keyword
https://read.qxmd.com/read/38350629/latest-advances-in-the-reversal-strategies-for-direct-oral-anticoagulants
#1
REVIEW
Jean Escal, Julien Lanoiselée, Géraldine Poenou, Paul Zufferey, Silvy Laporte, Patrick Mismetti, Xavier Delavenne
BACKGROUND: Since the late 2000s, Europe has granted approval for various thrombotic risk-related uses of direct oral anticoagulants (DOACs). Unlike traditional anticoagulants, DOACs do not necessitate routine coagulation monitoring. Nevertheless, clinical practice often encounters bleeding events associated with these medications, making the need for effective reversal strategies evident. OBJECTIVES: The study aims to take stock of current reversal strategies for DOACs, with a particular emphasis on the latest compounds that have been developed or are currently under development...
February 13, 2024: Fundamental & Clinical Pharmacology
https://read.qxmd.com/read/38230495/recommendations-of-polish-cardiac-society-expert-regarding-the-use-of-andexanet-alpha-in-the-polish-context-an-interdisciplinary-protocol
#2
JOURNAL ARTICLE
Ewelina Kazimierczyk, Milena Dąbrowska, Marek Gierlotka, Katarzyna Kapica-Topczewska, Bartosz Karaszewski, Adam Kobayashi, Zbigniew Krasiński, Jacek Kubica, Alina Kułakowska, Krzysztof Kurek, Robert Ładny, Eliza Pleban, Konrad Rejdak, Grażyna Rydzewska, Agnieszka Słowik, Piotr Szopiński, Arkadiusz Woźniak, Agnieszka Tycińska
Andexanet alfa (AA) is a recombinant, inactive analog of human factor Xa (FXa), effectively reversing the effects of its inhibitors - rivaroxaban and apixaban, which are available in Poland. The drug was granted registration after the publication of the ANNEXA-4 trial (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of FXA Inhibitors 4), in which its efficacy in restoring hemostasis in life-threatening hemorrhages in a group of patients using the aforementioned anticoagulants was proven. Hence, AA is now recommended for patients receiving apixaban or rivaroxaban therapy with massive and uncontrollable hemorrhages, including hemorrhagic strokes (HS) and gastrointestinal bleeding...
January 17, 2024: Kardiologia Polska
https://read.qxmd.com/read/37813368/-basics-for-the-use-of-andexanet
#3
JOURNAL ARTICLE
J Koscielny, I Birschmann, R Bauersachs, D Trenk, F Langer, P Möhnle, J Beyer-Westendorf
BACKGROUND:  For life-threatening or uncontrollable bleeding in association with the thrombin inhibitor dabigatran, the monoclonal antibody fragment idarucizumab is available, and for bleeding in association with the direct factor Xa inhibitors rivaroxaban or apixaban, the modified recombinant FXa protein andexanet is available for reversal. These antidotes represent emergency drugs that are typically used only after performing guideline-compliant multimodal measures. METHODS:  An interdisciplinary group of experienced experts in the fields of angiology, hematology, internal medicine, clinical pharmacology, laboratory medicine, transfusion medicine, anesthesiology, intensive care, and hemostaseology developed recommendations relevant to daily clinical practice based on the current scientific evidence...
October 9, 2023: Hämostaseologie
https://read.qxmd.com/read/37713998/in-vitro-effects-of-gla-domainless-factor-xa-analog-on-procoagulant-and-fibrinolytic-pathways-in-apixaban-treated-plasma-and-whole-blood
#4
JOURNAL ARTICLE
Rui Terada, Penny M Johnson, Amir L Butt, Yuko Mishima, Kenneth E Stewart, Jerold H Levy, Kenichi A Tanaka
BACKGROUND: Andexanet alfa is a Gla-domainless FXa (GDXa) analog used as an antidote to FXa inhibitors. Despite its clinical use, laboratory monitoring for anti-Xa reversal and the effect of andexanet on fibrinolysis has not been explored. We used a GDXa with a serine-to-alanine mutation at position 195 (chymotrypsin numbering) to model the interaction between andexanet and apixaban. METHODS: Six batches of pooled plasma, and whole blood from healthy volunteers were treated with increasing concentrations of apixaban with/without GDXa...
