Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial.

Clinical decision-making Emergency department Home treatment Pulmonary embolism Randomized controlled trial Risk assessment

Journal

European heart journal
ISSN: 1522-9645
Titre abrégé: Eur Heart J
Pays: England
ID NLM: 8006263

Informations de publication

Date de publication:
31 08 2021
Historique:
received: 02 12 2020
revised: 02 02 2021
accepted: 02 06 2021
pubmed: 8 8 2021
medline: 5 10 2021
entrez: 7 8 2021
Statut: ppublish

Résumé

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. 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. 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.

Identifiants

pubmed: 34363386
pii: 6345003
doi: 10.1093/eurheartj/ehab373
pmc: PMC8408662
doi:

Banques de données

ClinicalTrials.gov
['NCT02811237']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

3146-3157

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

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Auteurs

Pierre-Marie Roy (PM)

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.

Andrea Penaloza (A)

F-CRIN, INNOVTE, Saint-Etienne, France.
Emergency Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
UCLouvain, Brussels, Belgium.

Olivier Hugli (O)

Emergency Department, University Hospital of Lausanne, Lausanne, Switzerland.

Frederikus A Klok (FA)

Department of Medicine - Thrombosis and Hemostasis, DTN, Leiden University Medical Center, Leiden, the Netherlands.

Armelle Arnoux (A)

Computing, Statistics and Public Health & CIC1418, Hôpital Européen Georges Pompidou, APHP, Paris, France.
University of Paris, Paris, France.

Antoine Elias (A)

F-CRIN, INNOVTE, Saint-Etienne, France.
Department of Cardiology and Vascular Medicine, CH Sainte Musse - Toulon, Toulon, France.

Francis Couturaud (F)

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.

Luc-Marie Joly (LM)

Emergency Department, CHU Rouen, Normandy Univ, UNIROUEN, Rouen, France.

Raphaëlle Lopez (R)

Emergency Department, Sart Tilman University Hospital, Liège, Belgium.

Laura M Faber (LM)

Department of Internal Medicine, Rode Kruis Hospital, Beverwijk, DTN, the Netherlands.

Marie Daoud-Elias (M)

Department of Cardiology and Vascular Medicine, CH Sainte Musse - Toulon, Toulon, France.

Benjamin Planquette (B)

F-CRIN, INNOVTE, Saint-Etienne, France.
Department of Pneumology and Intensive Care, Hôpital Europeen Georges Pompidou, APHP, Paris, France.
University of Paris, INSERM UMR-S 1140 Innovaties Therapies in Haemostasis, Paris, France.

Jérôme Bokobza (J)

Emergency Department, Hôpital Cochin, APHP, Paris, France.

Damien Viglino (D)

Emergency Department, CHU Grenoble Alpes, Grenoble, France.
HP2 INSERM U 1042 Laboratory, University of Grenoble-Alpes, Grenoble, France.

Jeannot Schmidt (J)

F-CRIN, INNOVTE, Saint-Etienne, France.
Emergency Department, CHU Clermont-Ferrand, University of Clermont Auvergne, Clermont-Ferrand, France.

Henry Juchet (H)

Emergency Department, CHU Toulouse, Toulouse, France.

Isabelle Mahe (I)

F-CRIN, INNOVTE, Saint-Etienne, France.
Internal Medicine Department, HU Paris Nord, Louis Mourier Hospital, APHP, Colombes, France.
Inserm UMR_S1140 Hemostasis Therapeutical Innovations, University of Paris, Colombes, France.

Frits Mulder (F)

Department of Internal Medicine, Tergooi Hospital, Hilversum, the Netherlands.

Magali Bartiaux (M)

Emergency Department, Saint-Pierre Hospital, Brussels, Belgium.

Rosen Cren (R)

Emergency Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.

Thomas Moumneh (T)

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.

Isabelle Quere (I)

F-CRIN, INNOVTE, Saint-Etienne, France.
Vascular Medicine Department, CHU Montpellier, EA2992, CIC 1001, University of Montpellier, Montpellier, France.

Nicolas Falvo (N)

Vascular Medicine Department, CHU Dijon, Dijon, France.

Karine Montaclair (K)

F-CRIN, INNOVTE, Saint-Etienne, France.
Department of Cardiology, CH Le Mans, Le Mans, France.

Delphine Douillet (D)

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.

Charlotte Steinier (C)

Emergency Department, Cliniques Universitaires Saint-Luc, UCLouvain, Brussels, Belgium.

Stephan V Hendriks (SV)

Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.

Ygal Benhamou (Y)

Department of Internal Medicine, CHU Charles Nicolle, Rouen, France.
Normandie University, UNIROUEN, INSERM U1096 EnVI, Rouen, France.

Tali-Anne Szwebel (TA)

Department of Internal Medicine, Cochin Hospital, APHP, Paris, France.

Gilles Pernod (G)

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.

Nicolas Dublanchet (N)

Emergency Department, CHU Clermont-Ferrand, University of Clermont Auvergne, Clermont-Ferrand, France.

François-Xavier Lapebie (FX)

Vascular Medicine Department, CHU Toulouse, Toulouse, France.

Nicolas Javaud (N)

Emergency Department, CréAk, Louis Mourier Hospital, APHP, University of Paris, Colombes, France.

Alexandre Ghuysen (A)

Emergency Department, Sart Tilman University Hospital, Liège, Belgium.

Mustapha Sebbane (M)

F-CRIN, INNOVTE, Saint-Etienne, France.
Emergency Department, Lapeyronie Hospital, CHU Montpellier, University of Montpellier, Montpellier, France.

Gilles Chatellier (G)

Computing, Statistics and Public Health & CIC1418, Hôpital Européen Georges Pompidou, APHP, Paris, France.
University of Paris, Paris, France.

Guy Meyer (G)

Department of Pneumology and Intensive Care, Hôpital Europeen Georges Pompidou, APHP, Paris, France.
University of Paris, INSERM UMR-S 1140 Innovaties Therapies in Haemostasis, Paris, France.

David Jimenez (D)

Respiratory Department and Medicine Department, Ramon y Cajal Hospital IRYCIS Alcal de Henares University, Madrid, Spain.

Menno V Huisman (MV)

Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.

Olivier Sanchez (O)

F-CRIN, INNOVTE, Saint-Etienne, France.
University of Paris, INSERM UMR-S 1140 Innovaties Therapies in Haemostasis, Paris, France.
Pneumology Department and Intensive Care, Hôpital Européen Georges Pompidou, APHP, 20-40 rue Leblanc, Paris, France, F-75908.

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