title: Feasibility of TEE-guided stroke risk assessment in atrial fibrillation-background, aims, design and baseline data of the TIARA pilot study.
abstract: BACKGROUND
  Antithrombotic management in atrial fibrillation (AF) is currently based on clinical characteristics, despite evidence of potential fine-tuning with transoesophageal echocardiography (TEE). This open, randomised, multicentre study addresses the hypothesis that a comprehensive strategy of TEE-based aspirin treatment in AF patients is feasible and safe.
  
  
  METHODS
  Between 2005 and 2009, ten large hospitals in the Netherlands enrolled AF patients with a moderate risk of stroke. Patients without thrombogenic TEE characteristics were randomised to aspirin or vitamin K antagonists (VKA). The primary objective is to show that TEE-based aspirin treatment is safe compared with VKA therapy. The secondary objective tests feasibility of TEE as a tool to detect echocardiographic features of high stroke risk. This report compares randomised to non-randomised patients and describes the feasibility of a TEE-based approach.
  
  
  RESULTS
  In total, 310 patients were included. Sixty-nine patients were not randomised because of non-visualisation (n = 6) or TEE risk factors (n = 63). Compared with non-randomised patients, randomised patients (n = 241) were younger (65 ± 11 vs. 69 ± 9 years, p = 0.004), had less coronary artery disease (9 vs. 20%, p = 0.018), previous TIA (1.7 vs. 7.2%, p = 0.029), AF during TEE (25 vs. 54%, p < 0.001), mitral incompetence (55 vs. 70%, p = 0.038), VKA use (69 vs. 82%, p = 0.032), had a lower mean CHADS(2) score (1.2 ± 0.6 vs. 1.6 ± 1.0, p = 0.004), and left ventricular ejection fraction (59 ± 8 vs. 56 ± 8%, p = 0.016).
  
  
  CONCLUSIONS
  This study shows that a TEE-based approach for fine-tuning stroke risk in AF patients with a moderate risk for stroke is feasible. Follow-up data will address the safety of this TEE-based approach.
authors.affiliation: Department of Cardiology, Maastricht University Medical Center, PO Box 5800, 6202 AZ, Maastricht, the Netherlands, trang.dinh@mumc.nl.
authors.forename: T
authors.initials: T
authors.lastname: Dinh
authors.forename: L H B
authors.initials: LH
authors.lastname: Baur
authors.forename: R
authors.initials: R
authors.lastname: Pisters
authors.forename: O
authors.initials: O
authors.lastname: Kamp
authors.forename: F W A
authors.initials: FW
authors.lastname: Verheugt
authors.forename: J L R M
authors.initials: JL
authors.lastname: Smeets
authors.forename: E C
authors.initials: EC
authors.lastname: Cheriex
authors.forename: R G
authors.initials: RG
authors.lastname: Tieleman
authors.forename: M H
authors.initials: MH
authors.lastname: Prins
authors.forename: H J G M
authors.initials: HJ
authors.lastname: Crijns