The natural course of hemodynamically stable pulmonary embolism: Clinical outcome and risk factors in a large prospective cohort study.
BACKGROUND
Pulmonary embolism (PE) is a potentially fatal disease with risks of recurrent venous thrombotic events (venous thromboembolism [VTE]) and major bleeding from anticoagulant therapy. Identifying risk factors for recurrent VTE, bleeding, and mortality may guide clinical decision making.


OBJECTIVE
To evaluate the incidence of recurrent VTE, hemorrhagic complications, and mortality in patients with PE, and to identify risk factors and the time course of these events.


METHODS
We evaluated consecutive patients with PE derived from a prospective management study, who were followed for 3 months, treated with anticoagulants, and underwent objective diagnostic testing for suspected recurrent VTE or bleeding.


RESULTS
Of 673 patients with complete follow-up, 20 patients (3.0%; 95% confidence interval [CI], 1.8 to 4.6%) had recurrent VTE. Eleven of 14 patients with recurrent PE had a fatal PE (79%; 95% CI, 49 to 95%), occurring mostly in the first week after diagnosis of initial PE. In 23 patients (3.4%; 95% CI, 2.2 to 5.1%), a hemorrhagic complication occurred, 10 of which were major bleeds (1.5%; 95% CI, 0.7 to 2.7%), and 2 were fatal (0.3%; 95% CI, 0.04 to 1.1%). During the 3-month follow-up, 55 patients died (8.2%; 95% CI, 6.2 to 10.5%). Risk factors for recurrent VTE were immobilization for > 3 days and being an inpatient; having COPD or malignancies were risk factors for bleeding. Higher age, immobilization, malignancy, and being an inpatient were risk factors for mortality.


CONCLUSIONS
Recurrent VTE occurred in a small percentage of patients treated for an acute PE, and the majority of recurrent PEs were fatal. Immobilization, hospitalization, age, COPD, and malignancies were risk factors for recurrent VTE, bleeding, and mortality. Close monitoring may be indicated in these patients, precluding them from out-of-hospital start of treatment.
Nijkeuter
Mathilde
M
Vascular Unit, Department of General Internal Medicine and Endocrinology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, the Netherlands. M.Nijkeuter@lumc.nl
Söhne
Maaike
M
Tick
Lidwine W
LW
Kamphuisen
Pieter Willem
PW
Kramer
Mark H H
MH
Laterveer
Laurens
L
van Houten
Anja A
AA
Kruip
Marieke J H A
MJ
Leebeek
Frank W G
FW
Büller
Harry R
HR
Huisman
Menno V
MV
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects; D015331:Cohort Studies; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011655:Pulmonary Embolism / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology*; D012008:Recurrence; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors
D000925:Anticoagulants