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Aspirin versus vitamin K antagonist treatment guided by transoesophageal echocardiography in patients with atrial fibrillation: a pilot study
  1. Trang Dinh1,
  2. Leo H B Baur2,
  3. Ron Pisters1,
  4. Otto Kamp3,
  5. Freek W A Verheugt4,
  6. Joep L R M Smeets5,
  7. Emile C Cheriex1,
  8. Jan-Eize Lindeboom6,
  9. Wilfred F Heesen7,
  10. Robert G Tieleman8,
  11. Martin H Prins9,
  12. Harry J G M Crijns1,
  13. for the TIARA investigators
  1. 1Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands
  2. 2Department of Cardiology, Atrium Medical Center, Heerlen, The Netherlands
  3. 3Department of Cardiology, VU Medical Center, Amsterdam, The Netherlands
  4. 4Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
  5. 5Department of Cardiology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
  6. 6Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands
  7. 7Department of Cardiology, VieCuri Medical Center for Northern Limburg, Venlo, The Netherlands
  8. 8Department of Cardiology, Martini Hospital Groningen, Groningen, The Netherlands
  9. 9Department of Clinical Epidemiology, Maastricht University Medical Center, Maastricht, The Netherlands
  1. Correspondence to Dr T Dinh, Department of Cardiology, Maastricht University Medical Center, PO Box 5800, Maastricht 6202 AZ, The Netherlands; trang.dinh{at}mumc.nl

Abstract

Objective Current stroke risk schemes need improvement of predictive value in patients with atrial fibrillation. Transoesophageal echocardiography (TEE) may facilitate stroke risk assessment in such patients and guide antithrombotic treatment.

Methods We randomised 238 patients with non-valvular atrial fibrillation and a moderate stroke risk to aspirin or adjusted vitamin K antagonist therapy after TEE had ruled out thrombogenic features in the atria and aorta. The primary outcome was a composite of stroke, major bleeding, peripheral embolism and all-cause mortality.

Results Mean CHA2DS2-VASc score was 2.1±1.1. The incidences of the composite primary outcome at a mean follow-up of 1.6 years were 3.2% (2.02% per year) in the aspirin group compared to 6.1% (3.84% per year) in the vitamin K antagonists group with an absolute advantage of 2.9 percentage points. Aspirin was non-inferior to vitamin K antagonists (p<0.0001) because the upper limit of the 90% CI did not exceed the 7% absolute difference in event rate between the two treatment arms.

Conclusions This hypothesis-generating pilot trial has found that TEE may be used for refinement of stroke risk in paroxysmal atrial fibrillation patients. A larger trial is needed to confirm these data. (ClinicalTrials.gov number NTC00224757).

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