{"id":"95769536ce38","type":"article","url":"https://hartvaat.nl/2020/11/26/rivaroxaban-bij-af-met-bioprothese-mitralisklep-nejm-river/","title":"Rivaroxaban bij AF met bioprothese-mitralisklep: NEJM RIVER","title_en":"Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["klepprothese"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2029603","source_url":"https://doi.org/10.1056/NEJMoa2029603","authors":["Helio P Guimarães","Renato D Lopes","Pedro G M de Barros E Silva","Idelzuita L Liporace","Roney O Sampaio","Flávio Tarasoutchi","Conrado R Hoffmann-Filho","Rodrigo de Lemos Soares Patriota","Tiago L L Leiria","Diana Lamprea","Dalton B Precoma","Fernando A Atik","Fabio S Silveira","Fabio R Farias","Diogo O Barreto","Adail P Almeida","Alexandre C Zilli","João D de Souza Neto","Margaret A Cavalcante","Fernando A M S Figueira","Flávia C S Kojima","Lucas Damiani","Renato H N Santos","Nanci Valeis","Viviane B Campos","Jose F K Saraiva","Francisco H Fonseca","Ibraim M Pinto","Carlos C Magalhães","Joao F M Ferreira","John H Alexander","Ricardo Pavanello","Alexandre B Cavalcanti","Otavio Berwanger"],"significance":8,"published":"2020-11-26","source_date":"2020-11-26","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doacs-overzicht/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"The RIVER trial demonstrated that rivaroxaban was noninferior to warfarin for the composite of stroke, TIA, systemic embolism, valve thrombosis, or death in patients with atrial fibrillation and a bioprosthetic mitral valve. The result expanded the evidence for DOAC use in patients with bioprosthetic heart valves.","created":"2026-07-03T10:28:55Z","updated":"2026-07-03T13:28:04Z","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":"NEJM RIVER trial die rivaroxaban vergeleek met warfarine bij AF-patiënten met een bioprothese-mitralisklep. Bevestigt DOAC-gebruik bij biokleppen.","abstract_original":"BACKGROUND: The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain. METHODS: In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months. RESULTS: A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups. CONCLUSIONS: In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.)."}