Rivaroxaban After Transcatheter Aortic Valve Replacement: A Critical Appraisal of the GALILEO Trial

Abstract

Purpose: The anti-thrombotic approach in individuals undergoing transcatheter aortic valve replacement (TAVR) mirrors a controversial field in clinical practice. Methods/Results: The aim of this article was to critically appraise the randomized controlled GALILEO trial, where two different antithrombotic regimes (10 mg rivaroxaban + 3 months aspirin vs. aspirin + 3 months clopidogrel) were compared in patients who underwent TAVR as well as available evidence in literature in this field. Conclusion: The GALILEO trial was prematurely terminated as a consequence of increased risk of both death or thromboembolic complications and a higher risk of bleeding in the anticoagulation arm, compared to the antiplatelet-based strategy. Various concerns have been raised that the negative results of the GALILEO trial need to be regarded with caution. A routine use of oral anticoagulation (OAC) for the prevention of atherothrombotic events and valve thrombosis after TAVR in individuals who do not have an indication for oral anticoagulation, can currently not be recommended when considering the evidence base of available literature. However, the negative results of the GALILEO trial need to be interpreted with caution – especially in terms of dose of rivaroxaban – and should not discourage from performing further trials investigating safety and efficacy of this therapeutic approach. Additionally, further dose-finding trials for rivaroxaban should be considered.