Abstract
BackgroundAtrial fibrillation (AF) is an independent risk factor for stroke and a significant predictor of mortality. Evidence-based guidelines for stroke prevention in AF recommend antithrombotic therapy corresponding to the risk of stroke. In practice, many patients with AF do not receive the appropriate antithrombotic therapy and are left either unprotected or inadequately protected against stroke. The purpose of the Global Anticoagulant Registry in the FIELD (GARFIELD) is to determine the real-life management and outcomes of patients newly diagnosed with non-valvular AF.Methods/designGARFIELD is an observational, international registry of newly diagnosed AF patients with at least one additional investigator-defined risk factor for stroke. The aim is to enrol 55,000 patients at more than 1000 centres in 50 countries worldwide. Enrolment will take place in five independent, sequential, prospective cohorts; the first cohort includes a retrospective validation cohort. Each cohort will be followed up for 2 years. The UK stands to be a significant contributor to GARFIELD, aiming to enrol 4,582 patients, and reflecting the care environment in which patients with AF are managed. The UK protocol will also focus on better understanding the validity of the two main stroke risk scores (CHADS2 and CHA2DS2VASC) and the HAS-BLED bleeding risk score, in the context of a diverse patient population.DiscussionThe GARFIELD registry will describe how therapeutic strategies, patient care, and clinical outcomes evolve over time. This study will provide UK-specific comprehensive data that will allow a range of evaluations both at a national level and in relation to global data and contribute to a better understanding of AF management in the UK.Trial registrationClinicalTrial.gov: NCT01090362
Highlights
Atrial fibrillation (AF) is an independent risk factor for stroke and a significant predictor of mortality
The GARFIELD registry will describe how therapeutic strategies, patient care, and clinical outcomes evolve over time
Study aims The key aims of the GARFIELD registry are to determine the real-life treatment patterns and clinical outcomes of newly diagnosed patients with non-valvular AF with at least one additional risk factor for stroke
Summary
The development of this large, ongoing registry allows the opportunity to answer several research questions that have not previously been investigated within a nonrandomised, non-selected population. These questions will pertain to: Clinical risks within a non-selected population of newly diagnosed patients with AF, compared with data from randomised trials in which prevalent, stable VKA users were preferably enrolled [20]; Risks and benefits associated with oral anticoagulation; Quality of INR control in everyday clinical practice;. GARFIELD will inform on the effectiveness of the NICE treatment guidelines and allow an evaluation of such guidelines and patient outcomes. The study will provide real-world prospective data that will allow an evaluation of clinical practices and related outcomes in the VKA-only era, but will report on outcomes relating to any novel anticoagulants or new therapies licensed for use in the UK during the duration of the study
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