Regular Article
Home treatment in pulmonary embolism

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Abstract

Background

Limited data exist on the feasibility of providing outpatient care to patients with acute pulmonary embolism (PE).

Methods

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.

Results

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.

Conclusions

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.)

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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