ACC Issues Guidance for Managing Bleeds From Oral Anticoagulants

Marlene Busko

December 13, 2017

WASHINGTON, DC — The American College of Cardiology (ACC) has issued an expert consensus document, with "decision pathways" to guide clinicians in the management of major or minor bleeding in patients on oral anticoagulants[1].

The document, published in the December 19, 2017 issue of the Journal of the American College of Cardiology, complements the 2017 ACC expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation[2].

"The primary objective of this decision pathway is to provide a clinically applicable, easily referenced conceptual framework to support clinician decision making while caring for patients with bleeding complications during [oral anticoagulant] therapy," writing committee chair Dr Gordon F Tomaselli (Johns Hopkins School of Medicine, Baltimore, MD) states.

"The manuscript really helps to come up with decision pathways in first assessing the level of severity of the bleed, understanding how to use reversal agents, when to restart your anticoagulation, and how to do that," writing committee member Dr Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York City) told theheart.org | Medscape Cardiology.

"We did talk a lot about the [direct oral anticoagulants] DOACs—when the special assays are available and when they're not and what to do as far as lab measurements," she added, and the document also has an "important section on clinician-patient discussion."

Six easy-to-follow sequential treatment algorithms and seven comprehensive tables accompany the text.

"One of the nice things about [this guidance] is that it really does give you great graphics of how to go from one step to the next, by answering questions 'yes' or 'no' and moving into the different algorithm," Mehran said. "That's the most unique portion of this important document."

The document addresses bleeding that arises from treatment with a DOAC—dabigatran (Pradaxa, Boehringer Ingelheim), rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals), apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), or edoxaban (Savaysa/Lixiana, Daiichi Sankyo)—or a vitamin K antagonist (warfarin), for any indication, including atrial fibrillation (AF) in the absence of a prosthetic valve or venous thromboembolism.

Major bleeding is defined as "bleeding that is associated with hemodynamic compromise, occurs in an anatomically critical site, requires transfusion (>2 U of packed red blood cells), or results in a hemoglobin drop >2 g/dL."

All other bleeding is defined as nonmajor bleeding.

"The assessment of bleed severity in patients treated with OACs and/or antiplatelet therapy is crucial for treatment decisions to achieve hemostasis and preserve organ function," the document stresses.

"Measurement of anticoagulant activity is a key step in the evaluation of an anticoagulated patient who presents with clinically relevant bleeding," they add, going on to describe how to do this.

Patients taking a vitamin K antagonist may be evaluated with the prothrombin time/international normalized ratio (INR). The best tests for assessing the anticoagulant activity of dabigatran include the dilute thrombin time, ecarin clotting time, and ecarin chromogenic assay; and the preferred test for assessing apixaban, edoxaban, and rivaroxaban is a chromogenic anti-Xa assay, but these tests are not widely available.

The authors provide two tables with suggestions for lab measurement of DOACs, when specialized assays are available and when they are not.

They go on to provide a detailed explanation of how to manage major bleeds and minor bleeds and then discuss OAC reversal strategies.

"In a life-threatening or critical site bleed or in situations in which bleeding cannot be controlled, reversal of OACs is required," they write. Reversal agents include repletion strategies such a prothrombin complex concentrate, plasma, vitamin K, and idarucizumab (Praxbind, Boehringer Ingelheim) for dabigatran.

The document describes considerations for restarting and for delaying anticoagulation.

"Optimal patient engagement in the decision to restart anticoagulation involves shared decision-making with patients and care providers," they stress, and in a table they summarize what to discuss.

The expert consensus also covers medications that increase the risk of a bleeding event; gastrointestinal bleeding; intracranial hemorrhage (the most feared complication of anticoagulation therapy); and restarting anticoagulation after a surgery or procedure.

The ACC has two related free apps for clinicians, Mehran points out.

The updated AnticoagEvaluator app is designed to help clinicians make informed decisions about antithrombotic therapy for patients with nonvalvular AF, and the BridgeAnticoag app is designed manage anticoagulation around an invasive procedure for a patient with nonvalvular AF.  

"Patients who require anticoagulation are an at-risk patient population," she said, "and I think improving the quality of their health outcomes . . . is crucially important, so this expert document in the important decision pathways will hopefully help develop that."

Tomaselli has no relevant financial relationships. Mehran is a consultant for Janssen Pharmaceuticals and has received research funding from AstraZeneca, Bristol Myers Squibb, and CSL Behring. Disclosures for the coauthors are listed in the paper.

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