RE-LY sets benchmark for trials of thromboprophylaxis in AF

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A total of 20,240 patients with non-valvular atrial fibrillation (AF) were assessed for eligibility in the RE-LY trial. Gregory Lip, University of Birmingham, UK, presented the results of the RE-LY sub-studies at the annual Europe AF meeting in London.

The RE-LY trial is a randomised evaluation of long-term anticoagulant therapy with dabigatran etexilate. The primary objective was non-inferiority to warfarin with minimum one year follow-up.

The Lip and Lane study ‘Infarction events in atrial fibrillation trials, comparing warfarin against non-warfarin anticoagulant or anticoagulant equivalent’ saw an overall annual event rate on warfarin was 0.98% versus 1.32 with comparator. The study concluded, “Warfarin may provide a protective effect against myocardial infarction compared to non-warfarin anticoagulants or ‘anticoagulant equivalent’ in AF patients prescribed anticoagulation for stroke thromboprophylaxis”.

“Stroke and systemic embolism in relation to troponin 1: a RE-LY substudy”, hypothesed troponin levels are related to outcomes in patients with atrial fibrillation. Six thousand two hundred and four (out of 18,113) patients in the RE-LY trial underwent blood sampling. Venous blood was obtained at randomisation, centrifuged within 30 minutes, frozen at -20° or below and centrally analysed at the UCR Laboratory Uppsala in Sweden.

The study ‘The D-dimer is prognostic for stroke, major bleeding and death during anticoagulation of atrial fibrillation’ by Eikelboom et al revealed the concentration of D-dimer at start of treatment with warfarin or dabigatran is strongly related to the risk of stroke, death and bleeding independently of CHADS₂ risk factors and baselines anticoagulant treatment. It concluded that measurement of D-dimer might be useful to optimise patient selection and the intensity of anticoagulant treatment in atrial fibrillation.

Subgroup analyses from the 18,000 patient RE-LY trial have provided information on vitamin K antagonist naive, secondary prevention, effect of time in therapeutic range, cardioversion, biomarkers, etc.

“More information on impact of coagulation test monitoring and how to manage over-anticoagulation would be of great interest,” Lip concluded.