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Randomized Controlled Trial
. 2024 Nov 26;150(22):1747-1755.
doi: 10.1161/CIRCULATIONAHA.124.069903. Epub 2024 Sep 4.

Risk of Stroke or Systemic Embolism According to Baseline Frequency and Duration of Subclinical Atrial Fibrillation: Insights From the ARTESiA Trial

William F McIntyre  1 , Alexander P Benz  1 , Jeff S Healey  1 , Stuart J Connolly  1 , Mu Yang  1 , Shun Fu Lee  1 , Thalia S Field  2 , Marco Alings  3 , J Benezet-Mazuecos  4 , Giuseppe Boriani  5 , J Cosedis Nielsen  6 , Michael R Gold  7 , Francesco Pergolini  8 , Taya V Glotzer  9 , Christopher B Granger  10 , Renato D Lopes  10
Affiliations
Randomized Controlled Trial

Risk of Stroke or Systemic Embolism According to Baseline Frequency and Duration of Subclinical Atrial Fibrillation: Insights From the ARTESiA Trial

William F McIntyre et al. Circulation. .

Erratum in

Abstract

Background: In the ARTESiA trial (Apixaban for the Reduction of Thromboembolism in Patients With Device-Detected Subclinical Atrial Fibrillation), apixaban, compared with aspirin, reduced stroke or systemic embolism in patients with device-detected subclinical atrial fibrillation (SCAF). Clinical guidelines recommend considering SCAF episode duration when deciding whether to prescribe oral anticoagulation for this population.

Methods: We performed a retrospective cohort study in ARTESiA. Using Cox regression adjusted for CHA2DS2-VASc score and treatment allocation (apixaban or aspirin), we assessed frequency of SCAF episodes and duration of the longest SCAF episode in the 6 months before randomization as predictors of stroke risk and of apixaban treatment effect.

Results: Among 3986 patients with complete baseline SCAF data, 703 (17.6%) had no SCAF episode ≥6 minutes in the 6 months before enrollment. Among 3283 patients (82.4%) with ≥1 episode of SCAF ≥6 minutes in the 6 months before enrollment, 2542 (77.4%) had up to 5 episodes, and 741 (22.6%) had ≥6 episodes. The longest episode lasted <1 hour in 1030 patients (31.4%), 1 to <6 hours in 1421 patients (43.3%), and >6 hours in 832 patients (25.3%). Higher baseline SCAF frequency was not associated with increased risk of stroke or systemic embolism: 1.1% for 1 to 5 episodes versus 1.2%/patient-year for ≥6 episodes (adjusted hazard ratio, 0.89 [95% CI, 0.59-1.34]). In an exploratory analysis, patients with previous SCAF but no episode ≥6 minutes in the 6 months before enrollment had a lower risk of stroke or systemic embolism than patients with at least one episode during that period (0.5% versus 1.1%/patient-year; adjusted hazard ratio, 0.48 [95% CI, 0.27-0.85]). The frequency of SCAF did not modify the reduction in stroke or systemic embolism with apixaban (Pinteraction=0.1). The duration of the longest SCAF episode in the 6 months before enrollment was not associated with the risk of stroke or systemic embolism during follow-up (<1 hour: 1.0%/patient-year [reference]; 1-6 hours: 1.2%/patient-year [adjusted hazard ratio, 1.27 (95% CI, 0.85-1.90)]; >6 hours: 1.0%/patient-year [adjusted hazard ratio, 1.02 (95% CI, 0.63-1.66)]). SCAF duration did not modify the reduction in stroke or systemic embolism with apixaban (Ptrend=0.1).

Conclusions: In ARTESiA, baseline SCAF frequency and longest episode duration were not associated with risk of stroke or systemic embolism and did not modify the effect of apixaban on reduction of stroke or systemic embolism.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01938248.

Keywords: anticoagulants; atrial fibrillation; defibrillators; pacemaker; stroke.

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Conflict of interest statement

M. Yang and Drs Lee, Alings, Benezet-Mazuecos, Nielsen, and Pergolini report no disclosures. Dr Benz has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Bristol Myers Squibb and AstraZeneca. Dr Boriani has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Bayer, Boston Scientific, Boehringer Ingelheim, Daiichi-Sankyo, and Sanofi. Dr Connolly received research grants from Boehringer Ingelheim, Bristol Myers Squibb, Sanofi Aventis, and Boston Scientific; consulting fees from Boehringer Ingelheim, Bristol Myers Squibb, Sanofi Aventis, Portola, and Boston Scientific; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Boehringer Ingelheim and Bristol Myers Squibb. Dr Field has received research grants from Bayer and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from HLS Therapeutics. Dr Glotzer has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Abbott, Medtronic, and Boston Scientific. Dr Gold has received research grants from Abbott, Boston Scientific, and Medtronic; consulting fees from Boston Scientific and Medtronic; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Abbott and Boston Scientific. Dr Granger has received research grants from Alnylam, Boehringer Ingelheim, Bayer, Bristol Myers Squibb, the Food and Drug Administration, Janssen, Lilly, Novartis, Pfizer, Philips, and Roche; consulting fees from AbbVie, Abiomed, Alnylam Pharmaceuticals, Anthos, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardionomic, Cadrenal, CeleCore Therapeutics, HengRui, Janssen, Medscape, Medtronic Inc, Merck, the National Institutes of Health, Novo Nordisk, Novartis, Pfizer, Philips, REATA, Roche, and Veralox; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from AbbVie, Abiomed, Alnylam Pharmaceuticals, Anthos, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardionomic, Cadrenal, CeleCore Therapueutics, HengRui, Janssen, Medscape, Medtronic Inc, Merck, the National Institutes of Health, Novo Nordisk, Novartis, Pfizer, Philips, REATA, Roche, and Veralox. Dr Healey has received research grants from Boston Scientific, BMS Pfizer, and Medtronic; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from BMS/Pfizer, Servier, Novartis, and Boston Scientific. Dr Lopes has received research grants from Amgen, Bristol Myers Squibb, Sanofi, Glaxo Smith Kline, Pfizer, and Medtronic; consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, and Novo Nordisk; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from AstraZeneca, Daiichi Sankyo, Novo Nordisk, and Pfizer. Dr Mcintyre has received research grants from Trimedics; consulting fees from Trimedics and Atricure; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from iRhythm.

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