Andrea Penaloza1, Caroline Soulié2, Thomas Moumneh2, Quentin Delmez1, Alexandre Ghuysen3, Dominique El Kouri4, Christian Brice5, Nicolas S Marjanovic6, Jacques Bouget7, Fares Moustafa8, Albert Trinh-Duc9, Catherine Le Gall10, Lionel Imsaad11, Jean-Marie Chrétien12, Béatrice Gable2, Philippe Girard13, Olivier Sanchez14, Jeannot Schmidt8, Grégoire Le Gal15, Guy Meyer14, Nicolas Delvau1, Pierre-Marie Roy16. 1. Emergency Department, Cliniques Universitaires St-Luc, Université Catholique de Louvain, Brussels, Belgium. 2. Emergency Department, Centre Hospitalier Universitaire Angers, Institut Mitovasc, Université d'Angers, Angers, France. 3. Emergency Department, Centre Hospitalier Universitaire de Liège, Liège, Belgium. 4. Emergency Department, Médecine Polyvalente, Centre Hospitalier Universitaire Hôtel Dieu, Nantes, France. 5. Emergency Department, Centre Hospitalier de Saint-Brieuc, Saint-Brieuc, France. 6. Emergency Department, Centre Hospitalier Universitaire de Poitiers, Poitiers, France. 7. Emergency Department, Centre Hospitalier Universitaire de Rennes, Rennes, France. 8. Emergency Department, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France. 9. Emergency Department, Centre Hospitalier d'Agen, Agen, France. 10. Emergency Department, Centre Hospitalier d'Argenteuil, Argenteuil, France. 11. Emergency Department, Centre Hospitalier de Le Mans, Le Mans, France. 12. Research Unit, Centre Hospitalier Universitaire Angers, Institut Mitovasc, Université d'Angers, Angers, France. 13. Thorax Department, Institut Mutualiste Montsouris, Paris, France. 14. Pneumology Department, Hôpital Européen Georges Pompidou, APHP, Université Paris Descartes, Paris, France. 15. Division of Haematology-Thrombosis Program, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, ON, Canada. 16. Emergency Department, Centre Hospitalier Universitaire Angers, Institut Mitovasc, Université d'Angers, Angers, France. Electronic address: pmroy@chu-angers.fr.
Abstract
BACKGROUND: The ability of the pulmonary embolism rule-out criteria (PERC) to exclude pulmonary embolism without further testing remains debated outside the USA, especially in the population with suspected pulmonary embolism who have a high prevalence of the condition. Our main objective was to prospectively assess the predictive value of negative PERC to rule out pulmonary embolism among European patients with low implicit clinical probability. METHODS: We did a multicentre, prospective, observational study in 12 emergency departments in France and Belgium. We included consecutive patients aged 18 years or older with suspected pulmonary embolism. Patients were excluded if they had already been hospitalised for more than 2 days, had curative anticoagulant therapy in progress for more than 48 h, or had a diagnosis of thromboembolic disease documented before admission to emergency department. Physicians completed a standardised case report form comprising implicit clinical probability assessment (low, moderate, or high) and a list of risk factors including criteria of the PERC rule. They were asked to follow international recommendations for diagnostic strategy, masked to PERC assessment. The primary endpoint was the proportion of patients with low implicit clinical probability and negative PERC who had venous thromboembolic events, diagnosed during initial diagnostic work-up or during 3-month follow-up, as externally adjudicated by an independent committee masked to the PERC and clinical probability assessment. The upper limit of the 95% CI around the 3-month thromboembolic risk was set at 3%. We did all analyses by intention to treat, including all patients with complete follow-up. This trial is registered with ClinicalTrials.gov, number NCT02360540. FINDINGS: Between May 1, 2015, and April 30, 2016, 1773 consecutive patients with suspected pulmonary embolism were prospectively assessed for inclusion, of whom 1757 were included. 1052 (60%) patients were classed as having low clinical probability, 49 (4·7%, 95% CI 3·5-6·1) of whom had a venous thromboembolic event. In patients with a low implicit clinical probability, 337 (32%) patients had negative PERC, of whom four (1·2%; 95% CI 0·4-2·9) went on to have a pulmonary embolism. INTERPRETATION: In European patients with low implicit clinical probability, PERC can exclude pulmonary embolism with a low percentage of false-negative results. The results of our prospective, observational study allow and justify an implementation study of the PERC rule in Europe. FUNDING: French Ministry of Health.
BACKGROUND: The ability of the pulmonary embolism rule-out criteria (PERC) to exclude pulmonary embolism without further testing remains debated outside the USA, especially in the population with suspected pulmonary embolism who have a high prevalence of the condition. Our main objective was to prospectively assess the predictive value of negative PERC to rule out pulmonary embolism among European patients with low implicit clinical probability. METHODS: We did a multicentre, prospective, observational study in 12 emergency departments in France and Belgium. We included consecutive patients aged 18 years or older with suspected pulmonary embolism. Patients were excluded if they had already been hospitalised for more than 2 days, had curative anticoagulant therapy in progress for more than 48 h, or had a diagnosis of thromboembolic disease documented before admission to emergency department. Physicians completed a standardised case report form comprising implicit clinical probability assessment (low, moderate, or high) and a list of risk factors including criteria of the PERC rule. They were asked to follow international recommendations for diagnostic strategy, masked to PERC assessment. The primary endpoint was the proportion of patients with low implicit clinical probability and negative PERC who had venous thromboembolic events, diagnosed during initial diagnostic work-up or during 3-month follow-up, as externally adjudicated by an independent committee masked to the PERC and clinical probability assessment. The upper limit of the 95% CI around the 3-month thromboembolic risk was set at 3%. We did all analyses by intention to treat, including all patients with complete follow-up. This trial is registered with ClinicalTrials.gov, number NCT02360540. FINDINGS: Between May 1, 2015, and April 30, 2016, 1773 consecutive patients with suspected pulmonary embolism were prospectively assessed for inclusion, of whom 1757 were included. 1052 (60%) patients were classed as having low clinical probability, 49 (4·7%, 95% CI 3·5-6·1) of whom had a venous thromboembolic event. In patients with a low implicit clinical probability, 337 (32%) patients had negative PERC, of whom four (1·2%; 95% CI 0·4-2·9) went on to have a pulmonary embolism. INTERPRETATION: In European patients with low implicit clinical probability, PERC can exclude pulmonary embolism with a low percentage of false-negative results. The results of our prospective, observational study allow and justify an implementation study of the PERC rule in Europe. FUNDING: French Ministry of Health.
Authors: Hannah C Kulka; Andreas Zeller; Jürgen Fornaro; Walter A Wuillemin; Stavros Konstantinides; Michael Christ Journal: Dtsch Arztebl Int Date: 2021-09-17 Impact factor: 5.594
Authors: Geert-Jan Geersing; Toshihiko Takada; Frederikus A Klok; Harry R Büller; D Mark Courtney; Yonathan Freund; Javier Galipienzo; Gregoire Le Gal; Waleed Ghanima; Jeffrey A Kline; Menno V Huisman; Karel G M Moons; Arnaud Perrier; Sameer Parpia; Helia Robert-Ebadi; Marc Righini; Pierre-Marie Roy; Maarten van Smeden; Milou A M Stals; Philip S Wells; Kerstin de Wit; Noémie Kraaijpoel; Nick van Es Journal: PLoS Med Date: 2022-01-25 Impact factor: 11.069