Regular ArticleHome treatment in pulmonary embolism
Introduction
Home treatment with subcutaneous low-molecular-weight-heparin (LMWH) is a safe and effective therapy for selected patients with acute deep vein thrombosis (DVT) [1], [2]. Treatment with LMWH is as safe and effective for inpatient management of acute PE as conventional treatment with unfractioned heparin (UFH) [3], [4]. Some professional organizations such as The British Thoracic Society recommend consideration of outpatient treatment for clinically stable patients with PE [5], [6]. Outpatient treatment in selected patients with PE would lead to substantial cost savings [7]. However, the safety of this approach has not been adequately evaluated, and caution should be exercised as PE is a potentially life-threatening disease.
Mortality rates in patients with objectively confirmed acute PE during the first 3 months of anticoagulation vary greatly from 1.4% to 17.4% [8], [9]. Differences among studies might be explained through variation in the study design and selection of patients. Thus, identification of patients at low risk for death and other adverse effects is mandatory for outpatient treatment of clinically stable patients with PE. Several prognostic tools have been used to risk stratify patients with acute PE, including clinical prediction rules [10], cardiac biomarkers [11], and imaging testing [12]. Clinical prediction rules that accurately classify patients with PE into increasing risk categories have been derived and validated [10], [13], [14]. However, before low-risk patients with PE based on these models can be treated as outpatients, the safety and clinical usefulness of this approach must be tested in a clinical trial.
We designed a multicenter prospective randomized trial to compare the efficacy and safety of an early discharge program with standard hospitalization for acute management of PE.
Section snippets
Study Organization
We conducted a randomized clinical trial to compare the efficacy and safety of home treatment with those of hospitalized therapy in patients with acute symptomatic pulmonary embolism.
The steering committee had final responsibility for the study design, protocol, statistical analysis, study oversight, verification of the data, and data analysis. The protocol was approved by the institutional review board at each of the participating centers. An independent data and safety monitoring board (DSMB)
Results
Between February 2005 and April 2007, a total of 1016 patients with acute symptomatic PE were screened and 132 were randomly assigned. A diagram of the enrolment of patients and randomization is shown in Fig. 1. No patients were lost to follow-up. Compared to patients who were included, excluded patients were significantly older, had more often a history of respiratory disease, cancer and immobilization. Chest pain, syncope, hypotension, and renal insufficiency at admission were more frequent
Discussion
There are two principal conclusions that follow from our results. First, the rate of mortality, nonfatal recurrences, and hemorrhagic complications in highly selected patients with acute symptomatic PE randomized to standard hospitalization or early discharge did not differ significantly. Second, the rate of short-term mortality was unexpectedly high in a (a priori) low-risk group of patients with acute PE.
Previous clinical trials have shown that outpatient treatment of patients with deep vein
Funding/support
Supported by grants from the Ministry of Health and Consumer Affairs, Instituto de Salud Carlos III (FIS: PI03/0192), and the Sociedad Española de Neumologia y Cirugía Torácica (SEPAR).
Conflict of interest statement
None of the authors have conflict of interests.
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