ARTESIA
Trial question
What is the role of apixaban in patients with subclinical AF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 4012
4012 patients (1447 female, 2565 male).
Inclusion criteria: adult patients with subclinical AF lasting 6 minutes to 24 hours.
Key exclusion criteria: clinical AF; mechanical valve prosthesis, DVT, recent PE, or other condition requiring treatment with an anticoagulant; contraindication to apixaban or aspirin; pregnancy.
Interventions
N=2015 apixaban (at a dose of 5 mg BID).
N=1997 aspirin (at a daily dose of 81 mg daily).
Primary outcome
Stroke or systemic embolism
0.78
1.24
1.2 % / p-y
0.9 % / p-y
0.6 % / p-y
0.3 % / p-y
0.0 % / p-y
Apixaban
Aspirin
Significant
decrease ▼
Significant decrease in stroke or systemic embolism (0.78% / p-y vs. 1.24% / p-y; HR 0.63, 95% CI 0.45 to 0.88).
Secondary outcomes
Significant decrease in stroke, TIA, or systemic embolism (1.17% / p-y vs. 1.56% / p-y; HR 0.75, 95% CI 0.56 to 1).
No significant difference in MI (0.52% / p-y vs. 0.59% / p-y; HR 0.89, 95% CI 0.57 to 1.4).
No significant difference in death (5.06% / p-y vs. 4.82% / p-y; HR 1.04, 95% CI 0.9 to 1.21).
Safety outcomes
No significant difference in fatal bleeding.
Significant difference in major bleeding (1.71% per patient-year vs. 0.94% per patient-year).
Conclusion
In adult patients with subclinical AF lasting 6 minutes to 24 hours, apixaban was superior to aspirin with respect to stroke or systemic embolism.
Reference
Jeff S Healey, Renato D Lopes, Christopher B Granger et al. Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation. N Engl J Med. 2024 Jan 11;390(2):107-117.
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