Prevalence and Outcomes Associated with Idarucizumab Administration in Trauma Patients on Preinjury Dabigatran Therapy: Analyzing Clinical Utilization in 942 Patients from 74 Hospitals

Abstract

ABSTRACTBackgroundIncreasing numbers of injured patients taking dabigatran are presenting to trauma centers raising an important clinical question: Does reversal with idarucizumab outweigh potential bleeding risks associated with dabigatran? The purpose of this study was to describe the prevalence of idarucizumab administration in trauma patients and compare outcomes for those who received reversal to those who did not.MethodsThis retrospective cohort study included trauma inpatients>18 years on preinjury dabigatran. Patients were sourced from the registries of Level I–IV trauma centers with an arrival date 1/2017–12/2021. Preinjury dabigatran therapy and idarucizumab administration were confirmed via EMR chart review. Patients on preinjury dabigatran were grouped according to administration status of idarucizumab.Results942 trauma patients on preinjury dabigatran (49.7% male; mean GCS:15;>70 years: 85.7%) were included, with 10.8% patients reversed with idarucizumab. No statistically significant differences were found for preinjury dabigatran dose (p=0.703), age (p=0.494), blunt injury type (p=0.070), or mechanism of injury (p=0.248). Those reversed with idarucizumab had a greater median head AIS score (3 vs 2; p<0.001), higher proportion full trauma activations (16.7 vs 8.7%; p=0.019), higher median ISS (10 vs 9; p<0.001), were more likely to have a GCS 3–8 (4.9% vs 0.8%; p=0.006), and had increased rates of blood transfusion (4.9% vs 1.3%; p=0.022), ventilator use (10.8% vs 4.7%,p=0.009), and mortality (expired+hospice) (10.8% vs 4.9%; p=0.021). There was no difference between groups for thromboembolic events (1.0% vs 0.7%; p=0.553), hospital LOS (3 vs 4 days; p=0.147), or ICU LOS (3 vs 3 days; p=0.714).ConclusionsIn this large, retrospective cohort study of trauma patients, only 10.8% had reversal with idarucizumab. Patients reversed were more severely injured, with increased ICU and ventilator use, more transfusions ≤24 hours, and had increased mortality compared to those not reversed. There was no difference in thromboembolic events between groups. These findings suggest clinicians may be administering idarucizumab based on injury severity–especially head trauma–regardless of other variables, such as comorbidities. Additional research is needed to determine the optimal role of reversal with idarucizumab vs. other strategies for injured patients on dabigatran.Clinical PerspectiveWhat is new?Trauma patients on preinjury dabigatran reversed with idarucizumab were more severely injured and utilized more hospital resources (including increased intensive care unit length of stay and ventilator days) than those not reversed.There was no difference in thromboembolic events recorded between trauma patients administered idarucizumab compared to those who were not; however, reversal with idarucizumab was associated with increased rates of blood transfusion and total mortality (expired + hospice).What are the clinical implications?These findings suggest clinicians may be administering idarucizumab to trauma patients based primarily on injury severity, especially head trauma, regardless of other variables, such as comorbidities.A large, prospective randomized study of trauma inpatients on preinjury dabigatran that compares dabigatran reversal with idarucizumab to non-specific reversal agents is warranted to establish appropriate criteria for utilization of idarucizumab.