Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Subclinical Atrial Fibrillation - ARTESIA

Jul 16, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Canadian Institutes of Health Research
Date Presented:
11/12/2023
Date Published:
07/15/2024
Date Updated:
07/16/2024
Original Posted Date:
11/11/2023
References

Contribution To Literature:

Highlighted text has been updated as of July 16, 2024.

The ARTESIA trial showed that anticoagulation reduces adverse events compared with aspirin among patients with subclinical AF.

Description:

The goal of the trial was to evaluate apixaban compared with aspirin among patients with subclinical atrial fibrillation (AF).

Study Design

  • Randomized
  • Parallel
  • Blinded

Patients with subclinical AF and increased risk for stroke were randomized to apixaban 5 mg twice daily (n = 2,015) vs. aspirin 81 mg daily (n = 1,997).

  • Total number of enrollees: 4,012
  • Duration of follow-up: mean 3.5 years
  • Mean patient age: 76.8 years
  • Percentage female: 36%
  • Percentage with diabetes: 29%

Inclusion criteria:

  • Subclinical AF (detected by pacemaker, defibrillator, or cardiac monitor)
  • At least one episode of AF that lasted between 6 minutes and 24 hours
  • CHA2DS2-VASc score ≥3

Exclusion criteria:

  • Clinical AF
  • Ongoing indication for oral anticoagulation
  • History of major bleeding in the previous 6 months
  • Creatinine clearance <25 mL/min

Other salient features/characteristics:

  • Mean CHA2DS2-VASc score = 3.9
  • CHA2DS2-VASc score ≥4, 60.7%

Number of episodes of AF:

  • 0, 17.7%
  • 1 to 5, 63.7%
  • 6 to 50, 16.5%
  • >50, 4.1%

Longest episode of AF:

  • No episodes, 15.8%
  • <6 minutes, 2.1%
  • 6 minutes to <1 hour, 25.8%
  • 1 to <6 hours, 35.5%
  • 6 to <12 hours, 13.8%
  • 12 to 24 hours, 7.1%

Principal Findings:

The primary efficacy outcome, stroke or systemic embolism, was: 0.78%/person-year in the apixaban group vs. 1.24%/person-year in the aspirin group (p = 0.007).

The primary safety outcome, major bleeding, was: 1.53%/person-year in the apixaban group vs. 1.12%/person-year in the aspirin group (p = 0.04).

Treatment differences according to CHA2DS2-VASc:

Stroke or systemic embolism among those with:

  • CHA2DS2-VASc <4, absolute risk reduction for apixaban vs. aspirin: -0.04 (95% CI -1.94 to 1.85)
  • CHA2DS2-VASc = 4, absolute risk reduction for apixaban vs. aspirin: -2.25 (95% CI -4.19 to -0.31)
  • CHA2DS2-VASc >4, absolute risk reduction for apixaban vs. aspirin: -3.95 (95% CI -6.72 to -1.19) (p for interaction = 0.06)

Major bleeding among those with:

  • CHA2DS2-VASc <4, absolute risk reduction for apixaban vs. aspirin: 1.28 (95% CI -0.98 to 3.55)
  • CHA2DS2-VASc = 4, absolute risk reduction for apixaban vs. aspirin: 0.05 (95% CI -2.03 to 2.14)
  • CHA2DS2-VASc >4, absolute risk reduction for apixaban vs. aspirin: 1.70 (95% CI -1.25 to 4.66) (p for interaction = 0.6)

Interpretation:

Among patients with subclinical AF and increased risk for stroke, apixaban reduced the risk of stroke or systemic embolism compared with aspirin. However, apixaban was associated with an increased risk of major bleeding compared with aspirin. Subclinical AF is associated with a 2.5-fold increased risk of stroke or systemic embolism; however, until this trial, it was unknown if anticoagulation therapy would reduce stroke risk. The reduction in stroke or systemic embolism with apixaban needs to be balanced against the increased risk of major bleeding compared with aspirin. Among those with elevated CHA2DS2-VASc score, apixaban vs. aspirin was associated with a significant reduction in stroke or systemic embolism. Among those with low CHA2DS2-VASc score, apixaban vs. aspirin was not associated with a significant reduction in stroke or systemic embolism. These results directly apply to patients with subclinical AF detected by an implantable cardiac device with increased risk for stroke.

References:

Lopes RD, Granger CB, Wojdyla DM, et al. Apixaban vs Aspirin According to CHA2DS2-VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA. J Am Coll Cardiol 2024;84:354-64.

Editorial Comment: Shah SJ. Anticoagulants in Subclinical Atrial Fibrillation: Beginning to Define the Treatment Paradigm. J Am Coll Cardiol 2024;84:365-7.

Healey JS, Lopes RD, Granger CB, et al., on behalf of the ARTESIA Investigators. Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation. N Engl J Med 2024;390:107-17.

Svennberg E. Editorial: What Lies beneath the Surface — Treatment of Subclinical Atrial Fibrillation. N Engl J Med 2024;390:175-7.

Presented by Dr. Jeff Healey at the American Heart Association Scientific Sessions, Philadelphia, PA, November 12, 2023.

Clinical Topics: Arrhythmias and Clinical EP, Atrial Fibrillation/Supraventricular Arrhythmias, Anticoagulation Management and Atrial Fibrillation

Keywords: AHA23, Atrial Fibrillation, Stroke


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