Key result
In real-world settings, NOACs were generally superior to VKAs for stroke prevention in atrial fibrillation, with rivaroxaban reducing the risk of ischemic stroke or systemic embolism (NNT 107).
Why the study?
To evaluate the clinical efficacy and safety of NOACs compared to VKAs in stroke prevention for patients with AF by calculating the number needed to treat at 2 years using real-world evidence.
Do NOACs reduce ischaemic stroke, systemic embolism, and mortality compared to VKAs in patients with non-valvular atrial fibrillation?
Meta-Analysis
Do NOACs reduce ischaemic stroke, systemic embolism, and mortality compared to VKAs in patients with non-valvular atrial fibrillation?
Real-world evidence confirms that NOACs are safe and effective alternatives to VKAs for stroke prevention in non-valvular atrial fibrillation, with favorable NNTs for mortality, stroke, and bleeding.
Real-world NNTs favor rivaroxaban and dabigatran over VKAs for multiple outcomes; leaves open whether associations require randomized confirmation before practice change.
Aims: Non-vitamin K antagonist oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) are used to prevent stroke in patients with atrial fibrillation (AF). This paper aimed to evaluate the clinical efficacy and safety of NOACs when compared to VKAs by calculating the number needed to treat (NNT) at 2 years using incidence rates and hazard ratios (HRs) derived from a meta-analysis of studies conducted in real-world settings.Materials and methods: HRs were sourced from a published systematic literature review and a meta-analysis of real-world evidence on the use of NOACs vs VKAs. Rivaroxaban, dabigatran, and apixaban vs VKAs were investigated. The efficacy outcomes included: a composite of ischaemic stroke and systemic embolism (IS/SE), ischaemic stroke (IS), and all-cause mortality. The safety analysis assessed major bleeding and intracranial haemorrhage (ICH).Results: Superiority of NOACs vs VKAs was observed in 10/15 comparisons. Treating patients with rivaroxaban and dabigatran was associated with a reduced risk of IS and all-cause mortality compared to VKAs, with one death prevented every 22 and 32 patients, respectively, and one IS prevented every 206 and 166 patients, respectively. Rivaroxaban was significantly associated with a reduced risk of IS/SE compared to VKA (NNT: 107). No significant differences were observed between apixaban and VKAs. Dabigatran and apixaban were associated with a reduced risk of major bleeding compared to VKA (NNT: 59 and 38, respectively). No significant difference was observed between rivaroxaban and VKAs regarding major bleeding. Rivaroxaban, dabigatran, and apixaban were significantly associated with a reduced risk of ICH (NNT: 205, 115, and 108, respectively).Limitations: Heterogeneity in definitions of major bleeding across studies.Conclusions: The NNT calculation, when approached and interpreted properly, is a practical measure of the effectiveness of a treatment. The calculation based on HRs showed that NOACs are safe and effective alternatives to VKAs in real life.
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Brière et al. (2019) conducted a meta-analysis in non-valvular atrial fibrillation. Non-vitamin K antagonist oral anticoagulants (NOACs) vs. Vitamin K antagonist oral anticoagulants (VKAs) was evaluated on ischaemic stroke and systemic embolism (IS/SE) (NNT 107). In real-world settings, NOACs were generally superior to VKAs for stroke prevention in atrial fibrillation, with rivaroxaban reducing the risk of ischemic stroke or systemic embolism (NNT 107).
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