleveland Medical Center Division of Cardiac Surgery, Cleveland, OH, United States 5Department of Surgery, Case Western Reserve University, Cleveland, OH, United States 6Renibus Therapeutics, Southlake, TX, United States 7Population Health Research Institute, Hamilton, Canada |
BACKGROUND: Patients undergoing cardiac surgery are at risk of anemia from blood loss, inflammation, and red blood cell lysis, necessitating blood product utilization and increasing the risk of post-operative complications. RBT-1 is a novel preconditioning drug that upregulates anti-inflammatory, antioxidant, and iron-scavenging pathways. Activation of these pathways, along with the iron content of RBT-1, may improve iron levels, iron utilization, and reduce erythropoietin resistance. A recent Phase 2 trial showed that the drug increased cytoprotective protein levels and improved clinical outcomes. Analyses of anemia incidence, transfusion, and iron usage from the study are presented herein. METHODS: In this randomized, double-blind, placebo-controlled trial, 121 patients scheduled to undergo non-emergent coronary artery bypass graft (CABG) and/or valve surgery on cardiopulmonary bypass (CPB) received one intravenous dose of RBT-1 or placebo 24-48 hours before surgery. Incidence of post-operative anemia, need for blood transfusion, and iron supplementation were recorded. Hemoglobin levels were followed through index hospitalization. RESULTS: Baseline characteristics and comorbid conditions of the study population are summarized in Table 1. A significant relative risk reduction of 49% in the incidence of post-operative anemia was observed in response to RBT-1 compared with placebo (p=0.0447; Table 2). Relative risk reductions in the need for blood transfusion of 33% and 42% were observed in the RBT-1 group compared with placebo. When comparing all patients who required both blood transfusion and iron, a statistically significant reduction was observed in the RBT-1 group compared with placebo (RBT-1: 0.0% vs Placebo: 12.2%; p=0.0038). Importantly, hemoglobin levels at discharge in the RBT-1 group were comparable to those in the placebo group despite lesser rates of blood transfusion and iron supplementation (RBT-1: 9.8 g/dL vs Placebo: 9.8 g/dL). CONCLUSIONS: Treatment with the novel preconditioning drug RBT-1 before cardiac surgery may reduce the risk of post-operative anemia and need for blood transfusion and iron supplementation.   |