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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.

ABSTRACT: INTRODUCTION: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. METHODS AND ANALYSIS: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. ETHICS AND DISSEMINATION: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 REGISTRATION NUMBER:Trial NL7467, NTR7706 (https://www.trialregister.nl/trial/7464).

SUBMITTER: Chu G

PROVIDER: S-EPMC7449286 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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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.

Chu Gordon G Seelig Jaap J Trinks-Roerdink Emmy M EM van Alem Anouk P AP Alings Marco M van den Bemt Bart B Boersma Lucas Va LV Brouwer Marc A MA Cannegieter Suzanne C SC Ten Cate Hugo H Kirchhof Charles Jhj CJ Crijns Harry Jgm HJ van Dijk Ewoud J EJ Elvan Arif A van Gelder Isabelle C IC de Groot Joris R JR den Hartog Frank R FR de Jong Jonas Ssg JS de Jong Sylvie S Klok Frederikus A FA Lenderink Timo T Luermans Justin G JG Meeder Joan G JG Pisters Ron R Polak Peter P Rienstra Michiel M Smeets Frans F Tahapary Giovanni Jm GJ Theunissen Luc L Tieleman Robert G RG Trines Serge A SA van der Voort Pepijn P Geersing Geert-Jan GJ Rutten Frans H FH Hemels Martin Ew ME Huisman Menno V MV

BMJ open 20200824 8

<h4>Introduction</h4>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 q ...[more]

PMID: 32843516

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Project description:BackgroundAlthough triple antithrombotic therapy (TAT) is recommended in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), guidelines allow an option of dual antithrombotic therapy (DAT). This study assesses the everyday practice of 10 cardiology departments in antithrombotic therapy in AF patients undergoing PCI and its agreement with current guidelines.MethodsThis analysis included medical data of AF patients enrolled in the prospective, observational registry (The POLish Atrial Fibrillation-POL-AF) that underwent PCI [elective or due to acute coronary syndrome (ACS)].ResultsOf the 3,999 consecutive subjects included, a final analysis was performed on 359 patients that underwent PCI: 148 with urgent PCI due to ACSand 211 patients with elective PCI. Eighty patients in the ACS-group and 120 patients in the elective-PCI group were treated with TAT, although guidelines also allowed DAT. Of 316 patients treated with oral anticoagulants as a part of combination therapy, 275 were on non-vitamin K antagonist oral anticoagulant (NOAC). Reduced doses of NOAC were used in 74 patients treated with rivaroxaban, 60 patients with dabigatran, and 54 patients with apixaban. The proportion of patients treated with reduced NOAC doses adequately to the guidelines was 29%, 100%, and 33% for rivaroxaban, dabigatran, and apixaban, respectively. Inappropriate low doses of NOACs were used in 71% of subjects on rivaroxaban and 67% on apixaban.ConclusionsIn patients with AF undergoing PCI, NOACs are definitely preferred over vitamin-K antagonists (VKAs) in TAT/DAT, and an aggressive antithrombotic strategy with TAT is frequently chosen even if DAT is permissible by the guidelines. Label adherence of using reduced NOAC dose during combination therapy is not satisfactory for apixaban and rivaroxaban and probably results from too cautious an approach to the known indications for reduced therapy. The study is registered in the database Clinical Trials-NCT04419012.

