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Vol. 31. Issue 3.
Pages 263-264 (March 2012)
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Vol. 31. Issue 3.
Pages 263-264 (March 2012)
Recommended article of the month
DOI: 10.1016/j.repce.2012.02.002
Open Access
Comment on “Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial”
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Daniel Ferreira
Member of the Editorial Board of the Revista Portuguesa de Cardiologia
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Abstract
Background

Although practice guidelines recommend out-patient care for selected, haemodynamically stable patients with pulmonary embolism, most treatment is presently inpa-tient based. We aimed to assess non-inferiority of outpatient care compared with inpatient care.

Methods

We undertook an open-label, randomised non-inferiority trial at 19 emergency departments in Switzerland, France, Belgium, and the USA. We ran-domly assigned patients with acute, symptomatic pulmonary embolism and a low risk of death (pulmonary embolism severity index risk classes I or II) with a computer-generated randomisation sequence (blocks of 2-4) in a 1:1 ratio to initial outpatient (ie, discharged from hospital ≤24h after randomisation) or inpatient treatment with subcuta-neous enoxaparin (≥5 days) followed by oral anticoagulation (≥90 days). The primary outcome was symptomatic, recur-rent venous thromboembolism within 90 days; safety outcomes included major bleeding within 14 or 90 days and mortality within 90 days. We used a non-inferiority margin of 4% for a difference between inpatient and outpatient groups. We included all enrolled patients in the primary analysis, excluding those lost to follow-up. This trial is reg-istered with ClinicalTrials.gov, number NCT00425542.

Findings

Between February, 2007, and June, 2010, we enrolled 344 eligible patients. In the primary analysis, one (0.6%) of 171 outpatients developed recurrent venous thromboembolism within 90 days compared with none of 168 inpatients (95% upper confidence limit [UCL] 2.7%; p=0.011). Only one (0.6%) patient in each treatment group died within 90 days (95% UCL 2.1%; p=0.005), and two (1.2%) of 171 outpatients and no inpatients had major bleeding within 14 days (95% UCL 3.6%; p=0.031). By 90 days, three (1.8%) outpatients but no inpatients had developed major bleeding (95% UCL 4.5%; p=0.086). Mean length of stay was 0.5 days (SD 1.0) for outpatients and 3.9 days (SD 3.1) for inpatients.

Interpretation

In selected low-risk patients with pul-monary embolism, outpatient care can safely and effectively be used in place of inpatient care.

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References
[1]
A. Torbicki, A. Perrier, S. Konstantinides, et al.
Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC).
European Heart Journal, 29 (2008), pp. 2276-2315
[2]
J. Donzé, G. Le Gal, M.J. Fine, P.-M. Roy, O. Sanchez, F. Verschuren, et al.
Prospective validation of the Pulmonary Embolism Severity Index. A clinical prognostic model for pulmonary embolism.
Thrombosis and haemostasis, 100 (2008), pp. 943-948
[3]
L. Moores, D. Aujesky, D. Jiménez, et al.
Pulmonary Embolism Severity Index and troponin testing for the selection of low-risk patients with acute symptomatic pulmonary embolism.
Journal of Thrombosis and Haemostasis, 8 (2010), pp. 517-522
[4]
A. Squizzato, M. Galli, F. Dentali, et al.
Outpatient treatment and early discharge of symptomatic pulmonary embolism: a systematic review.
The European Respiratory Journal, 33 (2009), pp. 1148-1155
[5]
M. Janjua, A. Badshah, F. Matta, et al.
Treatment of acute pulmonary embolism as outpatients or following early discharge. A systematic review.
Thrombosis and haemostasis, 100 (2008), pp. 756-761
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D. Aujesky, P.-M. Roy, F. Verschuren, et al.
Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial.
Copyright © 2012. Sociedade Portuguesa de Cardiologia
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