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

Abstract

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.

Effectiveness, safety, and major adverse limb events in atrial fibrillation patients with concomitant diabetes mellitus treated with non-vitamin K antagonist oral anticoagulants

“…6 Department of Public Health, College of Medicine, Chang Gung University, No.259, Wenhua 1st Rd., Guishan Dist., Taoyuan City 33302, Taiwan. 7 Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. 8 Institute of Clinical Medicine, Cardiovascular Research Center, National Yang-Ming University, Taipei, Taiwan.…”

“…The efficacy and safety of NAOCs have been studied in AF patients in association with several difficult treatment scenarios including the elderly, chronic kidney disease, valvular heart disease, or history of intracranial hemorrhage [6][7][8]. Current international guidelines recommend the use of non-vitamin K antagonist oral anticoagulants (NOACs) as effective, safer and more convenient alternatives to warfarin among patients with non-valvular AF, including those with DM [9,10].…”

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

“…In many analysis, NOACs are considered as alternatives to VKAs in patients with BPV. 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.…”

“…Mechanical prosthetic valves are considered as more thrombogenic than biological prosthetic valves (BPV), hence the standard therapeutic option is long-term anticoagulation with VKAs as NOACs are currently not recommended in patients with MPV. 56 …”

Alternatives for Vitamin K Antagonists as Thromboprophylaxis for Mechanical Heart Valves and Mechanical Circulatory Support Devices: A Systematic Review

“…53 NOACs seem to have an improved safety profile with respect to bleeding risk. 54,55 Ideally, these favorable characteristics could be extended to patients after a MHV replacement or LVAD implantation.…”