[en] AIMS: The aim of this study is to compare the Hestia rule vs. the simplified Pulmonary Embolism Severity Index (sPESI) for triaging patients with acute pulmonary embolism (PE) for home treatment. METHODS AND RESULTS: Normotensive patients with PE of 26 hospitals from France, Belgium, the Netherlands, and Switzerland were randomized to either triaging with Hestia or sPESI. They were designated for home treatment if the triaging tool was negative and if the physician-in-charge, taking into account the patient's opinion, did not consider that hospitalization was required. The main outcomes were the 30-day composite of recurrent venous thrombo-embolism, major bleeding or all-cause death (non-inferiority analysis with 2.5% absolute risk difference as margin), and the rate of patients discharged home within 24 h after randomization (NCT02811237). From January 2017 through July 2019, 1975 patients were included. In the per-protocol population, the primary outcome occurred in 3.82% (34/891) in the Hestia arm and 3.57% (32/896) in the sPESI arm (P = 0.004 for non-inferiority). In the intention-to-treat population, 38.4% of the Hestia patients (378/984) were treated at home vs. 36.6% (361/986) of the sPESI patients (P = 0.41 for superiority), with a 30-day composite outcome rate of 1.33% (5/375) and 1.11% (4/359), respectively. No recurrent or fatal PE occurred in either home treatment arm. CONCLUSIONS: For triaging PE patients, the strategy based on the Hestia rule and the strategy based on sPESI had similar safety and effectiveness. With either tool complemented by the overruling of the physician-in-charge, more than a third of patients were treated at home with a low incidence of complications.
Disciplines :
Human health sciences: Multidisciplinary, general & others
Author, co-author :
Roy, Pierre-Marie ; Emergency Department, CHU Angers, 4 rue Larrey, Angers, France, F-49000. ; Univ. Angers, INSERM, CNRS, MITOVASC, Equipe CARME, SFR ICAT, Angers, France. ; F-CRIN, INNOVTE, Saint-Etienne, France.
Hugli, Olivier ; Emergency Department, University Hospital of Lausanne, Lausanne, Switzerland.
Klok, Frederikus A ; Department of Medicine - Thrombosis and Hemostasis, DTN, Leiden University Medical
Arnoux, Armelle ; Computing, Statistics and Public Health & CIC1418, Hôpital Européen Georges ; University of Paris, Paris, France.
Elias, Antoine; F-CRIN, INNOVTE, Saint-Etienne, France. ; Department of Cardiology and Vascular Medicine, CH Sainte Musse - Toulon, Toulon,
Couturaud, Francis; F-CRIN, INNOVTE, Saint-Etienne, France. ; Department of Internal Medicine and Chest Disease, CHU Brest, Brest, France. ; EA3878-GETBO, CIC-INSERM1412, Univ-Brest, Brest, France.
Faber, Laura M; Department of Internal Medicine, Rode Kruis Hospital, Beverwijk, DTN, the
Daoud-Elias, Marie; Department of Cardiology and Vascular Medicine, CH Sainte Musse - Toulon, Toulon,
Planquette, Benjamin; F-CRIN, INNOVTE, Saint-Etienne, France. ; Department of Pneumology and Intensive Care, Hôpital Europeen Georges Pompidou, ; University of Paris, INSERM UMR-S 1140 Innovaties Therapies in Haemostasis, Paris,
Bokobza, Jérôme; Emergency Department, Hôpital Cochin, APHP, Paris, France.
Viglino, Damien ; Emergency Department, CHU Grenoble Alpes, Grenoble, France. ; HP2 INSERM U 1042 Laboratory, University of Grenoble-Alpes, Grenoble, France.
Schmidt, Jeannot; F-CRIN, INNOVTE, Saint-Etienne, France. ; Emergency Department, CHU Clermont-Ferrand, University of Clermont Auvergne,
Juchet, Henry; Emergency Department, CHU Toulouse, Toulouse, France.
Mahe, Isabelle; F-CRIN, INNOVTE, Saint-Etienne, France. ; Internal Medicine Department, HU Paris Nord, Louis Mourier Hospital, APHP, Colombes, ; Inserm UMR_S1140 Hemostasis Therapeutical Innovations, University of Paris,
Mulder, Frits; Department of Internal Medicine, Tergooi Hospital, Hilversum, the Netherlands.
Moumneh, Thomas ; Emergency Department, CHU Angers, 4 rue Larrey, Angers, France, F-49000. ; Univ. Angers, INSERM, CNRS, MITOVASC, Equipe CARME, SFR ICAT, Angers, France. ; F-CRIN, INNOVTE, Saint-Etienne, France.
Quere, Isabelle; F-CRIN, INNOVTE, Saint-Etienne, France. ; Vascular Medicine Department, CHU Montpellier, EA2992, CIC 1001, University of
Falvo, Nicolas; Vascular Medicine Department, CHU Dijon, Dijon, France.
Montaclair, Karine; F-CRIN, INNOVTE, Saint-Etienne, France. ; Department of Cardiology, CH Le Mans, Le Mans, France.
Douillet, Delphine ; Emergency Department, CHU Angers, 4 rue Larrey, Angers, France, F-49000. ; Univ. Angers, INSERM, CNRS, MITOVASC, Equipe CARME, SFR ICAT, Angers, France. ; F-CRIN, INNOVTE, Saint-Etienne, France.
Hendriks, Stephan V ; Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical
Benhamou, Ygal; Department of Internal Medicine, CHU Charles Nicolle, Rouen, France. ; Normandie University, UNIROUEN, INSERM U1096 EnVI, Rouen, France.
Szwebel, Tali-Anne; Department of Internal Medicine, Cochin Hospital, APHP, Paris, France.
Pernod, Gilles; F-CRIN, INNOVTE, Saint-Etienne, France. ; Department of Vascular Medicine, CHU Grenoble Alpes, Grenoble, France. ; University Grenoble Alpes, CNRS / TIMC-IMAG UMR 5525 / Themas, Grenoble, France.
Dublanchet, Nicolas; Emergency Department, CHU Clermont-Ferrand, University of Clermont Auvergne,
Lapebie, François-Xavier; Vascular Medicine Department, CHU Toulouse, Toulouse, France.
Javaud, Nicolas; Emergency Department, CréAk, Louis Mourier Hospital, APHP, University of Paris,
GHUYSEN, Alexandre ; Centre Hospitalier Universitaire de Liège - CHU > > Service des urgences
Sebbane, Mustapha ; F-CRIN, INNOVTE, Saint-Etienne, France. ; Emergency Department, Lapeyronie Hospital, CHU Montpellier, University of
Chatellier, Gilles; Computing, Statistics and Public Health & CIC1418, Hôpital Européen Georges ; University of Paris, Paris, France.
Meyer, Guy; Department of Pneumology and Intensive Care, Hôpital Europeen Georges Pompidou, ; University of Paris, INSERM UMR-S 1140 Innovaties Therapies in Haemostasis, Paris,
Jimenez, David; Respiratory Department and Medicine Department, Ramon y Cajal Hospital IRYCIS Alcal
Huisman, Menno V; Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical
Sanchez, Olivier ; F-CRIN, INNOVTE, Saint-Etienne, France. ; University of Paris, INSERM UMR-S 1140 Innovaties Therapies in Haemostasis, Paris, ; Pneumology Department and Intensive Care, Hôpital Européen Georges Pompidou
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