Jean-Philippe Collet1, Sergio Berti2, Angel Cequier3, Eric Van Belle4, Thierry Lefevre5, Pascal Leprince6, Franz-Josef Neumann7, Eric Vicaut8, Gilles Montalescot9. 1. Sorbonne Université, ACTION Study Group, INSERM UMR_S 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France. Electronic address: Jean-philippe.collet@aphp.fr. 2. Fondazione Toscana G. Monasterio, Ospedale del Cuore G. Pasquinucci, Massa, Italy. Electronic address: sergio.berti@me.com. 3. Heart Disease Institute, Hospital Universitario de Bellvitge,University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: acequier@bellvigehospital.cat. 4. Department of Cardiology Centre, Hospitalier Universitaire (CHU), Lille, France. Electronic address: Ericvanbelle@aol.com. 5. Hopital privé Jacques Cartier, Institut cardiovasculaire Paris Sud, Massy, France. Electronic address: t.lefevre@angio-icps.com. 6. Sorbonne Université (UPMC), INSERM UMRS 1166, Chrirugie Cardiaque, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France. Electronic address: Pascal.leprince@aphp.fr. 7. Herz-Zentrum Bad Krozingen, Germany. Electronic address: franz-josef.neumann@universitaets-herzzentrum.de. 8. ACTION Study Group, Unité de Recherche Clinique, Hôpital Lariboisière, APHP, Paris, France. Electronic address: eric.vicaut@aphp.fr. 9. Sorbonne Université, ACTION Study Group, INSERM UMR_S 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France.
Abstract
BACKGROUND: Antithrombotic treatment regimen following transcatheter aortic valve replacement (TAVR) is not evidence-based. Apixaban, a non-vitamin K direct anticoagulant (NOAC) was shown to be superior to VKA and superior to aspirin to prevent cardioembolic stroke in non-valvular atrial fibrillation. It may have the potential to reduce TAVR-related thrombotic complications including subclinical valve thrombosis along with a better safety than the standard of care. DESIGN: ATLANTIS is a multicenter, randomized, phase IIIb, prospective, open-label, superiority study comparing standard of care (SOC Group) versus an apixaban-based strategy (Anti-Xa Group) after successful TAVR (ClinicalTrials.gov NCT 02664649). Randomization is stratified according to the need for chronic anticoagulation therapy for a reason other than the TAVR procedure. In the experimental arm, patients receive 5 mg bid of apixaban or a reduced dose of 2.5 mg bid according to the drug label or when apixaban is combined with antiplatelet therapy. In the control arm, patients receive VKA therapy if there is an indication for oral anticoagulation or antiplatelet therapy alone (single or dual) or the combination of both if needed. The primary study end point is the composite of all-cause death, TIA/stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, systemic embolism, life-threatening, disabling or major bleeding, according to the Valve Academic Research Consortium definitions. CONCLUSIONS: ATLANTIS tests the superiority of an apixaban-based strategy versus the recommended standard of care strategy to reduce the risk of post-TAVR thromboembolic and bleeding complications in an all comer population.
RCT Entities:
BACKGROUND: Antithrombotic treatment regimen following transcatheter aortic valve replacement (TAVR) is not evidence-based. Apixaban, a non-vitamin K direct anticoagulant (NOAC) was shown to be superior to VKA and superior to aspirin to prevent cardioembolic stroke in non-valvular atrial fibrillation. It may have the potential to reduce TAVR-related thrombotic complications including subclinical valve thrombosis along with a better safety than the standard of care. DESIGN: ATLANTIS is a multicenter, randomized, phase IIIb, prospective, open-label, superiority study comparing standard of care (SOC Group) versus an apixaban-based strategy (Anti-Xa Group) after successful TAVR (ClinicalTrials.gov NCT 02664649). Randomization is stratified according to the need for chronic anticoagulation therapy for a reason other than the TAVR procedure. In the experimental arm, patients receive 5 mg bid of apixaban or a reduced dose of 2.5 mg bid according to the drug label or when apixaban is combined with antiplatelet therapy. In the control arm, patients receive VKA therapy if there is an indication for oral anticoagulation or antiplatelet therapy alone (single or dual) or the combination of both if needed. The primary study end point is the composite of all-cause death, TIA/stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, systemic embolism, life-threatening, disabling or major bleeding, according to the Valve Academic Research Consortium definitions. CONCLUSIONS: ATLANTIS tests the superiority of an apixaban-based strategy versus the recommended standard of care strategy to reduce the risk of post-TAVR thromboembolic and bleeding complications in an all comer population.
Authors: Matej Samoš; Tomáš Bolek; Ingrid Škorňová; Jakub Benko; Ján Staško; Peter Kubisz; Peter Galajda; Marián Mokán Journal: J Thromb Thrombolysis Date: 2019-11 Impact factor: 2.300
Authors: Davide Capodanno; Deepak L Bhatt; John W Eikelboom; Keith A A Fox; Tobias Geisler; C Michael Gibson; Jose Ramon Gonzalez-Juanatey; Stefan James; Renato D Lopes; Roxana Mehran; Gilles Montalescot; Manesh Patel; P Gabriel Steg; Robert F Storey; Pascal Vranckx; Jeffrey I Weitz; Robert Welsh; Uwe Zeymer; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2020-01-17 Impact factor: 32.419