Fast track — ArticlesOutpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial
Introduction
Outpatient treatment of symptomatic deep vein thrombosis with low-molecular-weight heparin is regarded as usual care.1, 2, 3 Despite practice guideline recommendations to extend outpatient care to selected, haemodynamically stable patients with pulmonary embolism, management of symptomatic pulmonary embolism is predominantly inpatient based.4, 5, 6
Previous studies of outpatient care after pulmonary embolism were restricted by small sample sizes,7, 8, 9, 10, 11, 12 retrospective designs,13, 14, 15 and the absence of a randomised control group for comparison with inpatient care.7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 One randomised trial that compared medical outcomes of patients with pulmonary embolism who were assigned to inpatient versus outpatient care was stopped prematurely because mortality was unacceptably high in both treatment groups.19 We designed the Outpatient Treatment of Pulmonary Embolism (OTPE) trial to compare the effectiveness, safety, and efficiency of outpatient versus inpatient care for low-risk patients with acute, symptomatic pulmonary embolism as established with a validated clinical prognostic model.20
Section snippets
Study design and participants
We undertook an open-label, randomised, non-inferiority clinical trial at 19 emergency departments in Switzerland, France, Belgium, and the USA. Consecutive adults aged 18 years of age or older with acute, symptomatic, and objectively verified pulmonary embolism who were at low risk of death based on the pulmonary embolism severity index (risk classes I or II; table 1) were eligible to participate.20 The pulmonary embolism severity index is a clinical prognostic model that was derived and
Results
Between February, 2007, and June, 2010, we randomly allocated 172 eligible patients to the outpatient group and 172 to the inpatient group (figure; table 2). One outpatient and two inpatients were lost to follow-up and two inpatients withdrew consent during follow-up; therefore, we included 171 outpatients and 168 inpatients in the primary analysis.
Time from presentation to the emergency department until randomisation was much the same for outpatients and inpatients (13·9 h vs 13·3 h; p=0·24).
Discussion
Our multicentre trial of low-risk patients with acute, symptomatic pulmonary embolism showed that outpatient treatment with low-molecular-weight heparin is not inferior to inpatient treatment in terms of effectiveness and safety. Our findings are consistent with previous non-randomised studies and systematic reviews showing that outpatient care of pulmonary embolism is associated with low rates of recurrent VTE (0–6·2%), major bleeding (0–2·3%), and death (0–5·0%; panel).8, 9, 11, 12, 13, 14, 15
References (43)
- et al.
Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians evidence-based clinical practice guidelines (8th edn)
Chest
(2008) - et al.
Outpatient treatment of pulmonary embolism is feasible and safe in a substantial proportion of patients
J Thromb Haemost
(2003) - et al.
Home therapy for deep vein thrombosis and pulmonary embolism in cancer patients
Ann Oncol
(2005) - et al.
Ambulatory management of pulmonary embolism: a pragmatic evaluation
J Thromb Haemost
(2010) - et al.
Safety of outpatient treatment in acute pulmonary embolism
J Thromb Haemost
(2010) - et al.
Out of hospital treatment of acute pulmonary embolism in patients with a low NT-proBNP level
J Thromb Haemost
(2010) - et al.
Home treatment in pulmonary embolism
Thromb Res
(2010) - et al.
Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients
J Thromb Haemost
(2005) - et al.
Out of hospital anticoagulant therapy in patients with acute pulmonary embolism is frequently practised but not perfect
Thromb Res
(2010) - et al.
A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis
N Engl J Med
(1996)