EHRA Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary

Department of Cardiovascular Medicine, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium.
European Heart Journal (Impact Factor: 15.2). 04/2013; 34(27). DOI: 10.1093/eurheartj/eht134
Source: PubMed


New oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with non-valvular atrial fibrillation (AF). Both physicians and patients will have to learn how to use these drugs effectively and safely in specific clinical situations. This text is an executive summary of a practical guide that the European Heart Rhythm Association (EHRA) has assembled to help physicians in the use of the different NOACs. The full text is being published in EP Europace. Practical answers have been formulated for 15 concrete clinical scenarios: (i) practical start-up and follow-up scheme for patients on NOACs; (ii) how to measure the anticoagulant effect of NOACs; (iii) drug-drug interactions and pharmacokinetics of NOACs; (iv) switching between anticoagulant regimens; (v) ensuring compliance of NOAC intake; (vi) how to deal with dosing errors; (vii) patients with chronic kidney disease; (viii) what to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a risk of bleeding?; (ix) management of bleeding complications; (x) patients undergoing a planned surgical intervention or ablation; (xi) patients undergoing an urgent surgical intervention; (xii) patients with AF and coronary artery disease; (xiii) cardioversion in a NOAC-treated patient; (xiv) patients presenting with acute stroke while on NOACs; (xv) NOACs vs. VKAs in AF patients with a malignancy. Since new information is becoming available at a rapid pace, an EHRA web site with the latest updated information accompanies the guide ( It also contains links to the ESC AF Guidelines, a key message pocket booklet, print-ready files for a proposed universal NOAC anticoagulation card, and feedback possibilities. © 2013 Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2013. For permissions please email: [email protected]
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    • "However, INR control is a means of adjusting to therapeutic levels the anticoagulant effect of warfarin thus correcting any interaction and, on the other hand, dabigatran presents a number of minor drug interactions that could have clinical repercussions in some patients. Heidbuchel and colleagues have published a list of interactions and recommendations for adapting NOAC dosing [Heidbuchel et al. 2013]. First of all, there are some drugs that are contraindicated while on dabigatran: dronedarone and antifungals (itraconazole, ketoconazole , posaconazole and voriconazole); these drugs can be used in the US with a reduced dabigatran dose at 75mg twice daily. "
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    ABSTRACT: Dabigatran is increasingly being used in clinical practice for the thromboprophylaxis in atrial fibrillation as a convenient therapy that needs no drug level monitoring. However, analysis of the data of the same clinical trial that led to the adoption of dabigatran in fixed-dosing regimens has indicated a small subgroup of patients that could be either over-treated, risking bleeding, or under-treated, risking embolism. Additional post-marketing data lends support to the favorable therapeutic profile of dabigatran but at the same time raises doubts about patient characteristics such as weight, age, renal function and their pharmacokinetic effects that, in some cases, could be serious enough to expose a minority of patients to risk. We will present a clinical case of a patient with an ischemic stroke while on dabigatran that was found with low dabigatran plasma levels and we will discuss the currently available data on the effects of inherent patient characteristics on dabigatran pharmacokinetics, the clinical impact of dabigatran plasma levels on safety and efficacy as well as the possibility of improving the risk-benefit profile of this agent by tailoring the dose for selected patient groups.
    Therapeutic Advances in Neurological Disorders 08/2015; 8(6). DOI:10.1177/1756285615601360 · 3.14 Impact Factor
    • "e l s e v i e r . c o m / l o c a t e / t h r o m r e s Please cite this article as: A. Godier, et al., Peri-procedural management of dabigatran and rivaroxaban: Duration of anticoagulant discontinuation and drug concentrations, Thromb Res (2015), bleeding risk in patients with a normal kidney function, and 48 hours before procedure with a major bleeding risk regardless of the drug [3]. Similarly, the Italian Federation of Thrombosis Centers proposes stopping dabigatran 24 to 48 hours before surgery, depending on renal function [4]. "
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    ABSTRACT: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration ([DOAC]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients. To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal per-procedural [DOAC], defined as [DOAC]<30ng/mL. To investigate the factors associated with per-procedural [DOAC]. To evaluate the ability of normal PT and aPTT to predict [DOAC]<30ng/mL. Patients treated with dabigatran or rivaroxaban, and requiring any invasive procedure were included in this multicentre, prospective, observational study. [DOAC], PT and aPTT were measured during invasive procedure. Sixty-five patients were enrolled. Duration of DOAC discontinuation ranged from 1-168h. Per-procedural [DOAC] ranged from <30 to 466ng/mL. [DOAC]<30ng/mL occurred more frequently after 48-hour discontinuation than after a shorter delay. [DOAC] remained ≥30ng/mL in 36% and 14% of measurements performed 24-48h and 48h-120h after discontinuation, respectively. According to ROC curve, a cut-off value of 120hours for DOAC discontinuation had a better specificity than a cut-off value of 48hours to predict [DOAC]<30ng/mL. Normal PT and aPTT ratios had good specificity and positive predictive value, but limited sensitivity (74%) and negative predictive value (73%) to predict [DOAC]<30ng/mL. A 48-hour discontinuation does not guarantee a [DOAC]<30ng/mL in all patients. Normal PT and aPTT are flawed to predict this threshold and could not replace specific assays. Further studies are needed to define the relationship between per-procedural [DOAC] and clinical outcomes. Copyright © 2015 Elsevier Ltd. All rights reserved.
    Thrombosis Research 08/2015; 136(4). DOI:10.1016/j.thromres.2015.08.006 · 2.45 Impact Factor
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    • "Most patients were receiving additional medications at the time of the study, some of which could influence NOAC metabolism [22,23], including antidepressants (n = 8), antidiabetics (n = 1), anxiolytics (n = 10), beta-blockers (n = 8), ACE inhibitors (n = 8), lipid-lowering agents (n = 11), protein pump inhibitor (PPI) (n = 6), levothyroxine (n = 3), diuretics (n = 5), aspirin (n = 4), non-steroidal anti-inflammatory (n = 2), lanoxin (n = 1), allopurinol (n = 2), amiodarone (n = 4), and medication for prostatic hypertrophy (n = 2). No patients were active smokers. "
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    ABSTRACT: New oral anticoagulant (NOAC) drugs are known to influence the results of some routine hemostasis tests. Further data are needed to enable routine assessment of the effects of NOAC on clotting parameters in some special circumstances. Following administration of rivaroxaban to patients, at the likely peak and trough activity times, we assessed the effects on prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and clotting time using Russell's viper venom, and in the presence of phospholipids and calcium reagent available as DVVreagent(R) and DVVconfirm(R). The data were used to determine an adequate NOAC plasma level based on anticoagulant activities expressed as a ratio (patients/normal, R-C). DVVconfirm as R-C could be rapidly performed, and the results were reasonably sensitive for rivaroxaban and probably for other FX inhibitors. This assay is not influenced by lupus anticoagulant and heparin, does not require purified NOAC as control, and will measure whole-plasma clotting activity. We propose a cut-off R-C value of 4.52 +/- 0.33 for safety, but clinical studies are needed to establish whether this cut-off is useful for identifying patients at increased risk of hemorrhage or exhibiting low anticoagulation effect. It also seems possible that normal R-C could indicate an absence of anticoagulant activity when rivaroxaban is discontinued due to episodes of uncontrolled bleeding during anticoagulation or for emergency surgery.
    Thrombosis Journal 03/2014; 12(1):7. DOI:10.1186/1477-9560-12-7 · 1.31 Impact Factor
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