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)

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

doi:10.1186/s12872-019-1144-x

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)

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

Cardiovascular Sciences

Research output: Contribution to journal › Article › peer-review

10 Citations (Scopus)

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Abstract

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 CHA₂DS₂-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 (CHA₂DS₂-VASc = 0), intermediate (CHA₂DS₂-VASc = 1) and high (CHA₂DS₂-VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA₂DS₂-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.

Original language	English
Article number	165
Number of pages	11
Journal	BMC Cardiovascular Disorders
Volume	19
Issue number	1
DOIs	https://doi.org/10.1186/s12872-019-1144-x
Publication status	Published - 12 Jul 2019

Keywords

Major bleeding
Non-vitamin K antagonist oral anticoagulants
Real-world
Registry
Safety outcomes
Stroke prevention

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De Caterina, R., Kelly, P., Monteiro, P., Deharo, J. C., de Asmundis, C., López-de-Sá, E., Weiss, T. W., Waltenberger, J., Steffel, J., de Groot, J. R., Levy, P., Bakhai, A., Zierhut, W., Laeis, P., Kerschnitzki, M., Reimitz, P-E., Kirchhof, P., & ETNA-AF-Europe investigators (2019). 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). BMC Cardiovascular Disorders, 19(1), Article 165. https://doi.org/10.1186/s12872-019-1144-x

@article{a5d9444ad6f948978d4650503aa27726,

title = "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)",

abstract = "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 CHA2DS2-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 (CHA2DS2-VASc = 0), intermediate (CHA2DS2-VASc = 1) and high (CHA2DS2-VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA2DS2-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-na{\"i}ve, unselected European patients with AF, with a good overall adherence to the approved label.Trial registration: NCT02944019; Date of registration: October 24, 2016.",

keywords = "Major bleeding, Non-vitamin K antagonist oral anticoagulants, Real-world, Registry, Safety outcomes, Stroke prevention",

author = "{De Caterina}, Raffaele and Peter Kelly and Pedro Monteiro and Deharo, {Jean Claude} and {de Asmundis}, Carlo and Esteban L{\'o}pez-de-S{\'a} and Weiss, {Thomas W} and Johannes Waltenberger and Jan Steffel and {de Groot}, {Joris R} and Pierre Levy and Ameet Bakhai and Wolfgang Zierhut and Petra Laeis and Michael Kerschnitzki and Paul-Egbert Reimitz and Paulus Kirchhof and {ETNA-AF-Europe investigators}",

year = "2019",

month = jul,

day = "12",

doi = "10.1186/s12872-019-1144-x",

language = "English",

volume = "19",

journal = "BMC Cardiovascular Disorders",

issn = "1471-2261",

publisher = "Springer",

number = "1",

}

De Caterina, R, Kelly, P, Monteiro, P, Deharo, JC, de Asmundis, C, López-de-Sá, E, Weiss, TW, Waltenberger, J, Steffel, J, de Groot, JR, Levy, P, Bakhai, A, Zierhut, W, Laeis, P, Kerschnitzki, M, Reimitz, P-E, Kirchhof, P & ETNA-AF-Europe investigators 2019, '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)', BMC Cardiovascular Disorders, vol. 19, no. 1, 165. https://doi.org/10.1186/s12872-019-1144-x

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). / De Caterina, Raffaele; Kelly, Peter; Monteiro, Pedro et al.
In: BMC Cardiovascular Disorders, Vol. 19, No. 1, 165, 12.07.2019.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Characteristics of patients initiated on edoxaban in Europe

T2 - baseline data from edoxaban treatment in routine clinical practice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe)

AU - De Caterina, Raffaele

AU - Kelly, Peter

AU - Monteiro, Pedro

AU - Deharo, Jean Claude

AU - de Asmundis, Carlo

AU - López-de-Sá, Esteban

AU - Weiss, Thomas W

AU - Waltenberger, Johannes

AU - Steffel, Jan

AU - de Groot, Joris R

AU - Levy, Pierre

AU - Bakhai, Ameet

AU - Zierhut, Wolfgang

AU - Laeis, Petra

AU - Kerschnitzki, Michael

AU - Reimitz, Paul-Egbert

AU - Kirchhof, Paulus

AU - ETNA-AF-Europe investigators

PY - 2019/7/12

Y1 - 2019/7/12

N2 - 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 CHA2DS2-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 (CHA2DS2-VASc = 0), intermediate (CHA2DS2-VASc = 1) and high (CHA2DS2-VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA2DS2-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.

AB - 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 CHA2DS2-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 (CHA2DS2-VASc = 0), intermediate (CHA2DS2-VASc = 1) and high (CHA2DS2-VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA2DS2-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.

KW - Major bleeding

KW - Non-vitamin K antagonist oral anticoagulants

KW - Real-world

KW - Registry

KW - Safety outcomes

KW - Stroke prevention

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U2 - 10.1186/s12872-019-1144-x

DO - 10.1186/s12872-019-1144-x

M3 - Article

C2 - 31299906

SN - 1471-2261

VL - 19

JO - BMC Cardiovascular Disorders

JF - BMC Cardiovascular Disorders

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M1 - 165

ER -

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)

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