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

Drugs in R&D ◽  
2019 ◽  
Vol 19 (2) ◽  
pp. 117-126 ◽  
Author(s):  
Yasmin de Souza Lima Bitar ◽  
Mansueto Gomes Neto ◽  
Jose Admirço Lima Filho ◽  
Larissa Vitória Pereira ◽  
Kethyren Santos Oliveira Travassos ◽  
...  
2021 ◽  
Vol 8 ◽  
Author(s):  
Yasmin de Souza Lima Bitar ◽  
Andre Rodrigues Duraes ◽  
Leonardo Roever ◽  
Mansueto Gomes Neto ◽  
Liliane Lins-Kusterer ◽  
...  

Background: Direct oral anticoagulants (DOACS) are approved for use in non-valvular atrial fibrillation (AF). This systematic review and meta-analysis aimed to evaluate the efficacy and safety of DOACs vs. warfarin and update the evidence for treatment of AF and valvular heart disease (VHD).Methods: We identified randomized clinical trials (RCTs) and post-hoc analyses comparing the use of DOACS and Warfarin in AF and VHD, including biological and mechanical heart valves (MHV), updating from 2010 to 2020. Through systematic review and meta-analysis, by using the “Rev Man” program 5.3, the primary effectiveness endpoints were stroke and systemic embolism (SE). The primary safety outcome was major bleeding, while the secondary outcome included intracranial hemorrhage. We performed prespecified subgroup analyses. Data were analyzed by risk ratio (RR) and 95% confidence interval (CI) and the I-square (I2) statistic as a quantitative measure of inconsistency. Risk of bias and methodological quality assessment of included trials was evaluated with the modified Cochrane risk-of-bias tool.Results: We screened 326 articles and included 8 RCTs (n = 14.902). DOACs significantly reduced the risk of stroke/SE (RR 0.80, 95% CI: 0.68–0.94; P = 0.008; moderate quality evidence; I2 = 2%) and intracranial hemorrhage (RR 0.40, 95% CI: 0.24–0.66; P = 0.0004; I2 = 49%) with a similar risk of major bleeding (RR 0.83, 95% CI: 0.56–1.24; P = 0.36; I2 = 88%) compared to Warfarin.Conclusions: In this update, DOACs remained with similar efficacy and safety compared to warfarin in thromboprophylaxis for AF and VHD.


Heart ◽  
2019 ◽  
Vol 105 (18) ◽  
pp. 1432-1436 ◽  
Author(s):  
Aaqib H Malik ◽  
Srikanth Yandrapalli ◽  
Wilbert S Aronow ◽  
Julio A Panza ◽  
Howard A Cooper

ObjectiveCurrent guidelines endorse the use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). However, little is known about their safety and efficacy in valvular heart disease (VHD). Similarly, there is a paucity of data regarding NOACs use in patients with a bioprosthetic heart valve (BPHV). We, therefore, performed a network meta-analysis in the subgroups of VHD and meta-analysis in patients with a BPHV.MethodsPubMed, Cochrane and Embase were searched for randomised controlled trials. Summary effects were estimated by the random-effects model. The outcomes of interest were a stroke or systemic embolisation (SSE), myocardial infarction (MI), all-cause mortality, major adverse cardiac events, major bleeding and intracranial haemorrhage (ICH).ResultsIn patients with VHD, rivaroxaban was associated with more ICH and major bleeding than other NOACs, while edoxaban 30 mg was associated with least major bleeding. Data combining all NOACs showed a significant reduction in SSE, MI and ICH (0.70, [0.57 to 0.85; p<0.001]; 0.70 [0.50 to 0.99; p<0.002]; and 0.46 [0.24 to 0.86; p<0.01], respectively). Analysis of 280 patients with AF and a BPHV showed similar outcomes with NOACs and warfarin.ConclusionsNOACs performed better than warfarin for a reduction in SSE, MI and ICH in patients with VHD. Individually NOACs performed similarly to each other except for an increased risk of ICH and major bleeding with rivaroxaban and a reduced risk of major bleeding with edoxaban 30 mg. In patients with a BPHV, results with NOACs seem similar to those with warfarin and this needs to be further explored in larger studies.


