New EHRA Practical Guide on Novel Oral Anticoagulants

            A new version of the European Heart Rhythm Association (EHRA) practical guide on non–vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) aims to help physicians navigate various new data — including some just presented last month in the United States — but also a more complex clinical landscape.

            "As health care providers get more comfortable using NOACs, treatment of more complex patients, such as the elderly, frail, those with multiple co-medications, is getting increasingly more common. We felt that not only an update but a fully revised version would be appropriate," writing committee chair, Jan Steffel, MD, University Heart Center, Zurich, Switzerland, told | Medscape Cardiology.

            The guide, first published in 2013 and updated in 2015, includes a new chapter on how to deal with patients experiencing an acute stroke as well as the correct dosing of NOACs in conditions other than AF, such ischemic heart disease and venous thromboembolism, as well as prevention of deep venous thrombosis.

            One of the major new concepts where the task force is "sticking out its neck" is the recommendation for plasma measurements, which can be difficult because "ranges for trough levels are wide and for peak levels even wider," Steffel said when presenting the new guide in a special session here at the EHRA 2018 meeting.

            "It"s important to keep in mind that for the vast majority of patients there is no need for plasma level measurements. However, in certain very special situations we did feel this may be of use," he said when interviewed.

            Those situations may include severe or life-threatening bleeding, an emergency operation or elective operation with high bleeding risk, an ischemic stroke on NOACs, multiple drug-drug interactions, or when treating the very obese or underweight.

            "Again, we have to keep in mind though that hard endpoint data for such strategies are missing," he added. "Hence, this should be performed in the knowledge of this limitation and only by people used to assessing and interpreting these values."

            The guide includes updated information on measures to take in actively bleeding patients, including use of the reversal agent idarucizumab (Praxbind, Boehringer Ingelheim) for dabigatran and the investigational antidote, andexanet alfa (AndexXa, Portola Pharmaceuticals), which just last month demonstrated rapid reversal of anti–factor Xa activity out to 12 hours in the ANNEXA-4 trial.

            The guide also provides updated advice on combined use of antiplatelets and NOACs in patients with coronary artery disease, particularly those with an acute coronary syndrome or those scheduled for stenting.

            New information added to the 2018 version seeks to clarify the European Society of Cardiology recommendation to stop NOACs at least 24 hours prior to an elective operation, which has led to a large variety of time points for when the last dose was taken, up to 48 hours before the actual intervention, Steffel explained.

            "With the addition of the detailed table delineating the last dose relative to the operation, we hope to bring more clarity to these recommendations," he said. "One important take-home message here is: "Do not bridge." There are no data in favor of bridging, and if anything there are some data against it, and it also makes no sense from a pharmacodynamics or kinetic point of view."

            Finally, the chapter on drug-drug interactions was expanded quite dramatically to include two further tables specifically addressing interactions with anticancer and antiepileptic drugs.


Eur Heart J. Published March, 19, 2018. Full text