Rivaroxaban in Rheumatic Heart Disease-Associated Atrial Fibrillation.

N Engl J Med

From the Population Health Research Institute, McMaster University, Hamilton, ON, Canada (S.J.C., A.B., A.K., D.P., K.B., S.R., C.R., S.Y.); the All India Institute of Medical Sciences, New Delhi (G.K.); the Division of Cardiology, Faculty of Health Sciences, University of Cape Town (M.N., B.M.), and the South African Medical Research Council (L.Z.) - both in Cape Town, South Africa; Jimma University Medical Center, Jimma, Ethiopia (A.H.); the University of Gazira, Wad Madani, Sudan (A.E.S.); Mahalla Heart Center, El Mahalla El Kubra (A.E.G.), and Suez Canal University Hospital, Ismailia (F.M.) - both in Egypt; the Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique (A.D.); the International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo (A.A.); the College of Medicine, University of the Philippines, Manila (A.M.L.D.); Kenyatta National Hospital, Nairobi (B.G.); the People's Hospital of Peking University (D.H.) and the Beijing Anzhen Hospital (C.M.) - both in Beijing; the University Teaching Hospital of Kigali, Kigali, Rwanda (E.R.K.); the University of Zimbabwe, College of Health Sciences, Harare (G.F.); Instituto Nacional de Cardiología Ignacio Chávez, Mexico City (J.A.G.-H.); the University Teaching Hospital, Lusaka, Zambia (J.M.); the National Institute of Cardiovascular Diseases, Karachi, Pakistan (K.K.); Kamuzu Central Hospital, Lilongwe, Malawi (L.G.); Barrio Obrero Hospital, Asuncion, Paraguay (M.P.); the Department of Medicine, University of Ibadan-College Hospital, Ibadan, Nigeria (O.S.O.); Princess Marina Hospital, University of Botswana, Gaborone (O.J.M.-B.); Uganda Heart Institute, Kampala (P.L.); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (P.C.); the B.P. Koirala Institute of Health Sciences, Dharan, Nepal (S.K.S.); St. Elizabeth Catholic General Hospital, Kumbo, Cameroon (T.T.J.C.); the Department of Medicine, University of Saskatchewan, Saskatoon, the Department of Medicine, Western University, London, ON, and the Windsor Cardiac Centre, Windsor, ON - all in Canada (W.M.T.); the Department of Cardiology, Cardiology I, University Medical Center Mainz, Johannes Gutenberg University, Mainz (A.B.), and Bayer, Berlin (M.E.) - both in Germany.

Published: September 2022

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 CHADSVASc 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 cm, 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.).

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