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Therapeutic Methods and Therapies TCIM
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Am Heart J ; 231: 128-136, 2021 01.
Article in English | MEDLINE | ID: mdl-33045224

ABSTRACT

The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. DESIGN: RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome adjudication that enrolled 1005 patients from 49 sites in Brazil. Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter were randomly assigned (1:1) to rivaroxaban 20 mg once daily (15 mg in those with creatinine clearance <50 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-30.); the follow-up period was 12 months. The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure. Secondary outcomes included individual components of the primary composite outcome, bleeding events, and venous thromboembolism. SUMMARY: RIVER represents the largest trial specifically designed to assess the efficacy and safety of a direct oral anticoagulant in patients with bioprosthetic mitral valves and atrial fibrillation or flutter. The results of this trial can inform clinical practice and international guidelines.


Subject(s)
Atrial Fibrillation/complications , Atrial Flutter/complications , Bioprosthesis , Factor Xa Inhibitors/therapeutic use , Heart Valve Prosthesis , Mitral Valve , Rivaroxaban/therapeutic use , Thrombosis/prevention & control , Administration, Oral , Aspirin/administration & dosage , Bioprosthesis/adverse effects , Brazil , Cause of Death , Creatinine/metabolism , Embolism , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/adverse effects , Heart Valve Prosthesis/adverse effects , Hemorrhage/chemically induced , Hospitalization , Humans , Ischemic Attack, Transient , Rivaroxaban/administration & dosage , Rivaroxaban/adverse effects , Sample Size , Stroke , Surgical Procedures, Operative , Thrombosis/etiology , Treatment Outcome , Warfarin/administration & dosage , Warfarin/adverse effects , Warfarin/therapeutic use
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