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Multicenter Study
. 2023 Jun;123(6):613-626.
doi: 10.1055/a-2031-3859. Epub 2023 Feb 9.

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

Affiliations
Multicenter Study

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

Cecilia Becattini et al. Thromb Haemost. 2023 Jun.

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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Conflict of interest statement

C.B. reports lecture fees and consultancies from Bayer, Bristol Myers Squibb, Pfizer, and Daiichi Sankyo; G.A. reports lecture fees and consultancies from Bayer, Bristol Myers Squibb, and Pfizer; A.P.M., D.L., and M.M.G. declare payments made to their institution from Daiichi Sankyo; F.D. reports lecture fees from Bayer, Bristol Myers Squibb, Pfizer, and Daiichi Sankyo; A.F., I.E., F.P., M.P.R., A.D.L., L.A.C., G.P., and S.C. reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Figures

Fig. 1
Fig. 1
Cause of death during the hospital stay and at 30 days
Fig. 2
Fig. 2
Kaplan–Meier curve for time to all-cause death: in the overall study population ( A ); by category of risk according to ESC guidelines 2014 ( B ); and with further categorization of intermediate-risk patients ( C ).

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Grants and funding

Funding The study was supported by an unrestricted grant from Daiichi Sankyo Europe and Daiichi Sankyo Italy.