Abstract
Background. New oral anticoagulants (NOAC; rivaroxaban, dabigatran, apixaban) have become available as an alternative to warfarin anticoagulation in non-valvular atrial fibrillation (NVAF). Methods. MEDLINE and CENTRAL, regulatory agencies websites, clinical trials registers and conference proceedings were searched to identify randomised controlled trials of NOAC versus warfarin in NVAF. Two investigators reviewed all studies and extracted data on patient and study characteristics along with cardiovascular outcomes. Relative risks (RR) and 95% confidence intervals (CI) were estimated using a random effect meta-analysis. Results. Three clinical trials in 50,578 patients were included. The risk of non-hemorrhagic stroke and systemic embolic events (SEE) was similar with the NOAC and warfarin (RR = 0.93; 95% CI = 0.83–1.04), while the risk of intracranial bleeding (ICB) with the NOAC was lower than with warfarin (RR = 0.46; 95% CI = 0.33–0.65). We found differences in the effect size on all strokes and SEE depending on geographic region as well as on non-hemorrhagic stroke, SEE, bleeding and mortality depending on time in therapeutic range. Conclusion. The NOAC seem no more effective than warfarin for prevention of nonhemorrhagic stroke and SEE in the overall NVAF population, but are generally associated with a lower risk of ICB than warfarin.
Highlights
Atrial fibrillation (AF) represents the most common sustained cardiac arrhythmia, affecting more than 6 million people in Europe [1, 2]
We found differences in the effect size on all strokes and systemic embolic events (SEE) depending on geographic region as well as on non-hemorrhagic stroke, SEE, bleeding and mortality depending on time in therapeutic range
To maximize the real-world applicability of our results to relevant subgroups, we considered randomised phase III controlled trials with available subgroup analyses comparing any of the approved New oral anticoagulants (NOAC) with warfarin for prevention of stroke and SEE in patients with non-valvular atrial fibrillation (NVAF)
Summary
Atrial fibrillation (AF) represents the most common sustained cardiac arrhythmia, affecting more than 6 million people in Europe [1, 2]. Unlike VKA, these new compounds exhibit a predictable dose response and do not require routine coagulation monitoring, but their anticoagulant effect declines quickly in case of Thrombosis poor compliance, and not coagulation monitoring tests or specific antidotes are currently available [4]. Among other indications, these new compounds have been tested for prophylaxis of stroke and systemic embolic events (SEE) in patients with nonvalvular atrial fibrillation (NVAF) using a combined primary outcome of all strokes (nonhemorrhagic and haemorrhagic) and SEE. The NOAC seem no more effective than warfarin for prevention of nonhemorrhagic stroke and SEE in the overall NVAF population, but are generally associated with a lower risk of ICB than warfarin
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