Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial

Hans Christoph Diener; Nina Becher; Susanne Sehner; Tobias Toennis; Emanuele Bertaglia; Carina Blomstrom-Lundqvist; Axel Brandes; Vincent Beuger; Melanie Calvert; A. John Camm; Gregory Chlouverakis; Gheorghe-Andrei Dan; Wolfgang Dichtl; Alexander Fierenz; Andreas Goette; Joris R. de Groot; Astrid Hermans; Gregory Y. H. Lip; Andrzej Lubinski; Eloi Marijon; Béla Merkely; Lluís Mont; Julius Nikorowitsch; Ann-Kathrin Ozga; Kim Rajappan; Andrea Sarkozy; Daniel Scherr; Renate B. Schnabel; Ulrich Schotten; Emmanuel Simantirakis; Panos Vardas; Dan Wichterle; Antonia Zapf; Paulus Kirchhof; NOAH‐AFNET 6 investigators; Katja Holm

doi:10.1161/JAHA.124.036429

Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial

Hans Christoph Diener, Nina Becher, Susanne Sehner, Tobias Toennis, Emanuele Bertaglia, Carina Blomstrom-Lundqvist, Axel Brandes, Vincent Beuger, Melanie Calvert, A. John Camm, Gregory Chlouverakis, Gheorghe-Andrei Dan, Wolfgang Dichtl, Alexander Fierenz, Andreas Goette, Joris R. de Groot, Astrid Hermans, Gregory Y. H. Lip, Andrzej Lubinski, Eloi MarijonBéla Merkely, Lluís Mont, Julius Nikorowitsch, Ann-Kathrin Ozga, Kim Rajappan, Andrea Sarkozy, Daniel Scherr, Renate B. Schnabel, Ulrich Schotten, Emmanuel Simantirakis, Panos Vardas, Dan Wichterle, Antonia Zapf, Paulus Kirchhof^*, NOAH‐AFNET 6 investigators, Katja Holm (Member of study group)

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

19 Citations (Scopus)

48 Downloads (Pure)

Abstract

BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear.

METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients).

CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.

Original language	English
Article number	e036429
Journal	Journal of the American Heart Association
Volume	13
Issue number	17
Pages (from-to)	e036429
Number of pages	13
ISSN	2047-9980
DOIs	https://doi.org/10.1161/JAHA.124.036429
Publication status	Published - 3 Sept 2024

Keywords

Administration, Oral
Aged
Aged, 80 and over
Anticoagulants/administration & dosage
Atrial Fibrillation/drug therapy
CHA2DS2‐VASc score
Double-Blind Method
Female
Hemorrhage/chemically induced
Humans
Ischemic Attack, Transient/prevention & control
Male
NOAH‐AFNET 6
Pacemaker, Artificial
Stroke/prevention & control
Time Factors
Treatment Outcome
anticoagulation
atrial fibrillation
device‐detected atrial fibrillation
recurrent stroke
CHA DS -VASc score
NOAH-AFNET 6
device-detected atrial fibrillation

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Diener et al. (2024). Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack - The NOAH-AFNET 6 TrialFinal published version, 1.71 MBLicence: CC BY-NC-ND 4.0

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Diener, H. C., Becher, N., Sehner, S., Toennis, T., Bertaglia, E., Blomstrom-Lundqvist, C., Brandes, A., Beuger, V., Calvert, M., Camm, A. J., Chlouverakis, G., Dan, G.-A., Dichtl, W., Fierenz, A., Goette, A., de Groot, J. R., Hermans, A., Lip, G. Y. H., Lubinski, A., ... Holm, K. (2024). Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial. Journal of the American Heart Association, 13(17), e036429. Article e036429. https://doi.org/10.1161/JAHA.124.036429

@article{ad9a89f112ed46b987f2bb33050e9728,

title = "Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial",

abstract = "BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear.METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4\% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7\% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3\% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6\% per patient-year]; no anticoagulation: 6 out of 131 [2.3\% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients).CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.",

keywords = "Administration, Oral, Aged, Aged, 80 and over, Anticoagulants/administration \& dosage, Atrial Fibrillation/drug therapy, CHA2DS2‐VASc score, Double-Blind Method, Female, Hemorrhage/chemically induced, Humans, Ischemic Attack, Transient/prevention \& control, Male, NOAH‐AFNET 6, Pacemaker, Artificial, Stroke/prevention \& control, Time Factors, Treatment Outcome, anticoagulation, atrial fibrillation, device‐detected atrial fibrillation, recurrent stroke, CHA DS -VASc score, NOAH-AFNET 6, device-detected atrial fibrillation",

