TY - JOUR
T1 - Apixaban vs. standard of care after transcatheter aortic valve implantation
T2 - the ATLANTIS trial
AU - for the ATLANTIS Investigators of the ACTION Group
AU - Collet, Jean Philippe
AU - Van Belle, Eric
AU - Thiele, Holger
AU - Berti, Sergio
AU - Lhermusier, Thibault
AU - Manigold, Thibault
AU - Neumann, Franz Josef
AU - Gilard, Martine
AU - Attias, David
AU - Beygui, Farzin
AU - Cequier, Angel
AU - Alfonso, Fernando
AU - Aubry, Pierre
AU - Baronnet, Flore
AU - Ederhy, Stéphane
AU - Kasty, Mohamad El
AU - Kerneis, Mathieu
AU - Barthelemy, Olivier
AU - Lefèvre, Thierry
AU - Leprince, Pascal
AU - Redheuil, Alban
AU - Henry, Patrick
AU - Portal, Jean Jacques
AU - Vicaut, Eric
AU - Montalescot, Gilles
AU - Collet, Jean Philippe
AU - Leroux, Lionel
AU - Le Breton, Hervé
AU - Schiele, François
AU - Beygui, Farzin
AU - Van Belle, Eric
AU - Lhermusier, Thibault
AU - Cayla, Guillaume
AU - Eltchaninoff, Hélène
AU - Lefevre, Thierry
AU - Gilard, Martine
AU - Caussin, Christophe
AU - Souteyrand, Géraud
AU - Himbert, Dominique
AU - Manigold, Thibaut
AU - Maureira, Juan Pablo
AU - Rioufol, Gilles
AU - Leclercq, Florence
AU - Cuisset, Thomas
AU - Chassaing, Stéphane
AU - Dumonteil, Nicolas
AU - Karam, Nicole
AU - Lorgis, Luc
AU - Attias, David
AU - Kupatt, Christian
N1 - Publisher Copyright:
© 2022 The Author(s). Published by Oxford University Press on behalf of European Society of Cardiology. All rights reserved.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - 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.
AB - 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.
KW - Anticoagulation
KW - Stroke
KW - TAVI
KW - Valve thrombosis
UR - http://www.scopus.com/inward/record.url?scp=85135499924&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehac242
DO - 10.1093/eurheartj/ehac242
M3 - Article
C2 - 35583186
AN - SCOPUS:85135499924
SN - 0195-668X
VL - 43
SP - 2783
EP - 2797
JO - European Heart Journal
JF - European Heart Journal
IS - 29
ER -