ACC: Risk assessment, shared decision-making ideal for bleeding from oral anticoagulants
Click Here to Manage Email Alerts
Cardiologists should assess bleeding events in patients taking oral anticoagulation and discuss with them the best approach to minimize future risk, according to an American College of Cardiology expert consensus decision pathway.
This document published in the Journal of the American College of Cardiology serves as an update to the 2017 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants.
“The intent of this document was to provide a framework for clinical decision making around the management of bleeding for those on oral anticoagulant therapy,” Ty J. Gluckman, MD, FACC, FAHA, medical director of the Center for Cardiovascular Analytics, Research and Data Science (CARDS) at the Providence Heart Institute at Providence St. Joseph Health in Portland, Oregon, chair of the solution set oversight committee and Cardiology Today Next Gen Innovator, told Healio.
Bleeding severity assessment
Assessment of bleeding severity, which should be done promptly and repeated often, should determine treatment decisions to preserve organ function and achieve hemostasis, Gordon F. Tomaselli, MD, FACC, FAHA, FHRS, professor in the department of medicine (cardiology), executive vice president and chief academic officer of Montefiore Medicine and The Marilyn and Stanley M. Katz Dean at Albert Einstein College of Medicine and chair of the writing committee, and colleagues wrote in the document. Major bleeding is defined as meeting one or more of the following factors: bleeding in a critical site, hemodynamic instability or overt bleeding with a hemoglobin drop of 2 g/dL or more, or administration of two or more units of packed red blood cells. Patients who do not meet these criteria are considered to have a nonmajor bleeding event.
Laboratory measurements can help determine anticoagulant activity in patients with clinically relevant bleeding or require an urgent unplanned procedure. Several measurements of interest include prothrombin time, activated partial thromboplastin time. Patients taking a vitamin K antagonist should be evaluated with the prothrombin time/INR, whereas those taking dabigatran (Pradaxa, Boehringer Ingelheim) should have ecarin clotting time, dilute thrombin time and ecarin chromogenic assay assessed. If these are not available for those taking dabigatran, thrombin time and activated partial thromboplastin time can be used.
A chromogenic anti-factor-Xa assay is the preferred test for those taking edoxaban (Savaysa, Daiichi Sankyo), apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto, Janssen). This may also be used in patients taking betrixaban (Bevyxxa, Portola Pharmaceuticals), although the test would need to be modified to achieve appropriate sensitivity, according to the document. Prothrombin time can be used if an anti-factor-Xa assay is not available for patients taking edoxaban, betrixaban and rivaroxaban.
Patients with major bleeds should stop taking anticoagulants and antiplatelet agents, in addition to securing access to large-bore IV and the airway. Although oral anticoagulant reversal is recommended if an agent is available for most patients, that should not delay resuscitation and local hemostatic measures. The document also recommends early involvement of appropriate services such as interventional radiology and surgery for definitive bleeding management, especially for patients with bleeding at critical sites. Blood product transfusion and other supportive measures should be administered when appropriate.
Although local measures should still be taken to control nonmajor bleeds, patients with these particular events should not receive routine reversal of oral anticoagulation, according to the document. Instead, these patients should have temporary discontinuation of oral anticoagulation therapy until they achieve hemostasis and they are clinically stable. This should also include discussion with the patient and/or family.
“Determining whether the oral anticoagulant should be temporarily held in a patient with a nonmajor bleed depends upon individual patient characteristics, the nature of the bleed and the intensity of anticoagulation,” Tomaselli, past president of the American Heart Association, and colleagues wrote.
If a patient with a nonmajor bleed does not require a procedure, hospitalization or a transfusion all while achieving hemostasis, the oral anticoagulant can be continued. Patients on concomitant antiplatelet agents should have a discussion with their clinician about the risk vs. benefit of stopping the drugs.
Patients with major bleeding may benefit from reversal/hemostatic strategies.
“While there are currently no randomized trials comparing prothrombin complex concentrate or activated prothrombin complex concentrate with reversal agents indicated for use in patients taking dabigatran, apixaban, betrixaban, edoxaban or rivaroxaban, it is reasonable to consider idarucizumab (Praxbind, Boehringer Ingelheim) or andexanet alfa (Andexxa, Portola Pharmaceuticals) in situations in which reversal is required, if these agents are available at your institution,” Tomaselli and colleagues wrote.
Reinitiating anticoagulation after bleeding
Restarting anticoagulation can be done if it provides net clinical benefit after a bleeding event, according to the document. There are several conditions for which the treatment would no longer be indicated including a temporary indication for oral anticoagulation, nonvalvular AF with a CHA2DS2-VASc score of less than 2 in men and less than 3 in women, first time provoked venous thromboembolism more than 3 months ago, recovered acute stress cardiomyopathy and bioprosthetic valve replacement without AF more than 3 months ago. The net clinical benefit of oral anticoagulation should be considered if there is an ongoing indication for it and should be conducted with other practitioners such as interventionalists and surgeons in addition to patients or caregivers. The timing of initiation is based on thrombotic risk and rebleeding risk, according to the document.
“For patients experiencing bleeding that necessitates interruption of anticoagulant therapy, it is particularly important to conduct a clinician-patient discussion where the benefits and risks of anticoagulation are revisited,” Gluckman said in an interview. “Shared decision making is particularly important and should start early, allowing patients to ask questions or raise concerns. Discussion should also include an outline of the bleeding risks with resumption of anticoagulation, as well as the thrombotic risks without it.”
Gluckman said that documents like these provide members of the care team with a “teachable opportunity.” He added, “Our hope is that all stakeholders involved in the management of bleeding complications for patients on anticoagulant therapy would look to this document as a valuable resource to update existing protocols that may be in place. For hospitals and health systems that haven’t previously introduced a standardized approach to management of these patients, [this] serves as a framework that encourages clinicians to ask questions and consider important factors as they define a treatment plan for their patients.”
For more information:
Ty J. Gluckman, MD, FACC, FAHA, can be reached at tyler.gluckman@providence.org.
Collapse
Read more about
Click Here to Manage Email Alerts