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Stroke and bleeding in low, intermediate and high risk patients with atrial fibrillation treated with edoxaban: Results of the ETNA-AF Europe registry

Session Poster Session 5

Speaker Professor Joris R De Groot

Event : ESC Congress 2019

  • Topic : arrhythmias and device therapy
  • Sub-topic : Oral Anticoagulation
  • Session type : Poster Session

Authors : J R De Groot (Amsterdam,NL), R De Caterina (Pisa,IT), P Kelly (Dublin,IE), P Monteiro (Coimbra,PT), JC Deharo (Marseille,FR), C De Asmundis (Brussels,BE), E Lopez De Sa (Madrid,ES), TW Weiss (St. Polten,AT), J Waltenberger (Muenster,DE), J Steffel (Zurich,CH), P Levy (Paris,FR), A Bakhai (London,GB), P Kirchhof (Birmingham,GB)

J.R. De Groot1 , R. De Caterina2 , P. Kelly3 , P. Monteiro4 , J.C. Deharo5 , C. De Asmundis6 , E. Lopez De Sa7 , T.W. Weiss8 , J. Waltenberger9 , J. Steffel10 , P. Levy11 , A. Bakhai12 , P. Kirchhof13 , 1Academic Medical Center of Amsterdam, Cardiology - Amsterdam - Netherlands (The) , 2University of Pisa - Pisa - Italy , 3University College Dublin - Dublin - Ireland , 4University Hospitals of Coimbra - Coimbra - Portugal , 5Hospital La Timone of Marseille - Marseille - France , 6University Hospital (UZ) Brussels - Brussels - Belgium , 7University Hospital La Paz - Madrid - Spain , 8Karl Landsteiner Institute - Vienna - Austria , 9University of Muenster - Muenster - Germany , 10University Hospital Zurich - Zurich - Switzerland , 11Université Paris-Dauphine - Paris - France , 12Royal Free Hospital - London - United Kingdom , 13University of Birmingham - Birmingham - United Kingdom ,

On behalf: ETNA-AF investigators

Oral Anticoagulation

European Heart Journal ( 2019 ) 40 ( Supplement ), 2960

Background: Edoxaban, a direct FXa inhibitor, has been proven non-inferior in efficacy and safer compared to warfarin in the ENGAGE AF-TIMI 48 trial. In routine care, the safety of edoxaban has not been formally established. ETNA-AF-Europe is a multinational, multi-centre, post-authorisation, observational study (NCT02944019) conducted in 825 sites in 10 European countries. Here 13,980 edoxaban-treated patients with AF were enrolled between November 2016 and February 2018, and will be followed-up for 4 years.

Methods: 7,672 patients (73.4±9.26 years, 57.5% male) enrolled in the ETNA-AF Europe registry completed the one-year follow-up and were stratified into low-, intermediate- and high-risk for stroke and bleeding using the CHA2DS2-VASc and HASBLED score, respectively. We here analysed the occurrence of stroke, bleeding, intracranial haemorrhage and mortality in such categories.

Results: The mean CHA2DS2-VASc score at baseline was 3.1±1.38 and the mean HAS-BLED score was 2.5±1.1. Not surprisingly, patients at higher risk were older, had a lower body weight, more comorbidities, and a lower creatinine clearance. A higher proportion of patients at high risk received the reduced 30 mg edoxaban dose. Overall, the yearly event rates of stroke, intracranial haemorrhage, major bleeding and death were low. However, these rates increased consistently in patients with higher stroke and bleeding risks. Residual stroke risk on anticoagulation was comparable to the risk of major bleeding (Table 1).

Conclusions: In this unselected cohort of patients with AF anticoagulated with edoxaban, high CHA2DS2-VASc and HAS-BLED scores were associated with higher risks of stroke, bleeding and death. Indirectly compared with the expected rates in non-anticoagulated patients, our data underpin the value of anticoagulants such as edoxaban in patients at high risk of stroke and bleeding.

Outcomes by stroke and bleeding risk
CHA2DS2-VASc: mean 3.1±1.38HAS-BLED: mean 2.5±1.1All patients
Low risk (0, 1 if female)Intermediate risk (1, 2 if female)High risk (≥2, 3 if female)Low risk (0, 1)Intermediate risk (2, 3)High risk (≥4)
Patients, N2331,1336,3041,2244,9321,5167,672
First occurrence of outcomes, n (%/year)
  All-cause mortality2 (0.92%)12 (1.11%)242 (4.09%)14 (1.21%)161 (3.47%)82 (5.78%)257 (3.56%)
  Intracranial haemorrhage0 (0.00%)1 (0.09%)19 (0.32%)2 (0.17%)10 (0.22%)8 (0.56%)20 (0.28%)
  Major bleeding0 (0.00%)6 (0.56%)62 (1.05%)2 (0.17%)43 (0.93%)23 (1.63%)68 (0.95%)
  Stroke/SEE0 (0.00%)4 (0.37%)59 (1.00%)3 (0.26%)41 (0.89%)19 (1.34%)63 (0.88%)
SEE, systemic embolic event.

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