Idarucizumab for Reversing Dabigatran-Induced Anticoagulation: A Systematic Review

Thibault, Nathan; Morrill, Amanda M.; Willett, Kristine C.

doi:10.1097/mjt.0000000000000460

Cited by 22 publications

(15 citation statements)

References 10 publications

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“…If a tICH is identified, these patients often require administration of reversal agents and close monitoring for neurological deterioration. [13][14][15][16] In recognition of these concerns with head-injured older adults with anticoagulant and antiplatelet use, the most recent field triage guidelines were revised to recommend taking these patients to trauma centers or hospitals with the capability of rapid and comprehensive treatment. 3 These recommendations, however, were largely based on retrospective, registry-based studies.…”

Section: Introductionmentioning

confidence: 99%

The Incidence of Traumatic Intracranial Hemorrhage in Head-Injured Older Adults Transported by EMS with and without Anticoagulant or Antiplatelet Use

Nishijima

Gaona

Waechter

et al. 2018

Journal of Neurotrauma

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Field triage guidelines recommend transport of head-injured patients on anticoagulants or antiplatelets to a higher-level trauma center based on studies suggesting a high incidence of traumatic intracranial hemorrhage (tICH). We compared the incidence of tICH in older adults transported by EMS with and without anticoagulation or antiplatelet use and evaluated the accuracies of different sets of field triage criteria to identify tICH. This was a prospective, observational study at 5 EMS agencies and 11 hospitals. Older adults (≥55 years) with head trauma and transported by EMS from Aug 2015 to Sept 2016 were eligible. EMS providers completed standardized data forms and patients were followed through ED or hospital discharge. We enrolled 1,304 patients; 1147 (88%) received a cranial CT scan and were eligible for analysis. 434 (33%) patients had anticoagulant or antiplatelet use and 112 (10%) had tICH. The incidence of tICH in patients with (11%, 95%CI 8-14%) and without (9%, 95%CI 7-11%) anticoagulant or antiplatelet use was similar. Anticoagulant or antiplatelet use was not predictive of tICH on adjusted analysis. Steps 1-3 criteria alone were not sensitive in identifying tICH (27%) while the addition of anticoagulant or antiplatelet criterion improved sensitivity (63%). Other derived sets of triage criteria were highly sensitive (>98%) but poorly specific (<11%). The incidence of tICH was similar between patients with and without anticoagulant or antiplatelet use. Use of anticoagulant or antiplatelet medications was not a risk factor for tICH. We were unable to identify a set of triage criteria that was accurate for trauma center need.

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Section: Introductionmentioning

confidence: 99%

The Incidence of Traumatic Intracranial Hemorrhage in Head-Injured Older Adults Transported by EMS with and without Anticoagulant or Antiplatelet Use

Nishijima

Gaona

Waechter

et al. 2018

Journal of Neurotrauma

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“…It is indicated in dabigatran-treated patients with life-threatening or uncontrolled bleeding or those in need of urgent surgery or intervention. 9,10 To date, the use of idarucizumab in patients with acute ischemic stroke who qualify for systemic thrombolysis with rt-PA is limited to single case reports. [11][12][13][14][15] Aims This report summarizes national experience with idarucizumab administration in dabigatran-treated patients suffering from acute ischemic stroke or intracranial hemorrhage in Germany following market launch in January 2016, for the first eight months until August 2016.…”

Section: Introductionmentioning

confidence: 99%

Antagonizing dabigatran by idarucizumab in cases of ischemic stroke or intracranial hemorrhage in Germany – A national case collection

