Elsevier

The Lancet

Volume 353, Issue 9162, 24 April 1999, Pages 1386-1389
The Lancet

Articles
Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER)*

https://doi.org/10.1016/S0140-6736(98)07534-5Get rights and content

Summary

Background

Pulmonary embolism (PE) remains poorly understood. Rates of clinical outcomes such as death and recurrence vary widely among trials. We therefore established the International Cooperative Pulmonary Embolism Registry (ICOPER), with the aim of identifying factors associated with death.

Methods

2454 consecutive eligible patients with acute PE were registered from 52 hospitals in seven countries in Europe and North America. The primary outcome measure was all-cause mortality at 3 months. The prognostic effect of baseline factors on survival was assessed with multivariate analyses.

Findings

2110 (86·0%) patients had PE proven by necropsy, high-probability lung scan, pulmonary angiography, or venous ultrasonography plus high clinical suspicion; ICOPER accepted without independent review diagnoses and interpretation of imaging provided by participating centres; 3-month follow-up was completed in 98·0% of patients. The overall crude mortality rate at 3 months was 17·4% (426 of 2454 deaths, including 52 patients lost to follow-up): 179 of 397 (45·1%) deaths were ascribed to PE and 70 of 397 (17·6%) to cancer, and no information on the cause of death was available for 29 patients. After exclusion of 61 patients in whom PE was first discovered at necropsy, the mortality rate at 3 months was 15·3% (365 of 2393 deaths). On multiple-regression modelling, age over 70 years (hazard ratio 1·6 [95% Cl 1·1–2·3]), cancer (2·3 [1·5–3–5]), congestive heart failure (2·4 [1·5–3·7]), chronic obstructive pulmonary disease (1·8 [1·2–2–7]), systolic arterial hypotension (2·9 [1·7–5·0]), tachypnoea (2·0 [1·2–3·2]), and right-ventricular hypokinesis on echocardiography (2·0 [1·3–2·9]) were identified as significant prognostic factors.

Interpretation

PE remains an important clinical problem with a high mortality rate, Data from ICOPER provide rates and highlight adverse prognostic categories that will help in planning of future trials of high-risk PE patients.

Introduction

Despite advances in diagnosis and therapy, pulmonary embolism (PE) remains poorly understood, with wide discrepancies in reported rates of mortality and recurrence.1, 2, 3, 4, 5 Therefore, we organised the International Cooperative Pulmonary Embolism Registry (ICOPER) and analysed prospective cohort data.

Section snippets

Patients

We registered 2454 consecutive eligible patients with PE at 52 hospitals in seven countries between January, 1995 and November, 1996. Countries in Europe reported to the coordinating centre in Bologna, and those in North America to the Boston coordinating centre.

Inclusion criteria were acute PE (with or without symptoms) diagnosed by the attending physician within 31 days of symptom onset, or major PE first discovered at necropsy. ICOPER accepted without independent review the diagnoses and

Results

Overall, 86·0% (2110) of ICOPER patients had PE proven by necropsy, high-probability lung scan, pulmonary angiogram, or venous ultrasound scan of the deep leg veins in the presence of high clinical suspicion. At the time of enrolment, 88·9% (2182) of patients were symptomatic and haemodynamically stable; 4·2% (103) were haemodynamically unstable; and 6·9% (169) were symptom-free. In 61 patients major PE was first discovered at necropsy. The mean age was 62·3 years (median 66; range 4 months to

Discussion

Despite modern methods for diagnosis and treatment, PE continues to have a high mortality rate at 3 months. 75% of the deaths occurred during the initial hospital admission for PE. These deaths are most probably due to recurrent PE, and the frequency might be lowered if more intensive anticoagulation was used.6 In ICOPER, thrombolytic-treated patients had an intracranial haemorrhage rate of 3·0%, which is somewhat higher than the rate of 1·9% in a previously reported overview of 312 patients

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*

Study organisation given at the end of paper

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