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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Rivaroxaban in Rheumatic Heart Disease–Associated Atrial Fibrillation
New England Journal of Medicine, Volume 387, No. 11, Year 2022
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Description
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. Copyright © 2022 Massachusetts Medical Society.
Authors & Co-Authors
Connolly, Stuart J.
Canada, Hamilton
Mcmaster University
Karthikeyan, Ganesan
India, New Delhi
All India Institute of Medical Sciences, new Delhi
Nt, Mpiko
South Africa, Cape Town
University of Cape Town
Haileamlak, Abraham Mitike
Ethiopia, Jimma
Jimma University
El-Sayed, Ahmed
Sudan, Wad Madani
Gazira State Ministry of Health
El Ghamrawy, Alaa
Egypt, El Mahalla el Kubra
Mahalla Heart Center
Damasceno, A. Antonio Moura
Mozambique, Maputo
Universidade Eduardo Mondlane
Avezum, Álvaro Jr
Brazil, Sao Paulo
Hospital Alemao Oswaldo Cruz
Dans, Antonio L.L.
Philippines, Manila
University of the Philippines Manila
Gitura, Bernard Muriuki
Kenya, Nairobi
Kenyatta National Hospital
Hu, Dayi
China, Beijing
Peking University People's Hospital
Kamanzi, Emmanuel Rusingiza
Rwanda, Kigali
Centre Hospitalier Universitaire de Kigali
Maklady, Fathi A.
Egypt, Ismailia
Suez Canal University Hospitals
Fana, Golden Tafadzwa
Zimbabwe, Harare
University of Zimbabwe
González-Hermosillo, Jesús Antonio
Mexico, Tlalpan
Instituto Nacional de Cardiologia Ignacio Chavez
Musuku, John
Zambia, Lusaka
University Teaching Hospital Lusaka
Kazmi, Khawar Abbas
Pakistan, Karachi
National Institute of Cardiovascular Diseases Pakistan
Zühlke, Liesl Joanna
South Africa, Tygerberg
South African Medical Research Council
Gondwe, Lillian
Malawi, Lilongwe
Kamuzu Central Hospital
Ma, Changsheng
China, Beijing
Beijing Anzhen Hospital, Capital Medical University
Paniagua-Martín, María Jesús
Paraguay, Asuncion
Hospital General Barrio Obrero
Ogah, Okechukwu Samuel
Nigeria, Ibadan
University of Ibadan
Molefe-Baikai, Onkabetse Julia
Botswana, Gaborone
Princess Marina Hospital
Lwabi, Peter Solomon
Uganda, Kampala
Uganda Heart Institute
Chillo, Pilly
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Sharma, Sanjib Kumar
Nepal, Dharan
B.p. Koirala Institute of Health Sciences
Cabral, Tantchou Tchoumi Jacques
Cameroon, Kumbo
St Elizabeth Catholic General Hospital
Tarhuni, Wadea M.
Canada, Saskatoon
University of Saskatchewan
Canada, London
Western University
Canada, Windsor
Windsor Cardiac Centre
Benz, Alexander Philipp
Canada, Hamilton
Mcmaster University
Germany, Mainz
Johannes Gutenberg-universität Mainz
van Eikels, Martin
Germany, Leverkusen
Bayer ag
Krol, Amy
Canada, Hamilton
Mcmaster University
Pattath, Divya
Canada, Hamilton
Mcmaster University
Balasubramanian, Kumar
Canada, Hamilton
Mcmaster University
Rangarajan, Sumathy
Canada, Hamilton
Mcmaster University
Ramasundarahettige, Chinthanie F.
Canada, Hamilton
Mcmaster University
Mayosi, Bongani M.
South Africa, Cape Town
University of Cape Town
Yusuf, Salim
Canada, Hamilton
Mcmaster University
Statistics
Citations: 67
Authors: 37
Affiliations: 32
Identifiers
Doi:
10.1056/NEJMoa2209051
ISSN:
00284793
Research Areas
Noncommunicable Diseases
Study Design
Cohort Study
Participants Gender
Female