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).
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
About The Expert
Gordon Chu
Jaap Seelig
Emmy M Trinks-Roerdink
Anouk P van Alem
Marco Alings
Bart van den Bemt
Lucas Va Boersma
Marc A Brouwer
Suzanne C Cannegieter
Hugo Ten Cate
Charles Jhj Kirchhof
Harry Jgm Crijns
Ewoud J van Dijk
Arif Elvan
Isabelle C van Gelder
Joris R de Groot
Frank R den Hartog
Jonas Ssg de Jong
Sylvie de Jong
Frederikus A Klok
Timo Lenderink
Justin G Luermans
Joan G Meeder
Ron Pisters
Peter Polak
Michiel Rienstra
Frans Smeets
Giovanni Jm Tahapary
Luc Theunissen
Robert G Tieleman
Serge A Trines
Pepijn van der Voort
Geert-Jan Geersing
Frans H Rutten
Martin Ew Hemels
Menno V Huisman
References
PubMed