The quality of evidence is downgraded by inconsistency (unexplained variability in results) and by imprecise results (wide confidence intervals).
A Cochrane review [Abstract] 1 included 3 studies with a total of 5 498 subjects with heart failure (HF). One RCT compared warfarin, aspirin or no antithrombotic therapy, the second compared warfarin with placebo in patients with idiopathic dilated cardiomyopathy, and the third compared rivaroxaban with placebo in participants with HF and coronary artery disease.
The pooled analysis comparing warfarin with placebo or no treatment did not show a statistically significant difference in all-cause death (OR 0.66, 95% CI 0.38 to 1.18, statistical heterogeneity I2 =82%; 2 studies, n=324). Major bleeding was observed more often in the group treated with warfarin compared to control (OR 5.98, 95% CI 1.71 to 20.93; 2 studies, n=324; number needed to treat for an additional harmful outcome, NNTH=17). None of the studies reported stroke as an individual outcome.
No difference was observed in all-cause death between rivaroxaban and placebo (OR 0.99, 95% CI 0.87 to 1.13; 1 study, n=5 022). Rivaroxaban reduced the risk of stroke compared to placebo (OR 0.67, 95% CI 0.47 to 0.95; 1 study, n=5 022; number needed to treat for an additional beneficial outcome, NNTB=101), and increased the risk of major bleeding events (OR 1.65, 95% CI 1.17 to 2.33; 1 study, n=5 008; NNTH=79).
Although oral anticoagulation is indicated in certain groups of patients with heart failure (for example atrial fibrillation), the present data does not support its routine use in heart failure patients who remain in sinus rhythm.
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