Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy
- PMID: 36137682
- DOI: 10.1016/j.jcin.2022.07.014
Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy
Abstract
Background: Subclinical obstructive valve thrombosis after transcatheter aortic valve replacement (TAVR) is of uncertain frequency and clinical impact.
Objectives: The aim of this study was to determine the effects of apixaban vs standard of care on post-TAVR valve thrombosis detected by 4-dimensional (4D) computed tomography.
Methods: The randomized ATLANTIS (Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis) trial demonstrated that apixaban 5 mg twice daily was not superior to standard of care (vitamin K antagonists or antiplatelet therapy) after successful TAVR and was associated with similar safety but with more noncardiovascular deaths. Three months after randomization, 4D computed tomography was proposed to all patients to determine the percentage of patients with ≥1 prosthetic valve leaflet with grade 3 or 4 reduced leaflet motion or grade 3 or 4 hypoattenuated leaflet thickening (the primary endpoint) in the intention-to-treat population.
Results: Seven hundred sixty-two participants had complete multiphase datasets and were included in the 4D computed tomographic analysis. The primary endpoint occurred in 33 (8.9%) and 51 (13.0%) patients in the apixaban and standard-of-care groups, respectively. It was reduced with apixaban vs antiplatelet therapy (OR: 0.51; 95% CI: 0.30-0.86) but not vs vitamin K antagonists (OR: 1.80; 95% CI: 0.62-5.25) (Pinteraction = 0.037). The composite of death, myocardial infarction, any stroke, or systemic embolism at 1 year occurred in 10.7% (n = 9 of 84) and 7.1% (n = 48 of 178) of patients with and without subclinical valve thrombosis at 90 days, respectively (HR: 1.68; 95% CI: 0.82-3.44).
Conclusions: Apixaban reduced subclinical obstructive valve thrombosis in the majority of patients who underwent TAVR without having an established indication for anticoagulation. This study was not powered for clinical outcomes. (Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis [ATLANTIS]; NCT02664649).
Keywords: 4D CT; TAVR; anticoagulation; valve thrombosis.
Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures Both the prespecified ATLANTIS-4D-CT study and the main ATLANTIS study were conducted under the academic leadership of the ACTION Group (www.action-groupe.org), sponsored by AP-HP and funded in part by an unrestricted grant from Bristol Myers Squibb and Pfizer. Prof Montalescot has received research funds to the institution or fees from Abbott, Amgen, AstraZeneca, Axis, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Boston Scientific, Cell Prothera, CSL Behring, Idorsia, Leo Pharma, Eli Lilly, Medtronic, Novartis, Pfizer, Quantum Genomics, Sanofi, and Terumo. Prof Collet has received research funds to the institution or fees from AstraZeneca, Boston Scientific, Bristol Myers Squibb, COR2ED, Lead-Up, Medtronic, and WebMD. Prof Silvain has received fees or contributions to transportation costs from AstraZeneca, Bayer HealthCare, Abbott Medical France, Biotronik, Boehringer Ingelheim France, CSL Behring, Gilead Science, Sanofi France, Terumo France, and Zoll; and is a stockholder in PharmaSeeds. Dr Neumann has received grants or fees from Amgen, Bayer Health Care, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Ferrer, Pfizer, Novartis, Boehringer Ingelheim, GlaxoSmithKline, Abbott Vascular, and Medtronic. Dr Cequier has received grants to the institution from Abbott Vascular, Biosensors International, Boston Scientific, and Medtronic; has received fees from Amgen, Boehringer Ingelheim, Sanofi, Ferrer International; and has participated on data and safety monitoring boards or advisory boards for AstraZeneca, Biotronik, and Daiichi Sankyo. Dr Trenk has received honoraria for lectures or support for meeting attendance and travel or participation on boards from Bristol Myers Squibb Pfizer, Bayer, Novartis Pharma, Ferrer, Daiichi Sankyo, Boehringer Ingelheim, AstraZeneca, and Amgen. Dr Lefèvre has received grants to the institution, honoraria, or support from Terumo, Boston Scientific, Edwards Lifesciences, Abbott, the European Bifurcation Club, the European Association of Percutaneous Cardiovascular Interventions, EuroPCR, and Hightech. Prof Vicaut has received fees from Abbott, Amgen, Bristol Myers Squibb, Celgene, Laboratoire Français du fractionnement et des Biotechnologies, Pfizer, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Comment in
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Anticoagulation and Subclinical Valve Thrombosis After TAVR.JACC Cardiovasc Interv. 2022 Sep 26;15(18):1805-1807. doi: 10.1016/j.jcin.2022.08.003. Epub 2022 Aug 31. JACC Cardiovasc Interv. 2022. PMID: 36057537 No abstract available.
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Oral Anticoagulant Dose Adjustment After TAVR: The Role of Closure Time With Adenosine Diphosphate.JACC Cardiovasc Interv. 2022 Dec 26;15(24):2575. doi: 10.1016/j.jcin.2022.10.018. JACC Cardiovasc Interv. 2022. PMID: 36543454 No abstract available.
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Reply: Oral Anticoagulant Dose Adjustment After TAVR: The Role of Closure Time With Adenosine Diphosphate.JACC Cardiovasc Interv. 2022 Dec 26;15(24):2576. doi: 10.1016/j.jcin.2022.10.046. JACC Cardiovasc Interv. 2022. PMID: 36543455 No abstract available.
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