{"id":"8decaf7da5a7","type":"article","url":"https://hartvaat.nl/2018/08/21/apixaban-versus-heparine-vka-bij-cardioversie-voor-af-emanate-trial/","title":"Apixaban versus heparine/VKA bij cardioversie voor AF: EMANATE-trial","title_en":"Apixaban compared to heparin/vitamin K antagonist in patients with atrial fibrillation scheduled for cardioversion: the EMANATE trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["anticoagulantia"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehy148","source_url":"https://doi.org/10.1093/eurheartj/ehy148","authors":["Michael D Ezekowitz","Charles V Pollack","Jonathan L Halperin","Richard D England","Sandra VanPelt Nguyen","Judith Spahr","Maria Sudworth","Nilo B Cater","Andrei Breazna","Jonas Oldgren","Paulus Kirchhof"],"significance":7,"published":"2018-08-21","source_date":"2018-08-21","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/","https://hartvaat.nl/kennis/antistolling/doacs-overzicht/"],"congress":"","summary_en":"The EMANATE trial showed that apixaban is as safe as heparin/vitamin K antagonist in AF patients undergoing cardioversion with less than 48 hours of anticoagulation, supporting simplified DOAC-based management around cardioversion procedures.","created":"2026-07-03T10:27:26Z","updated":"2026-07-03T13:26:41Z","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":"EMANATE gerandomiseerde trial die apixaban vergeleek met heparine/VKA bij patiënten met AF gepland voor cardioversie. Ondersteunt DOAC-gebruik rond cardioversie.","abstract_original":"AIM: The primary objective was to compare apixaban to heparin/vitamin K antagonist (VKA) in patients with atrial fibrillation (AF) and ≤48 h anticoagulation prior to randomization undergoing cardioversion. METHODS: One thousand five hundred patients were randomized. The apixaban dose of 5 mg b.i.d. was reduced to 2.5 mg b.i.d. in patients with two of the following: age ≥ 80 years, weight ≤ 60 kg, or serum creatinine ≥ 133 µmol/L. To expedite cardioversion, at the discretion of the investigator, imaging and/or a loading dose of 10 mg (down-titrated to 5 mg) was allowed. The endpoints for efficacy were stroke, systemic embolism (SE), and death. The endpoints for safety were major bleeding and clinically relevant non-major (CRNM) bleeding. RESULTS: There were 1038 active and 300 spontaneous cardioversions; 162 patients were not cardioverted. Imaging was performed in 855 patients, and 342 received a loading dose of apixaban. Comparing apixaban to heparin/VKA in the full analysis set, there were 0/753 vs. 6/747 strokes [relative risk (RR) 0; 95% confidence interval (95% CI) 0-0.64; nominal P = 0.015], no SE, and 2 vs. 1 deaths (RR 1.98; 95% CI 0.19-54.00; nominal P > 0.999). In the safety population, there were 3/735 vs. 6/721 major (RR 0.49; 95% CI 0.10-2.07; nominal P = 0.338) and 11 vs. 13 CRNM bleeding events (RR 0.83; 95% CI 0.34-1.89; nominal P = 0.685). On imaging, 60/61 with thrombi continued randomized treatment; all (61) were without outcome events. CONCLUSIONS: Rates of strokes, systemic emboli, deaths, and bleeds were low for both apixaban and heparin/VKA treated AF patients undergoing cardioversion. CLINICAL TRIALS.GOV NUMBER: NCT02100228."}