September 9, 2023: Thrombosis Research
https://read.qxmd.com/read/37635060/andexanet-alfa-for-the-reversal-of-factor-xa-inhibitor-activity-prespecified-subgroup-analysis-of-the-annexa-4-study-in-japan
#5
JOURNAL ARTICLE
Kazunori Toyoda, Shuji Arakawa, Masayuki Ezura, Rei Kobayashi, Yoshihide Tanaka, Shu Hasegawa, Shigeo Yamashiro, Yoji Komatsu, Yuka Terasawa, Tomohiko Masuno, Hiroshi Kobayashi, Suzuko Oikawa, Masahiro Yasaka
AIMS: Andexanet alfa, a specific antidote to factor Xa (FXa) inhibitors, has been approved for clinical use in several countries, including Japan, based on the results from the phase 3 trial ANNEXA-4. W e aimed to assess the efficacy and safety of andexanet alfa treatment in FXa inhibitor-related acute major bleeding in patients enrolled for ANNEXA-4 in Japan. METHODS: This prespecified analysis included patients enrolled at Japanese sites in the prospective, open-label, single-arm ANNEXA-4 trial...
August 26, 2023: Journal of Atherosclerosis and Thrombosis
https://read.qxmd.com/read/37586394/-use-of-specific-antidotes-in-doac-associated-severe-gastrointestinal-bleeding-an-expert-consensus-antagonozation-of-direct-oral-anticoagulants-in-gastrointestinal-hemorrhages
#6
JOURNAL ARTICLE
Valentin Fuhrmann, Jürgen Koscielny, Thomas Vasilakis, Tilo Andus, Adam Herber, Stefano Fusco, Elke Roeb, Ingolf Schiefke, Jonas Rosendahl, Matthias Dollinger, Karel Caca, Frank Tacke
Gastrointestinal (GI) bleeding is one of the most common complications associated with the use of direct oral anticoagulants (DOAC). Clear algorithms exist for the emergency measures in (suspected) GI bleeding, including assessing the medication history regarding anti-platelet drugs and anticoagulants as well as simple coagulation tests during pre-endoscopic management. Platelet transfusions, fresh frozen plasma (FFP), or prothrombin complex concentrate (4F-PCC) are commonly used for optimizing the coagulation status...
August 16, 2023: Zeitschrift Für Gastroenterologie
https://read.qxmd.com/read/37427548/management-of-major-bleeding-for-anticoagulated-patients-in-the-emergency-department-an-european-experts-consensus-statement
#7
JOURNAL ARTICLE
Barbra Backus, Jan Beyer-Westendorf, Rick Body, Tobias Lindner, Martin Möckel, Vinay Sehgal, Adrian Parry-Jones, David Seiffge, Brian Gibler
An increasing number of patients presenting to the emergency department (ED) with life-threatening bleeding are using oral anticoagulants, such as warfarin, Factor IIa and Factor Xa inhibitors. Achieving rapid and controlled haemostasis is critically important to save the patient's life. This multidisciplinary consensus paper provides a systematic and pragmatic approach to the management of anticoagulated patients with severe bleeding at the ED. Repletion and reversal management of the specific anticoagulants is described in detail...
October 1, 2023: European Journal of Emergency Medicine: Official Journal of the European Society for Emergency Medicine
https://read.qxmd.com/read/37415195/extracorporeal-hemoadsorption-therapy-as-a-potential-therapeutic-option-for-rapid-removal-of-apixaban-in-high-risk-surgical-patients-a-case-report
#8
JOURNAL ARTICLE
Vittorio Dalmastri, Andrea Angelini, Vera Minerva, Melissa Ballarini, Francesco Grammatico, Paola Todeschini, Attilia Maria Pizzini, Mauro Silingardi, Gaetano La Manna
BACKGROUND: Apixaban is a non-vitamin K antagonist oral anticoagulant (NOACs) recently emerged as an effective alternative to conventional vitamin K antagonists (VKAs) in the treatment of several thromboembolic disorders. However, in case of overdose or in patients requiring emergency surgery there is a high bleeding rate and severe adverse side effects due to the absence of an antidote. There is promising data from in vitro and clinical studies, that certain antithrombotic agents (that is Rivaroxaban and Ticagrelor) have been successfully removed by the extracorporeal hemoadsorption therapy CytoSorb...
