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Clinical characteristics and 1-year outcomes in atrial fibrillation patients with or without history of intracranial haemorrhage treated with edoxaban: snapshot analysis of the Global ETNA-AF program

Session Poster Session 5

Speaker Paulus Kirchhof

Event : ESC Congress 2019

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

Authors : P Kirchhof (Birmingham,GB), M Unverdorben (Basking Ridge,US), Y Koretsune (Osaka,JP), CC Wang (Taipei,TW), YH Kim (Seoul,KR), B Brueggenjuergen (Berlin,DE), BC Lee (Anyang-Si, Gyeonggi-Do,KR), P Levy (Paris,FR), H Rauer (Munich,DE), PE Reimitz (Munich,DE), T Yamashita (Tokyo,JP), R De Caterina (Pisa,IT)

Authors:
P. Kirchhof1 , M. Unverdorben2 , Y. Koretsune3 , C.C. Wang4 , Y.H. Kim5 , B. Brueggenjuergen6 , B.C. Lee7 , P. Levy8 , H. Rauer9 , P.E. Reimitz9 , T. Yamashita10 , R. De Caterina11 , 1Institute of Cardiovascular Sciences, University of Birmingham and SWBH and UHB NHS Trusts - Birmingham - United Kingdom , 2Daiichi Sankyo, Inc - Basking Ridge - United States of America , 3National Hospital Organization Osaka National Hospital - Osaka - Japan , 4Chang Gung University, Department of Cardiology - Taipei - Taiwan , 5Korea University College of Medicine, Department of Internal Medicine - Seoul - Korea (Republic of) , 6Steinbeis-University, Head Institute for Health Economics - Berlin - Germany , 7Hallym University Sacred Heart Hospital - Anyang-Si, Gyeonggi-Do - Korea (Republic of) , 8Universite Paris-Dauphine - Paris - France , 9Daiichi Sankyo Europe GmbH - Munich - Germany , 10Cardiovascular Institute - Tokyo - Japan , 11University of Pisa, Chair of Cardiology - Pisa - Italy ,

Topic(s):
Oral Anticoagulation

Citation:
European Heart Journal ( 2019 ) 40 ( Supplement ), 2989

Background: Patients with atrial fibrillation (AF) who survive an intracranial haemorrhage (ICH) are at high risk of stroke, death, and recurrent haemorrhage. Effectiveness and safety of the nonvitamin K antagonist oral anticoagulant (NOAC) edoxaban in this patient population has not been reported.

Purpose: This snapshot analysis from the global ETNA-AF program compared 1-year outcomes in AF patients with and without history of ICH treated with edoxaban from Europe, Japan, and Korea/Taiwan.

Methods: Global ETNA-AF (EU: NCT02944019, Japan: UMIN000017011, Korea/Taiwan: NCT02951039) is a multinational, multicentre, prospective, noninterventional program of AF patients receiving edoxaban in regular clinical care. Demographics, baseline characteristics, and outcomes at 1-year follow-up were reported for 19416 patients with and without a history of ICH.

Results: Of the 19416 patients, 297 had a history of ICH. At 1-year follow-up, incidences of International Society on Thrombosis and Haemostasis (ISTH) major bleeding (including ICH) and clinically relevant nonmajor bleeding (CRNMB) were generally low. The rate of ischaemic stroke was higher in patients with a history of ICH than in those without prior ICH.

Conclusion: Our data underpin the need for effective stroke prevention. In AF patients with a history of ICH, data suggest that edoxaban can be safely and effectively administered in patients with and without prior ICH in regular clinical care.

Europe (N=7672)Korea/Taiwan (N=1701)Japan (N=10043)
History of ICH, n (%)YesNoYesNoYesNo
36 (0.5)636 (99.5)27 (1.6)1674 (98.4)234 (2.3)9809 (97.7)
Age, median (IQR)75 (69, 78)74 (68, 80)70 (66, 76)72 (66, 77)76 (71, 82)75 (68, 81)
Gender, male %72.257.470.459.960.759.3
Weight, median (IQR) kg80.0 (75.0, 88.0)80.0 (70.0, 92.0)68.0 (54.0, 77.0)65.0 (58.0, 73.0)57.0 (50.0, 65.0)59.0 (51.0, 68.0)
CHA2DS2-VASc, mean (SD)4.2 (1.44)3.1 (1.38)3.9 (1.63)3.0 (1.43)4.0 (1.56)3.4 (1.64)
HAS-BLED, mean (SD)4.3 (1.23)2.6 (1.12)3.9 (1.55)2.4 (10.7)3.7 (1.07)2.3 (1.12)
CrCl [mL/min], median (IQR)70.5 (58.8, 85.1)70.4 (53.8, 90.1)63.7 (45.8, 84.2)61.6 (48.4, 78.1)58.5 (46.0, 73.2)60.2 (46.1, 77.0)
Edoxaban 60/30 mg, %83.3 / 16.777.1 / 22.955.6 / 44.450.2 / 49.821.8 / 78.227.8 / 72.2
1-year outcome, n (%/year)
  Major bleeding (ISTH)2 (5.94)66 (0.92)0 (0)13 (0.82)3 (1.92)66 (0.96)
  Intracranial haemorrhage1 (2.91)19 (0.26)0 (0)5 (0.32)1 (0.64)18 (0.26)
  Major GI* bleeding0 (0.00)20 (0.28)0 (0)2 (0.13)2 (1.28)30 (0.43)
  CRNMB0 (0.00)102 (1.43)0 (0)11 (0.70)6 (3.82)219 (3.20)
  Ischaemic stroke1 (2.93)41 (0.57)1 (4.04)11 (0.70)4 (2.57)78 (1.13)
*Gastrointestinal.

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