Recently-approved treatments prompted an update to American College of Cardiology (ACC) guidance on managing bleeding in patients on oral anticoagulation.
New guidance included the consideration of bleeding on newer oral anticoagulants, such as the factor Xa inhibitor betrixaban (Bevyxxa) approved by the FDA in 2017.
In addition, the updated ACC Expert Consensus Decision Pathway (ECDP) -- published online Tuesday in the -- endorses andexanet alfa (Andexxa), approved in 2018, as a factor Xa inhibitor reversal strategy.
Andexanet alfa is "preferable to for treatment of patients with major bleeding on oral direct [factor Xa] inhibitors," according to the authors, headed by Gordon Tomaselli, MD, of Albert Einstein College of Medicine in New York City. They cited the positive ANNEXA-4 study that showed reversal of anticoagulant effect and evidence of clinical hemostasis in people who received andexanet alfa.
As in the original , the latest ECDP outlines how to assess and identify severity of bleeding, manage and control bleeding, and determine whether and when to restart anticoagulation.
"It is anticipated that as the population continues to age, more people will be treated with oral anticoagulants. As more evidence is generated from ongoing research and clinical practice, further refinement to this ECDP will be needed," they said.
A randomized trial is investigating the reversal agent in patients with acute intracranial hemorrhage who had taken an oral factor Xa inhibitor. And a novel reversal agent, ciraparantag, is in early development, the document noted.
Meanwhile, providers should "seek input from the appropriate specialists when indicated and involve the patient and/or family in shared decision making when possible," Tomaselli's group noted.
Disclosures
Tomaselli had no conflicts of interest.
Primary Source
Journal of the American College of Cardiology
Tomaselli GF, et al "2020 ACC Expert Consensus Decision Pathway on management of bleeding in patients on oral anticoagulants" J Am Coll Cardiol 2020; DOI: 10.1016/j.jacc.2020.04.053.