Shannon M. Bates, MD; Gordon H. Guyatt, MD
In low-risk patients with acute, symptomatic pulmonary embolism (PE), is outpatient treatment noninferior to inpatient treatment for preventing recurrent venous thromboembolism (VTE), major bleeding, and mortality?
Randomized, controlled, noninferiority trial (Outpatient Treatment of Pulmonary Embolism [OPTE]). ClinicalTrials.gov NCT00425542.
Blinded (outcome adjudicators).*
14 and 90 days.
19 emergency departments (EDs) in Switzerland, France, Belgium, and the USA.
344 patients ≥ 18 years of age (mean age 48 y, 50% men based on 339 patients) who had acute, symptomatic, objectively verified PE and were at low risk for death. Exclusion criteria included hypoxemia; hypotension; pain requiring parenteral opioids; high risk for bleeding; severe renal failure; extreme obesity; history of heparin-induced thrombocytopenia or allergy to heparins; therapeutic oral anticoagulation at PE diagnosis; and pregnancy.
Outpatient (n = 172) or inpatient care (n = 172). Outpatient care comprised standardized training by a study nurse on self-injection of subcutaneous enoxaparin, 1 mg/kg twice daily, and discharge from the ED ≤ 24 hours after randomization. Patients assigned to inpatient care were hospitalized and given the same enoxaparin regimen. Oral anticoagulation with vitamin K antagonists was recommended for ≥ 90 days.
Recurrent, symptomatic, objectively confirmed VTE (recurrent PE or new or recurrent deep venous thrombosis [DVT]) within 90 days. Secondary outcomes included major bleeding and all-cause mortality at 14 and 90 days.
Outpatient treatment was noninferior to inpatient treatment for recurrent VTE and all-cause mortality at 90 days, but not for major bleeding at 90 days (Table). At 14 days, outpatient treatment was noninferior to inpatient care for all outcomes.
In low-risk patients with acute, symptomatic pulmonary embolism, outpatient treatment was noninferior to inpatient treatment for recurrent venous thromboembolism and mortality at 90 days.
†Criterion for noninferiority: upper limit of the 95% CI for difference between groups < 4.0%.
‡1-sided exact P value for noninferiority.
§VTE = venous thromboembolism (recurrent PE or new or recurrent deep venous thrombosis).
Bates SM, Guyatt GH. Outpatient treatment was noninferior to inpatient treatment for preventing recurrent VTE in low-risk patients with acute PE. Ann Intern Med. 2011;155:JC4–2. doi: 10.7326/0003-4819-155-8-201110180-02002
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Published: Ann Intern Med. 2011;155(8):JC4-2.
Hospital Medicine, Pulmonary Embolism, Pulmonary/Critical Care, Venous Thromboembolism.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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