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https://www.readbyqxmd.com/read/27913536/reversal-of-direct-oral-anticoagulants-a-practical-approach
#1
Andrew W Shih, Mark A Crowther
Direct oral anticoagulants (DOACs) have at least noninferior efficacy compared with other oral anticoagulants and have ancillary benefits, including overall better safety profiles, lack of the need for routine monitoring, rapid onset of action, and ease of administration. Reversal of these agents may be indicated in certain situations such as severe bleeding and for perioperative management. DOAC-associated bleeding should be risk stratified: patients with moderate or severe bleeding should have the DOAC discontinued and reversal strategies should be considered...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/27895055/role-of-agents-for-reversing-the-effects-of-target-specific-oral-anticoagulants
#2
REVIEW
Tanya R Riley, Mary L Gauthier-Lewis, Chelsea K Sanchez, Janine S Douglas
PURPOSE: The available clinical data on target-specific oral anticoagulant (TSOAC) reversal agents that are currently in development or have been approved by the Food and Drug Administration (FDA) are reviewed. SUMMARY: The development of TSOACs such as dabigatran, rivaroxaban, edoxaban, and apixaban has presented benefits and new challenges. One of the main challenges associated with the use of TSOACs is the lack of suitable agent-specific reversal agents. Several treatment options for the management of life-threatening bleeding events associated with TSOAC use, such as fresh frozen plasma, prothrombin complex concentrates, and recombinant coagulation factor VIIa, have been used, with inconsistent results...
November 28, 2016: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/27851343/1708-emergent-reversal-of-apixaban-with-andexanet-alfa-to-facilitate-debridement-of-necrotizing-fasciitis
#3
John Fletcher, John Graybill, Carlos Alphonso, Truman Milling, Andrew Cap, Kevin Akers
No abstract text is available yet for this article.
December 2016: Critical Care Medicine
https://www.readbyqxmd.com/read/27789605/reversal-of-anticoagulation-and-management-of-bleeding-in-patients-on-anticoagulants
#4
Prajwal Dhakal, Supratik Rayamajhi, Vivek Verma, Krishna Gundabolu, Vijaya R Bhatt
Bleeding is the most common complication of all anticoagulants. Any bleeding patient on an anticoagulant should be risk-stratified based on hemodynamic instability, source of bleeding, and degree of blood loss. Although minor bleed may be managed with discontinuation of anticoagulant, major bleed may require transfusion of blood products and use of specific antidote. The residual effects of each anticoagulant may be monitored with distinct coagulation assay. Intravenous or oral vitamin K can reverse the effect of warfarin within 24 to 48 hours and is indicated for any bleeding, international normalized ratio of >10 or 4...
October 26, 2016: Clinical and Applied Thrombosis/hemostasis
https://www.readbyqxmd.com/read/27778054/-comment-on-andexanet-alfa-for-acute-major-bleeding-associated-with-factor-xa-inhibitors
#5
H Lier, O Grottke
No abstract text is available yet for this article.
October 24, 2016: Der Anaesthesist
https://www.readbyqxmd.com/read/27697443/preclinical-and-clinical-data-for-factor-xa-and-universal-reversal-agents
#6
Truman J Milling, Scott Kaatz
Oral Factor Xa (FXa) inhibitors, a growing class of direct-acting anticoagulants, are frequently used to prevent stroke and systemic embolism in patients with atrial fibrillation and to prevent and treat venous thromboembolism. These drugs reduce the risk of clotting at the expense of increasing the risk of bleeding, and currently they have no specific reversal agent. However, andexanet alfa, a recombinant modified FXa decoy molecule, is in a late-phase clinical trial in bleeding patients, and ciraparantag, a small molecule that appears to reverse many anticoagulants including the FXa inhibitors, is in development...
September 28, 2016: American Journal of Emergency Medicine
https://www.readbyqxmd.com/read/27697442/discontinuation-and-management-of-direct-acting-anticoagulants-for-emergency-procedures
#7
Jerrold H Levy
Patients taking direct oral anticoagulants (DOACs) who then need an emergency invasive procedure require specialized management strategies. Appropriate patient evaluation includes assessment of the current anticoagulation state, including timing of the last dose. DOACs require particular coagulation assays to measure anticoagulation levels accurately, although standard coagulation screening tests may provide qualitative guidance. Specialty societies have endorsed general recommendations for patient management to promote hemostasis in anticoagulated patients requiring surgery or other invasive procedures...
September 29, 2016: American Journal of Emergency Medicine
https://www.readbyqxmd.com/read/27697438/idarucizumab-and-factor-xa-reversal-agents-role-in-hospital-guidelines-and-protocols
#8
Menno V Huisman, John Fanikos
As expected with all antithrombotic agents, there is a risk of bleeding complications in patients receiving direct oral anticoagulants (DOACs) because of the DOAC itself, acute trauma, invasive procedures, or underlying comorbidities. For many bleeding events, a prudent course of action will be to withdraw the DOAC, then "wait and support" the patient, with the expectation that the bleeding event should resolve with time. Likewise, DOAC therapy may be interrupted ahead of a planned procedure, the stopping time being dependent on the agent involved and the patient's renal function...
