Contemporary clinical management of acute pulmonary embolism: the COPE study

Abstract

Background New management, risk stratification and treatment strategies have become available over the last years for patients with acute pulmonary embolism (PE), potentially leading to changes in clinical practice and improvement of patients’ outcome. Methods The COntemporary management of Pulmonary Embolism (COPE) is a prospective, non-interventional, multicentre study in patients with acute PE evaluated at internal medicine, cardiology and emergency departments in Italy. The aim of the COPE study is to assess contemporary management strategies in patients with acute, symptomatic, objectively confirmed PE concerning diagnosis, risk stratification, hospitalization and treatment and to assess rates and predictors of in-hospital and 30-day mortality. The composite of death (either overall or PE-related) or clinical deterioration at 30 days from the diagnosis of PE, major bleeding occurring in hospital and up to 30 days from the diagnosis of PE and adherence to guidelines of the European Society of Cardiology (ESC) are secondary study outcomes. Participation in controlled trials on the management of acute PE is the only exclusion criteria. Expecting a 10–15%, 3% and 0.5% incidence of death for patients with high, intermediate or low-risk PE, respectively, it is estimated that 400 patients with high, 2100 patients with intermediate and 2500 with low-risk PE should be included in the study. This will allow to have about 100 deaths in study patients and will empower assessment of independent predictors of death. Conclusions COPE will provide contemporary data on in-hospital and 30-day mortality of patients with documented PE as well as information on guidelines adherence and its impact on clinical outcomes. Trail registration NCT number: NCT03631810.

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

“…Patients aged 18 years old or older with symptomatic objectively confirmed PE were included in the study after release of informed consent. Criteria for diagnosis of PE have been reported elsewhere (21).…”

“…The co-primary outcomes of the study were in-hospital death and 30-day death. The cause of death was reported by the investigators and documented for central adjudication by an independent Clinical Event Committee unaware of physician classification (21,(23)(24).…”

“…21,23,24 Death or clinical deterioration was a secondary study outcome. 21 The safety outcome was major bleeding according to International Society on Thrombosis and Haemostasis criteria, occurring up to 30 days from the index PE. 25…”

“…Criteria for diagnosis of PE have been reported elsewhere. 21 Patients were excluded in case of participation in controlled trials on the management of acute PE. Patients were evaluated at the time of diagnosis, at discharge, and at 30 days ( AE 4) from the index PE.…”

“…The cause of death was reported by the investigators and documented for central adjudication by an independent Clinical Event Committee unaware of physician classification. 21,23,24 Death or clinical deterioration was a secondary study outcome. 21 The safety outcome was major bleeding according to International Society on Thrombosis and Haemostasis criteria, occurring up to 30 days from the index PE.…”