[Show abstract][Hide abstract] ABSTRACT: Limited data exist on the feasibility of providing outpatient care to patients with acute pulmonary embolism (PE).
We conducted a multicenter randomized clinical trial in acute symptomatic PE to compare the efficacy and safety of early discharge versus standard hospitalization. A clinical prediction rule was used to identify low-risk patients. All patients were followed for three months. The primary outcomes were venous thromboembolic recurrences, major and minor bleeding, and overall mortality.
One hundred and thirty two low-risk patients with acute symptomatic PE were randomized to early discharge (n=72) or standard hospitalization (n=60). Overall mortality was 4.2% (95% CI, 0.5-8.9) in the early discharge group and 8.3% (95% CI, 1.1-15) in the standard hospitalization group (Relative Risk (RR) 0.5; 95% confidence interval [CI], 0.12-2.01). Non-fatal recurrences were 2.8% (95% CI, 1.1-6.6) in the early discharge group and 3.3% (95% CI, 1.3-8%) in the standard hospitalization group (RR 0.8; 95% CI, 0.12-5.74). The rates of clinically relevant bleeding were 5.5% in the early discharge group and 5% in the standard hospitalization group (P=0.60). Short-term mortality was 2.8% (95% CI, 0.8-9.6%) in the early discharge group as compared with 0% in the standard hospitalization group. Based on the rate of short-term death in a carefully selected population, the study was suspended.
In spite of the number of complications in patients with acute symptomatic PE randomized to standard hospitalization or early discharge did not differ significantly. The rate of short-term mortality was unexpectedly high in a (a priori) low-risk group of patients with acute PE. The accuracy of clinical prediction scores needs to be validated in well designed clinical trials. (ClinicalTrials.gov number, NCT00214929.).
Thrombosis Research 10/2009; 126(1):e1-5. DOI:10.1016/j.thromres.2009.09.026 · 2.43 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Deep vein thrombosis (DVT) occurs when a blood clot blocks blood flow through a vein. This can happen after surgery, trauma, or when a person has been immobile. Clots can dislodge and block blood flow to the lungs, causing death. Heparin is a blood-thinning drug used in the first 3-5 days of DVT treatment. Low molecular weight heparins (LMWH) allow people with DVT to receive their initial treatment at home instead of in hospital.
To collate randomised controlled trials (RCTs) comparing home (LMWH) versus hospital (LMWH or UH) treatment for DVT, and to compare the safety, efficacy, acceptability and cost implications of home versus hospital treatment.
We searched the Cochrane Peripheral Vascular Diseases Group trials register (inception to May 2007) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (last searched Issue 2, 2007) which includes searches of MEDLINE (January 1966 onwards) and EMBASE (January 1980 onwards). We also handsearched non-listed journals and contacted researchers in the field.
RCTs of home versus hospital treatment for DVT in which DVT was clinically confirmed and treated with either LMWH or UH.
One reviewer selected the material for inclusion and another reviewed the literature and selection of trials. Two reviewers independently extracted data. Outcomes included PE, recurrent DVT, gangrene, heparin complications, and death.
Six RCTs involving 1708 participants with comparable treatment arms were included. All six had fundamental problems including high exclusion rates, partial hospital treatment of many in the LMWH arms, and comparison of UH in hospital with LMWH at home. The trials showed that patients treated at home with LMWH are less likely to have recurrence of venous thromboembolism (VTE) compared to hospital treatment with UH or LMWH (fixed effect relative risk (FE RR) 0.61; 95% confidence interval (CI) 0.42 to 0.90). Home treated patients also had lower mortality (FE RR 0.72; 95% CI 0.45 to 1.15) and fewer major bleeding (FE RR 0.67; 95% CI 0.33 to 1.36), but were more likely to have minor bleeding than those in hospital (FE RR 1.29; 95% CI 0.94 to 1.78) though these were not statistically significant.
The limited evidence suggests that home management is cost effective and preferred by patients. Further large trials comparing these treatments are unlikely to occur. Therefore, home treatment is likely to become the norm; further research will be directed to resolving practical issues.
[Show abstract][Hide abstract] ABSTRACT: The published literature regarding the safety of outpatient treatment of symptomatic pulmonary embolism (PE) was systematically summarised. A literature search was performed using the PubMed and EMBASE databases. Studies in which patients had symptomatic PE and the antithrombotic treatment was administered completely at home or the patients were discharged early were selected. A scoring system was used to divide studies into three quality categories. Short- and long-term outcomes were extracted: all-cause mortality, death from PE or from major haemorrhage, recurrent venous thromboembolism, and major bleeding. Eleven observational studies were included. No randomised controlled studies were identified. No study fulfilled the criteria for high quality. A total of 928 patients with symptomatic PE were treated completely as outpatients or discharged early; haemodynamic instability and hypoxia were the main exclusion criteria. No patient died during the first 7 days of antithrombotic treatment. Outpatient treatment of symptomatic PE is not based on high-quality evidence. Although the published data suggest that certain subgroups of haemodynamically and respiratorily stable patients may be safely treated at home when a well-defined management programme is applied, further studies are warranted for a short-term prognostic risk stratification of this PE subgroup.
European Respiratory Journal 06/2009; 33(5):1148-55. DOI:10.1183/09031936.00133608 · 7.13 Impact Factor
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