Anticoagulation therapy in heart failure and sinus rhythm: a systematic review and meta-analysis
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Key result
Anticoagulation did not reduce all-cause mortality (RR 0.99) but reduced non-fatal stroke (RR 0.63) at the expense of increased major haemorrhage (RR 1.88) in patients with HFrEF in sinus rhythm.
Why the study?
Heart failure is a prothrombotic state, and it was hypothesized that thrombosis and embolism cause events in HFrEF, prompting evaluation of anticoagulant therapy in patients in sinus rhythm.
Does oral anticoagulation therapy reduce mortality and cardiovascular events in adult patients with HFrEF in sinus rhythm?
Comparison
Anticoagulant therapy vs antiplatelet therapy, placebo, or control
Design
Systematic review and meta-analysis
Authors
Discussion
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Implication
Does not support routine anticoagulation in HFrEF sinus rhythm due to bleeding without mortality benefit; confirms prior evidence against its use.
Key Points
- To determine the impact of anticoagulant therapy on major clinical outcomes in patients with heart failure and reduced ejection fraction who remain in normal sinus rhythm.
- Systematic review and meta-analysis of five randomized trials comparing anticoagulant therapy against antiplatelet therapy, placebo, or control.
- Evaluated primary and secondary endpoints including all-cause mortality, heart failure rehospitalization, non-fatal myocardial infarction, non-fatal stroke, and major hemorrhage.
- Anticoagulant therapy did not reduce all-cause mortality (RR 0.99, 95% CI 0.90 to 1.08), heart failure rehospitalization (RR 0.97, 95% CI 0.82 to 1.13), or non-fatal myocardial infarction (RR 0.92, 95% CI 0.75 to 1.13).
- Anticoagulation significantly decreased the incidence of non-fatal stroke (RR 0.63, 95% CI 0.49 to 0.81, p=0.001), but significantly increased major hemorrhage (RR 1.88, 95% CI 1.49 to 2.38, p=0.001).
Study Design
Type
Meta-Analysis (n=9,390)
Structured PICO
Does oral anticoagulation therapy reduce mortality and cardiovascular events in adult patients with HFrEF in sinus rhythm?
P
Population
Up to 9,390 adult patients with heart failure with reduced ejection fraction (HFrEF) in sinus rhythm, pooled from 5 RCTs. Excluded patients in hospital with acute heart failure or in the acute phase of recovery following a myocardial infarction.
I
Intervention
Oral anticoagulation therapy (warfarin or rivaroxaban) as a class
C
Comparator
Control therapy (oral antiplatelet therapy [aspirin or clopidogrel], placebo, or no therapy)
O
Outcome
Death from any causehard clinical
Main Result
Effect estimate: RR 0.99 (95% CI 0.90-1.08)
Absolute Event Rate: 946% vs 1076%
In patients with HFrEF in sinus rhythm, routine anticoagulation does not reduce mortality or heart failure hospitalization but reduces stroke at the cost of significantly increased major bleeding.
Limitations
- Patient-level data were not available, necessitating the use of summary statistics
- Differentiation between ischaemic or haemorrhagic stroke was not made consistently across studies
- Limited power to detect publication bias due to the small number of available studies
- Use of trial-level data rather than patient-level data
- Pooled effects of different types of anticoagulants (VKA and NOACs)
- Varying intensity of warfarin-induced anticoagulation across trials
- Differences between trials in patient inclusion/exclusion criteria and geographical location
- Inability to differentiate between ischaemic and haemorrhagic stroke consistently
Cite This Study
Beggs et al. (2019) conducted a meta-analysis in Heart failure with reduced ejection fraction (HFrEF) in sinus rhythm (n=9,390). Anticoagulation therapy vs. Antiplatelet therapy, placebo, or control was evaluated on All-cause mortality (RR 0.99, 95% CI 0.90-1.08). Anticoagulation did not reduce all-cause mortality (RR 0.99) but reduced non-fatal stroke (RR 0.63) at the expense of increased major haemorrhage (RR 1.88) in patients with HFrEF in sinus rhythm.
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