Aspirin versus vitamin K antagonist treatment guided by transoesophageal echocardiography in patients with atrial fibrillation: a pilot study. Issue 7 (31st January 2014)

• Record Type: Journal Article
• Authors: Dinh, Trang; Baur, Leo H B; Pisters, Ron; Kamp, Otto; Verheugt, Freek W A; Smeets, Joep L R M; Cheriex, Emile C; Lindeboom, Jan-Eize; Heesen, Wilfred F; Tieleman, Robert G; Prins, Martin H; Crijns, Harry J G M
• Other Names: Dinh T author non-byline.; Pisters R author non-byline.; Tieleman RG author non-byline.; Prins MH author non-byline.; Crijns HJGM author non-byline.; Crijns HJGM author non-byline.; Dinh T author non-byline.; Baur LHB author non-byline.; Kamp O author non-byline.; Prins MH author non-byline.; Verheugt FWA author non-byline.; Pisters R author non-byline.; Limburg M author non-byline.; de Zwaan C author non-byline.; ten Cate H author non-byline.; Lip GY author non-byline.
• Is Part Of: Heart. Volume 100:Issue 7(2014)
• Page Start: 563
• Page End: 568
• Publication Date: 2014-01-31
• Subjects: Heart -- Diseases -- Treatment -- Periodicals; Cardiology -- Periodicals; 616.12
• DOI: 10.1136/heartjnl-2013-305017
• Languages: English
• ISSNs: 1355-6037

Abstract

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 CHA2 DS2 -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).