Abstract
BackgroundAtrial fibrillation (AF) patients with a high risk of stroke are recommended anticoagulation with warfarin. However, the benefit of warfarin is dependent upon time spent within the target therapeutic range (TTR) of their international normalised ratio (INR) (2.0 to 3.0). AF patients possess limited knowledge of their disease and warfarin treatment and this can impact on INR control. Education can improve patients' understanding of warfarin therapy and factors which affect INR control.Methods/DesignRandomised controlled trial of an intensive educational intervention will consist of group sessions (between 2-8 patients) containing standardised information about the risks and benefits associated with OAC therapy, lifestyle interactions and the importance of monitoring and control of their International Normalised Ratio (INR). Information will be presented within an 'expert-patient' focussed DVD, revised educational booklet and patient worksheets. 200 warfarin-naïve patients who are eligible for warfarin will be randomised to either the intervention or usual care groups. All patients must have ECG-documented AF and be eligible for warfarin (according to the NICE AF guidelines). Exclusion criteria include: aged < 18 years old, contraindication(s) to warfarin, history of warfarin USE, valvular heart disease, cognitive impairment, are unable to speak/read English and disease likely to cause death within 12 months. Primary endpoint is time spent in TTR. Secondary endpoints include measures of quality of life (AF-QoL-18), anxiety and depression (HADS), knowledge of AF and anticoagulation, beliefs about medication (BMQ) and illness representations (IPQ-R). Clinical outcomes, including bleeding, stroke and interruption to anticoagulation will be recorded. All outcome measures will be assessed at baseline and 1, 2, 6 and 12 months post-intervention.DiscussionMore data is needed on the clinical benefit of educational intervention with AF patients receiving warfarin.Trial registrationISRCTN93952605
Highlights
Atrial fibrillation (AF) patients with a high risk of stroke are recommended anticoagulation with warfarin
More data is needed on the clinical benefit of educational intervention with AF patients receiving warfarin
The TREAT trial seeks to recruit warfarin-naïve patients from cardiology clinics who are recommended for and accepting of oral anticoagulant (OAC) with warfarin
Summary
Atrial fibrillation (AF) patients with a high risk of stroke are recommended anticoagulation with warfarin. Recent analyses have demonstrated that the minimum threshold of time spent in the therapeutic INR range for warfarin to be efficacious is ≥ 58%, a TTR >65% is associated with a 2.29% (95% CI 1.57-3.35; p < 0.0001) reduction in stroke risk [8]. Analyses from an observational UK cohort of AF patients [9] found that 51% of patients at high risk of stroke (CHADS2 score ≥ 2) were outside the therapeutic range for 50% or more of the time for the duration of their warfarin treatment [9] and that TTR needed to be >71% for warfarin to be efficacious [9]
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