Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours

Nina Becher; Tobias Toennis; Emmanuele Bertaglia; Carina Blomstrom-Lundqvist; Axel Brandes; Nuno Cabanelas; Melanie Calvert; John Camm; Gregory Chlouverakis; Gheorghe-Andrei Dan; Wolfgang Dichtl; Hans Christoph Diener; Alexander Fierenz; Andreas Goette; Joris R de Groot; Astrid Hermans; Gregory Lip; Andrzej Lubinski; Eloi Marijon; Bela Merkely; Lluis Mont; Ann-Kathrin Ozga; Kim Rajappan; Andreas Sarkozy; Daniel Scherr; Renate Schnabel; Ulrich Schotten; Susanne Sehner; Emmanuel Simantirakis; Panos Vardas; Vasil Velchev; Daniel Wichterle; Antonia Zapf; Paulus Kirchhof

doi:10.1093/eurheartj/ehad771

Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours

Nina Becher, Tobias Toennis, Emmanuele Bertaglia, Carina Blomstrom-Lundqvist, Axel Brandes, Nuno Cabanelas, Melanie Calvert, John Camm, Gregory Chlouverakis, Gheorghe-Andrei Dan, Wolfgang Dichtl, Hans Christoph Diener, Alexander Fierenz, Andreas Goette, Joris R de Groot, Astrid Hermans, Gregory Lip, Andrzej Lubinski, Eloi Marijon, Bela MerkelyLluis Mont, Ann-Kathrin Ozga, Kim Rajappan, Andreas Sarkozy, Daniel Scherr, Renate Schnabel, Ulrich Schotten, Susanne Sehner, Emmanuel Simantirakis, Panos Vardas, Vasil Velchev, Daniel Wichterle, Antonia Zapf, Paulus Kirchhof^*

^*Corresponding author for this work

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

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Abstract

Background and Aims: Patients with long atrial high-rate episodes (AHRE) ≥ 24 hours and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared to no anticoagulation in these patients.

Methods: This secondary prespecified analysis of NOAH-AFNET 6 examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared to placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and ECG-diagnosed atrial fibrillation.

Results: AHRE ≥24 hours were present at baseline in 259/2389 patients enrolled in NOAH-AFNET 6 (11%, 78 ± 7 years old, 28% women, CHA₂DS₂-VASc score 4). Clinical characteristics were not different from patients with shorter AHRE. During a median follow-up of 1.8 years, the primary outcome occurred in 9/132 patients with AHRE ≥24 hours (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). AHRE duration did not interact with the efficacy (p-interaction = 0.65) or safety (p-interaction = 0.98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 hours developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; p < 0.001).

Conclusions: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk.

Original language	English
Article number	ehad771
Journal	European Society of Cardiology
Early online date	12 Nov 2023
DOIs	https://doi.org/10.1093/eurheartj/ehad771
Publication status	E-pub ahead of print - 12 Nov 2023

Keywords

atrial high-rate episodes
stroke
atrial fibrillation
NOAH-AFNET 6

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BecherN2023AnticoagulationAccepted author manuscript, 1.27 MBLicence: Creative Commons: Attribution-NonCommercial (CC BY-NC)

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Becher, N., Toennis, T., Bertaglia, E., Blomstrom-Lundqvist, C., Brandes, A., Cabanelas, N., Calvert, M., Camm, J., Chlouverakis, G., Dan, G.-A., Dichtl, W., Diener, H. C., Fierenz, A., Goette, A., de Groot, J. R., Hermans, A., Lip, G., Lubinski, A., Marijon, E., ... Kirchhof, P. (2023). Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours. European Society of Cardiology, Article ehad771. Advance online publication. https://doi.org/10.1093/eurheartj/ehad771

@article{e863bf54761f459eacbe1e6b54f0a0a4,

title = "Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours",

abstract = "Background and Aims: Patients with long atrial high-rate episodes (AHRE) ≥ 24 hours and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared to no anticoagulation in these patients.Methods: This secondary prespecified analysis of NOAH-AFNET 6 examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared to placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and ECG-diagnosed atrial fibrillation.Results: AHRE ≥24 hours were present at baseline in 259/2389 patients enrolled in NOAH-AFNET 6 (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc score 4). Clinical characteristics were not different from patients with shorter AHRE. During a median follow-up of 1.8 years, the primary outcome occurred in 9/132 patients with AHRE ≥24 hours (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). AHRE duration did not interact with the efficacy (p-interaction = 0.65) or safety (p-interaction = 0.98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 hours developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; p < 0.001).Conclusions: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk.",

keywords = "atrial high-rate episodes, stroke, atrial fibrillation, NOAH-AFNET 6",

