Design and rationale of DUTCH-AF: a prospective nationwide registry programme and observational study on long-term oral antithrombotic treatment in patients with atrial fibrillation.

Anticoagulation therapy is pivotal in the management of stroke prevention in atrial fibrillation (AF). Prospective registries, containing longitudinal data are lacking with detailed information on anticoagulant therapy, treatment adherence and AF-related adverse events in practice-based patient cohorts, in particular for non-vitamin K oral anticoagulants (NOAC). With the creation of DUTCH-AF, a nationwide longitudinal AF registry, we aim to provide clinical data and answer questions on the (anticoagulant) management over time and of the clinical course of patients with newly diagnosed AF in routine clinical care. Within DUTCH-AF, our current aim is to assess the effect of non-adherence and non-persistence of anticoagulation therapy on clinical adverse events (eg, bleeding and stroke), to determine predictors for such inadequate anticoagulant treatment, and to validate and refine bleeding prediction models. With DUTCH-AF, we provide the basis for a continuing nationwide AF registry, which will facilitate subsequent research, including future registry-based clinical trials. The DUTCH-AF registry is a nationwide, prospective registry of patients with newly diagnosed 'non-valvular' AF. Patients will be enrolled from primary, secondary and tertiary care practices across the Netherlands. A target of 6000 patients for this initial cohort will be followed for at least 2 years. Data on thromboembolic and bleeding events, changes in antithrombotic therapy and hospital admissions will be registered. Pharmacy-dispensing data will be obtained to calculate parameters of adherence and persistence to anticoagulant treatment, which will be linked to AF-related outcomes such as ischaemic stroke and major bleeding. In a subset of patients, anticoagulation adherence and beliefs about drugs will be assessed by questionnaire. This study protocol was approved as exempt for formal review according to Dutch law by the Medical Ethics Committee of the Leiden University Medical Centre, Leiden, the Netherlands. Results will be disseminated by publications in peer-reviewed journals and presentations at scientific congresses. Trial NL7467, NTR7706 (https://www.trialregister.nl/trial/7464).

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Competing interests: GC and EMT-R are supported by a research grant of ZonMW (project numbers 848050006 and 848050007). JS is supported by a grant from the Dutch Federation of Anticoagulation Clinics (FNT), outside the submitted work. FAK has received research support from Bayer, Bristol Myers Squibb, Boehringer Ingelheim, MSD, Daiichi Sankyo, Actelion, the Dutch Thrombosis Association and the Dutch Heart foundation. JRdG reports research grants from Abbott, AtriCure, Boston Scientific, Medtronic and Bayer. He received speaker/consultancy honoraria from AtriCure, Bayer, Daiichi Sankyo, Johnson & Johnson, Servier and Novartis; all outside the scope of this work. JGM received consultancy fees from BMS/Pfizer and Daiichi Sankyo. FS received consultancy fees from Daiichi Sankyo and BMS, and restricted institutional grants from Daiichi Sankyo. RGT reports grants and personal fees from Boehringer Ingelheim, Bayer, Pfizer, Bristol Meyer Squibb and Daiichi Sankyo. FHR and GJG received unrestricted institutional grants from Bayer, BMS/Pfizer, Boehringer Ingelheim and Daiichi Sankyo. MEWH received consultancy fees from Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo and Roche, and received a research grant from Federation of Dutch Thrombosis Services. MVH reports unrestricted grants from and personal fees from Boehringer Ingelheim, Pfizer/BMS, Bayer Health Care, Aspen and Daiichi Sankyo, outside the submitted work.