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Войти в исследования Rivaroxaban in Rheumatic Heart Disease-Associated Atrial Fibrillation.
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Connolly Stuart J, Karthikeyan Ganesan, Ntsekhe Mpiko, Haileamlak Abraham, El Sayed Ahmed, El Ghamrawy Alaa, Damasceno Albertino, Avezum Alvaro, Dans Antonio M L, Gitura Bernard, Hu Dayi, Kamanzi Emmanuel R, Maklady Fathi, Fana Golden, Gonzalez-Hermosillo J Antonio, Musuku John, Kazmi Khawar, Zühlke Liesl, Gondwe Lillian, Ma Changsheng, Paniagua Maria, Ogah Okechukwu S, Molefe-Baikai Onkabetse J, Lwabi Peter, Chillo Pilly, Sharma Sanjib K, Cabral Tantchou T J, Tarhuni Wadea M, Benz Alexander, van Eikels Martin, Krol Amy, Pattath Divya, Balasubramanian Kumar, Rangarajan Sumathy, Ramasundarahettige Chinthanie, Mayosi Bongani, Yusuf Salim, INVICTUS Investigators
Аннотация
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.).