Design and rationale of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study

Caterina, Raffaele De; Kelly, Peter; Monteiro, Pedro; Deharo, Jean Claude; Asmundis, Carlo de; López-de-Sá, Esteban; Weiss, Thomas W.; Waltenberger, Johannes; Steffel, Jan; Groot, Joris R. de; Lévy, Pierre; Bakhai, Ameet; Zierhut, Wolfgang; Laeis, Petra; Reimitz, Paul-Egbert; Kirchhof, Paulus

doi:10.2459/jcm.0000000000000737

Cited by 25 publications

(28 citation statements)

References 17 publications

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“…Power analyses for sample size justification were performed on a regional basis. Detailed sample size justification for ETNA‐AF and ETNA‐VTE Europe has been published previously . In ETNA‐AF Japan, a total of 10 000 patients will be enrolled.…”

Section: Methodsmentioning

confidence: 99%

“…The Global ETNA program encompasses several multinational, prospective, observational noninterventional studies, including a European noninterventional observational study (Germany, Austria, Switzerland, Belgium, Italy, Spain, UK, Ireland, the Netherlands, and Portugal) and similar noninterventional observational studies in Japan and other East and Southeast Asian countries that are intended to collect regular clinical care data in edoxaban patients with AF or acute or recurrent VTE (Supplemental Table 1). Within the Global ETNA‐AF and VTE program, regional ETNA‐AF and VTE studies are registered separately.…”

Section: Methodsmentioning

confidence: 99%

“…Detailed sample size justification for ETNA-AF and ETNA-VTE Europe has been published previously. 6,7 In ETNA-AF Japan, a total of 10 000 patients will be enrolled. Based on the interim analysis of a postmarketing surveillance of another new orally active anticoagulant, 2% of patients enrolled are expected to have severe renal impairment.…”

Section: Designmentioning

confidence: 99%

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The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

Caterina

Agnelli

Laeis

et al. 2019

Clinical Cardiology

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Background Randomized controlled trials showed the nonvitamin K oral anticoagulant (NOAC) edoxaban was effective and safe for stroke and systemic embolism prevention in nonvalvular atrial fibrillation (AF) and for the prevention and treatment of venous thromboembolism (VTE; including pulmonary embolism and deep vein thrombosis). Additional research is needed to evaluate the effects of edoxaban in routine clinical practice. Therefore, the Edoxaban Treatment in routine cliNical prActice (ETNA) program is being conducted to provide routine clinical care data on characteristics and outcomes in patients with AF or VTE receiving edoxaban. Methods The Global ETNA program integrates prospectively collected data from edoxaban patients in regional ETNA noninterventional studies across Europe, Japan, and East and Southeast Asia into indication‐specific databases for AF and VTE. Targeted enrollment is >31 000 patients (AF >26 000; VTE >4500), with a follow‐up of 2 years for AF and 1 year for VTE. Data integration will be possible using consistent terminology, parameter definitions, and data collection across the regional noninterventional studies. Safety and effectiveness data will be assessed. Crude rates of outcomes including bleeding and thromboembolic events will be reported. Results Globally, enrollment began in early 2015 and is ongoing. Conclusions Global ETNA will generate the largest integrated prospective repository of routine clinical care data for a single NOAC in patients with AF or VTE. It will provide important information on the safety of edoxaban in routine clinical care and gather further information on its effectiveness.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

Caterina

Agnelli

Laeis

et al. 2019

Clinical Cardiology

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“…Details of the design of ETNA-AF-Europe including the statistical rationale have been published [21]. In short, ETNA-AF-Europe is a multinational, multi-centre, post-authorisation, observational study (Clinicaltrials.gov: NCT02944019) conducted in 825 sites (with at least one patient enrolled) in 10 European countries.…”

Section: Methodsmentioning

confidence: 99%

Characteristics of patients initiated on edoxaban in Europe: baseline data from edoxaban treatment in routine clinical practice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe)

