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CC BY-NC-ND 4.0 · Thromb Haemost 2023; 123(06): 613-626
DOI: 10.1055/a-2031-3859
Stroke, Systemic or Venous Thromboembolism

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

Cecilia Becattini
1   Internal, Vascular and Emergency Medicine—Stroke Unit, University of Perugia, Perugia, Italy
,
Giancarlo Agnelli
1   Internal, Vascular and Emergency Medicine—Stroke Unit, University of Perugia, Perugia, Italy
,
Aldo P. Maggioni
2   ANMCO Research Center, Heart Care Foundation, Florence, Italy
,
Francesco Dentali 
3   Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy
,
Andrea Fabbri
4   Emergency Department, “Presidio Ospedaliero Morgagni-Pierantoni,” Forlì, Italy
,
Iolanda Enea
5   U.O.C. Medicina e Chirurgia d'Urgenza, A.O.R.N. “S. Anna e S. Sebastiano,” Caserta, Italy
,
Fulvio Pomero
6   Division of Internal Medicine, Michele and Pietro Ferrero Hospital, Verduno, Italy
,
Maria Pia Ruggieri
7   U.O.C. Medicina d'Urgenza e Pronto Soccorso, AO San Giovanni Addolorata, Roma, Italy
,
Andrea di Lenarda
8   Cardiovascular Center, University Hospital and Health Services of Trieste, Italy
,
Ludovica Anna Cimini
1   Internal, Vascular and Emergency Medicine—Stroke Unit, University of Perugia, Perugia, Italy
,
Giuseppe Pepe
9   PS e Medicina d'Urgenza, Nuovo Ospedale Versilia, Lido di Camaiore, Italy
,
Susanna Cozzio
10   Medicina Interna, Ospedale S. Maria del Carmine, Rovereto, Italy
,
Donata Lucci
2   ANMCO Research Center, Heart Care Foundation, Florence, Italy
,
Michele M. Gulizia
2   ANMCO Research Center, Heart Care Foundation, Florence, Italy
11   Division of Cardiology, Garibaldi-Nesima Hospital, Catania, Italy
,
on behalf of COPE Investigators › Institutsangaben Funding The study was supported by an unrestricted grant from Daiichi Sankyo Europe and Daiichi Sankyo Italy.
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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.

Keywords

pulmonary embolism - venous thromboembolism - anticoagulant - thrombolysis

Authors' Contribution

C.B. and G.A. contributed substantially to study conception and design. C.B., D.L., A.P.M., M.M.G., and G.A. had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. D.L. contributed substantially to data analysis. All authors contributed to interpretation of the data, critical revision, and the writing of the manuscript.


* See Appendix (available in the online version) for the complete list of Centers and Investigators.


Prior abstract presentation : 2021 Congress of the American Society of Hematology.


Supplementary Material



Publikationsverlauf

Eingereicht: 17. Mai 2022

Angenommen: 17. Dezember 2022

Accepted Manuscript online:
09. Februar 2023

Artikel online veröffentlicht:
20. März 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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