July 7, 2023: Journal of Medical Case Reports
https://read.qxmd.com/read/36802876/final-study-report-of-andexanet-alfa-for-major-bleeding-with-factor-xa-inhibitors
#9
MULTICENTER STUDY
Truman J Milling, Saskia Middeldorp, Lizhen Xu, Bruce Koch, Andrew Demchuk, John W Eikelboom, Peter Verhamme, Alexander T Cohen, Jan Beyer-Westendorf, C Michael Gibson, Jose Lopez-Sendon, Mark Crowther, Ashkan Shoamanesh, Michiel Coppens, Jeannot Schmidt, Pierre Albaladejo, Stuart J Connolly
BACKGROUND: Andexanet alfa is a modified recombinant inactive factor Xa (FXa) designed to reverse FXa inhibitors. ANNEXA-4 (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors) was a multicenter, prospective, phase-3b/4, single-group cohort study that evaluated andexanet alfa in patients with acute major bleeding. The results of the final analyses are presented. METHODS: Patients with acute major bleeding within 18 hours of FXa inhibitor administration were enrolled...
March 28, 2023: Circulation
https://read.qxmd.com/read/36599062/heparin-insensitivity-and-thrombotic-risk-associated-with-sequential-uses-of-prothrombin-complex-concentrate-and-andexanet-alfa-for-apixaban-reversal-during-acute-type-a-aortic-dissection-repair-a-case-report
#10
JOURNAL ARTICLE
Brian Brenner, Jessica Guerra, Campbell Williams, Keith Littlewood, John Kern, Kenichi Tanaka, John S McNeil, Venkat Mangunta
The management of patients on direct oral anticoagulants (DOACs) who require emergent cardiac surgery is slowly evolving. The introduction of andexanet alfa, a novel antidote for apixaban and rivaroxaban, added a specific reversal agent to our armamentarium, but its safety and efficacy are still being investigated. We report 2 patients on DOAC treatment who required emergency cardiac surgery. Both received perioperative andexanet alfa together with prothrombin complex concentrate (PCC) at some time during 6 hours before operative management...
November 1, 2022: A&A Practice
https://read.qxmd.com/read/36476125/differential-neutralization-of-apixaban-betrixaban-edoxaban-and-rivaroxaban-by-andexanet-alfa-as-measured-by-whole-blood-thromboelastographic-analysis
#11
JOURNAL ARTICLE
Siddharth Mehrotra, Debra Hoppensteadt, Walter Jeske, Fakiha Siddiqui, Omer Iqbal, Alfonso Tafur, Bruce Lewis, Mark Jaradeh, Bulent Kantarcioglu, Jawed Fareed
INTRODUCTION: The available oral anti-Xa agents are routinely used for the management of thrombotic disorders. A molecularly modified recombinant coagulation FXa, also known as Andexanet Alfa (AA), that has been developed as an antidote to neutralize the bleeding effects of oral FXa inhibitors, such as Apixaban and Rivaroxaban. MATERIALS AND METHODS: This study utilized thromboelastography (TEG 5000 Hemostasis System), to investigate the neutralizing effects of AA at different concentrations of oral FXa inhibitors measuring such parameters as R-Time, K-Time, Angle, and Max Amplitude (MA)...
2022: Clinical and Applied Thrombosis/hemostasis
https://read.qxmd.com/read/36305802/protocols-for-perioperative-management-of-direct-oral-anticoagulants-in-hospitals-opportunities-for-improvement
#12
JOURNAL ARTICLE
Darko Mitrovic, Margriet van Elp, Nic Veeger, Heleen Lameijer, Karina Meijer, Eric van Roon
OBJECTIVES: To investigate and describe the protocolized perioperative management in patient using DOACs in Dutch hospitals. METHODS: Between August and December 2020, a nationwide survey in 70 hospitals in the Netherlands was conducted. We asked hospital pharmacists to submit their protocols for perioperative management of DOAC (apixaban, dabigatran, edoxaban and rivaroxaban) users. The protocols were assessed for a number of parameters divided into categories: interruption and restart timetables DOACs for elective procedures, criteria for the start of an urgent procedure without antidotes, criteria for the use of antidotes and advised antidotes for urgent procedures...
