Safety and efficacy of non-vitamin K oral anticoagulants in non-valvular atrial fibrillation: a Bayesian meta-analysis approach

Verdecchia, Paolo; Angeli, Fabio; Bartolini, Claudia; Filippo, Valentina De; Aita, Adolfo; Giacomo, Letizia Di; Poltronieri, Cristina; Lip, Gregory Y.H.; Reboldi, Gianpaolo

doi:10.1517/14740338.2014.971009

Cited by 23 publications

(24 citation statements)

References 43 publications

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“…Sharma et al [ 26 ] performed a SR analysing patients aged 75 years or older and presented subgroup results for patients with AF. Six SRs performed a network meta-analysis (NMA) [ 40 , 42 , 43 , 46 , 67 , 68 ] and four showed subgroup results for each NOAC [ 26 , 32 , 43 , 69 ].…”

Section: Resultsmentioning

confidence: 99%

Effectiveness and safety of vitamin K antagonists and new anticoagulants in the prevention of thromboembolism in atrial fibrillation in older adults – a systematic review of reviews and the development of recommendations to reduce inappropriate prescribing

et al. 2017

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BackgroundOral anticoagulants are used for stroke prevention in patients with atrial fibrillation, the most common cardiac arrhythmia in older adults. The aim of our study was to identify the evidence on the risks and benefits of anticoagulant use among adults aged ≥65 years with atrial fibrillation and to develop recommendations to reduce inappropriate use with a primary focus on new oral anticoagulants.MethodsSystematic review (SR) with search in six databases (up to 12/2016). We included SRs/meta-analyses (MAs) with participants ≥65 years old with atrial fibrillation treated with oral anticoagulation. Two independent reviewers performed study selection, data extraction and quality appraisal. Recommendations were developed based on the evidence identified following a modified GRADE approach.ResultsThirty-eight SRs/MAs were included, drawing on evidence from 74 individual experimental studies. The mean age ranged from 68.2 to 73 years. Treatments investigated included vitamin K antagonists (VKA), new oral anticoagulants (NOACs), platelet aggregation inhibitors (PAI), placebo and no treatment. Comorbidities were reported in 23 SRs, but none reported on frailty status, cognitive status or polypharmacy. Sixteen SRs based on only 3–8 RCTs and thus conveying a significant overlap of studies evaluated the effectiveness of NOACs compared to warfarin. NOACs demonstrated at least equivalent ability to reduce stroke as VKA and a considerably lower risk (OR 0.37 to RR 0.50) of haemorrhagic stroke/intracranial bleeding. Seven SRs were identified comparing VKA to placebo. These revealed a substantial reduction in risk of stroke and mortality for VKA (RR 0.30–0.46)), outweighing an increased risk of bleeding (RR 1.04–3.63) associated with anticoagulation. Eight SRs evaluated the efficacy of VKA compared to PAI: overall, VKA were associated with a lower risk of stroke (OR 0.51–0.68)) and a comparable risk of major bleeding.ConclusionsAnticoagulation treatment using VKA in older people with atrial fibrillation appears beneficial in comparison to PAI and placebo. New oral anticoagulants appear to reduce haemorrhagic strokes and intracranial bleedings more effectively than VKAs and should be considered especially in patients with low TTR (time in therapeutic range)/labile INR (International Normalized Ratio). However, to determine if these results are applicable to all older people, further studies should provide information on frailty, significant impaired renal function, polypharmacy and cognitive status of the participants.Funded by the 7th framework programme of the European Union.

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Section: Resultsmentioning

confidence: 99%

Effectiveness and safety of vitamin K antagonists and new anticoagulants in the prevention of thromboembolism in atrial fibrillation in older adults – a systematic review of reviews and the development of recommendations to reduce inappropriate prescribing

et al. 2017

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“…A recent network meta-analysis published in 2018 compared different NOACs for their risk of ICH in patients with AF or venous thromboembolism (VTE), which drew a conclusion that dabigatran110 (SUCRA 0.83) ranked as the safest drug, but the NMA did not include the low dose edoxaban [27]. Another Bayesian meta-analysis published in 2015 also concluded that edoxaban30 was the safest drug with regard to preventing major bleeding, followed by dabigatran110 in patients with AF [28], which was closely consistent with our findings in patents with normal or mild renal function.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Non-Vitamin K Anticoagulants for Atrial Fibrillation in Relation to Different Renal Function Levels: A Network Meta-Analysis

