ESC Offers Recommendations on Use of New Oral Anticoagulants

With the recent introduction of several novel oral anticoagulants—including dabigatran, rivaroxaban, apixaban, and the still-experimental endoxaban—the European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC) has issued a consensus document that offers practical advice for using alternatives to vitamin K antagonists in patients with nonvalvular atrial fibrillation (A-fib).

Written by an expert panel led by Hein Heidbüchel, MD, PhD, of the University of Leuven (Leuven, Belgium), the document was published online April 26, 2013, ahead of print in the European Heart Journal.

According to the ESC statement, novel oral anticoagulants have emerged as an alternative to vitamin K antagonists for thromboembolic prevention in patients with nonvalvular A-fib. “Although very promising in many regards (predictable effect without need for monitoring, fewer food and drug interactions, shorter plasma half-life, and an improved efficacy/safety ratio), the proper use of [new oral anticoagulants] will require new approaches in many daily aspects,” the authors write.

In a press release, Dr. Heidbüchel explains that the documentation required by European regulators before a product goes to market is often not specific enough for physicians in the field. “EHRA goes further . . . and provides expert guidance, often admittedly based on incomplete data, on what to do in specific clinical situations,” he notes. “We have brought together information on all the [drugs] in one document so it’s clear for physicians what the similarities and differences are.”

Addressing Common Scenarios

The paper provides guidance on using new oral anticoagulants in 15 different clinical scenarios, including:

  • Initiating and monitoring use
  • Measuring the anticoagulant effect if needed in specific situations
  • Switching between anticoagulants
  • Ensuring compliance
  • Choosing and titrating a drug for patients with renal insufficiency
  • Managing bleeding complications

The EHRA writing committee proposes that each patient treated with a novel oral anticoagulant carry a uniform card that can not only list demographic and medication information but also help “structure a coordinated follow-up of the patient by different caregivers.”

While providing answers for many clinical situations, the document also lists circumstances in which use of a new anticoagulant should be forgone until more information is available—for example, when the effect of certain drug interactions is unknown.

Education to Improve Compliance

The authors also stress the importance of drug education, for both patients and physicians, with the goal of improving compliance. “Compliance is very important [with] the novel anticoagulant drugs because they have a very short half-life,” Dr. Heidbüchel says in the press release. “That means that if you don't take them you will not be protected by anticoagulation and are at greater risk of thromboembolic events.”

Helping patients to understand that minor bleeding is normal and expected with these drugs will help increase compliance, the authors write.

Dr. Heidbüchel also cautions that although the bleeding risk profile of the new oral anticoagulants is definitely better than that of vitamin K antagonists, “bleeding will occur, and so our practical document has outlined what action should be taken.”

A ‘Hypothesis-Generating’ Document

In a telephone interview with TCTMD, Philip M. Meyers, MD, of Columbia University Medical Center (New York, NY), praised the committee for creating the recommendations “because it’s an issue that’s coming up more and more commonly and there are very limited data.”

The value of this statement, he added, is that “it helps to generate hypotheses for how to study outstanding questions and also it helps to establish what information is known and what is not.”

Dr. Meyers said he did not see anything in the guide that would prompt him to change his practice. “I feel like we are [already] practicing the way they would have recommended, so [this is] encouragement to continue doing what we’re doing,” he commented.

 


Source:
Heidbüchel 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. Eur Heart J. 2013;Epub ahead of print.

 

 

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Disclosures
  • Dr. Heidbüchel reports receiving research funding from Biotronik, Boston Scientific, Medtronic, Siemens Medical Solutions, and St. Jude Medical; holding the AstraZeneca chair in cardiac electrophysiology at the University of Leuven; and serving as a member of the scientific advisory board of Bayer, Biosense Webster, Boehringer-Ingelheim, Sanofi-Aventis, Siemens Medical Solutions, and St. Jude Medical.
  • Dr. Meyers reports no relevant conflicts of interest.

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