October 28, 2022: Current Medical Research and Opinion
https://read.qxmd.com/read/35785621/management-of-urgent-invasive-procedures-in-patients-treated-with-direct-oral-anticoagulants-an-observational-registry-analysis
#13
JOURNAL ARTICLE
Alexandre Godon, Manon Gabin, Jerrold H Levy, Olivier Huet, Xavier Chapalain, Jean-Stéphane David, Charles Tacquard, Laurent Sattler, Vincent Minville, Vincent Mémier, Antonia Blanié, Thomas Godet, Marc Leone, Emmanuel De Maistre, Yves Gruel, Stéphanie Roullet, Céline Vermorel, Charles Marc Samama, Jean-Luc Bosson, Pierre Albaladejo
BACKGROUND: Patients treated with direct oral anticoagulants (DOACs) may require urgent procedures. Managing these patients is challenging due to different bleeding risks and may include laboratory testing, procedural delays, or haemostatic/reversal agent administration. OBJECTIVE: We evaluated management strategies and outcomes of urgent, non-haemostatic invasive procedures in patients treated with DOACs. METHODS AND RESULTS: In a descriptive cohort study, we prospectively evaluated 478 patients in the GIHP-NACO registry, from June 2013 to November 2015...
August 2022: Thrombosis Research
https://read.qxmd.com/read/35414442/prospective-cohort-study-on-the-use-of-low-molecular-weight-heparin-calibrated-anti-xa-assay-for-measurement-of-direct-oral-xa-inhibitors-in-ex-vivo-patient-samples
#14
JOURNAL ARTICLE
Ming Sheng Lim, Robert Hayes, Archna Sharma, Tanun Kitiponchai, Muhajir Mohamed, Simon Mcrae
Drug-specific anti-Xa chromogenic assays are recommended for measurement of direct anti-Xa inhibitor levels but are not routinely available in many institutions. We performed a prospective study to determine: (1) the relationship between low molecular weight heparin (LMWH) calibrated anti-Xa measurements and apixaban or rivaroxaban levels measured using drug-specific anti-Xa assays and, (2) if a LMWH calibrated anti-Xa assay can be used to detect clinically significant apixaban or rivaroxaban levels. Haematology outpatients on rivaroxaban or apixaban for at least 72 h were recruited for this study...
April 9, 2022: Pathology
https://read.qxmd.com/read/34984316/measurement-of-anticoagulation-in-patients-on-dabigatran-rivaroxaban-and-apixaban-therapy-by-novel-automated-thrombelastography
#15
JOURNAL ARTICLE
Ramin Artang, Joao D Dias, Mark Walsh, Kevin Bliden, Jorn D Nielsen, Maren Anderson, Brian C Thurston, Udaya S Tantry, Jan Hartmann, Paul A Gurbel
Background  Direct-acting oral anticoagulants (DOACs) do not require monitoring. Measurement of DOAC effect would be useful in the event of bleeding, trauma, and thromboembolism while on anticoagulation. We evaluated the effectiveness of the investigational DOAC assays on the TEG®6s Hemostasis Analyzer to assess the anticoagulant effect of DOACs in patients treated for atrial fibrillation or deep vein thrombosis (DVT). Methods  Patients on treatment for a minimum of 7 days with standard doses of dabigatran, rivaroxaban, and apixaban were included...
October 2021: TH Open: Companion Journal to Thrombosis and Haemostasis
https://read.qxmd.com/read/34645283/hematoma-expansion-and-clinical-outcomes-in-patients-with-factor-xa-inhibitor-related-atraumatic-intracerebral-hemorrhage-treated-within-the-annexa-4-trial-versus-real-world-usual-care
#16
MULTICENTER STUDY
Hagen B Huttner, Stefan T Gerner, Joji B Kuramatsu, Stuart J Connolly, Jan Beyer-Westendorf, Andrew M Demchuk, Saskia Middeldorp, Elena Zotova, Julia Altevers, Frank Andersohn, Mary J Christoph, Patrick Yue, Leonhard Stross, Stefan Schwab
BACKGROUND AND PURPOSE: It is unestablished whether andexanet alfa, compared with guideline-based usual care including prothrombin complex concentrates, is associated with reduced hematoma expansion (HE) and mortality in patients with factor-Xa inhibitor-related intracerebral hemorrhage (ICH). We compared the occurrence of HE and clinical outcomes in patients treated either with andexanet alfa or with usual care during the acute phase of factor-Xa inhibitor-related ICH. METHODS: Data were extracted from the multicenter, prospective, single-arm ANNEXA-4 trial (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors) and a multicenter observational cohort study, RETRACE-II (German-Wide Multicenter Analysis of Oral Anticoagulant-Associated Intracerebral Hemorrhage - Part Two)...
