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 14 publications

(3 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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“…, atrial fibrillation; CAD, coronary artery disease; CrCl, creatinine clearance; DOACS, direct oral anticoagulants; DTI, direct thrombin inhibitors; FXaI, factor Xa inhibitors; HR, hazard ratio; ICH, intracranial hemorrhage; INR, international normalized ratio; NOACs, non-vitamin K antagonists; NVAF, nonvalvular atrial fibrillation; ROCKET AF trial, Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; TIA, transient ischemic attack; VKAs, vitamin K antagonists[14][15][16][17][18][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] …”

mentioning

confidence: 99%

Assessing the Safety and Efficacy of Rivaroxaban for Stroke Prevention in Patients With Atrial Fibrillation: A Systemic Review and Meta-Analysis

Virk,

Javed,

Chaudhry

et al. 2024

Cureus

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An effective anticoagulation therapy is required for patients with atrial fibrillation because it presents a significant risk of stroke. The current study evaluates the relative safety as well as efficacy of rivaroxaban in patients who are diagnosed with atrial fibrillation. A thorough literature review of relevant databases was conducted, focusing on academic and clinical studies that were published from 2017 onward. Inclusion criteria comprised randomized controlled trials and other observational studies comparing the incidence of stroke and the safety index of rivaroxaban in atrial fibrillation. We followed the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) for data overview reporting and overview. A total of 21 studies were selected based on the inclusion criteria. A total of 19/21 studies advocated the adoption of rivaroxaban for minimizing stroke incidence. Rivaroxaban also showed superiority in achieving the therapeutic objectives, i.e., reduction in the incidence of stroke. The results for rivaroxaban against warfarin showed an improved safety index and effectiveness of rivaroxaban. The total effect size for the analysis was calculated to be Z=2.62 (p-value=0.009). The individual effect of all studies favored the "rivaroxaban" group.The heterogeneity in the study was as follows: tau 2 =0.10; chi 2 =110.10, df=6; I 2 =95%. The second analysis for risk reduction and incidence of stroke after rivaroxaban therapy also showed a bias towards rivaroxaban therapy. The combined effect for the analysis was found to be as follows: HR=0.73 ((95% CI: 0.50, 1.07). The total effect was calculated to be Z=1.61 (p-value= 0.10). The heterogeneity was found to be as follows: tau 2 = 0.20, chi 2 =89.97, df=6, I 2 =93%. Standard dosing of rivaroxaban emerges as a preferred strategy for stroke prevention, balancing efficacy and safety. Clinical decision-making should consider individual patient characteristics and future research should delve into specific subpopulations and long-term outcomes to further refine treatment guidelines.

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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 14 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

Assessing the Safety and Efficacy of Rivaroxaban for Stroke Prevention in Patients With Atrial Fibrillation: A Systemic Review and Meta-Analysis

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