Chest
Volume 131, Issue 2, February 2007, Pages 517-523
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Original Research: Venous Thromboembolism
The Natural Course of Hemodynamically Stable Pulmonary Embolism: Clinical Outcome and Risk Factors in a Large Prospective Cohort Study

https://doi.org/10.1378/chest.05-2799Get rights and content

Abstract

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.

Design: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.

Section snippets

Study Design

Consecutive patients with PE confirmed by helical CT were included. They were derived from a large, prospective management study using a diagnostic algorithm that consisted of a clinical decision rule, a d-dimer test, and helical CT.6Outpatients as well as inpatients were eligible. Exclusion criteria of this management study were as follows: treatment with therapeutic doses of unfractionated or low-molecular-weight heparin for > 24 h; life expectancy < 3 months; pregnancy; geographic

Study Patients

Between November 2002 and September 2004, a total of 3,503 patients with clinically suspected PE were screened, of whom 197 patients (5.6%) were excluded because of predefined exclusion criteria or refused informed consent: > 24 h of low-molecular-weight heparin (n = 50), life expectancy < 3 months (n = 47), pregnancy (n = 26), geographic inaccessibility precluding follow-up (n = 20), and other reasons (n = 41). In addition, 13 patients refused informed consent.6In 674 patients (20%), PE was

Discussion

We evaluated the clinical outcome of a large prospective cohort of patients with symptomatic, confirmed PE and aimed to assess an accurate incidence of recurrent VTE, mortality, and hemorrhagic complications during 3 months of anticoagulant treatment (Table 5). Moreover, we aimed to identify risk factors for these events and to determine the time course within 3 months of the start of treatment.

There are two important conclusions to be drawn from our analysis. First, a recurrent thromboembolic

Appendix

Members of the writing group of the Christopher Study, in alphabetical order, are as follows: Arne van Belle, MD, Harry R. Büller, MD, Menno V. Huisman, MD, Peter M. Huisman, MD, Karin Kaasjager, MD, Pieter Willem Kamphuisen, MD, Mark Kramer, MD, Marieke J.H.A. Kruip, MD, Johanna M. Kwakkel-van Erp, MD, Frank W.G. Leebeek, MD, Mathilde Nijkeuter, MD, Martin H. Prins, MD, Maaike Söhne, MD, Lidwine W. Tick MD.

Acknowledgments

M. Nijkeuter and M.V. Huisman had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

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This study was supported in part by unrestricted grants from the participating hospitals.

None of the authors have any conflicts of interest to disclose.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

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