Assessment of DOAC in GEriatrics (Adage Study): Rivaroxaban/Apixaban Concentrations and Thrombin Generation Profiles in NVAF Very Elderly Patients.
Autor: | Foulon-Pinto G; Université Paris Cité, INSERM UMR-S-1140, Innovations Thérapeutiques en Hémostase, Paris, France.; Service d'Hématologie Biologique, AP-HP. Université Paris Cité, Hôpital Lariboisière, Paris, France., Lafuente-Lafuente C; Service de gériatrie à orientation cardiologique et neurologique, AP-HP, Sorbonne Université, Hôpitaux universitaires Pitié-Salpêtrière-Charles Foix, Ivry-sur-Seine, France.; CEpiA Team (Clinical Epidemiology and Ageing), Université Paris Est Créteil, INSERM, IMRB, Créteil, France., Jourdi G; Université Paris Cité, INSERM UMR-S-1140, Innovations Thérapeutiques en Hémostase, Paris, France.; Research Center, Institut de Cardiologie de Montréal - Université de Montréal, Montréal, QC, Canada., Guen JL; Service de Gériatrie, AP-HP. Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France., Tall F; Service de Gériatrie, AP-HP. Université Paris Cité, Hôpital Rothschild, Paris, France., Puymirat E; Service de Cardiologie, AP-HP. Université de Paris Cité, Hôpital Européen Georges Pompidou, Paris, France., Delrue M; Service d'Hématologie Biologique, AP-HP. Université Paris Cité, Hôpital Lariboisière, Paris, France., Rivière L; Service de gériatrie aiguë polyvalente, Hôpital Charles-Foix, AP-HP Sorbonne Université, Ivry-sur-Seine, France, UFR Médecine Sorbonne Université, Paris, France., Ketz F; Service de gériatrie aiguë polyvalente, Hôpital Charles-Foix, AP-HP Sorbonne Université, Ivry-sur-Seine, France, UFR Médecine Sorbonne Université, Paris, France., Gouin-Thibault I; INSERM, CIC 1414 (Centre d'Investigation Clinique de Rennes), Université de Rennes, CHU de Rennes, Rennes, France.; Service d'Hématologie Biologique, CHU de Rennes, Rennes, France., Mullier F; Department of Laboratory Medicine, Namur Thrombosis and Hemostasis Center (NTHC), Université Catholique de Louvain, Yvoir, Belgium.; Hematology-Hemostasis Laboratory, CHU UCL Namur, Yvoir, Belgium., Gaussem P; Université Paris Cité, INSERM UMR-S-1140, Innovations Thérapeutiques en Hémostase, Paris, France.; Service d'Hématologie Biologique, AP-HP. Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France., Pautas E; Université Paris Cité, INSERM UMR-S-1140, Innovations Thérapeutiques en Hémostase, Paris, France.; Service de gériatrie aiguë polyvalente, Hôpital Charles-Foix, AP-HP Sorbonne Université, Ivry-sur-Seine, France, UFR Médecine Sorbonne Université, Paris, France., Lecompte T; Service d'Hématologie Biologique, CHU de Rennes, Rennes, France.; Université de Lorraine, Faculté de médecine de Nancy, Nancy, France., Curis E; Université de Paris Cité, UR 7537 BioSTM (Biostatistics), Faculté de Pharmacie, Paris, France., Siguret V; Université Paris Cité, INSERM UMR-S-1140, Innovations Thérapeutiques en Hémostase, Paris, France.; Service d'Hématologie Biologique, AP-HP. Université Paris Cité, Hôpital Lariboisière, Paris, France. |
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Jazyk: | angličtina |
Zdroj: | Thrombosis and haemostasis [Thromb Haemost] 2023 Apr; Vol. 123 (4), pp. 402-414. Date of Electronic Publication: 2022 Nov 17. |
DOI: | 10.1055/a-1981-1763 |
Abstrakt: | Background: Although a growing number of very elderly patients with atrial fibrillation (AF), multiple conditions, and polypharmacy receive direct oral anticoagulants (DOACs), few studies specifically investigated both apixaban/rivaroxaban pharmacokinetics and pharmacodynamics in such patients. Aims: To investigate: (1) DOAC concentration-time profiles; (2) thrombin generation (TG); and (3) clinical outcomes 6 months after inclusion in very elderly AF in-patients receiving rivaroxaban or apixaban. Methods: Adage-NCT02464488 was an academic prospective exploratory multicenter study, enrolling AF in-patients aged ≥80 years, receiving DOAC for at least 4 days. Each patient had one to five blood samples at different time points over 20 days. DOAC concentrations were determined using chromogenic assays. TG was investigated using ST-Genesia (STG-ThromboScreen, STG-DrugScreen). Results: We included 215 patients (women 71.1%, mean age: 87 ± 4 years), 104 rivaroxaban and 111 apixaban, and 79.5% receiving reduced-dose regimen. We observed important inter-individual variabilities (coefficient of variation) whatever the regimen, at C Conclusion: Our study provides original data in very elderly patients receiving DOAC in a real-life setting, showing great inter-individual variability in plasma concentrations and TG parameters. Further research is needed to understand the potential clinical impact of these findings. Competing Interests: V.S., I.G.-T., E.Pa, E.Pu, F.M., M.D., and P.G. have received honoraria for participating in expert meetings on dabigatran (from Boehringer Ingelheim), rivaroxaban (from Bayer Healthcare AG), or apixaban (Bristol Myers Squibb-Pfizer). G.F. and E.Pu received a grant from Bayer. The other authors declare no conflicts of interest. (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).) |
Databáze: | MEDLINE |
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