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Randomized Controlled Trial
. 2024 Sep 3;13(17):e036429.
doi: 10.1161/JAHA.124.036429. Epub 2024 Aug 27.

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  1 , Nina Becher  2   3 , Susanne Sehner  4 , Tobias Toennis  2   3 , Emanuele Bertaglia  5 , Carina Blomstrom-Lundqvist  6   7 , Axel Brandes  8   9 , Vincent Beuger  9 , Melanie Calvert  10   11 , A John Camm  12 , Gregory Chlouverakis  13 , Gheorghe-Andrei Dan  14 , Wolfgang Dichtl  15 , Alexander Fierenz  4 , Andreas Goette  9   16   17 , Joris R de Groot  18 , Astrid Hermans  19 , Gregory Y H Lip  20   21 , Andrzej Lubinski  22 , Eloi Marijon  23 , Béla Merkely  24 , Lluís Mont  25   26   27 , Julius Nikorowitsch  2   3 , Ann-Kathrin Ozga  4 , Kim Rajappan  28 , Andrea Sarkozy  29 , Daniel Scherr  30 , Renate B Schnabel  2   3   9 , Ulrich Schotten  9   19 , Emmanuel Simantirakis  31 , Panos Vardas  31   32 , Dan Wichterle  33 , Antonia Zapf  4   9 , Paulus Kirchhof  2   3   9 ; NOAH‐AFNET 6 investigators
Affiliations
Randomized Controlled Trial

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 et al. J Am Heart Assoc. .

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: CHA2DS2‐VASc score; NOAH‐AFNET 6; anticoagulation; atrial fibrillation; device‐detected atrial fibrillation; recurrent stroke.

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Figures

Figure 1
Figure 1. CONSORT flow diagram of this analysis of the NOAH‐AFNET 6 trial in patients with a prior stroke or transient ischemic attack.
ER, event rate (% per patient‐year); CONSORT, Consolidated Standards of Reporting Trials; CV indicates cardiovascular; mITT, modified intention‐to‐treat population (the primary analysis population in NOAH‐AFNET 6); NOAH‐AFNET 6, Non‐Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes; and TIA, transient ischemic attack.
Figure 2
Figure 2. Efficacy outcomes in this subanalysis.
Shown are time‐to‐event Aalen‐Johansen curves in patients with (dark colors) and without (light colors) a prior stroke by randomized group. Orange curves show time‐to‐event curves in patients randomized to edoxaban, blue curves show time‐to‐event curves in patients randomized to no anticoagulation (placebo, containing aspirin in most patients with a prior stroke). A, Primary outcome, a composite of stroke, systemic embolism, and cardiovascular death. B through D, Components of the primary outcome, namely ischemic stroke (B), systemic embolism (C), and cardiovascular death (D). TIA indicates transient ischemic attack.
Figure 3
Figure 3. Safety outcomes in this subanalysis.
Shown are time‐to‐event Aalen‐Johansen curves in patients with (dark colors) and without (light colors) a prior stroke by randomized group. Orange curves show time‐to‐event curves in patients randomized to edoxaban, blue curves show time‐to‐event curves in patients randomized to no anticoagulation (placebo, containing aspirin in most patients with a prior stroke). A, Primary safety outcome, a composite of death or major ISTH bleeding. B and C, Components of the safety outcome, namely death (B) and major ISTH bleeding (C). ISTH indicates International Society of Thrombosis and Hemostasis; and TIA, transient ischemic attack.
Figure 4
Figure 4. Stroke severity in the NOAH‐AFNET 6 trial.
Shown is the distribution of mRS scores after a stroke experienced during the trial. The mRS estimates stroke severity on an ordinal scale from 0 (no residual deficit or symptoms) to 6 (patient died). mRS indicates modified Rankin Scale.
See this image and copyright information in PMC

Comment in

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