A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial

Guimarães, Hélio Penna; Silva, Pedro Gabriel Melo de Barros e; Liporace, Idelzuíta Leandro; Sampaio, Roney Orismar; Tarasoutchi, Flávio; Paixão, Milena Ribeiro; Hoffmann-Filho, Conrado R; Patriota, Rodrigo de Lemos Soares; Leiria, Tiago Luiz Luz; Lamprea, Diana; Précoma, Dalton Bertolim; Atik, Fernando Antibas; Silveira, Fábio Serra; Farias, Fabio Rocha; Barreto, Diogo O; Almeida, A P; Zilli, Alexandre Cabral; Neto, João David de Souza; Cavalcante, Margaret Assad; Figueira, Fernando Augusto Marinho dos Santos; Roque, Ana Beatriz Alves de Oliveira; Moisés, Valdir Ambrósio; Mesas, Cézar; Ardito, Roberto Vito; Kalil, Paulo Sergio Abunader; Paiva, Maria Sanali Moura Oliveira; Maldonado, Jaime Giovany Arnez; Lima, Carlos Eduardo Batista de; Vieira, Ricardo D’Oliveira; Laranjeira, Lígia Nasi; Kojima, Flávia; Damiani, Lucas Petri; Renato, Nakagawa,; Santos, Juliana R Y Dos; Sampaio, Bruna; Campos, Viviane Bezerra; Saraiva, José Francisco Kerr; Fonseca, Francisco H.; Pinto, Ibraim Masciarelli Francisco; Magalhães, Carlos Costa; Ferreira, João Fernando Monteiro; Lópes, Renato D.; Pavanello, Ricardo; Cavalcanti, Alexandre Biasi; Berwanger, Otávio

doi:10.1016/j.ahj.2020.10.001

Cited by 12 publications

(2 citation statements)

References 44 publications

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“…9,10 The recent landmark Rivaroxaban for Valvular Heart DiseasE and atRial Fibrillation (RIVER) trial investigated the safety and efficacy of rivaroxaban compared with warfarin in 1005 patients with bioprosthetic MV and AF. 11 Patients with bioprosthetic valves form a unique group of patients with AF. Valvular or nonvalvular AF with a mitral bioprosthesis has a higher risk of stroke compared with those without.…”

Section: Direct Anticoagulants In Atrial Fibrillation and Bioprosthetic Valvesmentioning

confidence: 99%

Bioprosthetic valves and atrial fibrillation: Direct anticoagulants or warfarin

Kapadia¹,

Svensson²

2023

The Journal of Thoracic and Cardiovascular Surgery

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Section: Direct Anticoagulants In Atrial Fibrillation and Bioprosthetic Valvesmentioning

confidence: 99%

Bioprosthetic valves and atrial fibrillation: Direct anticoagulants or warfarin

Kapadia¹,

Svensson²

2023

The Journal of Thoracic and Cardiovascular Surgery

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“…Based on the asymptotic properties of RMST(𝜏), Zhao et al (2016) developed the frequentist inference procedure for RMST with right-censored data. Nowadays, RMST has been widely used in clinical data analysis (Saluja et al, 2019;Angelucci et al, 2020) and trial design (Guimarães et al, 2021). It has also been used for developing the number needed to treat (NNT) for survival endpoints, which has better interpretations than the traditional NNT (Yang & Yin, 2019).…”

Section: Rmstmentioning

confidence: 99%

Bayesian Nonparametric Analysis of Restricted Mean Survival Time

Zhang

Yin

2022

Biometrics

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The restricted mean survival time (RMST) evaluates the expectation of survival time truncated by a prespecified time point, because the mean survival time in the presence of censoring is typically not estimable. The frequentist inference procedure for RMST has been widely advocated for comparison of two survival curves, while research from the Bayesian perspective is rather limited. For the RMST of both right-and interval-censored data, we propose Bayesian nonparametric estimation and inference procedures. By assigning a mixture of Dirichlet processes (MDP) prior to the distribution function, we can estimate the posterior distribution of RMST. We also explore another Bayesian nonparametric approach using the Dirichlet process mixture model and make comparisons with the frequentist nonparametric method. Simulation studies demonstrate that the Bayesian nonparametric RMST under diffuse MDP priors leads to robust estimation and under informative priors it can incorporate prior knowledge into the nonparametric estimator. Analysis of real trial examples demonstrates the flexibility and interpretability of the Bayesian nonparametric RMST for both rightand interval-censored data.

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The Use of Fondaparinux with Mechanical Mitral Valve Replacement in a HIT-Like Situation: a Case Report

Tabbah

Rachoin

2022

SN Compr. Clin. Med.

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A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial

Cited by 12 publications

References 44 publications

Bioprosthetic valves and atrial fibrillation: Direct anticoagulants or warfarin

Bioprosthetic valves and atrial fibrillation: Direct anticoagulants or warfarin

Bayesian Nonparametric Analysis of Restricted Mean Survival Time

The Use of Fondaparinux with Mechanical Mitral Valve Replacement in a HIT-Like Situation: a Case Report

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