Project description:OBJECTIVE:To investigate evolving patterns in antithrombotic treatment in UK patients with newly diagnosed non-valvular atrial fibrillation (AF). DESIGN:Prospective, multicentre, international registry. SETTING:186 primary care practices in the UK. PARTICIPANTS:3482 participants prospectively enrolled in four sequential cohorts (cohort 2 (C2) n=830, diagnosed September 2011 to April 2013; cohort 3 (C3) n=902, diagnosed April 2013 to June 2014; cohort 4 (C4) n=850, diagnosed July 2014 to June 2015; cohort 5 (C5) n=900, diagnosed June 2015 to July 2016). Participants had newly diagnosed non-valvular AF and at least one risk factor for stroke, were aged ?18,?and provided informed consent. MAIN OUTCOME MEASURES:Antithrombotic treatment initiated at diagnosis, overall and according to stroke and bleeding risks. Stroke risk was retrospectively calculated using CHA2DS2-VASc (cardiac failure, hypertension, age ?75 (doubled), diabetes, stroke (doubled)-vascular disease, age 65-74 and sex category (female)) and bleeding risk using HAS-BLED (hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, elderly (>65), drugs/alcohol concomitantly (1 point each)). RESULTS:42.7% were women and the mean age was 74.5 years. The median CHA2DS2-VASc score was 3 in all cohorts and the median HAS-BLED score was 2 in all cohorts. There was a statistically significant increase in the use of anticoagulant therapy from C2 to C5 (C2 54.7%, C3 60.3%, C4 73.1%, C5 73.9%; P value for trend <0.0001). The increase in the use of anticoagulant was mainly in patients with CHA2DS2-VASc ?2. The use of vitamin K antagonists (VKAs)±antiplatelet (AP) drugs decreased from C2 to C5 (C2 53.3%, C3 52.1%, C4 50.3%, C5 30.6%), while the use of non-vitamin K antagonist oral anticoagulants (NOACs)±AP increased (C2 1.3%, C3 8.0%, C4 22.7%, C5 43.3%). The use of AP only decreased (C2 36.4%, C3 25.5%, C4 11.9%, C5 10.5%), as did the combination therapy of VKA+AP (C2 13.6%, C3 11.0%, C4 9.6%, C5 5.8%). CONCLUSION:There has been a progressive increase in the proportion of patients newly diagnosed with AF receiving guideline-recommended therapy in the UK, potentially driven by the availability of NOACs. TRIAL REGISTRATION NUMBER:NCT01090362; Pre-results.

Project description:BackgroundStroke prevention with oral anticoagulant (OAC) therapy, including non-vitamin K antagonist oral anticoagulants (NOACs), is recommended in patients with atrial fibrillation (AF). This analysis describes the antithrombotic prescription patterns for Chinese patients enrolled post-dabigatran approval during Phase II and III of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) program in China.MethodsPatients aged ≥ 18 years with newly diagnosed (< 3 months before baseline visit) nonvalvular AF at risk of stroke (CHA2DS2-VASc score ≥ 1) were consecutively enrolled in the GLORIA-AF registry. This cross-sectional analysis provides descriptive comparison of Chinese patients in Phase III (2015-2016) with those enrolled in Phase II (2013-2014).ResultsOverall, 1,018 and 1,911 Chinese patients were eligible for analysis in Phase II and III, respectively. Most patients (69.6% and 69.1%, respectively) had high stroke risk (CHA2DS2-VASc score ≥ 2 for males and ≥ 3 for females). High bleeding risk (HAS-BLED score ≥ 3) rates were similar (17.3% for Phase II, 17.6% for Phase III). In Phase II, 5.8%, 15.2%, 36.7% and 42.2% of patients were prescribed NOACs, vitamin K antagonists (VKAs), antiplatelet therapies or no antithrombotic treatment, respectively. The corresponding figures were 17.2%, 23.5%, 37.4% and 21.8% for patients in Phase III, with an overall increase in OAC prescriptions (NOACs or VKAs). In patients with high stroke risk, the prescription patterns in Phase II were 5.6%, 14.4%, 41.0% and 38.9% for NOACs, VKAs, antiplatelets or no antithrombotic treatment, respectively. The respective proportions in Phase III were 15.1%, 23.5%, 40.9% and 20.5%.ConclusionsSince the availability of dabigatran in China, the overall trend of OAC, including NOAC, prescriptions in Chinese patients with nonvalvular AF has increased over time, albeit with VKAs as the most common antithrombotic treatment. Most patients, including those at high stroke risk, remain undertreated according to best practice guidelines.Trial registrationClinicalTrials.gov NCT01468701.

Dataset Information

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.

Publications

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.

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