ABSTRACT
BACKGROUND: Although practice guidelines recommend outpatient care for selected, haemodynamically stable patients with pulmonary embolism, most treatment is presently inpatient 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 randomly 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 ≤24 h after randomisation) or inpatient treatment with subcutaneous enoxaparin (≥5 days) followed by oral anticoagulation (≥90 days). The primary outcome was symptomatic, recurrent 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 registered 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 pulmonary embolism, outpatient care can safely and effectively be used in place of inpatient care. FUNDING: Swiss National Science Foundation, Programme Hospitalier de Recherche Clinique, and the US National Heart, Lung, and Blood Institute. Sanofi-Aventis provided free drug supply in the participating European centres.
Subject(s)
Ambulatory Care , Hospitalization , Pulmonary Embolism/drug therapy , Acute Disease , Administration, Oral , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Enoxaparin/administration & dosage , Enoxaparin/adverse effects , Female , Health Resources/statistics & numerical data , Hemorrhage/chemically induced , Humans , Injections, Subcutaneous , Length of Stay , Male , Middle Aged , Outcome Assessment, Health Care , Patient Readmission , Patient Satisfaction , Pulmonary Embolism/diagnosis , RecurrenceABSTRACT
OBJECTIVES: Predicting medical outcomes for pyelonephritis in women is difficult, leading to unnecessary hospitalization. Unlike other serious infectious diseases, high procalcitonin (PCT) level has never been associated with 28-d adverse medical outcomes in women with pyelonephritis. Therefore, we sought to determine the accuracy of PCT in discriminating between pyelonephritis with adverse medical outcome (PAMO) and pyelonephritis without adverse medical outcome (PWAMO). PATIENTS AND METHODS: Adult women with pyelonephritis presenting to the emergency department of a French tertiary care hospital were consecutively included. Those patients who developed adverse medical outcomes during a 28-d follow-up period were identified as having PAMO. Baseline characteristics and PCT level were compared between patients with PAMO and PWAMO. RESULTS: Eleven women (19.0%) had PAMO and 47 (81%) had PWAMO. The median PCT level was higher in PAMO compared with PWAMO 0.51 ng/ml (IQR: 0.04-3.8) and 0.08 ng/ml (IQR: 0.01-1.0), but this difference was not statistically significant (p=0.07). We failed to find a threshold value for PCT that discriminated between PAMO and PWAMO (ROC, AUC=0.67 [95%CI, 0.51-0.86]). All but one subject with PAMO had either a PCT level >0.1 ng/ml or an underlying genitourinary abnormality by radiographic testing. CONCLUSIONS: A single PCT level was a poor predictor of 28-d adverse medical outcomes in women with pyelonephritis treated in the emergency department. Prediction based on underlying genitourinary abnormality by radiographic testing in addition to the PCT level should be investigated in future studies.
