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1.
Am. heart j ; (231): 128-136, Jan. 2021. tab.
Article de Anglais | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1145450

RÉSUMÉ

Background 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.


Sujet(s)
Fibrillation auriculaire , Rivaroxaban , Bioprothèse , Valve atrioventriculaire gauche , Anticoagulants
2.
Am Heart J ; 231: 128-136, 2021 01.
Article de Anglais | MEDLINE | ID: mdl-33045224

RÉSUMÉ

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.


Sujet(s)
Fibrillation auriculaire/complications , Flutter auriculaire/complications , Bioprothèse , Inhibiteurs du facteur Xa/usage thérapeutique , Prothèse valvulaire cardiaque , Valve atrioventriculaire gauche , Rivaroxaban/usage thérapeutique , Thrombose/prévention et contrôle , Administration par voie orale , Acide acétylsalicylique/administration et posologie , Bioprothèse/effets indésirables , Brésil , Cause de décès , Créatinine/métabolisme , Embolie , Inhibiteurs du facteur Xa/administration et posologie , Inhibiteurs du facteur Xa/effets indésirables , Prothèse valvulaire cardiaque/effets indésirables , Hémorragie/induit chimiquement , Hospitalisation , Humains , Accident ischémique transitoire , Rivaroxaban/administration et posologie , Rivaroxaban/effets indésirables , Taille de l'échantillon , Accident vasculaire cérébral , Procédures de chirurgie opératoire , Thrombose/étiologie , Résultat thérapeutique , Warfarine/administration et posologie , Warfarine/effets indésirables , Warfarine/usage thérapeutique
3.
N Engl J Med ; 383(22): 2117-2126, 2020 11 26.
Article de Anglais | MEDLINE | ID: mdl-33196155

RÉSUMÉ

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.).


Sujet(s)
Anticoagulants/usage thérapeutique , Fibrillation auriculaire/traitement médicamenteux , Bioprothèse , Valve atrioventriculaire gauche , Rivaroxaban/usage thérapeutique , Warfarine/usage thérapeutique , Sujet âgé , Anticoagulants/effets indésirables , Fibrillation auriculaire/complications , Fibrillation auriculaire/mortalité , Maladies cardiovasculaires/épidémiologie , Inhibiteurs du facteur Xa/usage thérapeutique , Femelle , Hémorragie/induit chimiquement , Humains , Mâle , Adulte d'âge moyen , Rivaroxaban/effets indésirables , Méthode en simple aveugle , Accident vasculaire cérébral/prévention et contrôle , Warfarine/effets indésirables
4.
N. Engl. j. med ; 383(22): 1-11, Nov. 2020. graf, tab
Article de Anglais | CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1146447

RÉSUMÉ

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.


Sujet(s)
Fibrillation auriculaire , Bioprothèse , Maladies cardiovasculaires/épidémiologie , Accident vasculaire cérébral , Valve atrioventriculaire gauche , Warfarine , Rivaroxaban , Anticoagulants/effets indésirables
5.
Arq. bras. cardiol ; 63(6): 481-484, dez. 1994. tab
Article de Portugais | LILACS | ID: lil-155779

RÉSUMÉ

Objetivo - Comparar o tempo e o índice de sucesso para reversäo da fibrilaçäo atrial (FA) aguda, com o uso de amiodarona, procainamida ou quinidina. Métodos - Aleatoriamente, 60 pacientes com FA aguda foram divididos em três grupos, recebendo o grupo quinidina (GQ), constituído de 21 pacientes, digital EV + quinidina até 600mg VO; o grupo procainamida (GP) com 23 pacientes, digital EV + 10mg/kg de procainamida EV e o grupo amiodarona (GA), com 16 pacientes 5mg/kg de amiodarona EV. O período de observaçäo foi de no máximo 4h, através de Holter. Na análise estatíca foi utilizado o teste de x2 com o método de Kruskall-Wallis, considerando-se significativo p<0,05. Resultados - Os três grupos foram similares quanto a idade, sexo e tempo de instalaçäo da FA. A reversäo ocorreu em 71,4 por cento dos casos no GQ, em 47,8 por cento no GP e em 50 por cento no GA, (p>0,05). O tempo para reversäo em minutos foi de 112 + ou - 43 no G!, de 44,1 + ou - 28 no GP, de 20 + ou - 13 no GA, sendo menor e estatisticamente significante no GP e, principalmente, no GA (p= 0,001) em relaçäo ao GQ. Os efeitos colaterais foram mais freqüentes no GP, embora sem significância estatística. Conclusäo - A amiodarona, especialmente na ausência de cardiopatia de base, é uma boa opçäo para maior rapidez na reversäo da FA, enquanto a quinidina propicia maior taxa de reversäo, com menos efeitos colaterais


Sujet(s)
Humains , Mâle , Femelle , Adulte , Adulte d'âge moyen , Procaïnamide/usage thérapeutique , Quinidine , Amiodarone/usage thérapeutique , Fibrillation auriculaire/traitement médicamenteux , Facteurs temps , Urgences , Maladie aigüe , Fibrillation auriculaire/physiopathologie , Noeud sinuatrial , Noeud sinuatrial/physiopathologie
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