Caterina

Kelly

Monteiro

et al. 2019

BMC Cardiovasc Disord

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Background Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). The available routine care data have demonstrated the safety of different NOACs; however, such data for edoxaban are scarce. Here, we report baseline characteristics of 13,638 edoxaban-treated patients with AF enrolled between November 2016 and February 2018. Methods ETNA-AF-Europe is a multinational, multi-centre, post-authorisation, observational study conducted in 825 sites in 10 European countries. Patients will be followed up for four years. Results Overall, 13,980 patients were enrolled of which 342 patients were excluded from the analysis. Mean patient age was 73.6 years with an average creatinine clearance of 69.4 mL/min. 56.6% were male. The calculated CHA 2 DS 2 -VASc and HAS-BLED mean scores were 3.1 and 2.6, respectively. Overall, 3.3, 14.6 and 82.0% of patients had low (CHA 2 DS 2 -VASc = 0), intermediate (CHA 2 DS 2 -VASc = 1) and high (CHA 2 DS 2 -VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA 2 DS 2 -VASc ≥4) comprised 38.4% of the overall population. For 75.1% of patients edoxaban was their first anticoagulant prescription, whilst 16.9% switched from a VKA and 8.0% from another NOAC. A total of 23.4% of patients in ETNA-AF-Europe received the reduced dose of edoxaban 30 mg. Overall, 83.8% of patients received an edoxaban dose in line with the criteria outlined in the label. Conclusion Edoxaban was predominantly initiated in older, often anticoagulation-naïve, unselected European patients with AF, with a good overall adherence to the approved label. Trial registration NCT02944019; Date of registration: October 24, 2016.

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“…These observations are likely attributable to differences in patient selection. For example, one of the inclusion criteria for the RCT was a CHADS2 score of ≥2 [3], whereas in ETNA-AF-Europe, patients were el-Original Article igible for inclusion regardless of their baseline stroke risk [17].…”

Section: Higher Stroke Risks In the Randomised Trial Than In Clinicalmentioning

confidence: 99%

Characteristics of patients with atrial fibrillation prescribed edoxaban in Belgium and the Netherlands: insights from the ETNA-AF-Europe study

Vries

Hemels²,

Cools

et al. 2021

Neth Heart J

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Background Studies on the use of non-vitamin K antagonist oral anticoagulants in unselected patients with atrial fibrillation (AF) show that clinical characteristics and dosing practices differ per region, but lack data on edoxaban. Methods With data from Edoxaban Treatment in routiNe clinical prActice for patients with AF in Europe (ETNA-AF-Europe), a large prospective observational study, we compared clinical characteristics (including the dose reduction criteria for edoxaban: creatinine clearance 15–50 ml/min, weight ≤60 kg, and/or use of strong p‑glycoprotein inhibitors) of patients from Belgium and the Netherlands (BeNe) with those from other European countries (OEC). Results Of all 13,639 patients in ETNA-AF-Europe, 2579 were from BeNe. BeNe patients were younger than OEC patients (mean age: 72.3 vs 73.9 years), and had lower CHA2DS2-VASc (mean: 2.8 vs 3.2) and HAS-BLED scores (mean: 2.4 vs 2.6). Patients from BeNe less often had hypertension (61.6% vs 80.4%), and/or diabetes mellitus (17.3% vs 23.1%) than patients from OEC. Moreover, relatively fewer patients in BeNe were prescribed the reduced dose of 30 mg edoxaban (14.8%) than in OEC (25.4%). Overall, edoxaban was dosed according to label in 83.1% of patients. Yet, 30 mg edoxaban was prescribed in the absence of any dose reduction criteria in 36.9% of 30 mg users (5.5% of all patients) in BeNe compared with 35.5% (9.0% of all patients) in OEC. Conclusion There were several notable differences between BeNe and OEC regarding clinical characteristics and dosing practices in patients prescribed edoxaban, which are relevant for the local implementation of dose evaluation and optimisation. Trial registration NCT02944019; Date of registration 24 October 2016

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Design and rationale of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study

Cited by 25 publications

References 17 publications

The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

Characteristics of patients initiated on edoxaban in Europe: baseline data from edoxaban treatment in routine clinical practice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe)

Characteristics of patients with atrial fibrillation prescribed edoxaban in Belgium and the Netherlands: insights from the ETNA-AF-Europe study

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