Article

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: 14.72). 04/2013; 34(27). DOI: 10.1093/eurheartj/eht134
Source: PubMed

ABSTRACT 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 (www.NOACforAF.eu). 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.

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    • "In the United States, dabigatran etexilate is not indicated if creatinine clearance is less than 15 mL/min in patients with acute renal failure or ESRD. However, there are no outcome data for the newer anticoagulants in patients with creatinine clearance less than 30 mL/min, and the current European Society of Cardiology (ESC) guidelines advise against their use in this patient population [18]. However, because dabigatran etexilate is mainly prescribed by primary care physicians and cardiologists, not all patients' renal functions are assessed properly before starting dabigatran etexilate, as we could see in our case. "
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    ABSTRACT: Introduction. Dabigatran is an oral direct thrombin inhibitor which has been approved for prophylaxis of stroke in patients with atrial fibrillation. The use of dabigatran etexilate increased rapidly due to many benefits. However, questions have been raised constantly regarding the safety of dabigatran etexilate. Case. A 58-year-old Caucasian male with a history of recurrent paroxysmal atrial fibrillation status after pacemaker and end-stage renal disease on hemodialysis came to the Emergency Department with the complaint of severe epistaxis. He had been started on dabigatran 150 mg twice a day about 4 months ago as an outpatient by his cardiologist. His prothrombin time (PT) was 63 seconds with international normalized ratio (INR) of 8.8 and his activated partial thromboplastin time (aPTT) was 105.7 seconds. Otherwise, all labs were unremarkable including the liver function test. Dabigatran was stopped immediately. His INR and aPTT trended downward, reaching normal levels 5 days after admission. Conclusion. Dabigatran is contraindicated in patients with severe kidney insufficiency as it is predominantly excreted via the kidney (~80%). Elderly patients over 75 and patients with chronic renal impairment should be carefully evaluated before starting dabigatran. Despite studies showing only mild increase in aPTT and PT/INR in patients receiving dabigatran, close monitoring may be reasonable in patients with renal insufficiency.
    Case Reports in Medicine 09/2013; 2013:131395. DOI:10.1155/2013/131395
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    ABSTRACT: Incidence of stroke attributable to atrial fibrillation increases from 1.5% at age 50–59 years to 23.5% at age 80–89 years. The use of oral anticoagulants to reduce the risk of stroke is well established, but all the available agents can cause bleeds if used in excess dose, in high-risk patients or in patients with reduced kidney function. This article highlights the need to assess kidney function as stated in the newly published European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC) practical guide on the use of the new oral anticoagulants (NOACs). The EHRA guide has a section on NOACs for patients with chronic kidney disease (CKD) where it is stated that “a careful follow-up of renal function is required in CKD patients, since all (NOACs) are cleared more or less by the kidney”. It continues “in the context of NOAC treatment, creatinine clearance is best assessed by the Cockcroft method, as this was used in most NOAC trials”. The authors discuss the issues and present a simple guide on why and how to use the Cockcroft Gault equation for kidney function estimation. They also note that for drug and dosing decisions, reduced kidney function, for whatever reason (not just where a patient has been assessed as having CKD), needs to be assessed to reduce the risk of harm.
    British Journal of Cardiology 06/2013; 20(2):61-4. DOI:10.5837/bjc.2013.16
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    ABSTRACT: With the advent of new oral anticoagulants (NOACs) for the treatment of deep-vein thrombosis (DVT) and/or pulmonary embolism (PE), a new era of oral anticoagulation for patients with venous thromboembolism (VTE) has begun. Rivaroxaban is the first NOAC to receive regulatory approval for the acute and continued treatment of DVT and PE, and for the secondary prevention of VTE. Here, the clinical trials of rivaroxaban in patients with VTE are reviewed, and the clinical use of rivaroxaban for patients with PE is discussed. Even though rivaroxaban will facilitate the therapeutic management of PE, its use in specific clinical situations needs further study.
    Advances in Therapy 06/2013; 30(6). DOI:10.1007/s12325-013-0041-4 · 2.44 Impact Factor
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