The risk of delayed intracranial hemorrhage with direct acting oral anticoagulants after trauma: A two-center study

Purpose: Current guidelines favor 4F-PCC over plasma for reversal of warfarin. Uncertainty remains on the hemostatic effectiveness and thrombotic risk of 4F-PCC for direct-acting oral anticoagulants (DOACs), particularly in patients with intracranial hemorrhage (ICH). This study sought to evaluate the effectiveness and safety of a lower dose protocol of 25 units/kg 4F-PCC for the management of DOAC-associated ICH in a real-world setting. Materials and Methods: This was a retrospective study of adult patients who received at least one dose of 4F-PCC from March 2014 to December 2015 for DOAC-associated ICH. The primary outcome was hemostatic effectiveness within 24 hours. The secondary outcome was thromboembolic events within 14 days. Results: Twenty-two patients received 4F-PCC for DOAC-associated ICH and were included in the analysis. Hemostasis was evaluable in 19 patients with post-4F-PCC imaging available and occurred in 18/19 (94.7%) patients. Thromboembolism occurred in 2 out of 22 patients (9.1%). Conclusions: The use of a lower dose protocol of 25 units/kg of 4F-PCC resulted in high rates of hemostasis in patients with DOAC-associated ICH. Two patients developed thrombotic events within 14 days of 4F-PCC administration.

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Efficacy and Safety of Direct Oral Anticoagulants for Atrial Fibrillation Across Body Mass Index Categories

Journal of the American Heart Association ◽

10.1161/jaha.120.017383 ◽

2020 ◽

Vol 9 (24) ◽

Author(s):

Rachel M. Kaplan ◽

Yoshihiro Tanaka ◽

Rod S. Passman ◽

Michelle Fine ◽

Laura J. Rasmussen‐Torvik ◽

...

Keyword(s):

Atrial Fibrillation ◽

Body Mass Index ◽

Body Mass ◽

Intracranial Hemorrhage ◽

Oral Anticoagulants ◽

Efficacy And Safety ◽

Class 1 ◽

Direct Acting ◽

Direct Acting Oral Anticoagulants

Background Direct‐acting oral anticoagulants are now the preferred method of anticoagulation in patients with atrial fibrillation. Limited data on efficacy and safety of these fixed‐dose regimens are available in severe obesity where drug pharmacokinetics and pharmacodynamics may be altered. The objectives of this study were to evaluate efficacy and safety in patients with atrial fibrillation taking direct‐acting oral anticoagulants across body mass index (BMI) categories in a contemporary, real‐world population. Methods and Results We performed a retrospective study of patients with atrial fibrillation at an integrated multisite healthcare system. Patients receiving a direct‐acting oral anticoagulant prescription and ≥12 months of follow‐up between 2010 and 2017 were included. The primary efficacy and safety outcomes were ischemic stroke or systemic embolism and intracranial hemorrhage. We performed Cox proportional hazards modeling to compute hazard ratios (HRs) adjusted for CHA 2 DS 2 ‐VASc score to examine differences by excess BMI categories relative to normal BMI. Of 7642 patients, mean±SD age was 69±12 years with a median (interquartile range) follow‐up of 3.8 (2.2–6.0) years. Approximately 22% had class 1 obesity and 19% had class 2 or 3 obesity. Stroke risks were similar in patients with and without obesity (HR, 1.2; 95% CI, 0.5–2.9; and HR, 0.68; 95% CI, 0.23–2.0 for class 1 and class 2 or 3 obesity compared with normal BMI, respectively). Risk of intracranial hemorrhage was also similar in class 1 and class 2 or 3 obesity compared with normal BMI (HR, 0.64; 95% CI, 0.35–1.2; and HR, 0.66; 95% CI, 0.35–1.2, respectively). Conclusions Direct‐acting oral anticoagulants demonstrated similar efficacy and safety across all BMI categories, even at high weight values.

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Terapia antitrombótica en pacientes con hemorragia intracraneal. ¿Revertimos?

Revista Electrónica AnestesiaR ◽

10.30445/rear.v10i8.599 ◽

2018 ◽

Vol 10 (8) ◽

pp. 6

Author(s):

Jose Vicente Catalá Ripoll ◽

Jose Ángel Monsalve Naharro ◽

Esther Domingo Chiva ◽

Pablo Cuesta Montero ◽

Jose María Jiménez Vizuete

Keyword(s):

Molecular Weight ◽

Clinical Practice ◽

Intracranial Hemorrhage ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Fibrinolytic Therapy ◽

Low Molecular Weight ◽

Low Molecular Weight Heparins ◽

Direct Acting ◽

Direct Acting Oral Anticoagulants

Realizamos una revisión de la guía de práctica clínica de la reversión de la terapia antitrombótica en pacientes con hemorragia intracraneal que hayan recibido terapia antiagregante, anticoagulante o fibrinolítica. Se analizan recomendaciones para la reversión de antagonistas de vitamina K, anticoagulantes orales de acción directa, heparinas no fraccionadas y de bajo peso molecular, trombolíticos y antiagregantes plaquetarios, en el contexto de una hemorragia intracraneal. ABSTRACT Review the clinical practice guidelines for the reversal of antithrombotic therapy in patients with intracranial hemorrhage with antiplatelet, anticoagulant or fibrinolytic therapy. We analyzed the most important recommendations for the reversal of vitamin K antagonists, direct-acting oral anticoagulants, unfractionated and low-molecular-weight heparins, thrombolytics and platelet antiaggregants, in the context of an intracranial hemorrhage.

