Home versus in-patient treatment for deep vein thrombosis.

BACKGROUND: Deep vein thrombosis (DVT) occurs when a blood clot blocks blood flow through a vein, which can occur after surgery, after trauma, or when a person has been immobile for a long time. Clots can dislodge and block blood flow to the lungs (pulmonary embolism (PE)), causing death. DVT and PE are known by the term venous thromboembolism (VTE). Heparin (in the form of unfractionated heparin (UFH)) is a blood-thinning drug used during the first three to five days of DVT treatment. Low molecular weight heparins (LMWHs) allow people with DVT to receive their initial treatment at home instead of in hospital. This is an update of a review first published in 2001 and updated in 2007.

OBJECTIVES: To compare the incidence and complications of venous thromboembolism (VTE) in patients treated at home versus patients treated with standard in-patient hospital regimens. Secondary objectives included assessment of patient satisfaction and cost-effectiveness of treatment.

SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (last searched 16 March 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2), and trials registries. We also checked the reference lists of relevant publications.

SELECTION CRITERIA: Randomised controlled trials (RCTs) examining home versus hospital treatment for DVT, in which DVT was clinically confirmed and was treated with LMWHs or UFH.

DATA COLLECTION AND ANALYSIS: One review author selected material for inclusion, and another reviewed the selection of trials. Two review authors independently extracted data and assessed included studies for risk of bias. Primary outcomes included combined VTE events (PE and recurrent DVT), gangrene, heparin complications, and death. Secondary outcomes were patient satisfaction and cost implications. We performed meta-analysis using fixed-effect models with risk ratios (RRs) and 95% confidence intervals (CIs) for dichotomous data.

MAIN RESULTS: We included in this review seven RCTs involving 1839 randomised participants with comparable treatment arms. All seven had fundamental problems including high exclusion rates, partial hospital treatment of many in the home treatment arms, and comparison of UFH in hospital versus LMWH at home. These trials showed that patients treated at home with LMWH were less likely to have recurrence of VTE events than those given hospital treatment with UFH or LMWH (fixed-effect risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.86; 6 studies; 1708 participants; P = 0.007; low-quality evidence). No clear difference was seen between groups for major bleeding (RR 0.67, 95% CI 0.33 to 1.36; 6 studies; 1708 participants; P = 0.27; low-quality evidence), minor bleeding (RR 1.29, 95% CI 0.94 to 1.78; 6 studies; 1708 participants; P = 0.11; low-quality evidence), or mortality (RR 0.69, 95% CI 0.44 to 1.09; 6 studies; 1708 participants; P = 0.11; low-quality evidence). The included studies reported no cases of venous gangrene. We could not combine patient satisfaction and quality of life outcomes in meta-analysis owing to heterogeneity of reporting, but two of three studies found evidence that home treatment led to greater improvement in quality of life compared with in-patient treatment at some point during follow-up, and the third study reported that a large number of participants chose to switch from in-patient care to home-based care for social and personal reasons, suggesting it is the patient's preferred option (very low-quality evidence). None of the studies included in this review carried out a full cost-effectiveness analysis. However, a small randomised economic evaluation of the two alternative treatment settings involving 131 participants found that direct costs were higher for those in the in-patient group. These findings were supported by three other studies that reported on their costs (very low-quality evidence).Quality of evidence for data from meta-analyses was low to very low. This was due to risk of bias, as many of the included studies used unclear randomisation techniques, and blinding was a concern for many. Also, indirectness was a concern, as most studies included a large number of participants randomised to the home (LMWH) treatment group who were treated in hospital for some or all of the treatment period. A further issue for some outcomes was heterogeneity that was evident in measurement and reporting of outcomes.

AUTHORS' CONCLUSIONS: Low-quality evidence suggests that patients treated at home with LMWH are less likely to have recurrence of VTE than those treated in hospital. However, data show no clear differences in major or minor bleeding, nor in mortality (low-quality evidence), indicating that home treatment is no worse than in-patient treatment for these outcomes. Because most healthcare systems are moving towards more LMWH usage in the home setting it is unlikely that additional large trials will be undertaken to compare these treatments. Therefore, home treatment is likely to become the norm, and further research will be directed towards resolving practical issues by devising local guidelines that include clinical prediction rules, developing biomarkers and imaging that can be used to tailor therapy to disease severity, and providing training for community healthcare workers who administer treatment and monitor treatment progress.