{"id":"044874b3d763","type":"article","url":"https://hartvaat.nl/2026/05/19/eldercare-af-post-hoc-edoxaban-spiegel-en-pt-13s-voorspellen-bloedingsrisico-bij/","title":"ELDERCARE-AF post-hoc: edoxaban-spiegel én PT >13s voorspellen bloedingsrisico bij zeer oude AF-patiënten","title_en":"","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","internist"],"tags":["abelacimab","anemie-ckd","anticoagulatie-kwetsbare-ouderen","bloeddrukbehandeling","ouderen"],"journal":"Journal of the American Heart Association","doi":"10.1161/JAHA.125.042950","source_url":"https://doi.org/10.1161/JAHA.125.042950","authors":["Ken Okumura","Masaharu Akao","Masayuki Fukuzawa","Yoshiyuki Igawa","Takuya Hayashi","Takeshi Yamashita"],"significance":6,"published":"2026-06-16","source_date":"2026-05-19","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/af-en-hartfalen/","https://hartvaat.nl/kennis/atriumfibrilleren/hasbled-score/"],"congress":"","summary_en":"Post-hoc analysis of the randomised double-blind ELDERCARE-AF trial (Japanese patients ≥80 years with atrial fibrillation and high bleeding risk), in which 427 patients received edoxaban 15 mg/day or placebo. After 8 weeks, trough edoxaban concentration (E-trough) and prothrombin time (PT) were measured. Older age, lower body weight, lower creatinine clearance, and congestive heart failure were independent predictors of higher E-trough. Higher E-trough was associated with more major bleeding (0.8%, 1.9%, 3.4%, 4.7% per year across quartiles; p=0.04). E-trough correlated strongly with PT (r=0.43; p<0.0001). At PT >13 seconds, significantly more major bleeding occurred (4.61% vs 0.98%/year; p=0.006). PT may thus serve as a simple bedside marker to identify bleeding risk in very old edoxaban patients.","created":"2026-07-03T10:33:03Z","updated":"2026-07-03T13:31:58Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Post-hoc analyse van de gerandomiseerde dubbelblinde ELDERCARE-AF-studie (Japanse patiënten ≥80 jaar met atriumfibrilleren en hoog bloedingsrisico), waarbij 427 patiënten edoxaban 15 mg/dag of placebo kregen. Na 8 weken werd edoxaban-troughspiegel (E-trough) en protrombinetijd (PT) gemeten. Hogere leeftijd, lager lichaamsgewicht, lagere creatinineklaring en aanwezigheid van congestief hartfalen waren onafhankelijke voorspellers van een hogere E-trough. Hogere E-trough was geassocieerd met meer major bleeding (0,8%, 1,9%, 3,4% en 4,7% per jaar over kwartielen; p=0,04). E-trough correleerde sterk met PT (r=0,43; p<0,0001). Bij PT >13 seconden trad significant meer major bleeding op (4,61% vs 0,98%/jaar; p=0,006). PT kan dus een eenvoudige bedside-marker zijn om bloedingsrisico bij zeer oude edoxaban-patiënten te identificeren.","abstract_original":"BACKGROUND: Edoxaban is a direct oral anticoagulant used for stroke prevention in patients with atrial fibrillation (AF) and treatment of venous thromboembolism. We examined the relationship between trough edoxaban concentrations (E-trough) and prothrombin time (PT) and major bleeding in very old Japanese patients with atrial fibrillation and high bleeding risk. METHODS: In this post hoc analysis of the multicenter, randomized, double-blind, placebo-controlled ELDERCARE-AF (Study of DU-176b Aged 80 Years or Older) trial, patients were randomly assigned 1:1 to edoxaban 15 mg or placebo once daily. After 8 weeks of treatment, E-trough was determined and the incidence of major bleeding examined in each quartile. The incidence of major bleeding by PT was also examined. RESULTS: Data were obtained from 427 patients. E-trough (ng/mL) was ≤9.24 in the first quartile (107 patients), >9.24 to ≤13.6 in the second (111 patients), >13.6 to ≤21.6 in the third (103 patients), and >21.6 in the fourth (106 patients). Older age, lower body weight, lower creatinine clearance, and the presence of congestive heart failure were independent predictors of higher E-trough. Higher E-trough was associated with greater incidence of major bleeding (0.8%, 1.9%, 3.4%, and 4.7%/year, respectively, P=0.0408). There was a significant positive correlation between E-trough and PT (r=0.426, P<0.0001). Significantly more major bleeding events occurred in the longer (>13 seconds) versus shorter (≤13 seconds) PT subgroups (4.61% versus 0.98%/year, P=0.0060). CONCLUSIONS: Several factors were associated with higher E-trough and increased risk of major bleeding events. PT >13 seconds may be a useful predictor of the development of major bleeding. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02801669."}