February 2022: Stroke; a Journal of Cerebral Circulation
https://read.qxmd.com/read/34534272/ciraparantag-reverses-the-anticoagulant-activity-of-apixaban-and-rivaroxaban-in-healthy-elderly-subjects
#17
RANDOMIZED CONTROLLED TRIAL
Jack Ansell, Sasha Bakhru, Bryan E Laulicht, Gregory Tracey, Stephen Villano, Daniel Freedman
AIMS: Ciraparantag is a reversal agent for anticoagulants including direct oral anticoagulants. The aim was to evaluate the efficacy and safety of ciraparantag to reverse anticoagulation induced by apixaban or rivaroxaban in healthy elderly adults. METHODS AND RESULTS: Two randomized, placebo-controlled, dose-ranging trials conducted in healthy subjects aged 50-75 years. Subjects received apixaban (Study 1) 10 mg orally twice daily for 3.5 days or rivaroxaban (Study 2) 20 mg orally once daily for 3 days...
March 7, 2022: European Heart Journal
https://read.qxmd.com/read/34060371/investigation-of-the-optimal-dose-apcc-in-reversing-the-effect-of-factor-xa-inhibitors-an-in-vitro-study
#18
JOURNAL ARTICLE
Nina Haagenrud Schultz, Jawed Fareed, Pål Andre Holme
Factor (F) Xa inhibitors are safe and effective alternatives to warfarin. There are concerns about the lack of a reversal strategy in case of serious bleeds or need for emergency surgery in situations when the antidote andexanet alfa is not available. Factor concentrates are widely used, but there are few clinical studies regarding the reversal effect of activated prothrombin complex concentrate (aPCC). Because of the feared thrombogenicity, administration of the lowest effective dose would be desirable. To determine the lowest concentration of aPCC sufficient to reverse the effect of rivaroxaban and apixaban...
January 2021: Clinical and Applied Thrombosis/hemostasis
https://read.qxmd.com/read/33966491/hemostatic-efficacy-and-anti-fxa-factor-xa-reversal-with-andexanet-alfa-in-intracranial-hemorrhage-annexa-4-substudy
#19
JOURNAL ARTICLE
Andrew M Demchuk, Patrick Yue, Elena Zotova, Juliet Nakamya, Lizhen Xu, Truman J Milling, Tomoyuki Ohara, Joshua N Goldstein, Saskia Middeldorp, Peter Verhamme, Jose Luis Lopez-Sendon, Pamela B Conley, John T Curnutte, John W Eikelboom, Mark Crowther, Stuart J Connolly
[Figure: see text].
June 2021: Stroke; a Journal of Cerebral Circulation
https://read.qxmd.com/read/33843267/factor-viii-inhibitor-bypassing-activity-feiba-reversal-for-apixaban-and-rivaroxaban-in-patients-with-acute-intracranial-and-nonintracranial-hemorrhage
#20
JOURNAL ARTICLE
Aleah R Hunt, Shawn N Coffeen, Dane L Shiltz, Calvin Ice, Jessi Parker
BACKGROUND: The clinical use of factor VIII inhibitor bypassing activity (FEIBA) for factor Xa (FXa) inhibitor reversal is derived from small studies with notable variation in patient eligibility for use, dosage regimens, concurrent supportive care, and outcome measures. Consequently, additional effectiveness and safety data are warranted to expand the literature evaluating FEIBA for FXa inhibitor reversal. OBJECTIVE: This study sought to determine the incidence of observed effective hemostasis within 24 hours of post-FEIBA® administration as well as in-hospital and 30-day post-discharge incidences of thromboembolic event (TEE) and mortality between apixaban and rivaroxaban in the intracranial hemorrhage (ICH) and non-ICH populations...
April 10, 2021: Annals of Pharmacotherapy
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