My name is Gordon Tomaselli. I am the Marilyn and Stanley M. Katz Dean of the Albert Einstein College of Medicine, as well as the Chief Academic Officer of Montefiore Medicine.
On this episode of Clot Chronicles, I’ll be discussing the 2020 Update of the Expert Consensus Decision Pathway on the Management of Bleeding in Patients on Oral Anticoagulants, which was published in July of this year. First, I want to thank all my coauthors on this document, in particular Dr. Ken Mahaffey at Stanford University, and the ACC staff, particularly Ashley Covington, without whom this document would never have taken place.
So, maybe the first question is what’s the need here? So the development of new oral anticoagulants and reversal agents in an environment of ever-increasing use and indications for anticoagulation really is the need. This ECDP focuses on bleeding management in patients treated with these drugs for any indication. Some of the key points are simplified classification of bleeding into major—that is those with hemodynamic compromise at an anatomically critical site or with a hemoglobin drop of 2 grams per deciliter or transfusion requirement of >2 units—and non-major categories to help direct decisions about temporary or even permanent interruption of anticoagulation. It also helps to direct decisions about the acute management of bleeding, decisions regarding the use of reversal agents—most recently, factor Xa inhibitors—and reinstitution of anticoagulation therapy when that’s appropriate.
When we put this document together, there were several assumptions. One, that acute bleeds should undergo standard resuscitative measures. Both vitamin K antagonists as well as direct oral anticoagulants (DOACs) are considered in this document. And the specific agents that we considered are, obviously, warfarin and coumadin, and DOACs – apixaban, betrixaban, dabigatran, edoxaban, and rivaroxaban.
And the reversal strategies and agents that we consider are prothrombin complex concentrates (PCCs), plasma, idarucizumab for dabigatran, andexanet alfa for apixaban or rivaroxaban. The other thing that we thought was important is that in managing these patients, engaging of experts is expected, and all decision-making should be shared with patients and families.
So, perhaps, the most efficient way to summarize this is to walk you through the graphical summary, Figure 1 of this document, which actually takes the reader through the hierarchal decision tree and treatment algorithm. The topline determination in this algorithm is whether a bleed is major or non-major. If it’s the latter, then a series of questions regarding the need for intervention and hospitalization directs the need and question of whether or not anticoagulation should be interrupted.
Implicit in this question is what was the original underlying indication for the patient to be anticoagulated? If there is a need for interruption of therapy, then considerations regarding resuming anticoagulation are also addressed. Again here, the indication is central to answering this question.
On the other side of this diagram addresses situation when the bleed is considered major. Invariably under these circumstances, anticoagulation is interrupted or permanently terminated depending on the ability to acutely control bleeding and the risk of continued bleeding. The ability to acutely control bleeding drives decisions about reversal strategies using either blood products, vitamin K, or specific reversal agents.
Finally, the specific details regarding the nature of the bleed, the ability and durability of control of that bleeding, as well as the risk of rebleeding and additionally planned therapies that patient might be undergoing inform the decision whether or not to restart anticoagulation and the timing of that restart.
So, I think this document guides the reader in a fairly detailed fashion through an assessment of the severity of bleeding, the monitoring of DOACs, and the limitations of quantitative assessment of the action of these agents, as well as the strategies for reversal of anticoagulation and considerations for restart.
You might ask if we just published this document in 2017, what’s new since then? Well, we felt the need to do this because of the emergence of new oral anticoagulants for use in the prevention of venous thromboembolism and atrial fibrillation, as well as the introduction of new reversal strategies, particularly those directed at activated factor X.
So, thank you for your time and consideration.