ESC and EHRA release guide on new oral anticoagulants use

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The European Society of Cardiology (ESC) and the European Heart Rhythm Association (EHRA) of the European Society of Cardiology have produced a practical guide on the use of the new oral anticoagulants.

According to an ESC release, the guide was designed responding to the need to summarise existing information on different drugs, to answer clinical questions that fall outside what drug companies can legally answer, and to make distinctions between the different drugs.

ESC guidelines on atrial fibrillation recommend the new oral anticoagulants as preferable to vitamin K antagonists for stroke prevention in patients with non-valvular atrial fibrillation.1 Companies provide a summary of product characteristics for their drug but the content is bound by legal restrictions and this summaries overlap between the different new oral anticoagulants.

Hein Heidbuchel, Belgium, lead author of the EHRA guide, said: “Companies are bound by legal restrictions in their summary of product characteristics and for physicians in the field the information is often not specific enough. EHRA goes further than the summary of product characteristics and provides expert guidance, often admittedly based on incomplete data, on what to do in specific clinical situations.”

“We have brought together information on all the novel oral anticoagulants in one document so it is clear for physicians what the similarities and differences are. We worked closely with the drug companies to make sure that all of the information in the summary of product characteristics is also in our document.”

The paper provides practical advice on how to handle 15 clinical scenarios. The full paper was published on 26 April in EHRA’s official journal, EP-Europace,2 and the executive summary is published online in European Heart Journal.3

The clinical situations include how to initiate and monitor novel oral anticoagulants use, how to measure the anticoagulant effect if needed in specific situations, switching between anticoagulants, ensuring compliance, patients with chronic kidney disease and management of bleeding complications.

Novel oral anticoagulants remove the regular monitoring of anticoagulation level that was required for the vitamin K antagonists. However, Heidbuchel said: “Compliance is very important for the novel anticoagulant drugs because they have a very short half-life. That means that if you do not take them you will not be protected by anticoagulation and are at greater risk of thromboembolic events.”

The document provides tips on how to improve compliance. These include educating patients about the drug’s short half-life, and that small minor bleeding such as a nose bleed will stop by itself and patients should continue taking the drug. Compliance can also be improved with a pre-specified follow-up scheme.

The guide does not cover the indications for switching from a vitamin K antagonist to a novel oral anticoagulant but it does advise how to switch safely. Heidbuchel said: “We have learned from the big trials that these moments of transitioning from one anticoagulant to another can be dangerous in the sense that patients can be under-anticoagulated.”

He added: “The bleeding risk profile of the novel oral anticoagulants is definitely better than that of vitamin K antagonists. Nevertheless bleedings will occur and so our practical document has outlined what action should be taken.”

Stefan Hohnloser, Germany, a reviewer of the EHRA guide and a member of the ESC atrial fibrillation guidelines task force, said: “The updated ESC guidelines on the treatment of atrial fibrillation recommend the novel oral anticoagulants to be used rather than the vitamin K antagonists. Like all new drugs, these drugs have pitfalls – for example they are excreted via the kidneys and therefore physicians need to measure renal function regularly. Physicians who follow the practical advice in this guide will dramatically improve the safety of their patients.”

Visit EHRA’s website with the latest information on oral anticoagulants: www.NOACforAF.eu.

References

  1. Camm AJ, Lip GYH, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. European Heart Journal. 2012; 33:2719-2747.
  2. Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P. EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace. 2013; 15:625-651
  3. Heidbuchel H, Verhamme P, Alings M, et al. EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Advance Access published, European Heart Journal.213; DOI: 10.1093/eurheartj/eht134