The Cochrane database of systematic reviews | 2021
Anticoagulation versus placebo for heart failure in sinus rhythm.
Abstract
BACKGROUND\nPeople with chronic heart failure (HF) are at risk of thromboembolic events, including stroke, pulmonary embolism, and peripheral arterial embolism; coronary ischaemic events also contribute to the progression of HF. The use of long-term oral anticoagulation is established in certain populations, including people with HF and atrial fibrillation (AF), but there is wide variation in the indications and use of oral anticoagulation in the broader HF population.\n\n\nOBJECTIVES\nTo determine whether long-term oral anticoagulation reduces total deaths and stroke in people with heart failure in sinus rhythm.\n\n\nSEARCH METHODS\nWe updated the searches in CENTRAL, MEDLINE, and Embase in March 2020.\xa0We screened reference lists of papers and abstracts from national and international cardiovascular meetings to identify unpublished studies. We contacted relevant authors to obtain further data. We did not apply any language restrictions.\n\n\nSELECTION CRITERIA\nRandomised controlled trials (RCT) comparing oral anticoagulants with placebo or no treatment in adults with HF, with treatment duration of at least one month.\xa0We made inclusion decisions in duplicate, and resolved any disagreements between review authors by discussion, or a third party.\n\n\nDATA COLLECTION AND ANALYSIS\nTwo review authors independently assessed trials for inclusion, and assessed the risks and benefits of antithrombotic therapy by calculating odds ratio (OR), accompanied by the 95% confidence intervals (CI).\n\n\nMAIN RESULTS\nWe identified three RCTs (5498 participants). One RCT compared warfarin, aspirin, and no antithrombotic therapy, the second compared warfarin with placebo in participants with idiopathic dilated cardiomyopathy, and the third compared rivaroxaban with placebo in participants with HF and coronary artery disease. We pooled data from the studies that compared warfarin with a placebo or no treatment. We are uncertain if there is an effect on\xa0all-cause death (OR 0.66, 95% CI 0.36 to 1.18; 2 studies, 324 participants; low-certainty evidence); warfarin may\xa0increase\xa0the risk of major bleeding events (OR 5.98, 95% CI 1.71 to 20.93, NNTH 17). 2 studies, 324 participants; low-certainty evidence). None of the studies reported stroke as an individual outcome. Rivaroxaban\xa0makes little to no difference to all-cause death compared with placebo (OR 0.99, 95% CI 0.87 to 1.13; 1 study, 5022 participants; high-certainty evidence). Rivaroxaban probably reduces the risk of stroke compared to placebo (OR\xa00.67, 95% CI\xa00.47 to 0.95; NNTB 101; 1 study, 5022 participants; moderate-certainty evidence), and probably increases the risk of major bleeding events (OR\xa01.65, 95% CI\xa01.17 to 2.33; NNTH 79; 1 study, 5008 participants; moderate-certainty evidence).\n\n\nAUTHORS CONCLUSIONS\nBased on the three RCTs, there is no\xa0evidence that oral anticoagulant therapy modifies mortality\xa0in people with HF in sinus rhythm. The evidence is uncertain if warfarin has any effect on all-cause death compared to placebo or no treatment, but it may increase the risk of major bleeding events.\xa0There is no evidence of a difference\xa0in the effect of\xa0rivaroxaban\xa0on all-cause death compared to placebo. It probably reduces\xa0the risk of stroke, but probably increases the risk of major bleedings. The available evidence does not support the routine use of anticoagulation in people with HF who remain in sinus rhythm.