ARTESIA: How useful is anticoagulation in subclinical AF? 

Compared with aspirin, apixaban was associated with a reduced risk of stroke or systemic embolism in patients with subclinical atrial fibrillation (AF). However, an increased risk for major bleeding was observed in the phase 4 ARTESIA study. 

The randomised, double-blind, active-controlled ARTESIA trial (NCT01938248) compared the efficacy and safety of the direct oral anticoagulant (DOAC) 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. Prof. Jeff Healey (McMaster University, Canada) presented the main results.

After a mean of 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,” said Prof. Healey (HR 0.63; 95% CI 0.45–0.88; P=0.007) [1]. 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). Shared decision-making regarding the initiation of anticoagulation in this patient population should be tailored to patient-specific risk stratification for thromboembolism and bleeding with consideration of patient-specific values and preferences.

Prof. Christine Albert (Cedars-Sinai Medical Center, CA, USA) explained that the number needed to treat is 47 in clinical AF, but 250 in subclinical AF. On the other hand, the number needed to harm is 130 in the apixaban arm and only 210 in the aspirin arm. “Given the benefit-to-risk ratio, there should be a pause and further consideration by expert guideline committees before implementing DOACs in patients with subclinical AF and a risk factor for ischaemic events,” she reasoned. If a decision is made to defer anticoagulation, it should be recognised that a substantial proportion of patients with device-detected AF go on to develop clinically overt AF. Accordingly, such patients merit close surveillance, as the development of clinical AF warrants reconsideration of anticoagulation.

1. 
   
   1. Healey JS, et al. The ARTESIA trial: apixaban for stroke prevention in subclinical atrial fibrillation. LB05, AHA Scientific Sessions 2023, 11–13 November, Philadelphia, USA.
   2. Healey JS, et al. N Engl J Med 2023;Nov 12. DOI: 10.1056/NEJMoa2310234.

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Posted on 29 January 202422 February 2024