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The effect of non-recommended dosing of non-vitamin K antagonist oral anticoagulants (NOACs) on 1-year mortality in patients with newly diagnosed AF? Results from the GARFIELD-AF registry

Session Atrial fibrillation - Detection, treatment, outcomes

Speaker John Camm

Event : ESC Congress 2018

  • Topic : arrhythmias and device therapy
  • Sub-topic : Oral Anticoagulation
  • Session type : Rapid Fire Abstracts

Authors : A J Camm (London,GB), F Cools (Brasschaat,BE), S Virdone (London,GB), J-P Bassand (Besançon,FR), D A Fitzmaurice (Coventry,GB), KAA Fox (Edinburgh,GB), S Z Goldhaber (Boston,US), S Goto (Kanagawa,JP), S Haas (Munich,DE), L G Mantovani (Monza,IT), K Pieper (London,GB), A G G Turpie (Hamilton,CA), F W A Verheugt (Amsterdam,NL), A K Kakkar (London,GB)

Authors:
A.J. Camm1 , F. Cools2 , S. Virdone3 , J.-P. Bassand4 , D.A. Fitzmaurice5 , K.A.A. Fox6 , S.Z. Goldhaber7 , S. Goto8 , S. Haas9 , L.G. Mantovani10 , K. Pieper11 , A.G.G. Turpie12 , F.W.A. Verheugt13 , A.K. Kakkar14 , 1St. George's University of London and Imperial College - London - United Kingdom , 2AZ KLINA Cardiology - Brasschaat - Belgium , 3Thrombosis Research Institute - London - United Kingdom , 4Thrombosis Research Institute, London, UK and University of Besançon - Besançon - France , 5University of Warwick Medical School - Coventry - United Kingdom , 6University of Edinburgh - Edinburgh - United Kingdom , 7Brigham and Women's Hospital and Harvard Medical School - Boston - United States of America , 8Tokai University School of Medicine - Kanagawa - Japan , 9Formerly Department of Medicine, Technical University of Munich - Munich - Germany , 10University of Milan Bicocca - Monza - Italy , 11Duke Clinical Research Institute, Durham, NC, USA & Thrombosis Research Institute - London - United Kingdom , 12McMaster University - Hamilton - Canada , 13Onze Lieve Vrouwe Gasthuis (OLVG) - Amsterdam - Netherlands , 14Thrombosis Research Institute and University College London - London - United Kingdom ,

On behalf: GARFIELD-AF Investigators

Citation:
European Heart Journal ( 2018 ) 39 ( Supplement ), 262-263

Background: The recommended doses for a NOAC to prevent stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (AF) are specified in the prescribing information. Prospective observational studies provide an opportunity to evaluate whether the actual dosing of these drugs in real-life conforms with the approved dosing.

Methods: This analysis assesses the impact of NOAC dosing (i.e., recommended vs. non-recommended) on all-cause mortality at 1 year in patients in newly diagnosed AF. Of patients enrolled consecutively into the Global Anticoagulant Registry in the FIELD-AF (GARFIELD-AF) between Apr-2013 and Sep-2015, 10,417 from 35 countries were eligible for this analysis: rivaroxaban (n=4490, 43.1%), apixaban (n=3283, 31.5%), dabigatran (n=2359, 22.6%) and edoxaban (n=285, 2.7%). Recommended dosing was determined according to differing country criteria, including: impaired kidney function and/or low body weight (≤60 kg) or age ≥80 yrs.

Results: Compared with patients who received the recommended dose, non-recommended dosing according to country-specific guidelines was associated with a higher all-cause mortality. The hazard ratios were: 1.51, 95% confidence interval 1.16 to 1.96 (for dosing below recommendations) and 1.57, 95% CI 0.97 to 2.56 (for dosing above recommendations) after adjusting for age, sex, ethnicity, smoking, alcohol consumption, diabetes, hypertension, history of bleeding, history of stroke/TIA, heart failure, vascular disease, and AF type. Prescribing patterns according to country-specific guidelines are reported in the figure. More than 70% of patients received the correct dose of rivaroxaban, apixaban or dabigatran. Treatment below the recommended doses with rivaroxaban or apixaban was more common in patients from Japan (38.0% [rivaroxaban], 39.4% [apixaban]) than other regions (17.8% [rivaroxaban], 24.0% [apixaban]). Patients on edoxaban were more likely to receive doses below the recommendations compared with the other NOACs; approximately two-thirds of these patients were from Japan. Few patients (3.6%, overall) were treated above the recommended doses. Of those who were treated over the recommended doses, 67.7% had moderate-to severe CKD. By comparison, 8.9% of patients on recommended doses and 7.1% on non-recommended low-doses had moderate-to severe CKD.

Conclusion: Since the introduction of NOACs, most patients receive the recommended NOAC doses according to country-specific guidelines. Treatment above the recommended doses is relatively rare compared with non-recommended low dosing. Prescription of non-recommended doses is associated with an increased the risk of death compared with patients on recommended doses, even after adjusting for baseline factors.

NOAC dosing in 35 countries

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