Home treatment in pulmonary embolism.
BACKGROUND
Limited data exist on the feasibility of providing outpatient care to patients with acute pulmonary embolism (PE).


METHODS
We conducted a multicenter randomized clinical trial in acute symptomatic PE to compare the efficacy and safety of early discharge versus standard hospitalization. A clinical prediction rule was used to identify low-risk patients. All patients were followed for three months. The primary outcomes were venous thromboembolic recurrences, major and minor bleeding, and overall mortality.


RESULTS
One hundred and thirty two low-risk patients with acute symptomatic PE were randomized to early discharge (n=72) or standard hospitalization (n=60). Overall mortality was 4.2% (95% CI, 0.5-8.9) in the early discharge group and 8.3% (95% CI, 1.1-15) in the standard hospitalization group (Relative Risk (RR) 0.5; 95% confidence interval [CI], 0.12-2.01). Non-fatal recurrences were 2.8% (95% CI, 1.1-6.6) in the early discharge group and 3.3% (95% CI, 1.3-8%) in the standard hospitalization group (RR 0.8; 95% CI, 0.12-5.74). The rates of clinically relevant bleeding were 5.5% in the early discharge group and 5% in the standard hospitalization group (P=0.60). Short-term mortality was 2.8% (95% CI, 0.8-9.6%) in the early discharge group as compared with 0% in the standard hospitalization group. Based on the rate of short-term death in a carefully selected population, the study was suspended.


CONCLUSIONS
In spite of the number of complications in patients with acute symptomatic PE randomized to standard hospitalization or early discharge did not differ significantly. The rate of short-term mortality was unexpectedly high in a (a priori) low-risk group of patients with acute PE. The accuracy of clinical prediction scores needs to be validated in well designed clinical trials. (ClinicalTrials.gov number, NCT00214929.).
Otero
Remedios
R
Service of Pneumology, Hospital Universitario Virgen del Rocío, Avda Manuel Siurot s/n, 41013 Seville, Spain. rotero@separ.es
Uresandi
Fernando
F
Jiménez
David
D
Cabezudo
Miguel Angel
MA
Oribe
Mikel
M
Nauffal
Dolores
D
Conget
Francisco
F
Rodríguez
Consolación
C
Cayuela
Aurelio
A
D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000150:complications; D006760:Hospitalization; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality*; D012008:Recurrence; D012306:Risk; D013923:Thromboembolism / Q000150:complications; D013997:Time Factors; D016896:Treatment Outcome