New EHRA Practical Guide on Novel Oral Anticoagulants

Patrice Wendling

March 29, 2018

BARCELONA, Spain — 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 theheart.org | 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.

Commenting for theheart.org |Medscape Cardiology, chair of the special session, Professor John Camm, MD, from St George's, University of London, United Kingdom, also highlighted the new concept of plasma measurements and the added information on drug-drug interactions and use of NOACs in different kinds of valvular conditions.

"The most important thing is that the literature between 2015 and 2017 has all been reviewed and all the new relevant content has been added," he said.

Senior guide author and EHRA President-Elect Professor Hein Heidbuchel, MD, Antwerp University and University Hospital, Belgium, told attendees when they published the first EHRA guideline in 2013, "There was sort of a chaos arising in how to use these new agents in clinical practice. We involved from the very beginning all the medical companies that were marketing these new NOACs. And it was a very positive experience and collaborative way of producing this document."

That collaboration continued for the 2018 guide, which follows the same outline as the 2015 update but was rewritten to include some 476 citations and 17 tables.

"It looks like a Bible but we think it is still a very practical document," he said, noting that the guide as well as links to the AF guidelines and the wildly popular key messages booklet are also available online here.

Steffel reported having received consultant and/or speaker fees from Amgen, Astra-Zeneca, Atricure, Bayer, Biosense Webster, Biotronik, Boehringer-Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cook Medical, Daiichi Sankyo, Medtronic, Novartis, Pfizer, Sanofi-Aventis, Sorin, St Jude/Abbott, and Zoll; ownership of CorXL; and grant support through his institution from Bayer Healthcare, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and St Jude/Abbott. Camm reported serving as an advisor and investigator for Bayer, Boehringer Ingelheim, Pfizer/Bristol-Myers Squibb, and Daiichi Sankyo.

European Heart Rhythm Association (EHRA) 2018. Special Session. Presented March 19, 2018.

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

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