Jin

Zhu

Wang

et al. 2020

Cardiovascular Therapeutics

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Background. We performed a network meta-analysis (NMA) comparing the efficacy (stroke or systemic embolism) and safety (major bleeding) among different non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) and renal impairment, with the aim of recommending the proper drug and the dose based on renal function. Methods. We searched PubMed, EMBASE, Web of Science, and Cochrane Library with the items “dabigatran, edoxaban, apixaban, rivaroxaban, warfarin, and atrial fibrillation” through August 2019. NMA was analyzed with R (version 3.5.1, R Foundation for Statistical Computing) with the packages gemtc recalling JAGS (version 4.3.0) for the efficacy and safety of each drug with regard to different levels of renal function. NetMetaXL (version 1.6.1) and winBUGS (version 1.4.3) were used to obtain the cumulative ranking curve (SUCRA) of each drug. Result. In patients with normal renal function, dabigatran150 was ranked as the most effective drug (SUCRA 0.90), followed by dabigatran110 (SUCRA 0.68), apixaban (SUCRA 0.66), and rivaroxaban (SUCRA 0.59). With regard to the safety for preventing major bleeding, there was high probability that edoxaban30 (SUCRA 0.99) ranked first, compared to dabigatran110 (SUCRA 0.78) and edoxaban60 (SUCRA 0.66). For patients with mild renal impairment, with respect to the most effective drug for preventing stroke or systemic embolism, edoxaban60 ranked first (SUCRA 0.98), in comparison with dabigatran150 (SUCRA 0.74) and apixaban (SUCRA 0.64). Possibility of ranking first for the safest drug was edoxaban30 (SUCRA 0.99), followed by dabigatran110 (SUCRA 0.70) and apixaban (SUCRA 0.69). In patients with moderate renal function, dabigatran150 (SUCRA 0.95) ranked as the most effective drug in comparison with apixaban (SUCRA 0.66). Dabigatran110 (SUCRA 0.53), rivaroxaban (SUCRA 0.51), and edoxaban60 (SUCRA 0.50) had the similar probability of ranking third. When referred to the safest drug, probability of ranking first for preventing major bleeding was edoxaban30 (SUCRA 0.98), followed by apixaban (SUCRA 0.85) and edoxaban60 (SUCRA 0.64). Conclusion. In patients with AF and renal impairment and for patients with normal renal function, dabigatran 110 mg (bid) might have a better effect on the clinical results. And it does not coincide with patients taking dabigatran 110 mg with dose reduction for other factors including aged ≥75 years, renal impairment (CrCL 30–50 mL/min), gastritis, esophagitis, or gastroesophageal reflux, receiving concomitant verapamil, and so on. For patients with mild renal impairment, apixaban 5 mg (bid) would be a better choice for preventing stroke or systemic embolism and major bleeding, while apixaban 5 mg (bid) and edoxaban 60 mg (qd) were recommended for patients with moderate renal impairment. However, considering the fact of no RCTs for the head-to-head comparison, caution should be exercised over selecting each of NOACs for patients.

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“…A prior Bayesian meta‐analysis by Verdecchia et al . published in 2015 used data from major trials in which DOACs were compared with warfarin for stroke prevention in NVAF (RE‐LY, ROCKET‐AF, ARISTOTLE and ENGAGE AF). They also ranked the anticoagulants and, as in our analysis, found that dabigatran 110 mg was the safest DOAC and rivaroxaban the least safe DOAC with regards to ICH.…”

Section: Discussionmentioning

confidence: 99%

A systematic review and Bayesian network meta‐analysis of risk of intracranial hemorrhage with direct oral anticoagulants

Wolfe

Khan

Nasir

et al. 2018

Journal of Thrombosis and Haemostasis

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Background The comparative risk of intracranial hemorrhage (ICH) among direct oral anticoagulants (DOACs) (dabigatran, rivaroxaban, apixaban and edoxaban) remains unclear. Objective To determine the difference in risk of ICH between DOACs Methods Seventeen randomized controlled trials (RCTs) were selected using PubMed/MEDLINE, EMBASE and CENTRAL (Inception, 31 December 2017). Estimates were reported as odds ratio (OR) with 95% credible interval (CR.I) in Bayesian network meta-analysis (NMA), and OR with 95% confidence interval (CI) in traditional meta-analyses. Relative ranking probability of each group was generated based on surface under the cumulative ranking curve (SUCRA). Results In NMA of 116 618 patients from 17 RCTs (apixaban = 19 495 patients, rivaroxaban = 14 157 patients, dabigatran = 16 074 patients, edoxaban = 11 652 patients, and comparator = 55 315 patients), all DOACs were safer than warfarin for risk of ICH. Dabigatran 110 mg ranked as the safest drug (SUCRA, 0.85) and reduced the risk of ICH by 56% compared to rivaroxaban (OR, 0.44; 95% Cr.I, 0.22-0.82). Pairwise meta-analysis validated these findings, showing that DOACs were safer than warfarin (OR, 0.46; 95% CI, 0.35-0.59). Subgroup analysis showed that the benefit was present when DOACs were used in non-valvular atrial fibrillation (NVAF) (OR, 0.51; 95% CI, 0.38-0.68) or venous thromboembolism (VTE) (OR, 0.32; 95% CI, 0.18-0.58). Conclusion Dabigatran 110 mg may be the safest choice among any anticoagulant regarding risk of ICH. Both dabigatran 110 mg and 150 mg were safer than rivaroxaban.

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Safety and efficacy of non-vitamin K oral anticoagulants in non-valvular atrial fibrillation: a Bayesian meta-analysis approach

Cited by 23 publications

References 43 publications

Effectiveness and safety of vitamin K antagonists and new anticoagulants in the prevention of thromboembolism in atrial fibrillation in older adults – a systematic review of reviews and the development of recommendations to reduce inappropriate prescribing

Effectiveness and safety of vitamin K antagonists and new anticoagulants in the prevention of thromboembolism in atrial fibrillation in older adults – a systematic review of reviews and the development of recommendations to reduce inappropriate prescribing

Efficacy and Safety of Non-Vitamin K Anticoagulants for Atrial Fibrillation in Relation to Different Renal Function Levels: A Network Meta-Analysis

A systematic review and Bayesian network meta‐analysis of risk of intracranial hemorrhage with direct oral anticoagulants

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