RESUMO
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 max [49-46%] and C min [75-61%] in 15 mg rivaroxaban and 2.5 mg apixaban patients, respectively. The dose regimen was associated with C max and C min plasma concentrations in apixaban (p = 0.0058 and p = 0.0222, respectively), but not in rivaroxaban samples (multivariate analysis). Moreover, substantial variability of thrombin peak height (STG-ThromboScreen) was noticed at a given plasma concentration for both xabans, suggesting an impact of the underlying coagulation status on TG in elderly in-patients. After 6-month follow-up, major bleeding/thromboembolic event/death rates were 6.7%/1.0%/17.3% in rivaroxaban and 5.4%/3.6%/18.9% in apixaban patients, respectively. 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.
Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Idoso , Humanos , Feminino , Idoso de 80 Anos ou mais , Rivaroxabana/efeitos adversos , Anticoagulantes/uso terapêutico , Trombina , Dabigatrana/uso terapêutico , Estudos Prospectivos , Piridonas/efeitos adversos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Administração Oral , Acidente Vascular Cerebral/tratamento farmacológicoRESUMO
Introduction: Diabetes, a high prevalence chronic disease, especially in the elderly, is a risk factor of chronic lower limb wounds, whose management involves screening and treatment of peripheral arterial obstructive disease (PAOD), which must be systematic. Aim : Evaluate the screening and the management of PAOD amongst those patients, hospitalized in a Geriatric Department. Methods: Observational, retrospective, monocentric study, including all the elderly above 75 years old, with diabetes, and a wound in the lower limb, hospitalized from 01/01/2018 to 29/02/2020 at Henri Mondor hospital in Créteil. Results: Over the study period, 2567 patients were hospitalized, including 501 diabetic patients (19,5 %). 38 patients were included. Amongst them, 66 % had a bedsore, 18 % a leg ulcer, and 24 % a diabetic foot ulcer. Concerning the screening of PAOD, 66 % was screened for peripheral pulses, 8 % had an ankle-brachial index, and 45 % at least an imaging including 39 % arterial doppler. Amongst the 21 patients with PAOD, only one had a complete medical treatment, 6 had a revascularization including 5 amputations. Conclusion: Management of PAOD in the wound of lower limb amongst diabetic elderly patients is insufficient. Although it can be difficult to revascularize them, the screening must be systematic. Educate geriatric doctors in the screening of PAOD and build an expert team amongst them would help to improve that problematic.
Objectifs: Évaluer le dépistage et la prise en charge de l'artériopathie oblitérante des membres inférieurs (AOMI) chez les patients âgés diabétiques, hospitalisés en court séjour gériatrique. Méthodes: Étude observationnelle, rétrospective et monocentrique sur le service de gériatrie de l'hôpital Henri-Mondor, du 1er janvier 2018 au 29 février 2020. Inclusion des patients de plus de 75 ans, diabétiques, avec une plaie du membre inférieur. Résultats: 2 567 patients ont été hospitalisés, dont 501 diabétiques (19,5 %). Trente-huit (38) patients ont été inclus. Parmi eux, 66 % présentaient une escarre, 18 % un ulcère et 24 % une plaie du pied diabétique. Dans le dépistage de l'AOMI, 66 % des patients avaient eu une recherche des pouls périphériques, 8 % un indice de pression systolique et 45 % au moins une imagerie dont 39 % un Doppler artériel. Parmi les 21 patients avec AOMI, un seul avait un traitement médicamenteux complet, un autre avait bénéficié d'un geste de revascularisation et cinq avaient subi une amputation. Conclusion: La prise en charge de l'AOMI dans la plaie du membre inférieur chez le sujet âgé diabétique est insuffisante. La réalisation d'un geste vasculaire peut être compliquée, mais le dépistage est simple et devrait être systématique.
