Apixaban outcomes comparable with current standard of care following TAVR

The safety profile of apixaban with respect to bleeding is similar to that of the current standard of care (SOC), and the net clinical benefit of administering apixaban following transcatheter aortic valve replacement (TAVR) is not superior to current SOC antithrombotic approaches [1].

The current standard of post-TAVR care involves the use of either an antiplatelet or a vitamin K antagonist therapy. Dr Jean-Phillippe 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 SOC 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 or not 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 thrombus, 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 SOC arm, yielding a hazard ratio (HR) of 0.92 (95% CI 0.73-1.16). Analysis of the subgroup of participants who had a need for anticoagulation (n=451) showed 49 (21.9%) events in the apixaban group and 50 (21.9%) in the SOC 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 SOC group (HR 0.88; 95% CI 0.66-1.17).

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

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   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.

Posted on 17 May 20216 July 2021