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  • br Place in Therapy In the case of

    2022-05-20


    Place in Therapy In the case of minor bleeding, the anticoagulant effects of all FXa inhibitors except betrixaban, which has a longer half-life, will diminish within 24-48 hours of discontinuation of the drug provided the patient has normal renal function. In these cases stopping the FXa inhibitor is often all that is needed to resolve a minor bleed. Bleeding associated with hemodynamic compromise, occurring in a critical site, associated with a decrease in Aurora Kinase Inhibitor III of ≥2 gm/dL, or requiring a transfusion is defined as a major bleed, and patients with such bleeding can be considered for the Aurora Kinase Inhibitor III administration of a reversal agent along with local hemostatic and supportive measures. Andexanet alfa represents the first in its class for reversing the effects of FXa inhibitors. The current FDA approval is for the reversal of apixaban and rivaroxaban only when a patient experiences uncontrolled major or life-threatening bleeding. Current ongoing trials evaluating the reversal effects of andexanet alfa include edoxaban and enoxaparin.
    Conclusion Despite the advantages of efficacy, safety, and ease of using direct oral anticoagulants over warfarin, patients in the United States are prescribed these agents less frequently than warfarin, although prescription rates are increasing. Regardless, the use of FXa inhibitors, including apixaban and rivaroxaban, is greater than the use of dabigatran in the United States despite the availability of idarucizumab, a reversal agent for dabigatran that has been available since 2015. Although rare, the consequences of a major bleed from direct oral anticoagulants can be severe, and the addition of another reversal agent for these agents will increase the safety of patients who require reversal while receiving FXa inhibitors because of acute uncontrolled or life-threatening major bleeding events. Andexanet alfa represents an advancement in this area and is the first reversal agent for apixaban and rivaroxaban in the case of uncontrolled major or life-threatening bleeding.
    Introduction These past years Direct Oral Anti-Coagulants (DOACs), targeted to Thrombin or to Factor Xa, have been introduced and they greatly facilitate the daily treatment of all relevant patients, many of them on lifelong therapy [1], [2], [3], [4]. These DOACs present important advantages over the use of oral Vitamin K Antagonist (VKA) treatments, especially because they have no or little food interaction, little interference with drugs, present a wide therapeutic window, do not need adjustment for age, gender or weight, (except in some extreme circumstances such as a very low weight <40 kg or obesity >120 kg, or when liver or kidney failure is present), and they do not usually need monitoring, except in some specific contexts where the patient is exposed to a high risk of bleeding [5], [6], [7], [8], [9], [10]. Adjusted therapeutic protocols and dosages are developed for Asian countries, as Asians tend to have a greater propensity to develop intra-cranial bleeding, especially with VKA treatments, and DOACs reduce that incidence [11], [12], but this is still a matter of debate for implementing the best comprise, which ensures the highest antithrombotic efficacy, with the lowest incidence of bleeding risk and side effects. These DOACs are released for many curative or preventive thrombo-embolic indications, and they are increasingly used for prevention of stroke in patients with nonvalvular atrial fibrillation, which includes a large cohort of patients, which is constantly expanding due to population aging [5], [6], [8], [9], [10]. Dabigatran (Pradaxa®, or Prazaxa® in Japan) is the sole Direct Thrombin Inhibitor (DTI) available today [6], whilst 3 different Direct Factor Xa Inhibitors (DiXaIs) are or are being introduced in most countries: Rivaroxaban (Xarelto®), Apixaban (Equalis®) or Edoxaban (Lixiana®) are now available for clinical application [13], [14], [15], [16], [17], [18] and others are under current development (Betrixaban).