{"id":"3f893c3a2366","type":"article","url":"https://hartvaat.nl/2022/09/15/invictus-rivaroxaban-versus-warfarine-bij-reumatische-hartziekte-en-af/","title":"INVICTUS: rivaroxaban versus warfarine bij reumatische hartziekte en AF","title_en":"Rivaroxaban in Rheumatic Heart Disease-Associated Atrial Fibrillation.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog","internist"],"tags":["aperitif-trial","rivaroxaban"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2209051","source_url":"https://doi.org/10.1056/NEJMoa2209051","authors":["Stuart J Connolly","Ganesan Karthikeyan","Mpiko Ntsekhe","Abraham Haileamlak","Ahmed El Sayed","Alaa El Ghamrawy","Albertino Damasceno","Alvaro Avezum","Antonio M L Dans","Bernard Gitura","Dayi Hu","Emmanuel R Kamanzi","Fathi Maklady","Golden Fana","J Antonio Gonzalez-Hermosillo","John Musuku","Khawar Kazmi","Liesl Zühlke","Lillian Gondwe","Changsheng Ma","Maria Paniagua","Okechukwu S Ogah","Onkabetse J Molefe-Baikai","Peter Lwabi","Pilly Chillo","Sanjib K Sharma","Tantchou T J Cabral","Wadea M Tarhuni","Alexander Benz","Martin van Eikels","Amy Krol","Divya Pattath","Kumar Balasubramanian","Sumathy Rangarajan","Chinthanie Ramasundarahettige","Bongani Mayosi","Salim Yusuf"],"significance":10,"published":"2022-09-15","source_date":"2022-09-15","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/","https://hartvaat.nl/kennis/antistolling/antistolling-bij-kankerpatienten/"],"congress":"","summary_en":"The INVICTUS trial showed that rivaroxaban was inferior to warfarin for preventing cardiovascular events in patients with rheumatic heart disease-associated atrial fibrillation, with higher rates of stroke, systemic embolism, and death. This landmark negative result confirmed that DOACs cannot replace warfarin in valvular AF due to rheumatic heart disease.","created":"2026-07-03T10:29:56Z","updated":"2026-07-03T13:29:02Z","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":"De INVICTUS-trial in de NEJM toonde dat rivaroxaban inferieur was aan warfarine bij patiënten met reumatische hartziekte en AF. Rivaroxaban gaf meer trombo-embolische events en meer sterfte. Warfarine blijft de standaard bij reumatische klepziekte met AF, in tegenstelling tot de trend bij niet-valvulair AF.","abstract_original":"BACKGROUND: Testing of factor Xa inhibitors for the prevention of cardiovascular events in patients with rheumatic heart disease-associated atrial fibrillation has been limited. METHODS: We enrolled patients with atrial fibrillation and echocardiographically documented rheumatic heart disease who had any of the following: a CHA2DS2VASc score of at least 2 (on a scale from 0 to 9, with higher scores indicating a higher risk of stroke), a mitral-valve area of no more than 2 cm2, left atrial spontaneous echo contrast, or left atrial thrombus. Patients were randomly assigned to receive standard doses of rivaroxaban or dose-adjusted vitamin K antagonist. The primary efficacy outcome was a composite of stroke, systemic embolism, myocardial infarction, or death from vascular (cardiac or noncardiac) or unknown causes. We hypothesized that rivaroxaban therapy would be noninferior to vitamin K antagonist therapy. The primary safety outcome was major bleeding according to the International Society of Thrombosis and Hemostasis. RESULTS: Of 4565 enrolled patients, 4531 were included in the final analysis. The mean age of the patients was 50.5 years, and 72.3% were women. Permanent discontinuation of trial medication was more common with rivaroxaban than with vitamin K antagonist therapy at all visits. In the intention-to-treat analysis, 560 patients in the rivaroxaban group and 446 in the vitamin K antagonist group had a primary-outcome event. Survival curves were nonproportional. The restricted mean survival time was 1599 days in the rivaroxaban group and 1675 days in the vitamin K antagonist group (difference, -76 days; 95% confidence interval [CI], -121 to -31; P<0.001). A higher incidence of death occurred in the rivaroxaban group than in the vitamin K antagonist group (restricted mean survival time, 1608 days vs. 1680 days; difference, -72 days; 95% CI, -117 to -28). No significant between-group difference in the rate of major bleeding was noted. CONCLUSIONS: Among patients with rheumatic heart disease-associated atrial fibrillation, vitamin K antagonist therapy led to a lower rate of a composite of cardiovascular events or death than rivaroxaban therapy, without a higher rate of bleeding. (Funded by Bayer; INVICTUS ClinicalTrials.gov number, NCT02832544.)."}