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Published: April 30, 2013
- Note that this guidance document from the European Heart Rhythm Association provides clinical support for the management of nonwarfarin anticoagulants in atrial fibrillation.
- Be aware that the quality of evidence for most of the recommendations is quite low (primarily expert opinion).
A practical guide that summarizes the similarities and differences of the new oral anticoagulants and describes their use in specific clinical situations has been published by the European Heart Rhythm Association (EHRA).
The three drugs, which are discussed in terms of stroke prevention in nonvalvular atrial fibrillation and are approved in the European Union and the U.S. for this indication, are:
- Dabigatran (Pradaxa) — direct thrombin inhibitor, doses 150 and 110 mg bid, pivotal trial: RE-LY
- Rivaroxaban (Xarelto) — factor Xa inhibitor, doses 20 and 15 mg qd, pivotal trial: ROCKET-AF
- Apixaban (Eliquis) — factor Xa inhibitor, doses 5 and 2.5 mg bid, pivotal trials: ARISTOTLE and AVERROES
Hein Heidbuchel, MD, from the University of Leuven in Leuven, Belgium, led the writing committee. The document was published online in Europace.
The guide presents 15 clinical scenarios regarding oral anticoagulants, from starting the drugs to treating patients with atrial fibrillation (Afib) and cancer.
Regarding the latter clinical scenario, the writing committee noted that Afib patients with cancer are at increased risks for thromboembolic events and interaction between cancer and antithrombotic therapy, as well as the potential for an increased risk of bleeding associated with the cancer therapy.
For these reasons, the document suggests warfarin as the initial choice of anticoagulation therapy because it is more familiar to clinicians, can be closely monitored, and is easily reversed.
The updated European Society of Cardiology (ESC) guidelines on Afib treatment recommend using the new oral anticoagulants over warfarin.
The American Heart Association updated its guidelines in 2012 and laid out the evidence for each drug:
Warfarin: Class I, Level of Evidence A
Dabigatran: Class I, Level of Evidence B
Apixaban: Class I, Level of Evidence B
Rivaroxaban: Class IIa, Level of Evidence B
Heidbuchel and colleagues included a comprehensive table in the guidance document that details certain potential drug-drug interactions and how the dosage of the oral anticoagulants could be adjusted.
One of the more challenging clinical aspects associated with anticoagulants is switching between them. When warfarin is replacing a new oral anticoagulant, for example, clinicians should be aware of large fluctuations in the international normalized ratio (INR).
Warfarin’s slow onset of action (5 to 10 days) requires the administration of both drugs concomitantly until the INR is in the appropriate range. Because the new oral anticoagulants can influence the INR, the guide suggests checking the INR before the next oral anticoagulant is administered and re-test the patient 24 hours after the last dose.
Regarding compliance, Heidbuchel and colleagues stressed the importance of patient education, offered advice to schedule follow-up visits, and noted that technological aids might help.
The authors included another comprehensive table on measures to enact in case of bleeding. The table is divided into non-life-threatening and life-threatening bleeds.
The investigators admit the evidence for a specific antidote for the new oral anticoagulants is scarce, and the available evidence “reflects experts’ opinions or laboratory endpoints.”
However, they present a thorough list of options should the need arise to reverse one of these drugs.
Other scenarios in the guidance document include:
- Patients in need of urgent surgical intervention
- Patients who require anticoagulation and antiplatelet therapy
- Patients who need to undergo cardioversion
- Patients with intracranial bleeding or ischemic stroke
In response to the rapidity with which new medical data become available, the EHRA has dedicated a portion of its ESC website to house the latest information on this topic.
This article and its related educational material (slide set, website, booklet, etc.) were produced by and under the sole responsibility of the European Heart Rhythm Association, and funded by unrestricted and unconditional educational grants from Boehringer-Ingelheim, Bayer, Daiichi Sankyo, and the Pfizer/BMS Alliance. The writing committee collaborated with medical experts from the different companies to assure data accuracy and completeness.
Heidbuchel reported relationships with Biosense Webster, St Jude Medical, Siemens Medical Solutions, Boehringer-Ingelheim, Bayer HealthCare, sanofi-aventis, AstraZeneca, Medtronic, Biotronik, and Boston Scientific. His co-authors reported relationships with Bristol-Myers Squibb, Daiichi Sankyo, sanofi-aventis, Servier, Boehringer Ingelheim, Bayer HealthCare, ThromboGenics, Boston Scientific, Pfizer, Merck Sharp and Dohme, AstraZeneca, Pioneer Medical Devices, Actelion Pharmaceuticals, ARYx Therapeutics,Cardiome Pharma, CV Therapeutics, Menarini Group, Novartis Pharmaceuticals, Xention, Johnson & Johnson, Micrus Endovascular, PhotoThera, 3M Medica, MEDA Pharma, Otsuka Pharma, Takeda, Omron, GSK, and Abbott. P.V.
From the American Heart Association:
- AHA Emerging Science Series 2012: Outcomes of Discontinuing Rivaroxaban Compared with Warfarin in Patients with Nonvalvular Atrial Fibrillation: Analysis from the ROCKET AF Trial
- ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death – Full Text
Primary source: Europace
Heidbuchel H, et al “European heart rhythm association practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation” Europace 2013; 15l:625–651.
- AHA: Pradaxa Safety Appears Durable
- Apixaban Shines in ARISTOTLE Canadian Cohort
- ESC: Novel Drug Beats Aspirin in Afib Patients
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