Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Subclinical Atrial Fibrillation - ARTESIA
Contribution To Literature:
The ARTESIA trial showed that anticoagulation reduces adverse events compared with aspirin among patients with subclinical AF.
The goal of the trial was to evaluate apixaban compared with aspirin among patients with subclinical atrial fibrillation (AF).
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%
- 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
- 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%
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).
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. These results directly apply to patients with subclinical AF detected by an implantable cardiac device with increased risk for stroke.
Presented by Dr. Jeff Healey at the American Heart Association Scientific Sessions, Philadelphia, PA, November 12, 2023.
Keywords: AHA23, Atrial Fibrillation, Stroke
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