author = "Diener, \{Hans Christoph\} and Nina Becher and Susanne Sehner and Tobias Toennis and Emanuele Bertaglia and Carina Blomstrom-Lundqvist and Axel Brandes and Vincent Beuger and Melanie Calvert and Camm, \{A. John\} and Gregory Chlouverakis and Gheorghe-Andrei Dan and Wolfgang Dichtl and Alexander Fierenz and Andreas Goette and \{de Groot\}, \{Joris R.\} and Astrid Hermans and Lip, \{Gregory Y. H.\} and Andrzej Lubinski and Eloi Marijon and B{\'e}la Merkely and Llu{\'i}s Mont and Julius Nikorowitsch and Ann-Kathrin Ozga and Kim Rajappan and Andrea Sarkozy and Daniel Scherr and Schnabel, \{Renate B.\} and Ulrich Schotten and Emmanuel Simantirakis and Panos Vardas and Dan Wichterle and Antonia Zapf and Paulus Kirchhof and \{NOAH‐AFNET 6 investigators\} and Katja Holm",

year = "2024",

month = sep,

day = "3",

doi = "10.1161/JAHA.124.036429",

language = "English",

volume = "13",

pages = "e036429",

journal = "Journal of the American Heart Association",

issn = "2047-9980",

publisher = "American Heart Association Inc.",

number = "17",

}

Diener, HC, Becher, N, Sehner, S, Toennis, T, Bertaglia, E, Blomstrom-Lundqvist, C, Brandes, A, Beuger, V, Calvert, M, Camm, AJ, Chlouverakis, G, Dan, G-A, Dichtl, W, Fierenz, A, Goette, A, de Groot, JR, Hermans, A, Lip, GYH, Lubinski, A, Marijon, E, Merkely, B, Mont, L, Nikorowitsch, J, Ozga, A-K, Rajappan, K, Sarkozy, A, Scherr, D, Schnabel, RB, Schotten, U, Simantirakis, E, Vardas, P, Wichterle, D, Zapf, A, Kirchhof, P, NOAH‐AFNET 6 investigators & Holm, K 2024, 'Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial', Journal of the American Heart Association, vol. 13, no. 17, e036429, pp. e036429. https://doi.org/10.1161/JAHA.124.036429

Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial. / Diener, Hans Christoph; Becher, Nina; Sehner, Susanne et al.
In: Journal of the American Heart Association, Vol. 13, No. 17, e036429, 03.09.2024, p. e036429.

Research output: Contribution to journal › Journal article › Research › peer-review

TY - JOUR

T1 - Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial

AU - Diener, Hans Christoph

AU - Becher, Nina

AU - Sehner, Susanne

AU - Toennis, Tobias

AU - Bertaglia, Emanuele

AU - Blomstrom-Lundqvist, Carina

AU - Brandes, Axel

AU - Beuger, Vincent

AU - Calvert, Melanie

AU - Camm, A. John

AU - Chlouverakis, Gregory

AU - Dan, Gheorghe-Andrei

AU - Dichtl, Wolfgang

AU - Fierenz, Alexander

AU - Goette, Andreas

AU - de Groot, Joris R.

AU - Hermans, Astrid

AU - Lip, Gregory Y. H.

AU - Lubinski, Andrzej

AU - Marijon, Eloi

AU - Merkely, Béla

AU - Mont, Lluís

AU - Nikorowitsch, Julius

AU - Ozga, Ann-Kathrin

AU - Rajappan, Kim

AU - Sarkozy, Andrea

AU - Scherr, Daniel

AU - Schnabel, Renate B.

AU - Schotten, Ulrich

AU - Simantirakis, Emmanuel

AU - Vardas, Panos

AU - Wichterle, Dan

AU - Zapf, Antonia

AU - Kirchhof, Paulus

AU - NOAH‐AFNET 6 investigators

A2 - Holm, Katja

PY - 2024/9/3

Y1 - 2024/9/3

N2 - BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear.METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients).CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.

AB - BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear.METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients).CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.

KW - Administration, Oral

KW - Aged

KW - Aged, 80 and over

KW - Anticoagulants/administration & dosage

KW - Atrial Fibrillation/drug therapy

KW - CHA2DS2‐VASc score

KW - Double-Blind Method

KW - Female

KW - Hemorrhage/chemically induced

KW - Humans

KW - Ischemic Attack, Transient/prevention & control

KW - Male

KW - NOAH‐AFNET 6

KW - Pacemaker, Artificial

KW - Stroke/prevention & control

KW - Time Factors

KW - Treatment Outcome

KW - anticoagulation

KW - atrial fibrillation

KW - device‐detected atrial fibrillation

KW - recurrent stroke

KW - CHA DS -VASc score

KW - NOAH-AFNET 6

KW - device-detected atrial fibrillation

UR - https://www.scopus.com/pages/publications/85203203071

U2 - 10.1161/JAHA.124.036429

DO - 10.1161/JAHA.124.036429

M3 - Journal article

C2 - 39190564

SN - 2047-9980

VL - 13

SP - e036429

JO - Journal of the American Heart Association

JF - Journal of the American Heart Association

IS - 17

M1 - e036429

ER -

Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial

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