{"id":"cf6aa03860e4","type":"article","url":"https://hartvaat.nl/2026/03/28/champion-af-watchman-flx-non-inferieur-aan-noac-s-en-superieur-in-bloedingsreduc/","title":"CHAMPION-AF: WATCHMAN FLX non-inferieur aan NOAC's en superieur in bloedingsreductie bij atriumfibrilleren","title_en":"","category":"algemeen","category_label":"Algemeen","professions":["cardioloog","internist"],"tags":["abelacimab","acc-2026","linkerhartoorsluiting"],"journal":"NEJM","doi":"https://www.nejm.org/doi/full/10.1056/NEJMoa2517213&rss=currentIssue","source_url":"https://doi.org/https://www.nejm.org/doi/full/10.1056/NEJMoa2517213&rss=currentIssue","authors":["Shephal K. Doshi","Saibal Kar","Devi G. Nair","Thomas Waggoner","Himanshu Agarwal","Mehran Moussavian","Amir Kashani","Saumil Oza","Leon Feldman","Ashish Sadhu","David DeLurgio","Oluseun Alli","Jens Erik Nielsen-Kudsk","Masanori Yamamoto","Mohamad Alkhouli","A. John Camm","Megan Coylewright","C. Michael Gibson","Christopher B. Granger","Mahmut Edip Gurol"],"significance":10,"published":"2026-03-29","source_date":"2026-03-28","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/coronairlijden/esc-richtlijn-chronisch-coronairlijden-2024/"],"congress":"acc-2026","summary_en":"In CHAMPION-AF, 3,000 patients with non-valvular AF were randomized to WATCHMAN FLX LAA closure or NOAC therapy. At 36 months, the device was noninferior for the primary efficacy endpoint (stroke, CV death, systemic embolism: 5.7% vs 4.8%; P<0.001 for noninferiority) and superior for non-procedural bleeding (45% reduction: 10.9% vs 19.0%; P<0.001). This contrasts with the negative CLOSURE-AF trial and establishes WATCHMAN FLX as the first LAA closure device to demonstrate noninferiority vs NOACs as first-line therapy.","created":"2026-07-03T10:32:15Z","updated":"2026-07-03T18:39:21Z","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":"In de CHAMPION-AF-trial werden 3.000 patiënten met niet-valvulair atriumfibrilleren gerandomiseerd naar WATCHMAN FLX linker-hartoorsluiting of NOAC-therapie. Na 36 maanden was het device non-inferieur voor het primaire effectiviteitseindpunt (beroerte, cardiovasculair overlijden, systemische embolie: 5,7% vs 4,8%; P<0,001 voor non-inferioriteit). Het device was superieur voor bloedingsveiligheid: 45% minder niet-procedurele bloedingen (10,9% vs 19,0%; P<0,001). Dit contrasteert met de negatieve CLOSURE-AF-trial en maakt de WATCHMAN FLX de eerste LAA-occluder die non-inferioriteit aantoont versus NOAC's als eerstelijnstherapie.","abstract_original":"New England Journal of Medicine, Ahead of Print."}