Aspirin versus vitamin K antagonist treatment guided by transoesophageal echocardiography in patients with atrial fibrillation: a pilot study.
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).
Department of Cardiology, Maastricht University Medical Center, , Maastricht, The Netherlands.
Trang
T
Dinh
Leo H B
LH
Baur
Ron
R
Pisters
Otto
O
Kamp
Freek W A
FW
Verheugt
Joep L R M
JL
Smeets
Emile C
EC
Cheriex
Jan-Eize
JE
Lindeboom
Wilfred F
WF
Heesen
Robert G
RG
Tieleman
Martin H
MH
Prins
Harry J G M
HJ
Crijns
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D001241:Aspirin / Q000008:administration & dosage*; D001281:Atrial Fibrillation / Q000150:complications / Q000000981:diagnostic imaging*; D017548:Echocardiography, Transesophageal; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D018570:Risk Assessment / Q000379:methods; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D014812:Vitamin K / Q000037:antagonists & inhibitors*
D000925:Anticoagulants; D005343:Fibrinolytic Agents; D014812:Vitamin K; D001241:Aspirin