The randomised, double-blind, active-controlled ARTESIA trial (NCT01938248) compared the efficacy and safety of the direct anticoagulant agent apixaban with aspirin in patients with subclinical AF and a risk factor for ischaemic events [1,2]. The participants (n=4,012) were randomised 1:1 to apixaban, either 2.5 mg or 5 mg twice daily, or aspirin 81 mg once daily. The primary endpoint was the rate of stroke or systemic embolism, and Prof. Jeff Healey (McMaster University, Canada) presented the main results [1].
After a mean 3.5 years of follow-up, “the risk of stroke or systemic embolism was significantly reduced in the apixaban arm as compared with the aspirin arm (HR 0.63; 95% CI 0.45–0.88; P=0.007),” said Prof. Healey. However, major bleedings occurred more frequently in the apixaban arm than in the aspirin arm (1.71% per year vs 0.94% per year; HR 1.80; P<0.001). Thus, these results trigger a discussion of whether there is a positive risk-benefit ratio for the use of anticoagulants in patients with subclinical AF.
- Healey J, et al. The ARTESIA trial: apixaban for stroke prevention in subclinical atrial fibrillation. LB05, AHA Scientific Sessions 2023, 10–12 November, Philadelphia, USA.
- Healey J, et al. N Engl J Med 2023;Nov 12. DOI: 10.1056/NEJMoa2310234.
Medical writing support was provided by Robert van den Heuvel.
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