author = "Nina Becher and Tobias Toennis and Emmanuele Bertaglia and Carina Blomstrom-Lundqvist and Axel Brandes and Nuno Cabanelas and Melanie Calvert and John Camm and Gregory Chlouverakis and Gheorghe-Andrei Dan and Wolfgang Dichtl and Diener, {Hans Christoph} and Alexander Fierenz and Andreas Goette and {de Groot}, {Joris R} and Astrid Hermans and Gregory Lip and Andrzej Lubinski and Eloi Marijon and Bela Merkely and Lluis Mont and Ann-Kathrin Ozga and Kim Rajappan and Andreas Sarkozy and Daniel Scherr and Renate Schnabel and Ulrich Schotten and Susanne Sehner and Emmanuel Simantirakis and Panos Vardas and Vasil Velchev and Daniel Wichterle and Antonia Zapf and Paulus Kirchhof",

year = "2023",

month = nov,

day = "12",

doi = "10.1093/eurheartj/ehad771",

language = "English",

journal = "European Society of Cardiology",

}

Becher, N, Toennis, T, Bertaglia, E, Blomstrom-Lundqvist, C, Brandes, A, Cabanelas, N, Calvert, M, Camm, J, Chlouverakis, G, Dan, G-A, Dichtl, W, Diener, HC, Fierenz, A, Goette, A, de Groot, JR, Hermans, A, Lip, G, Lubinski, A, Marijon, E, Merkely, B, Mont, L, Ozga, A-K, Rajappan, K, Sarkozy, A, Scherr, D, Schnabel, R, Schotten, U, Sehner, S, Simantirakis, E, Vardas, P, Velchev, V, Wichterle, D, Zapf, A & Kirchhof, P 2023, 'Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours', European Society of Cardiology. https://doi.org/10.1093/eurheartj/ehad771

TY - JOUR

T1 - Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours

AU - Becher, Nina

AU - Toennis, Tobias

AU - Bertaglia, Emmanuele

AU - Blomstrom-Lundqvist, Carina

AU - Brandes, Axel

AU - Cabanelas, Nuno

AU - Calvert, Melanie

AU - Camm, John

AU - Chlouverakis, Gregory

AU - Dan, Gheorghe-Andrei

AU - Dichtl, Wolfgang

AU - Diener, Hans Christoph

AU - Fierenz, Alexander

AU - Goette, Andreas

AU - de Groot, Joris R

AU - Hermans, Astrid

AU - Lip, Gregory

AU - Lubinski, Andrzej

AU - Marijon, Eloi

AU - Merkely, Bela

AU - Mont, Lluis

AU - Ozga, Ann-Kathrin

AU - Rajappan, Kim

AU - Sarkozy, Andreas

AU - Scherr, Daniel

AU - Schnabel, Renate

AU - Schotten, Ulrich

AU - Sehner, Susanne

AU - Simantirakis, Emmanuel

AU - Vardas, Panos

AU - Velchev, Vasil

AU - Wichterle, Daniel

AU - Zapf, Antonia

AU - Kirchhof, Paulus

PY - 2023/11/12

Y1 - 2023/11/12

N2 - Background and Aims: Patients with long atrial high-rate episodes (AHRE) ≥ 24 hours and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared to no anticoagulation in these patients.Methods: This secondary prespecified analysis of NOAH-AFNET 6 examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared to placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and ECG-diagnosed atrial fibrillation.Results: AHRE ≥24 hours were present at baseline in 259/2389 patients enrolled in NOAH-AFNET 6 (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc score 4). Clinical characteristics were not different from patients with shorter AHRE. During a median follow-up of 1.8 years, the primary outcome occurred in 9/132 patients with AHRE ≥24 hours (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). AHRE duration did not interact with the efficacy (p-interaction = 0.65) or safety (p-interaction = 0.98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 hours developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; p < 0.001).Conclusions: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk.

AB - Background and Aims: Patients with long atrial high-rate episodes (AHRE) ≥ 24 hours and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared to no anticoagulation in these patients.Methods: This secondary prespecified analysis of NOAH-AFNET 6 examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared to placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and ECG-diagnosed atrial fibrillation.Results: AHRE ≥24 hours were present at baseline in 259/2389 patients enrolled in NOAH-AFNET 6 (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc score 4). Clinical characteristics were not different from patients with shorter AHRE. During a median follow-up of 1.8 years, the primary outcome occurred in 9/132 patients with AHRE ≥24 hours (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). AHRE duration did not interact with the efficacy (p-interaction = 0.65) or safety (p-interaction = 0.98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 hours developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; p < 0.001).Conclusions: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk.

KW - atrial high-rate episodes

KW - stroke

KW - atrial fibrillation

KW - NOAH-AFNET 6

U2 - 10.1093/eurheartj/ehad771

DO - 10.1093/eurheartj/ehad771

M3 - Article

JO - European Society of Cardiology

JF - European Society of Cardiology

M1 - ehad771

ER -

Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours

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Keywords

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