Outpatient treatment can replace inpatient treatment in low-risk pulmonary embolism patients
Author：Yang Lixi Source：China Medical Tribune Date：2011-07-06
Deng Hong, Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine
A study by European and American scholars suggests that outpatient treatment can be a safe and effective alternative to inpatient treatment in patients with elective low-risk pulmonary embolism. The paper was published online in The Lancet on June 23, 2011.
The open-label, randomized, noninferiority trial was conducted within 19 emergency departments in Switzerland, France, Belgium, and the United States.
Patients with acute symptomatic pulmonary embolism at low risk of death (Pulmonary Embolism Severity Index risk class I or II, see link) were randomized in a 1:1 ratio to the outpatient or inpatient group and given subcutaneous low-molecular-weight heparin (≥5 days) followed by oral anticoagulant therapy (≥90 days).
The primary patient regression was symptomatic, recurrent venous thromboembolism within 90 days; safety regression included major bleeding within 14 or 90 days and mortality within 90 days. A 4% noninferiority cutoff was used to distinguish differences between the outpatient and inpatient groups.
The results showed that 344 appropriate patients were enrolled in the study from February 2007 to June 2010. Preliminary analysis showed that 1 of 171 outpatients (0.6%) developed recurrent venous thromboembolism within 90 days; none of the 168 inpatients developed recurrence (P=0.011).
Only 1 (0.6%) of patients in both groups died within 90 days (P=0.005); 2 (1.2%) of 171 outpatients had major bleeding within 14 days, and none of the inpatients had major bleeding (P=0.031).
At 90 days, three outpatients had major bleeding and none of the inpatients had major bleeding (P=0.086). The mean length of stay was 0.5 and 3.9 days for outpatients and inpatients, respectively.
■ Link
Pulmonary embolism severity index risk classification
Grade I: Pulmonary embolism severity index (table) score <66;
Grade II: Pulmonary embolism severity index score of 66 to 85
Grade III: pulmonary embolism severity index score of 86~105
Grade IV: pulmonary embolism severity index score of 106~125
Grade V: Pulmonary embolism severity index score >125
Expert comments
Pulmonary embolism outpatient treatment focuses on patient selection
Dr. Howard, Imperial University, UK
The feasibility of outpatient treatment for patients with deep vein thrombosis has been established in several randomized clinical trials. However, patients with pulmonary embolism have poorer short-term outcomes and higher mortality than patients with DVT, with in-hospital mortality of 1.1% even in low-risk patients.
The only other randomized trial comparing outpatient and inpatient treatment of low-risk pulmonary embolism was prematurely terminated by its Data and Safety Monitoring Board (DSMB) because of 2 deaths in the early discharge group of 132 patients. Notably, the non-validated risk score used in the above study confirmed that 55% of patients were suitable for outpatient treatment, whereas a recent study published in The Lancet identified only 30% of the initial population as potentially suitable for outpatient treatment. This suggests better patient selection in the latter and demonstrates the importance of patient selection in the outpatient management of pulmonary embolism. Although this study provides good proof of concept, prospective validation of outpatient pulmonary embolism treatment in a large sample is needed.
Treatment and Issues for Patients with Low-Risk Pulmonary Embolism
Liu Shuang, Department of Respiratory Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Pulmonary embolism (PE) is a fatal cardiopulmonary disease with a dangerous onset. In recent years, PE treatment, especially thrombolysis and anticoagulation, has been the focus of physicians’ attention at home and abroad.
Currently, risk stratification along with the diagnosis of PE can provide a better reference for disease assessment and treatment decision making. While patients diagnosed with acute pulmonary embolism have traditionally been hospitalized, the aforementioned study in The Lancet suggests outpatient treatment of low-risk pulmonary embolism.
However, there are some risks associated with outpatient treatment, especially in the current medical environment in China. First, patient risk stratification for acute pulmonary embolism is extremely important. Patients with an initial risk stratification of low risk may progress to intermediate to high risk during disease progression. We have followed up 90 low- and intermediate-risk acute pulmonary embolism patients hospitalized in 2010 for 30 days and found that 7 (7.8%) patients developed more serious complications. Therefore, it is recommended that for low- and intermediate-risk pulmonary embolism patients, clinicians perform myocardial markers (cTnI, NT-proBNP, and H-FABP), and combine them with clinical manifestations and dynamic observation by echocardiography to facilitate early disease assessment and short-term prognostic evaluation in patients with PE. Secondly, frequent monitoring of plasma prothrombin time (PT) and international normalized ratio (INR) compliance is required during initial warfarin anticoagulation therapy. Third, the number of cases enrolled in the study published in The Lancet was only 171, and more cases need to be accumulated and observed. With the application of new anticoagulants that do not require monitoring of PT and INR (such as rivaroxaban, apixaban and other factor Xa antagonists), outpatient treatment will be more convenient, and there will be good prospects for outpatient treatment of low-risk pulmonary embolism without considering the price of new anticoagulants
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