What is the clinical evidence from this study?

Study design: Observational. Population: Acute symptomatic pulmonary embolism (n=5213). Intervention: Contemporary clinical management of acute pulmonary embolism. Primary outcome: In-hospital mortality.

February 9, 2023Thrombosis and Haemostasis39 citationsOpen Access

Contemporary Management and Clinical Course of Acute Pulmonary Embolism: The COPE Study

CBCecilia Becattini GAGiancarlo Agnelli AMAldo P. Maggioni

Key Result

In a contemporary cohort of patients with acute pulmonary embolism, overall in-hospital and 30-day mortalities were 3.4% and 4.8%, respectively, with mortality remaining high in intermediate and high-risk patients.

Study Design

Type

Observational (n=5,213)

Multicenter

Yes

Structured PICO

Population

5,213 adult patients with acute symptomatic pulmonary embolism in Italy, followed for 30 days to assess contemporary management and clinical outcomes.

Exposure

Contemporary clinical management including risk stratification and treatment (parenteral anticoagulants, direct oral anticoagulants, vitamin K antagonists, or reperfusion)

Outcome

In-hospital and 30-day deathhard clinical

Contemporary management of acute PE predominantly utilizes direct oral anticoagulants, but in-hospital mortality remains high for intermediate and high-risk patients.

Limitations

Observation period was limited to 30 days, so data on long-term clinical course are not available.
Patients with incidental pulmonary embolism were excluded from the study.
Timing of echocardiography or biomarker testing was left to the attending physicians.
The simplified Pulmonary Embolism Severity Index (sPESI) was only calculated at admission.

Abstract

Background New diagnosis, risk stratification, and treatment strategies became recently available for patients with acute pulmonary embolism (PE) leading to changes in clinical practice and potentially influencing short-term patients' outcomes. Research question The COntemporary management of PE (COPE) study is aimed at assessing the contemporary clinical management and outcomes in patients with acute symptomatic PE. Study Design and Methods Prospective, noninterventional, multicenter study. The co-primary study outcomes, in-hospital and 30-day death, were reported overall and by risk categories according to the European Society of Cardiology (ESC) and American Heart Association guidelines. Results Among 5,213 study patients, PE was confirmed by computed tomography in 96.3%. In-hospital, 289 patients underwent reperfusion (5.5%), 92.1% received parenteral anticoagulants; at discharge, 75.6% received direct oral anticoagulants and 6.7% vitamin K antagonists. In-hospital and 30-day mortalities were 3.4 and 4.8%, respectively. In-hospital death occurred in 20.3% high-risk patients (n = 177), in 4.0% intermediate-risk patients (n = 3,281), and in 0.5% low-risk patients (n = 1,702) according to ESC guidelines. Further stratification in intermediate-high and intermediate-low risk patients did not reach statistical significance, but intermediate-risk patients with sPESI > 0 alone had lower mortality compared to those with one or both among right ventricular dilation at echocardiography or increased troponin. Death or clinical deterioration occurred in 1.5, 5.0, and 9.4% of patients at low, intermediate-low, and intermediate-high risk for death according to ESC guidelines. Conclusion For the majority of patients with PE, contemporary initial management includes risk stratification and treatment with direct oral anticoagulants. In-hospital mortality remains high in intermediate and high-risk patients calling for and informing research focused on its reduction. Trial Registration number: NCT03631810.

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