1. Detection of subclinical atrial fibrillation with cardiac implanted electronic devices: What decision making on anticoagulation after the NOAH and ARTESiA trials?
- Author
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Boriani G, Gerra L, Mei DA, Bonini N, Vitolo M, Proietti M, and Imberti JF
- Subjects
- Humans, Pacemaker, Artificial adverse effects, Clinical Decision-Making, Risk Assessment, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Defibrillators, Implantable, Stroke prevention & control, Stroke etiology, Randomized Controlled Trials as Topic
- Abstract
Atrial fibrillation (AF) may be asymptomatic and the extensive monitoring capabilities of cardiac implantable electronic devices (CIEDs) revealed asymptomatic atrial tachi-arrhythmias of short duration (minutes-hours) occurring in patients with no prior history of AF and without AF detection at a conventional surface ECG. Both the terms "AHRE" (Atrial High-Rate Episodes) and subclinical AF were used in a series of prior studies, that evidenced the association with an increased risk of stroke. Two randomized controlled studies were planned in order to assess the risk-benefit profile of anticoagulation in patients with AHRE/subclinical AF: the NOAH and ARTESiA trials. The results of these two trials (6548 patients enrolled, overall) show that the risk of stroke/systemic embolism associated with AHRE/subclinical AF is in the range of 1-1.2 % per patient-year, but with an important proportion of severe/fatal strokes occurring in non-anticoagulated patients. The apparent discordance between ARTESiA and NOAH results may be approached by considering the related study-level meta-analysis, which highlights a consistent reduction of ischemic stroke with oral anticoagulants vs. aspirin/placebo (relative risk [RR] 0.68, 95 % CI 0.50-0.92). Oral anticoagulation was found to increase major bleeding (RR 1.62, 95 % CI 1.05-2.5), but no difference was found in fatal bleeding (RR 0.79, 95 % CI 0.37-1.69). Additionally, no difference was found in cardiovascular death or all-cause mortality. Taking into account these results, clinical decision-making for patients with AHRE/subclinical AF at risk of stroke, according to CHA
2 DS2 -VASc, can now be evidence-based, considering the benefits and related risks of oral anticoagulants, to be shared with appropriately informed patients., Competing Interests: Declaration of competing interest The authors report no conflict of interests related to the present article. G Boriani reported small speaker fees from Bayer, Boehringer Ingelheim, Boston, Daiichi Sankyo, Janssen, and Sanofi outside of the submitted work. G Boriani is the Principal Investigator of the ARISTOTELES project (Applying ARtificial Intelligence to define clinical trajectorieS for personalized predicTiOn and early deTEction of comorbidity and muLtimorbidity pattErnS) that received funding from the European Union within the Horizon 2020 Research and Innovation Program (Grant N. 101080189). M Proietti is the Italian national leader of the AFFIRMO project on multimorbidity in atrial fibrillation, that received funding from the European Union within the Horizon 2020 Research and Innovation Program (Grant N. 899871). The other authors did not report conflicts of interest to disclose outside of the submitted work., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)- Published
- 2024
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