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Apixaban vs. standard of care after transcatheter aortic valve implantation: the ATLANTIS trial

2022; Oxford University Press; Volume: 43; Issue: 29 Linguagem: Inglês

10.1093/eurheartj/ehac242

1522-9645

Jean‐Philippe Collet, Éric Van Belle, Hölger Thiele, Sérgio Berti, Thibault Lhermusier, Thibault Manigold, Franz‐Josef Neumann, Martine Gilard, David Attias, Farzin Beygui, Ángel Cequier, Fernándo Alfonso, P Aubry, Flore Baronnet, Stéphane Éderhy, Mohamad El Kasty, Mathieu Kerneïs, Olivier Barthélémy, Thierry Lefévre, Pascal Leprince, Alban Redheuil, Patrick Henry, Jean Jacques Portal, Éric Vicaut, Gilles Montalescot, Jean‐Philippe Collet, Lionel Leroux, Hervé Breton, François Schiele, Farzin Beygui, Éric Van Belle, Thibault Lhermusier, Guillaume Cayla, Hélène Eltchaninoff, Thierry Lefévre, Martine Gilard, Christophe Caussin, Géraud Souteyrand, Dominique Himbert, Thibaut Manigold, Juan Pablo Maureira, Gilles Rioufol, Florence Leclercq, Thomas Cuisset, Stéphane Chassaing, Nicolas Dumonteil, Nicole Karam, Luc Lorgis, David Attias, Olivier Varenne, Olivier Morel, Karl Isaaz, Saïd Ghostine, Franz‐Josef Neumann, Roland Klingenberg, Christoph Liebetrau, Hölger Thiele, Axel Linke, Julinda Mehilli, Christian Kupatt, Uwe Zeymer, Hueseyin Ince, Peter Boekstegers, Sérgio Berti, Marco De Carlo, Mauro De Benedictis, Caterina Gandolfo, Ángel Cequier, José M. de la Torre Hernández, Ramiro Trillo, Javier Martín Moreiras, José Alberto San Román, Francisco Fernández‐Avilés, Fernándo Alfonso, Bruno García del Blanco, Carlos Cuellas Ramón, Manuel Pan Álvarez Osorio,

Cardiac Imaging and Diagnostics

Abstract Aims The respective roles of oral anticoagulation or antiplatelet therapy following transcatheter aortic valve implantation (TAVI) remain debated. ATLANTIS is an international, randomized, open-label, superiority trial comparing apixaban to the standard of care. Methods and results After successful TAVI, 1500 patients were randomized (1:1) to receive apixaban 5 mg (2.5 mg if impaired renal function or concomitant antiplatelet therapy) (n = 749) twice daily, or standard of care (n = 751). Randomization was stratified by the need for chronic anticoagulation therapy. Standard-of-care patients received a vitamin K antagonist (VKA) (Stratum 1) or antiplatelet therapy (Stratum 2) if there was an indication for anticoagulation or not, respectively. The primary endpoint was the composite of death, myocardial infarction, stroke or transient ischaemic attack, systemic embolism, intracardiac or bioprosthesis thrombosis, deep vein thrombosis or pulmonary embolism, and life-threatening, disabling, or major bleeding over 1-year follow-up. The primary safety endpoint was major, disabling, or life-threatening bleeding. The primary outcome occurred in 138 (18.4%) and 151 (20.1%) patients receiving apixaban or standard of care, respectively [hazard ratio (HR) 0.92; 95% confidence interval (CI) 0.73–1.16] and there was no evidence of interaction between treatment and stratum (Pinteraction = 0.57). The primary safety endpoint was similar in both groups (HR 1.02; 95% CI 0.72–1.44). In Stratum 1 (n = 451), an exploratory analysis showed no difference for all endpoints between apixaban and VKA. In Stratum 2 (n = 1049), the primary outcome and primary safety endpoint did not differ, but obstructive valve thrombosis was reduced with apixaban vs. antiplatelet therapy (HR 0.19; 95% CI 0.08–0.46), while a signal of higher non-cardiovascular mortality was observed with apixaban. Conclusion After TAVI, apixaban was not superior to the standard of care, irrespective of an indication for oral anticoagulation.