Key result
Oral anticoagulation reduced stroke risk compared to antiplatelets or placebo (OR 0.60; 95% CI 0.46-0.78; ARR 1.3%), but increased major bleeding risk (OR 1.92; 95% CI 1.51-2.45).
Why the study?
Previous meta-analyses on oral anticoagulation in heart failure patients with sinus rhythm had imprecise effect estimates, and new randomized trial data recently became available.
Does oral anticoagulation reduce stroke risk in patients with heart failure and sinus rhythm compared to antiplatelet or placebo?
Meta-Analysis (n=9,490)
Does oral anticoagulation reduce stroke risk in patients with heart failure and sinus rhythm compared to antiplatelet or placebo?
Odds Ratio: 0.6 (95% CI 0.46–0.78)
Absolute Risk Reduction: 1.3%
Number Needed to Treat: 77
In patients with heart failure and sinus rhythm, oral anticoagulation reduces stroke risk but is offset by a significant increase in major bleeding, with no mortality benefit.
Bleeding risk offsets stroke reduction without mortality benefit; argues against routine oral anticoagulation in heart failure with sinus rhythm and reinforces trial consensus.
BACKGROUND: Previous meta-analyses of randomized controlled trials of oral anticoagulation in patients with heart failure and sinus rhythm reported reduced stroke risk and increased bleeding risk compared to antiplatelets or placebo. However, the effect estimates may be subject to imprecision, as all included trials were prematurely terminated; stroke was not the primary outcome and overall results were primarily driven by a single trial. Recently, new trial data became available. AIM: To provide more accurate estimates of the effect of oral anticoagulation on stroke risk in heart failure patients with sinus rhythm by systematic review and meta-analysis of available randomized controlled trials including recently published evidence. METHODS: We searched PubMed and Scopus for full-text articles of randomized controlled trials of oral anticoagulation versus antiplatelet or placebo in heart failure patients with sinus rhythm published between inception and 28 August 2018. The outcomes assessed were any stroke, major bleeding, and death. RESULTS: In five trials (9490 patients; 21,067 patient-years), oral anticoagulation-treated patients had lower stroke risk (odds ratio (OR) 0.60, 95%CI: 0.46-0.78, absolute-risk-reduction: 1.3%, number-needed-to-treat: 77), higher major bleeding risk (OR: 1.92, 95%CI: 1.51-2.45, absolute-risk-increase: 2.0%, number-needed-to-harm: 50), and no significant difference in death rates (OR: 0.90, 95%CI: 0.73-1.11) compared to antiplatelets or placebo. CONCLUSIONS: In the largest meta-analysis to date, oral anticoagulation is associated with a considerable reduction of stroke risk, which is offset by a significant increase in major bleeding risk. For every 1000 patients treated with oral anticoagulation rather than antiplatelet or no antithrombotic treatment for 2.21 years, 13 strokes are prevented but 20 additional major hemorrhages occur, without significant difference in death rates.
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Ntaios et al. (2019) conducted a meta-analysis in heart failure and sinus rhythm (n=9,490). Oral anticoagulation vs. antiplatelet or placebo was evaluated on any stroke (OR 0.60, 95% CI 0.46-0.78). Oral anticoagulation reduced stroke risk compared to antiplatelets or placebo (OR 0.60; 95% CI 0.46-0.78; ARR 1.3%), but increased major bleeding risk (OR 1.92; 95% CI 1.51-2.45).
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