Kermer

Eschenfelder

Diener

et al. 2017

International Journal of Stroke

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Background Idarucizumab is a monoclonal antibody fragment with high affinity for dabigatran that reverses its anticoagulant effects within minutes. It may exhibit the potential for patients under dabigatran therapy suffering ischemic stroke to regain eligibility for thrombolysis with rt-PA and may inhibit lesion growth in patients with intracerebral hemorrhage on dabigatran. Aims To provide insights into the clinical use of idarucizumab in patients under effective dabigatran anticoagulation presenting with signs of ischemic stroke or intracranial hemorrhage. Methods Retrospective data collected from German neurological/neurosurgical departments administering idarucizumab following product launch from January to August 2016 were used. Results Thirty-one patients presenting with signs of stroke received idarucizumab in 22 stroke centers. Nineteen patients treated with dabigatran presented with ischemic stroke and 12 patients suffered from intracranial bleeding. In patients receiving rt-PA thrombolysis following idarucizumab, 79% benefitted from i.v. thrombolysis with a median improvement of five points in NIHSS. No bleeding complications occurred. Hematoma growth was observed in 2 out of 12 patients with intracranial hemorrhage. The outcome was favorable with a median NIHSS improvement of 5.5 points and mRS 0-3 in 67%. Overall, mortality was low with 6.5% (one patient in each group). Conclusion Administration of rt-PA after reversing dabigatran activity with idarucizumab in case of ischemic stroke is feasible, easy to manage, effective, and appears to be safe. In dabigatran-associated intracranial hemorrhage, idarucizumab has the potential to prevent hematoma growth and improve outcome. Idarucizumab represents a new therapeutic option for patients under dabigatran treatment presenting with ischemic stroke or intracranial hemorrhage.

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“…11-13 Patients taking antiplatelet medications or direct oral anticoagulants with significant bleeding after trauma or requiring emergent surgery may require careful evaluation and specific reversal agents. 14-17 …”

Section: Introductionmentioning

confidence: 99%

Out-of-Hospital Triage of Older Adults With Head Injury: A Retrospective Study of the Effect of Adding “Anticoagulation or Antiplatelet Medication Use” as a Criterion

Nishijima

Gaona

Waechter

et al. 2017

Annals of Emergency Medicine

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Study Objective Field triage guidelines recommend EMS providers consider transport of head injured older adults with anticoagulation use to trauma centers. However the triage patterns and the incidence of intracranial hemorrhage or neurosurgery in these patients are unknown. Our objective was to describe the characteristics and outcomes of older adults with head trauma transported by EMS, particularly in patients that do not meet physiological, anatomical, or mechanism of injury (Step 1-3) field triage criteria but are taking anticoagulant or antiplatelet medications. Methods This was a retrospective study at 5 EMS agencies and 11 hospitals (4 trauma centers, 7 non-trauma centers). Patients ≥55 years with head trauma who were transported by EMS were included. The primary outcome was the presence of intracranial hemorrhage. The secondary outcome was a composite measure of in-hospital death or neurosurgery. Results 2110 patients were included; 131 (6%) had intracranial hemorrhage and 41 (2%) had in-hospital death or neurosurgery. There were 162 patients (8%) with Step 1-3 criteria. Of the remaining 1948 patients without Step 1-3 criteria, 566 (29%) had anticoagulant or antiplatelet use. Of these patients, 52 (9%) had traumatic intracranial hemorrhage and 15 (3%) died or had neurosurgery. The sensitivity of Step 1-3 criteria was 19.8% (26/131; 95% CI 5.5-51.2%) for identifying traumatic intracranial hemorrhage and 34.1% (14/41; 95% CI 28.9-90.1%) for death or neurosurgery. The additional criterion of anticoagulant or antiplatelet use improved the sensitivity for intracranial hemorrhage (78/131; 59.5%, 95% 42.9-74.2%) and death or neurosurgery (29/41; 70.7%, 95% CI 61.0-78.9%). Conclusions Relatively few patients met Step 1-3 triage criteria. In those who did not have Step 1-3 criteria, nearly 30% had anticoagulant or antiplatelet use. A relatively high proportion of these patients had intracranial hemorrhage but a much smaller proportion died or had neurosurgery during hospitalization. Use of Step 1-3 triage criteria alone is not sufficient in identifying intracranial hemorrhage and death or neurosurgery in this patient population. The additional criterion of anticoagulant or antiplatelet use improves the sensitivity of the instrument with only a modest decrease in specificity.

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Idarucizumab for Reversing Dabigatran-Induced Anticoagulation: A Systematic Review

Cited by 22 publications

References 10 publications

The Incidence of Traumatic Intracranial Hemorrhage in Head-Injured Older Adults Transported by EMS with and without Anticoagulant or Antiplatelet Use

The Incidence of Traumatic Intracranial Hemorrhage in Head-Injured Older Adults Transported by EMS with and without Anticoagulant or Antiplatelet Use

Antagonizing dabigatran by idarucizumab in cases of ischemic stroke or intracranial hemorrhage in Germany – A national case collection

Out-of-Hospital Triage of Older Adults With Head Injury: A Retrospective Study of the Effect of Adding “Anticoagulation or Antiplatelet Medication Use” as a Criterion

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