Abstract
BackgroundThe diagnosis of Pulmonary Embolism (PE) in the emergency department (ED) is crucial. As emergency physicians fear missing this potential life-threatening condition, PE tends to be over-investigated, exposing patients to unnecessary risks and uncertain benefit in terms of outcome. The Pulmonary Embolism Rule-out Criteria (PERC) is an eight-item block of clinical criteria that can identify patients who can safely be discharged from the ED without further investigation for PE. The endorsement of this rule could markedly reduce the number of irradiative imaging studies, ED length of stay, and rate of adverse events resulting from both diagnostic and therapeutic interventions. Several retrospective and prospective studies have shown the safety and benefits of the PERC rule for PE diagnosis in low-risk patients, but the validity of this rule is still controversial. We hypothesize that in European patients with a low gestalt clinical probability and who are PERC-negative, PE can be safely ruled out and the patient discharged without further testing.Methods/DesignThis is a controlled, cluster randomized trial, in 15 centers in France. Each center will be randomized for the sequence of intervention periods: a 6-month intervention period (PERC-based strategy) followed by a 6-month control period (usual care), or in reverse order, with 2 months of “wash-out” between the 2 periods. Adult patients presenting to the ED with a suspicion of PE and a low pre test probability estimated by clinical gestalt will be eligible. The primary outcome is the percentage of failure resulting from the diagnostic strategy, defined as diagnosed venous thromboembolic events at 3-month follow-up, among patients for whom PE has been initially ruled out.DiscussionThe PERC rule has the potential to decrease the number of irradiative imaging studies in the ED, and is reported to be safe. However, no randomized study has ever validated the safety of PERC. Furthermore, some studies have challenged the safety of a PERC-based strategy to rule-out PE, especially in Europe where the prevalence of PE diagnosed in the ED is high. The PROPER study should provide high-quality evidence to settle this issue. If it confirms the safety of the PERC rule, physicians will be able to reduce the number of investigations, associated subsequent adverse events, costs, and ED length of stay for patients with a low clinical probability of PE.Trial registrationNCT02375919.
Highlights
The diagnosis of Pulmonary Embolism (PE) in the emergency department (ED) is crucial
The Pulmonary Embolism Rule-out Criteria (PERC) rule has the potential to decrease the number of irradiative imaging studies in the ED, and is reported to be safe
The PROPER study should provide high-quality evidence to settle this issue. If it confirms the safety of the PERC rule, physicians will be able to reduce the number of investigations, associated subsequent adverse events, costs, and ED length of stay for patients with a low clinical probability of PE
Summary
The wide availability of D-dimer testing, combined with the fear of missing PE, has led to lowering the testing threshold for suspicion of PE; the Subsequently, there has been a marked rise (up to 15fold) in the utilization of CTPA in the last 15 years [18] and in the incidence of diagnosed PE [19] This greater incidence of PE was not followed by a decrease in the mortality rate from PE, but rather a global decrease in PE fatality [19, 20]: the prognosis of a patient with a PE improves, but the overall number of deaths from PE do not change. This increased exposure to CTPA may be a source of unnecessary risks, such as contrast-induced nephropathy and allergic reactions, adverse events after anticoagulation treatment or the delayed occurrence of radiationinduced cancer [21,22,23]
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