Apixaban vs. standard of care after transcatheter aortic valve implantation: the ATLANTIS trial
Authors: Collet Jean Philippe , Van Belle Eric , Thiele Holger , Berti Sergio , Lhermusier Thibault , Manigold Thibault , Neumann Franz Josef , Gilard Martine , Attias David , Beygui Farzin , Cequier Angel , Alfonso Fernando , Aubry Pierre , Baronnet Flore , Ederhy Stéphane , Kasty Mohamad El , Kerneis Mathieu , Barthelemy Olivier , Lefèvre Thierry , Leprince Pascal , Redheuil Alban , Henry Patrick , Portal Jean Jacques , Vicaut Eric , Montalescot Gilles ,   for the ATLANTIS Investigators of the ACTION Group, Collet Jean-Philippe , Leroux Lionel , Le Breton Hervé , Schiele François , Beygui Farzin , Van Belle Eric , Lhermusier Thibault , Cayla Guillaume , Eltchaninoff Hélène , Lefevre Thierry , Gilard Martine , Caussin Christophe , Souteyrand Géraud , Himbert Dominique , Manigold Thibaut , Maureira Juan Pablo , Rioufol Gilles , Leclercq Florence , Cuisset Thomas , Chassaing Stéphane , Dumonteil Nicolas , Karam Nicole , Lorgis Luc , Attias David , Varenne Olivier , Morel Olivier , Isaaz Karl , Ghostine Said , Neumann Franz-Josef , Klingenberg Roland , Liebetrau Christoph , Thiele Holger , Linke Axel , Mehilli Julinda , Kupatt Christian , Zeymer Uwe , Ince Hueseyin , Boekstegers Peter , Berti Sergio , De Carlo Marco , De Benedictis Mauro , Gandolfo Caterina , Cequier Angel , Hernandez José Maria , Trillo Nouche Ramiro , Martin Moreiras Javier , San Roman Calvar Alberto , Fernandez Aviles Francisco , Alfonso Fernando , Garcia Del Blanco Bruno , Cuellas Ramon Carlos , Pan Álvarez Osorio Manuel 
Published: April 2022

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.