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Reversal of warfarin and direct-acting oral anticoagulants in traumatic intracranial hemorrhage: Four factor prothrombin complex concentrates for all?

Trauma ◽

10.1177/1460408620970504 ◽

2020 ◽

pp. 146040862097050

Author(s):

Kerry K Moore ◽

Cassie A Barton ◽

Elizabeth S Levins ◽

Heath Oetken ◽

Elizabeth N Dewey ◽

...

Keyword(s):

Intracranial Hemorrhage ◽

Prothrombin Complex Concentrate ◽

Oral Anticoagulants ◽

Inclusion Criteria ◽

Prothrombin Complex Concentrates ◽

Traumatic Intracranial Hemorrhage ◽

Baseline Characteristics ◽

Direct Acting ◽

Anticoagulated Patients ◽

Direct Acting Oral Anticoagulants

Background Patients receiving oral anticoagulation who experience a traumatic intracranial hemorrhage (ICH) should receive anticoagulation reversal. Four factor prothrombin complex concentrate (4FPCC) is indicated for reversal of warfarin, and is frequently used for reversal of direct-acting oral anticoagulants (DOACs). The purpose of this study is to compare the safety and efficacy of 4FPCC reversal for traumatic ICH in DOAC- and warfarin-anticoagulated patients. Methods This was a single-center, retrospective review of adult patients with traumatic ICH who received 4FPCC for reversal of anticoagulation between April 2013 and August 2018. The ICH volume on the pre- and post-reversal head CT scans was measured. The primary endpoint was the incidence of expansion of ICH volume of blood using pre-and post-4FPCC imaging. Results A total of 102 patients meeting inclusion criteria were identified with 75 patients in the warfarin group and 27 patients in the DOAC group. There were no significant differences in baseline characteristics between the groups except DOAC patients had larger ICH volumes at baseline as compared to warfarin patients (23.4 mm3 vs 3.7 mm3, p = 0.0001). There was neither a statistical difference in change in ICH volume pre-and post-4FPCC administration, nor in the rate of >20% ICH expansion between the warfarin and DOAC groups. There was no difference in the rate of adverse events compared between groups. Conclusion There was no difference in the either the change in ICH volume or the rate of >20% ICH expansion in patients receiving 4FPCC for reversal DOAC versus warfarin anticoagulation. Rates of complications were low in both groups.

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Delayed intracranial hemorrhage after head trauma in patients on direct-acting oral anticoagulants

The American Journal of Emergency Medicine ◽

10.1016/j.ajem.2016.08.024 ◽

2017 ◽

Vol 35 (2) ◽

pp. 377.e1-377.e2 ◽

Cited By ~ 6

Author(s):

Austin T. Smith ◽

Keith D. Wrenn ◽

Tyler W. Barrett ◽

Ian D. Jones ◽

John P. Rohde ◽

...

Keyword(s):

Head Trauma ◽

Intracranial Hemorrhage ◽

Oral Anticoagulants ◽

Direct Acting ◽

Direct Acting Oral Anticoagulants

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Reversal of DIRECT-ACTING Oral Anticoagulants in Urgent Surgery of the Proximal Aorta: case Series and Review of the literature

Current Pharmaceutical Design ◽

10.2174/1381612825666181226150006 ◽

2019 ◽

Vol 24 (38) ◽

pp. 4534-4539 ◽

Cited By ~ 1

Author(s):

Eric Zimmermann ◽

Fawzi Ameer ◽

Berhane Worku ◽

Dimitrios Avgerinos

Keyword(s):

Oral Anticoagulants ◽

Aortic Surgery ◽

Management Strategies ◽

Case Series ◽

Published Data ◽

Review Of Literature ◽

Clotting Factors ◽

Urgent Surgery ◽

Direct Acting ◽

Direct Acting Oral Anticoagulants

Introduction: Proximal aorta interventions impose significant bleeding risk. Patients on concomitant anticoagulation regimens compound the risk of bleeding in any surgery, but especially cardiothoracic interventions. The employment of direct-acting oral anticoagulants (DOAC), namely those that target clotting factors II or X, has expanded at a precipitous rate over the last decade. The emergence of their reversal agents has followed slowly, leaving clinicians with management dilemmas in urgent surgery. We discuss current reversal strategies based on the available published data and our experience with proximal aortic surgery in patients taking DOACs. Literature Search: We performed a review of literature and present three cases from our experience to offer insight into management strategies that have been historically successful. A review of literature was conducted via PubMed with the following search string: (NOAC or DOAC or TSOAC) and (aorta or aortic or (Stanford and type and a)). Case Presentation: We present three case presentations that illustrate the importance of DOAC identification and offer management strategies in mitigating associated bleeding risks in urgent or emergent surgeries. Conclusion: Treatment teams should be aware of the technical limitations of identifying and reversing DOACs. In view of the tendency toward publishing positive outcomes, more scientific rigor is required in the area of emergency DOAC reversal strategies.

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