2021 ◽  
Author(s):  
Nischit Baral ◽  
Anjan Katel ◽  
Govinda Adhikari ◽  
Mahin R Khan ◽  
Hafiz M. W. Khan ◽  
...  

Objectives: While the use of novel oral anticoagulants (NOACs) has been approved in the treatment of non-valvular atrial fibrillation (NVAF), we are lacking studies on individual NOACs in NVAF with valvular heart disease (VHD) including bio-prosthetic valve and valve repair. We aimed to determine the efficacy and safety of rivaroxaban compared to warfarin in prevention of thromboembolism in patients with NVAF with VHD. Methods: We searched PubMed, MEDLINE, and EMBASE including only RCTs and Cohort studies from inception till April 2021. Eligible studies compared rivaroxaban with warfarin in patients with NVAF with VHD. We excluded patients with valvular AF. We used Review Manager (version 5.4, Cochrane Collaboration, Oxford, UK) applying the Mantel-Haenszel test and followed PRISMA guidelines. Risk ratio (RR) and 95% confidence intervals (CIs) were estimated using a random-effects method and heterogeneity using I squared test. Results: We had total of 23136 participants in both groups. Our results showed stroke and systemic thromboembolism in 88 of 4258 (2.06%) patients in the rivaroxaban group compared to 351 of 18878 (1.85%) patients in the warfarin group (RR 0.76; 95% CI, 0.55, 1.06; heterogeneity I2 = 35%, P = 0.10), major bleeding in 247 of 4258 (5.8%) patients in the rivaroxaban group compared to 270 of 18879 (1.4%) patients in the warfarin group (HR 1.68; 95% CI, 0.59, 4.77; heterogeneity I2 = 97%) and intracranial hemorrhage in 24 out of 2583 (0.9%) patients in the rivaroxaban group compared to 35 of 2160 (1.6%) in warfarin group (HR 0.49; 95% CI, 0.16, 1.56; heterogeneity I2 = 70%). Conclusions: Our results show that rivaroxaban is comparable to warfarin in prevention of stroke and systemic thromboembolism in patients with NVAF with VHD. Rivaroxaban is also comparable to warfarin in bleeding risks in these patients.


2021 ◽  
Vol 8 ◽  
Author(s):  
Januar Wibawa Martha ◽  
Raymond Pranata ◽  
Wilson Matthew Raffaelo ◽  
Arief Wibowo ◽  
Mohammad Rizki Akbar

Purpose: There is uncertainty as to which anticoagulant should be used in non-valvular atrial fibrillation (AF) with valvular heart disease. This systematic review and meta-analysis aimed to assess the efficacy and safety of direct-acting oral anticoagulants (DOACs) compared with warfarin in patients with non-valvular AF with valvular heart disease.Methods: We performed a comprehensive literature search using PubMed, Scopus, Embase, and Clinicaltrials.gov from the inception of databases up until August 2, 2021, and the search was updated and finalized on October 17, 2021. The intervention group was DOACs and the control group was warfarin. The primary outcome was systemic embolism and stroke (SSE), and the secondary outcome was major bleeding and intracranial hemorrhage. The pooled effect estimate was reported as the hazard ratio (HR) and odds ratio (OR).Results: There were 21,185 patients from seven studies included in this systematic review and meta-analysis. Stroke and systemic embolism were lower in patients receiving DOACs [HR 0.76 (95% CI 0.67, 0.87), p &lt; 0.001; I2: 5%] compared with warfarin. The subgroup analysis on RCTs showed the significant reduction of SSE in the DOACs group [HR 0.73 (95% CI 0.60, 0.89), p = 0.002; I2: 16%]. There was no significant difference in terms of major bleeding [HR 0.89 (95% CI 0.75, 1.05), p = 0.18; I2: 69%]. Intracranial hemorrhage [HR 0.42 (95% CI 0.22, 0.80), p = 0.008; I2: 73%] were lower in the DOAC group.Conclusion: This meta-analysis indicates that DOACs were associated with a lower risk of SSE and intracranial hemorrhage compared with patients receiving warfarin. There was no significant difference between the two groups in terms of major bleeding.


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