Key result
New oral anticoagulants significantly reduced the odds of fatal bleeding by 35% compared to vitamin K antagonists in patients who experienced a major bleeding event (OR 0.65).
Why the study?
Do NOACs reduce the odds of fatal bleeding compared to VKAs in patients who suffer a major bleeding event?
Meta-Analysis (n=4,056)
Yes
Do NOACs reduce the odds of fatal bleeding compared to VKAs in patients who suffer a major bleeding event?
Odds Ratio: 0.65 (95% CI 0.52–0.81)
Absolute Event Rate: 7.6% vs 11.3%
p-value: p=0.0001
NOACs are associated with a lower overall risk of fatal bleeding compared to VKAs following a major bleed, which is primarily driven by a lower incidence of intracranial hemorrhage rather than improved outcomes for specific bleeding sites.
Supports NOAC preference to lower fatal bleeding risk in major events; reinforces meta-analytic evidence from trials.
BACKGROUND: The reversibility of new/novel oral anticoagulants (NOAC) is not well understood, whereas the reversal strategies for bleeding associated with vitamin k antagonists (VKA), such as warfarin, is well established. It is unknown whether outcomes are different between bleeds occurring with NOAC compared to VKA use. OBJECTIVES: This systematic review and meta-analysis of randomized controlled trials determines the relative odds of fatal bleeding given that a patient suffered a major bleed while on NOAC versus VKA therapy. SEARCH METHODS: Data on major and fatal bleeding events was sought from randomized controlled trials of NOAC agents compared to VKAs. MAIN RESULTS: 20 trials were included in the meta-analysis. From which, 4056 first-time, major bleeding events were reported and included in the primary analysis. The summary odds ratio for the conditional odds of fatal bleeding given that a major bleeding event occurred was 0.65 [0.52, 0.81] favoring the NOAC agents (p = 0.0001). The reduced odds of fatal bleeding with NOACs was not demonstrated after controlling for bleeding location. Given that an intracranial bleeding event occurred, the summary odds ratio for the conditional odds of fatal bleeding was 0.96 [0.70, 1.32]. For extracranial bleeding events, the summary odds ratio was also statistically insignificant at 0.945 [0.66, 1.35]. AUTHOR’S CONCLUSIONS: The odds ratio calculated in this meta-analysis showed a reduced odds of death in major bleeding associated with NOAC use. This risk reduction was due to a disproportionate amount of intracranial bleeding in the VKA arms. For any given bleeding site, there was no evidence of a significant difference in fatal outcomes from bleeds associated with NOAC versus VKA use. PROTOCOL REGISTRATION: Protocol registered on PROSPERO under CRD42014013294.
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Skaistis et al. (2015) conducted a meta-analysis in Major bleeding events during anticoagulation for atrial fibrillation or venous thromboembolism (n=4,056). New oral anticoagulants (NOACs) vs. Vitamin K antagonists (VKA) was evaluated on Fatal bleeding given that a major bleeding event occurred (OR 0.65, 95% CI 0.52, 0.81, p=0.0001). New oral anticoagulants significantly reduced the odds of fatal bleeding by 35% compared to vitamin K antagonists in patients who experienced a major bleeding event (OR 0.65).
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