Apixaban outcomes similar to current standard of care following TAVR

The bleeding safety profile of apixaban was similar to that of the current standard of care, and the net clinical benefit of administering apixaban following transcatheter aortic valve replacement (TAVR) was not superior to current standard-of-care antithrombotic approaches in the ATLANTIS trial [1].

Prof. Jean-Philippe Collet (Sorbonne Université, France) presented results of the multicentre, phase 3, prospective, open-label, randomised ATLANTIS (NCT02664649) trial. ATLANTIS sought to compare the efficacy of apixaban, an anti-Xa, direct oral anticoagulant, with the current standard of care in patients who had undergone TAVR. The investigators randomised 1,510 participants to receive either apixaban (n=749) twice daily or usual care (n=751) for 1 year following TAVR. Randomisation was stratified according to the presence of an indication for anticoagulation other than the TAVI procedure (e.g. atrial fibrillation). The primary outcome was a composite of death, myocardial infarction, stroke, systemic or pulmonary embolism, cardiac, bioprosthetic, or deep-vein thrombosis, or major bleeding at 1-year follow-up.

After 1 year, 138 (18.4%) events had occurred in the apixaban arm and 151 (20.1%) in the standard-of-care arm (HR 0.92; 95% CI 0.73–1.16; see Figure). Analysis of the subgroup of participants who required anticoagulation (n=451) showed 49 (21.9%) events in the apixaban group and 50 (21.9%) in the standard-of-care group (HR 1.02; 95% CI 0.68–1.51). In the subgroup of participants with no indication for anticoagulation (n=1,049), 89 (16.9%) events had occurred in the apixaban group and 101 (19.3%) in the standard-of-care group (HR 0.88; 95% CI 0.66–1.17).

Figure: Primary endpoint in intention-to-treat groups (standard of care vs apixaban) [1]



 

A slightly higher number of non-cardiovascular deaths occurred in the cohort of patients taking apixaban with no need for anticoagulation. This difference was not statistically significant.

Results of the ATLANTIS trial suggest that apixaban following TAVR is not superior to current standard-of-care antithrombotic management in terms of net clinical benefit.

1. 
   
   1. Collet JP. Oral Anti-Xa Anticoagulation After Trans-aortic Valve Implantation for Aortic Stenosis: The Randomized ATLANTIS Trial. ACC Scientific Session, 15–17 May 2021.

 

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Posted on 9 July, 202128 March, 2024