Usefulness and Safety of Rivaroxaban in Patients Following Isolated Mitral Valve Replacement With a Mechanical Prosthesis

Durães, André Rodrigues; Bitar, Yasmin de Souza Lima; Lima, Maria Luiza G.; Santos, Caroline Carvalho dos; Schonhofen, Igor; Filho, José Admirço Lima; Roever, Leonardo

doi:10.1016/j.amjcard.2018.06.015

Cited by 25 publications

(17 citation statements)

References 15 publications

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“…In vitro and animal models have shown promising results in the efficacy of rivaroxaban as thromboprophylaxis in MHV [ 27 , 28 ]. Recently, we reported promising results from the first experience of a Factor Xa inhibitor (rivaroxaban) in humans, where we followed seven patients with MHV over 3 months [ 29 ]. An RCT is currently comparing rivaroxaban and warfarin in patients with MHV [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

Comparison of the New Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: Systematic Review and Meta-Analysis

Bitar

Neto

Filho³

et al. 2019

Drugs R D

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Introduction New oral anticoagulants (NOACs) are approved for use in nonvalvular atrial fibrillation (AF). Objectives This study aimed to evaluate the efficacy and safety of NOACs compared with warfarin in AF and valvular heart disease (VHD). Methods We identified randomized controlled trials (RCTs) and post-hoc analyses comparing NOACs and warfarin in AF and VHD, including biological and mechanical heart valves (MHV). Through systematic review and meta-analysis, with the aid of the “Rev Man” program 5.3, the primary effectiveness endpoints were stroke and systemic embolism (SE). The primary safety outcome was major bleeding, and the secondary outcome included intracranial hemorrhage. Data were analyzed using risk ratios (RRs) and 95% confidence intervals (CIs), and heterogeneity was assessed using the I 2 statistic. Results Six RCTs were included, involving 13,850 patients with AF and VHD. NOACs significantly reduced the risk of stroke/SE (RR 0.78; 95% CI 0.66–0.91; P = 0.002) and intracranial hemorrhage (RR 0.51; 95% CI 0.33–0.79; P = 0.003) and lowered the risk of major bleeding (RR 0.77; 95% CI 0.58–1.02; P = 0.07) compared with warfarin. Conclusions The efficacy and safety of NOACs as thromboprophylaxis for AF and VHD are similar to those of warfarin. Electronic supplementary material The online version of this article (10.1007/s40268-019-0274-z) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Comparison of the New Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: Systematic Review and Meta-Analysis

Bitar

Neto

Filho³

et al. 2019

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“… 56–58 No significant differences were found between NOACs and VKAs in terms of primary outcomes including stroke or systemic embolism, all-cause stroke, ischaemic stroke, myocardial infarction, all-cause death, and cardiovascular death as well as its safety regarding occurrence of bleeding (major bleeding, intracranial haemorrhage, and gastrointestinal haemorrhage). 59 That indicates that NOACs, mainly edoxaban and apixaban are safe and effective also in patients with AF and prior BPV replacement or valve repair. 60 , 61 …”

Section: Non-vitamin K Antagonist Oral Anticoagulants As a Groupmentioning

confidence: 99%

Practice-derived data on non-vitamin K antagonist oral anticoagulant therapy to complement observations from randomized trials

Domek

Gumprecht

Ding

et al. 2020

European Heart Journal Supplements

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Anticoagulation is fundamental in the management of patients with atrial fibrillation (AF). The study aims to provide a comparative review of the major phase III randomized clinical trials (RCTs) and real-world data (RWD) from reliable, high-grade Phase IV studies that assess the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) vs. vitamin K antagonists (VKAs). Observational studies based on nationwide or health insurance database records on the use of NOACs vs. VKAs in patients with AF were included. We performed a comparison of the efficacy and safety characteristics associated with NOACs vs. VKAs in RCTs and RWD. Although RCTs provide strong support for evidence-based practice, RWD may be used to reflect the broader picture of various clinical settings, provide supplementary insight and fulfil knowledge gaps. Both study types confirmed the safety and efficacy of NOACs in preventing stroke and thromboembolism in patients with AF. In comparison to VKAs, NOACs were associated with reduced risk of ischaemic events and lower rates of adverse events such as major bleeding or intracranial haemorrhage. Administration of NOACs might be associated with increased risk of dose-related gastrointestinal bleeding and myocardial ischaemic events, especially in the early treatment period after switching from VKAs. Special care should be taken in challenging clinical situations like severe renal or hepatic impairment when the treatment regimen needs to be considered individually. Randomized clinical trial and RWD studies are complementary and present comparable findings, affirming that NOACs are safe and effective for anticoagulation of patients with AF in daily clinical practice.

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“…Despite discouraging results from the RE-ALIGN Trial, Durães and coworkers [33] designed a pilot study to investigate the potential role of rivaroxaban as an alternative to VKA in patients with mechanical prosthetic valves. Their rationale [34,35] was that clotting on the mechanical valves is triggered by the contact and that dabigatran administered in the RE-ALIGN Trial was insufficient to inhibit thrombus formation in this scenario.…”

Section: Discussionmentioning

confidence: 99%

“A Tale of Two Cities”: Anticoagulation Management in Patients with Atrial Fibrillation and Prosthetic Valves in the Era of Direct Oral Anticoagulants

2019

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Valvular heart disease and atrial fibrillation often coexist. Oral vitamin K antagonists have represented the main anticoagulation management for antithrombotic prevention in this setting for decades. Novel direct oral anticoagulants (DOACs) are a new class of drugs and currently, due to their well-established efficacy and security, they represent the main therapeutic option in non-valvular atrial fibrillation. Some new evidences are exploring the role of DOACs in patients with valvular atrial fibrillation (mechanical and biological prosthetic valves). In this review we explore the data available in the medical literature to establish the actual role of DOACs in patients with valvular heart disease and atrial fibrillation.

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Usefulness and Safety of Rivaroxaban in Patients Following Isolated Mitral Valve Replacement With a Mechanical Prosthesis

Cited by 25 publications

References 15 publications

Comparison of the New Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: Systematic Review and Meta-Analysis

Comparison of the New Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: Systematic Review and Meta-Analysis

Practice-derived data on non-vitamin K antagonist oral anticoagulant therapy to complement observations from randomized trials

“A Tale of Two Cities”: Anticoagulation Management in Patients with Atrial Fibrillation and Prosthetic Valves in the Era of Direct Oral Anticoagulants

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