[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 · 2.45 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Deep vein thrombosis (DVT) occurs when a blood clot blocks blood flow through a vein, generally in the legs. This can happen after surgery, trauma, or when a person is immobile. Clots can dislodge and block blood flow to the lungs, which can be fatal. Heparin is a blood-thinning drug used to treat DVT during the first three to five days. Unfractionated heparin is administered intravenously in hospital with laboratory monitoring. New, low molecular weight heparins (LMWH) are given by subcutaneous injection once a day and can be given at home. Oral anticoagulants are then continued for three to six months. After recovery from the acute episode, people may develop post-thrombotic syndrome with leg swelling, varicose veins and ulceration. The review reports that home treatment with LMWH is more effective in preventing recurrence of venous clotting (thromboembolism) than hospital treatment with heparin or LMWH. Six randomized controlled trials involving 1708 patients with clinically confirmed DVT compared home (LMWH) versus hospital (heparin or LMWH in one trial) treatment. The trials showed that patients treated at home with LMWH had a lower recurrence of venous thromboembolism (RR 0.6, range 0.4 to 0.9) compared with hospital-treated patients. The review also showed trends for home treated patients to be less likely to have major bleeding and fewer deaths but they were more likely to have minor bleeding than people treated in hospital. Limited evidence suggests that home management is cost effective. Trials had limitations including high exclusion rates and designs that did not take into account short hospital stays for any of the people who were treated at home to allow fair comparison of heparin in hospital with LMWH at home.
[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 · 7.64 Impact Factor
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