September 28, 2016: American Journal of Emergency Medicine
https://www.readbyqxmd.com/read/27695508/reversal-agents-of-non-vitamin-k-dependent-anticoagulants-a-rapid-review-of-the-changing-horizon
#9
Supreet Kaur, Abhishek Kumar, Robert G Lerner, Wilbert S Aronow
The newer non-vitamin K dependent anticoagulants (NOACs) have provided a new tool in the armamentarium of physicians treating nonvalvular atrial fibrillation and thromboembolism. Slowly, but steadily, there has been an increased preference of NOACs over vitamin K antagonists. However, the major limiting factor and the concern that precluded their use was lack of reversal in emergent situations. With the advent of reversal agents such as idarucizumab, andexanet alfa and PER977, this gap is also being filled...
October 1, 2016: Archives of Medical Science: AMS
https://www.readbyqxmd.com/read/27659071/nonvitamin-k-antagonist-oral-anticoagulant-activity-challenges-in-measurement-and-reversal
#10
Karen S Brown, Hamim Zahir, Michael A Grosso, Hans J Lanz, Michele F Mercuri, Jerrold H Levy
BACKGROUND: Four nonvitamin K antagonist oral anticoagulants (NOACs) are approved for the prevention of stroke in patients with nonvalvular atrial fibrillation and for the treatment of venous thromboembolism. These include the direct thrombin inhibitor dabigatran and the direct factor Xa inhibitors rivaroxaban, apixaban, and edoxaban. Bleeding is a complication for all anticoagulants and concerns regarding bleeding risk and the suitability of effective reversal strategies may be a barrier to their prescription...
September 23, 2016: Critical Care: the Official Journal of the Critical Care Forum
https://www.readbyqxmd.com/read/27575436/preclinical-and-clinical-data-for-factor-xa-and-universal-reversal-agents
#11
Truman J Milling, Scott Kaatz
Oral Factor Xa (FXa) inhibitors, a growing class of direct-acting anticoagulants, are frequently used to prevent stroke and systemic embolism in patients with atrial fibrillation and to prevent and treat venous thromboembolism. These drugs reduce the risk of clotting at the expense of increasing the risk of bleeding, and currently they have no specific reversal agent. However, andexanet alfa, a recombinant modified FXa decoy molecule, is in a late-phase clinical trial in bleeding patients, and ciraparantag, a small molecule that appears to reverse many anticoagulants including the FXa inhibitors, is in development...
November 2016: American Journal of Medicine
https://www.readbyqxmd.com/read/27573206/andexanet-alfa-for-acute-major-bleeding-associated-with-factor-xa-inhibitors
#12
Stuart J Connolly, Truman J Milling, John W Eikelboom, C Michael Gibson, John T Curnutte, Alex Gold, Michele D Bronson, Genmin Lu, Pamela B Conley, Peter Verhamme, Jeannot Schmidt, Saskia Middeldorp, Alexander T Cohen, Jan Beyer-Westendorf, Pierre Albaladejo, Jose Lopez-Sendon, Shelly Goodman, Janet Leeds, Brian L Wiens, Deborah M Siegal, Elena Zotova, Brandi Meeks, Juliet Nakamya, W Ting Lim, Mark Crowther
Background Andexanet alfa (andexanet) is a recombinant modified human factor Xa decoy protein that has been shown to reverse the inhibition of factor Xa in healthy volunteers. Methods In this multicenter, prospective, open-label, single-group study, we evaluated 67 patients who had acute major bleeding within 18 hours after the administration of a factor Xa inhibitor. The patients all received a bolus of andexanet followed by a 2-hour infusion of the drug. Patients were evaluated for changes in measures of anti-factor Xa activity and were assessed for clinical hemostatic efficacy during a 12-hour period...
September 22, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27569675/discontinuation-and-management-of-direct-acting-anticoagulants-for-emergency-procedures
#13
Jerrold H Levy
Patients taking direct oral anticoagulants (DOACs) who then need an emergency invasive procedure require specialized management strategies. Appropriate patient evaluation includes assessment of the current anticoagulation state, including timing of the last dose. DOACs require particular coagulation assays to measure anticoagulation levels accurately, although standard coagulation screening tests may provide qualitative guidance. Specialty societies have endorsed general recommendations for patient management to promote hemostasis in anticoagulated patients requiring surgery or other invasive procedures...
November 2016: American Journal of Medicine
https://www.readbyqxmd.com/read/27569673/idarucizumab-and-factor-xa-reversal-agents-role-in-hospital-guidelines-and-protocols
#14
Menno V Huisman, John Fanikos
As expected with all antithrombotic agents, there is a risk of bleeding complications in patients receiving direct oral anticoagulants (DOACs) because of the DOAC itself, acute trauma, invasive procedures, or underlying comorbidities. For many bleeding events, a prudent course of action will be to withdraw the DOAC, then "wait and support" the patient, with the expectation that the bleeding event should resolve with time. Likewise, DOAC therapy may be interrupted ahead of a planned procedure, the stopping time being dependent on the agent involved and the patient's renal function...
