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New EHRA Practical Guide on non-vitamin K antagonist oral anticoagulants launched

Safe and effective use of NOACs for stroke prevention in patients with atrial fibrillation

Embargo: 19 March 2018 at 08:00 CET

Arrhythmias, General
Atrial Fibrillation
Stroke


Barcelona, Spain – 19 March 2018: A new version of the EHRA Practical Guide on the use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation is published online today in European Heart Journal and an executive summary in EP Europace, and presented at EHRA 2018, a European Society of Cardiology (ESC) congress.1–3 The guide, now in its third edition with more than 400,000 copies of previous versions distributed worldwide, was produced by the European Heart Rhythm Association (EHRA), a branch of the ESC.

“ESC guidelines state that NOACs should be preferred over vitamin K antagonists, such as warfarin, for stroke prevention in patients with atrial fibrillation, except those with a mechanical heart valve or rheumatic mitral valve stenosis, and their use in clinical practice is increasing,” said first author Jan Steffel.4

The guide gives concrete, practical advice on how to use NOACs in specific clinical situations. While companies provide a Summary of Product Characteristics for a drug, there are legal restrictions on the content and the information is often not detailed enough for doctors.

The 2018 edition has several new chapters. One outlines how to use NOACs in particular groups of patients, including those with very low body weight, the very obese, athletes, frail patients in whom there is concern about bleeding, and patients with cognitive impairment who may forget to take their pills.

Another new chapter briefly summarises the correct dosing of NOACs in conditions other than atrial fibrillation, such as prevention of deep venous thrombosis, treatment of venous thromboembolism, and treatment of ischaemic heart disease. “The dosing for each condition is different, which may lead to confusion, so we have outlined this clearly,” said senior author Professor Hein Heidbuchel, who initiated the EHRA Practical Guide in 2013 and an update in 2015.

Updated advice is given on the combined use of antiplatelets and NOACs in patients with coronary artery disease, particularly those with an acute coronary syndrome or patients scheduled for percutaneous coronary intervention with stenting. “We provide guidance around which and how many antiplatelets, for how long, with which NOAC, and at what dose of that NOAC,” said Professor Heidbuchel.

There is also more scientific evidence on the use of anticoagulants around cardioversion. The document gives detailed advice on what to do in patients on long-term NOAC treatment who need cardioversion versus patients newly diagnosed with atrial fibrillation and started on a NOAC before cardioversion.

Since the previous edition of the guide was published, the first NOAC reversal agent has received market approval. Advice is given on how to use idarucizumab – which reverses the anticoagulant effect of dabigatran – when there is acute bleeding, when urgent surgery is required, or when the patient has a stroke. Guidance is also included on andexanet alfa, another reversal agent expected to receive market approval, with the caveat that the instructions on the label should be followed.

Unlike warfarin, NOACs do not require monitoring of plasma levels followed by dose adjustments. The guide describes rare scenarios in which physicians might want to know the NOAC plasma level. One scenario concerns patients undergoing major surgery in whom it is unclear, for example because of other drugs or renal dysfunction, whether the usual practice of stopping the NOAC 48 hours in advance is sufficient. The plasma level of the NOAC could be measured just before surgery to confirm that the anticoagulant effect has waned.

The chapter on drug-drug interactions has been expanded with anticancer and antiepileptic drugs, Dr Steffel added: “While this is mostly based on potential pharmacokinetic interactions and case reports, it is the first of its kind. This is likely to be adapted and become more complete over the years as our experience increases at this new frontier.”

ENDS

Notes to editor

ESC Press Office
Tel: +33 (0) 4 89 87 24 83
Email: press@escardio.org

SOURCES OF FUNDING: EHRA received unconditional grants from Pfizer/BMS, Daiichi-Sankyo, Boehringer-Ingelheim and Bayer.

DISCLOSURES: Dr Steffel has 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 Medical / Abbott and Zoll. He reports ownership of CorXL. Dr Steffel has received grant support through his institution from Bayer Healthcare, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, und St. Jude Medical / Abbott. Dr Heidbuchel reports personal lecture and advisory board fees before June 2017 from Pfizer/BMS, Daiichi-Sankyo, Bayer, Boehringer-Ingelheim, Cardiome, and Abbott. He has no disclosures after that date. He receives unconditional research grants from Bracco Imaging Europe, Medtronic and Abbott through the University of Antwerp, and from Bayer from the University of Hasselt, Belgium.

References and notes

1 Steffel J, Verhamme P, Potpara TS, et al. The 2018 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. Eur Heart J. 2018. doi: 10.1093/eurheartj/ehy136.

2 Steffel J, Verhamme P, Potpara TS, et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non‐vitamin K antagonist anticoagulants in patients with atrial fibrillation: executive summary. EP Europace 2018, doi: 10.1093/europace/euy054.

3 The 2018 EHRA Practical Guide for the use of NOACs in patients with atrial fibrillation on 19 March from 08:00 to 08:30 in the Mirowski lecture room.

4 Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37(38):2893–2962. doi:10.1093/eurheartj/ehw210

About the European Heart Rhythm Association

The European Heart Rhythm Association (EHRA) is a branch of the European Society of Cardiology (ESC). Its aim is improving the quality of life and reducing sudden cardiac death by limiting the impact of heart rhythm disturbances. EHRA ensures the dissemination of knowledge and standard setting; provides continuous education, training and certification to physicians and allied professionals involved in the field of cardiac arrhythmias with a special focus on Atrial Fibrillation (AF) and Electrophysiology (EP). EHRA releases international consensus documents and position papers, it is a source of high-quality, unbiased, evidence-based, scientific information that promotes the quality of care for patients with AF. It also has a dedicated a website for patients: www.afibmatters.org

About the European Society of Cardiology

The ESC brings together health care professionals from more than 150 countries, working to advance cardiovascular medicine and help people to live longer, healthier lives.

Information for journalists attending EHRA 2018

EHRA 2018 will be held from 18 to 20 March in Barcelona, Spain, at the Fira Gran Via. The full scientific programme is available here

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