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Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes

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Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes. / Kirchhof, Paulus; Toennis, Tobias; Goette, Andreas; Camm, A John; Diener, Hans Christoph; Becher, Nina; Bertaglia, Emanuele; Blomstrom Lundqvist, Carina; Borlich, Martin; Brandes, Axel; Cabanelas, Nuno; Calvert, Melanie; Chlouverakis, Gregory; Dan, Gheorghe-Andrei; de Groot, Joris R; Dichtl, Wolfgang; Kravchuk, Borys; Lubiński, Andrzej; Marijon, Eloi; Merkely, Béla; Mont, Lluís; Ozga, Ann-Kathrin; Rajappan, Kim; Sarkozy, Andrea; Scherr, Daniel; Sznajder, Rafał; Velchev, Vasil; Wichterle, Dan; Sehner, Susanne; Simantirakis, Emmanuel; Lip, Gregory Y H; Vardas, Panos; Schotten, Ulrich; Zapf, Antonia; NOAH-AFNET 6 Investigators.

in: NEW ENGL J MED, Jahrgang 389, Nr. 13, 28.09.2023, S. 1167-1179.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Kirchhof, P, Toennis, T, Goette, A, Camm, AJ, Diener, HC, Becher, N, Bertaglia, E, Blomstrom Lundqvist, C, Borlich, M, Brandes, A, Cabanelas, N, Calvert, M, Chlouverakis, G, Dan, G-A, de Groot, JR, Dichtl, W, Kravchuk, B, Lubiński, A, Marijon, E, Merkely, B, Mont, L, Ozga, A-K, Rajappan, K, Sarkozy, A, Scherr, D, Sznajder, R, Velchev, V, Wichterle, D, Sehner, S, Simantirakis, E, Lip, GYH, Vardas, P, Schotten, U, Zapf, A & NOAH-AFNET 6 Investigators 2023, 'Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes', NEW ENGL J MED, Jg. 389, Nr. 13, S. 1167-1179. https://doi.org/10.1056/NEJMoa2303062

APA

Kirchhof, P., Toennis, T., Goette, A., Camm, A. J., Diener, H. C., Becher, N., Bertaglia, E., Blomstrom Lundqvist, C., Borlich, M., Brandes, A., Cabanelas, N., Calvert, M., Chlouverakis, G., Dan, G-A., de Groot, J. R., Dichtl, W., Kravchuk, B., Lubiński, A., Marijon, E., ... NOAH-AFNET 6 Investigators (2023). Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes. NEW ENGL J MED, 389(13), 1167-1179. https://doi.org/10.1056/NEJMoa2303062

Vancouver

Kirchhof P, Toennis T, Goette A, Camm AJ, Diener HC, Becher N et al. Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes. NEW ENGL J MED. 2023 Sep 28;389(13):1167-1179. https://doi.org/10.1056/NEJMoa2303062

Bibtex

@article{25d069f0d30942b6865e327a95c95933,
title = "Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes",
abstract = "BACKGROUND: Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known.METHODS: We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding.RESULTS: The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year).CONCLUSIONS: Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.).",
author = "Paulus Kirchhof and Tobias Toennis and Andreas Goette and Camm, {A John} and Diener, {Hans Christoph} and Nina Becher and Emanuele Bertaglia and {Blomstrom Lundqvist}, Carina and Martin Borlich and Axel Brandes and Nuno Cabanelas and Melanie Calvert and Gregory Chlouverakis and Gheorghe-Andrei Dan and {de Groot}, {Joris R} and Wolfgang Dichtl and Borys Kravchuk and Andrzej Lubi{\'n}ski and Eloi Marijon and B{\'e}la Merkely and Llu{\'i}s Mont and Ann-Kathrin Ozga and Kim Rajappan and Andrea Sarkozy and Daniel Scherr and Rafa{\l} Sznajder and Vasil Velchev and Dan Wichterle and Susanne Sehner and Emmanuel Simantirakis and Lip, {Gregory Y H} and Panos Vardas and Ulrich Schotten and Antonia Zapf and {NOAH-AFNET 6 Investigators}",
note = "Copyright {\textcopyright} 2023 Massachusetts Medical Society.",
year = "2023",
month = sep,
day = "28",
doi = "10.1056/NEJMoa2303062",
language = "English",
volume = "389",
pages = "1167--1179",
journal = "NEW ENGL J MED",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "13",

}

RIS

TY - JOUR

T1 - Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes

AU - Kirchhof, Paulus

AU - Toennis, Tobias

AU - Goette, Andreas

AU - Camm, A John

AU - Diener, Hans Christoph

AU - Becher, Nina

AU - Bertaglia, Emanuele

AU - Blomstrom Lundqvist, Carina

AU - Borlich, Martin

AU - Brandes, Axel

AU - Cabanelas, Nuno

AU - Calvert, Melanie

AU - Chlouverakis, Gregory

AU - Dan, Gheorghe-Andrei

AU - de Groot, Joris R

AU - Dichtl, Wolfgang

AU - Kravchuk, Borys

AU - Lubiński, Andrzej

AU - Marijon, Eloi

AU - Merkely, Béla

AU - Mont, Lluís

AU - Ozga, Ann-Kathrin

AU - Rajappan, Kim

AU - Sarkozy, Andrea

AU - Scherr, Daniel

AU - Sznajder, Rafał

AU - Velchev, Vasil

AU - Wichterle, Dan

AU - Sehner, Susanne

AU - Simantirakis, Emmanuel

AU - Lip, Gregory Y H

AU - Vardas, Panos

AU - Schotten, Ulrich

AU - Zapf, Antonia

AU - NOAH-AFNET 6 Investigators

N1 - Copyright © 2023 Massachusetts Medical Society.

PY - 2023/9/28

Y1 - 2023/9/28

N2 - BACKGROUND: Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known.METHODS: We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding.RESULTS: The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year).CONCLUSIONS: Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.).

AB - BACKGROUND: Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known.METHODS: We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding.RESULTS: The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year).CONCLUSIONS: Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.).

U2 - 10.1056/NEJMoa2303062

DO - 10.1056/NEJMoa2303062

M3 - SCORING: Journal article

C2 - 37622677

VL - 389

SP - 1167

EP - 1179

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 13

ER -