November 2016: American Journal of Medicine
https://www.readbyqxmd.com/read/27436881/management-of-bleeding-with-non-vitamin-k-antagonist-oral-anticoagulants-in-the-era-of-specific-reversal-agents
#15
Christian T Ruff, Robert P Giugliano, Elliott M Antman
Vitamin K antagonists are commonly used by clinicians to provide anticoagulation to patients who have or are at risk of having thrombotic events. In addition to familiarity with the dosing and monitoring of vitamin K antagonists, clinicians are accustomed to using vitamin K if there is a need to reverse the anticoagulant effect of vitamin K antagonists. There are now 4 new non-vitamin K antagonist oral anticoagulants (NOACs) that are attractive alternatives to vitamin K antagonists. Despite similar or lower rates of serious bleeding with NOACs in comparison with warfarin, there is a pressing need for strategies to manage bleeding when it does occur with NOACs and to reverse the pharmacological effect of these agents if needed...
July 19, 2016: Circulation
https://www.readbyqxmd.com/read/27399455/176%C3%A2-andexanet-alfa-an-investigational-universal-antidote-for-reversal-of-anticoagulation-of-factor-xa-inhibitors-in-healthy-human-volunteers
#16
Florie Mar, Mark Crowther, Alex Gold, Genmin Lu, Janet Leeds, Brian Wiens, Vandana Mathur, Janice Castillo, Pamela Conley, Stuart Connolly, John Curnutte
INTRODUCTION: Direct FXa inhibitors have demonstrated convincing anticoagulant efficacy. However, risk of major bleeding is a concern and no specific antidotes are available for reversal. Andexanet alfa (AnXa), a recombinant modified FXa, is an investigational specific antidote for FXa inhibitors. We report data from the ANNEXA"! Phase 3 registration studies in older healthy subjects anticoagulated with apixaban (apix) or rivaroxaban (riva). METHODS: ANNEXA A&R were 2 phase 3, randomized, double-blind, placebo-controlled studies of AnXa in healthy subjects age 50 to 75 administered either apixaban or rivaroxaban...
August 2016: Neurosurgery
https://www.readbyqxmd.com/read/27351643/which-antidotes-are-available-for-the-novel-oral-anticoagulants
#17
Rebekah Thomas, Renzo Gonzalez
Use of novel (or target-specific) oral anticoagulants continues to increase. This article reviews idarucizumab and andexanet alfa, two antidotes that can be used to reverse anticoagulation in patients needing emergency surgery or with life-threatening bleeding.
July 2016: JAAPA: Official Journal of the American Academy of Physician Assistants
https://www.readbyqxmd.com/read/27277596/a-review-of-the-key-clinical-trials-of-2015-results-and-implications
#18
Claire McCune, Peter McKavanagh, Ian B A Menown
INTRODUCTION: Multiple significant, potentially practice changing clinical trials in cardiology have been conducted and subsequently presented throughout the past year. METHODS: In this paper, the authors have reviewed and contextualized significant cardiovascular clinical trials presented at major international conferences of 2015 including American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, American Diabetes Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, Heart Rhythm Congress, and the American Heart Association Scientific Sessions...
June 8, 2016: Cardiology and Therapy
https://www.readbyqxmd.com/read/27268941/an-algorithmic-approach-to-management-of-venous-thromboembolism
#19
Prajwal Dhakal, Krishna Gundabolu, Vijaya R Bhatt
Venous thromboembolism (VTE) is associated with significant morbidity and mortality. Factors such as the presence of transient risk factors for VTE, risk of bleeding, and location of deep vein thrombosis (DVT) determine the duration of anticoagulation. Extended anticoagulation is offered to patients with unprovoked pulmonary embolism (PE) or proximal DVT and a low risk of bleeding. Anticoagulation for 3 months is advised in patients with provoked DVT or PE, high risk of bleeding, and isolated distal or upper extremity DVT...
June 5, 2016: Clinical and Applied Thrombosis/hemostasis
https://www.readbyqxmd.com/read/27223896/the-toxicology-of-heparin-reversal-with-protamine-past-present-and-future
#20
Emilia Sokolowska, Bartlomiej Kalaska, Joanna Miklosz, Andrzej Mogielnicki
INTRODUCTION: Unfractionated heparin is a strongly anionic anticoagulant used extensively in medicine to prevent blood clotting. In the case of an emergency bleeding in response to heparin, the protamine sulfate is administered. Despite its extensive clinical use, protamine may produce life-threatening side effects such as systemic hypotension, catastrophic pulmonary vasoconstriction or allergic reactions. Recent studies have demonstrated new organ-specific complications of the heparin reversal with protamine...
August 2016: Expert Opinion on Drug Metabolism & Toxicology
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