RESUMO
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.
Assuntos
Fibrilação Atrial/complicações , Flutter Atrial/complicações , Bioprótese , Inibidores do Fator Xa/uso terapêutico , Próteses Valvulares Cardíacas , Valva Mitral , Rivaroxabana/uso terapêutico , Trombose/prevenção & controle , Administração Oral , Aspirina/administração & dosagem , Bioprótese/efeitos adversos , Brasil , Causas de Morte , Creatinina/metabolismo , Embolia , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Hemorragia/induzido quimicamente , Hospitalização , Humanos , Ataque Isquêmico Transitório , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Tamanho da Amostra , Acidente Vascular Cerebral , Procedimentos Cirúrgicos Operatórios , Trombose/etiologia , Resultado do Tratamento , Varfarina/administração & dosagem , Varfarina/efeitos adversos , Varfarina/uso terapêuticoRESUMO
BACKGROUND: The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain. METHODS: In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months. RESULTS: A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups. CONCLUSIONS: In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).
Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Bioprótese , Valva Mitral , Rivaroxabana/uso terapêutico , Varfarina/uso terapêutico , Idoso , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/mortalidade , Doenças Cardiovasculares/epidemiologia , Inibidores do Fator Xa/uso terapêutico , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Rivaroxabana/efeitos adversos , Método Simples-Cego , Acidente Vascular Cerebral/prevenção & controle , Varfarina/efeitos adversosRESUMO
O HDL-colesterol tem demonstrado ser um importante preditor de risco cardiovascular em vários estudos epidemiológicos e clínicos, em decorrência de sua relação inversa com a doença arterial coronária, e principalmente pacientes que apresentam HDL-colesterol baixo têm risco comparável ou até mesmo mais importante que aqueles com LDL-colesterol alto.O benefício clínico do tratamento do HDL-colesterol baixo já foi demonstrado em estudos publica dos nos últimos anos, como LCAS, AFCAPS/TexCAPS e VA-HIT. A presença dessa alteração lipídica em pacientes submetidos a cirurgia de revascularização miocárdica também já foi demonstrada nos estudos da Cleveland Clinic ("HDL-Cholesterol Levei Predicts Survival in Men after CABG"), no estudo sueco (publicado por Linden e colaboradores) e no LOCAT,que demonstraram mortalidade cardiovascular expressiva na associação com pacientes portadores de HDL-colesterol baixo...