Meta-analysis of real-world evidence comparing non-vitamin K antagonist oral anticoagulants with vitamin K antagonists for the treatment of patients with non-valvular atrial fibrillation
Why the study?
Numerous real-world studies had compared NOACs with VKAs in non-valvular atrial fibrillation, motivating a meta-analysis to synthesize the available evidence.
Do NOACs reduce the risk of ischemic stroke and intracranial hemorrhage compared to VKAs in patients with non-valvular atrial fibrillation?
Population
Patients with non-valvular atrial fibrillation across real-world studies
Comparison
NOACs (rivaroxaban, dabigatran, and apixaban) vs VKAs
Design
Meta-analysis of non-randomized real-world studies
Authors
Discussion
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Implication
NOACs appear at least as effective and safe as VKAs in real-world NVAF; reinforces RCT findings in observational data but should not yet change practice.
Key Points
- To synthesize real-world observational evidence comparing non-vitamin K antagonist oral anticoagulants with vitamin K antagonists for effectiveness, safety, and persistence in non-valvular atrial fibrillation.
- Systematically searched literature through December 2016 for non-randomized studies comparing non-vitamin K antagonist oral anticoagulants with vitamin K antagonists in non-valvular atrial fibrillation.
- Identified 562 citations and evaluated real-world studies reporting effectiveness, safety, or persistence outcomes for rivaroxaban (n=49), dabigatran (n=79), and apixaban (n=18).
- Rivaroxaban was associated with significantly reduced risk of ischemic stroke (HR = 0.83, 95% CI = 0.75–0.93), intracranial haemorrhage (HR = 0.69, 95% CI = 0.52–0.90), and non-persistence (HR = 0.62, 95% CI = 0.60–0.65) versus vitamin K antagonists.
- Dabigatran was associated with significantly lower risk of ischemic stroke (HR = 0.80, 95% CI = 0.65–0.98) and intracranial haemorrhage (HR = 0.45, 95% CI = 0.36–0.58), but showed no difference in non-persistence (HR = 0.91, 95% CI = 0.53–1.55).
- Apixaban was associated with significantly reduced intracranial haemorrhage risk (HR = 0.41, 95% CI = 0.28–0.60) compared with vitamin K antagonists, with no significant differences in ischemic stroke (HR = 1.01, 95% CI = 0.87–1.17) or non-persistence (HR = 1.08, 95% CI = 0.81–1.45).
Structured PICO
Do NOACs reduce the risk of ischemic stroke and intracranial hemorrhage compared to VKAs in patients with non-valvular atrial fibrillation?
P
Population
Patients with non-valvular atrial fibrillation (NVAF) from non-randomized real-world studies (49 studies for rivaroxaban, 79 for dabigatran, 18 for apixaban).
I
Intervention
Non-vitamin K antagonist oral anticoagulants (NOACs) including rivaroxaban, dabigatran, and apixaban
C
Comparator
Vitamin K antagonists (VKAs)
O
Outcome
Effectiveness (ischemic stroke), safety (intracranial haemorrhage), and persistencehard clinical
This meta-analysis of real-world studies confirms that NOACs are as effective as VKAs for stroke prevention in NVAF while significantly reducing the risk of intracranial hemorrhage.
Cite This Study
Coleman et al. (2019) studied this question.