Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Aug 5:S1547-5271(25)02729-8.
doi: 10.1016/j.hrthm.2025.07.048. Online ahead of print.

Apixaban for stroke prevention in subclinical atrial fibrillation detected by an implantable cardiac monitor: A subgroup analysis of ARTESiA

Lucas Yixi Xing  1 , Renato Delascio Lopes  2 , William Finlay McIntyre  3 , Roopinder K Sandhu  4 , José Manuel Rubio Campal  5 , Clarence Khoo  6 , Christopher Bull Granger  2 , Michael R Gold  7 , Jesper Hastrup Svendsen  8 , Søren Zöga Diederichsen  9 , Marco Alings  10 , Philippe Mabo  11 , Valentina Kutyifa  12 , Jens Cosedis Nielsen  13 , David H Birnie  14 , Alexander P Benz  15 , Thenmozhi Mani  3 , Chinthanie Ramasundarahettige  3 , Jeffrey Sean Healey  16 ; ARTESiA investigators (NCT01938248)
Affiliations

Apixaban for stroke prevention in subclinical atrial fibrillation detected by an implantable cardiac monitor: A subgroup analysis of ARTESiA

Lucas Yixi Xing et al. Heart Rhythm. .

Abstract

Background: The ARTESiA trial randomized patients with a pacemaker (PM), implantable cardioverter-defibrillator (ICD), or implantable cardiac monitor (ICM) and with subclinical atrial fibrillation to either apixaban or aspirin.

Objective: We aimed to explore the effects of apixaban in the subset of patients with an ICM.

Methods: We assessed the efficacy outcome of stroke or systemic embolism and the safety outcome of major bleeding, stratifying by device type.

Results: Of 4012 participants, 209 (5.2%) had ICM and 3803 (94.8%) had PM/ICD. Patients with ICM were younger (74.9 ± 7.4 vs 76.9 ± 7.6 years) and more likely to be female (50.2% vs 35.3%) and to have a previous stroke (24.9% vs 7.7%) than those with PM/ICD. In the ICM cohort, stroke/systemic embolism occurred in 1 of 103 in the apixaban group (0.3%/year) vs 9 of 106 in the aspirin group (2.6%/year) (hazard ratio [HR], 0.11; [95% confidence interval {CI}, 0.01-0.88]; absolute risk reduction [ARR] 2.31%/year [95% CI, 0.55-4.07]). The corresponding rates in the PM/ICD cohort were 0.8%/year with apixaban vs 1.2%/year with aspirin (HR, 0.69 [95% CI, 0.49-0.98]; ARR 0.36%/year [95% CI, 0.02-0.70]; Pinteraction = .078 and .002, respectively). Among patients with ICM, major bleeding occurred at 1.3%/year vs 1.1%/year for apixaban vs aspirin (HR, 1.13 [95% CI, 0.30-4.31]). No significant difference in HR or ARR was observed across the device types (Pinteraction = .808 and .406, respectively).

Conclusion: In ARTESiA, patients with ICM experienced a stroke rate of 2.6%/year on aspirin, higher than that in the remaining trial population. The risk was significantly reduced by apixaban, consistent with the overall ARTESiA results.

Keywords: Aspirin; Atrial fibrillation; Monitoring; Oral anticoagulation; Pacemaker; Stroke.

PubMed Disclaimer

Conflict of interest statement

Disclosures R.D.L. reports to have received research grants from Amgen, Boehringer Ingelheim, GlaxoSmithKline, Medtronic, Novo Nordisk, Pfizer, and Sanofi US Services and to be a consultant to Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo Company, GlaxoSmithKline, Medtronic, Portola Pharmaceuticals, Merck, Novo Nordisk, Pfizer, and Sanofi US Services. W.F.M. reports to have received speaker fees from iRhythm, consulting fees from Atricure, and research support from the Canadian Institutes of Health Research and the Heart and Stroke Foundation of Canada. C.B.G. reports to be a consultant to Anthos, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific Corporation, Bristol Myers Squibb, Cadrenal, Daiichi Sankyo Company, Janssen Global Services, Merck, Pfizer, and Tenac and to have received research grants from Bayer and Boehringer Ingelheim. M.R.G. reports to be a consultant to Abbott Fund, Boston Scientific Corporation, and Medtronic USA. J.H.S. reports to be a member of Medtronic and Vital Beats advisory boards and to have received speaker honoraria and research grants from Medtronic. S.Z.D. reports to be a part-time employee of Vital Beats and an advisor to Acesion Pharma, Bristol Myers Squibb/Pfizer, and Cortrium; to have received speaker fees from Bayer and Bristol Myers Squibb/Pfizer; and to have received travel grants from Boston Scientific. P.M. reports to have received speaker fees from BMS and Pfizer. V.K. reports to have received consultant/speaker fees from Biotronik, ZOLL, Medtronic, and Abbott Medical and research grants from Biotronik, Boston Scientific, Spire Inc, ZOLL Medical Corporation, and National Institutes of Health. J.C.N. reports to have received research grant from Novo Nordisk Fond. A.P.B. reports to have received lecturing fees from Bristol Myers Squibb and AstraZeneca and participation in an educational program supported by Boston Scientific (“Fellowship Herzrhythmus”). J.S.H. reports to be a consultant to Bayer, Boston Scientific Corporation, Medtronic, Novartis, and Servier Affaires Medicales and to have received research grants from Boston Scientific Corporation, Bristol Myers Squibb, Medtronic, and Pfizer. Other authors have no conflicts of interest to report.

LinkOut - more resources