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1. Evaluation of the 'hemoptysis' item in clinical decision rules for the diagnosis of pulmonary embolism in the emergency department

Author: Héloïse Bannelier, Judith Gorlicki, Andrea Penaloza, Delphine Douillet, Pierre‐Marie Roy, Yonathan Freund, Melanie Roussel, dilanian, gilles, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Marqueurs cardiovasculaires en situation de stress (MASCOT (UMR_S_942 / U942)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Université Catholique de Louvain = Catholic University of Louvain (UCL), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), FHU IMPEC Improving Emergency Care (FHU IMPEC), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Sorbonne Paris Nord
Subjects: Adult, Male, revised Geneva, emergency department, probability scores, [SDV]Life Sciences [q-bio], General Medicine, Middle Aged, hemoptysis, [SDV] Life Sciences [q-bio], Fibrin Fibrinogen Degradation Products, D-dimer, computed tomography pulmonary angiography, Clinical Decision Rules, Emergency Medicine, PERC, Humans, YEARS, Female, Prospective Studies, Wells, Emergency Service, Hospital, Pulmonary Embolism, Tomography, X-Ray Computed, PEGeD
Abstract: International audience; Background: Hemoptysis is not common in pulmonary embolism (PE) and lacks specificity for its diagnosis. However, this item is present in different validated scores that estimate the clinical probability of PE. The relevance of this item in clinical decision rules (CDRs) is not clearly established.Objective: The aim of this study was to evaluate the impact of removing the "hemoptysis" item from the PERC, YEARS, and PEGeD CDR in patients with low clinical probability of PE.Design: This was a post hoc analysis of two European prospective cohorts, which included 2968 patients presenting to the ED with a low clinical probability of PE (PROPER and PERCEPIC) and a 3-month follow-up. The primary endpoint was the false-negative rate of a CDR score without the hemoptysis item. Secondary endpoints included the potential reduction of chest imaging if the item hemoptysis was to be removed and risk stratification of the Geneva and Wells scores without the hemoptysis item.Results: Of 2968 patients included (mean ± SD age 46 ± 18 years, 53% female), 87 patients (3%) had a PE diagnosed at 3 months. A total of 2908 were followed-up at 3 months and analyzed. Using the PERC rule with and without the hemoptysis item, there were 13 and 14 missed cases of PE, respectively (failure rate 0.45% [95% CI 0.25%-0.78%] and 0.48% [95% CI 0.27%-0.82%]). Using the YEARS strategy, there were 11 missed PE cases with or without the hemoptysis item (false-negative rate 0.57% [95% CI 0.30%-1.05%]). With the PERC and YEARS rule, removing the hemoptysis item would have led to a 1% reduction in chest imaging. The PEGeD strategy was not modified by the removal of the hemoptysis item.Conclusions: The hemoptysis item could be safely removed from the PERC, YEARS, and PEGeD CDRs. However, there was no subsequent clinically relevant reduction of chest imaging.
Published: 2022
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2. Pulmonary embolism detection on venous thrombosis ultrasound images with bi-dimensional entropy measures: preliminary results

Author: Jamin, Antoine, Hoffmann, Clément, Mahé, Guillaume, Bressollette, Luc, Humeau-Heurtier, Anne, Laboratoire Angevin de Recherche en Ingénierie des Systèmes (LARIS), Université d'Angers (UA), Laboratoire d'Etudes et de Recherche en Informatique d'Angers (LERIA), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Laboratoire Mouvement Sport Santé (M2S), Université de Rennes (UR)-École normale supérieure - Rennes (ENS Rennes)-Université de Brest (UBO)-Université de Rennes 2 (UR2)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), and Open access funding provided by University of Angers.
Subjects: [SPI]Engineering Sciences [physics], pulmonary embolism, [INFO.INFO-TS]Computer Science [cs]/Signal and Image Processing, bidimensional entropy, ultrasound images
Abstract: International audience; Background: Venous thromboembolism (VTE) is a common health issue. A clinical expression of VTE is a deep vein thrombosis (DVT) that may lead to pulmonary embolism (PE), a critical illness. When DVT is suspected, an ultrasound exam is performed.However, the characteristics of the clot observed on ultrasound images cannot be linked with the presence of PE. Computed tomography angiography is the gold standard to diagnose PE. Nevertheless, the latter technique is expensive and requires the use of contrast agents.Purpose: In this article, we present an image processing method based on ultrasound images to determine whether PE is associated or not with lower limb DVT. In terms of medical equipment, this new approach (Doppler ultrasound image processing) is inexpensive and quite easy.Methods: With the aim to help medical doctors in detecting PE, we herein propose to process ultrasound images of patients with DVT. After a first step based on histogram equalization, the analysis procedure is based on the use of bi-dimensional entropy measures. Two different algorithms are tested: the bi-dimensional dispersion entropy (DispEn2D) mesure and the bi-dimensional fuzzy entropy (FuzEn2D) mesure. Thirty-two patients (12 women and 20 men, 67.63±16.19 years old), split into two groups (16 with and 16 without PE), compose our database of around 1490 ultrasound images (split into seven different sizes from 32x32 px to 128x128 px). p-values, computed with the Mann-Whitney test, are used to determine if entropy values of the two groups are statistically significantly different. Receiver operating characteristic (ROC) curves are plotted and analyzed for the most significant cases to define if entropy values are able to discriminate the two groups.Results: p-values show that there are statistical differences between FuzEn2D of patients with PE and patients without PE for 112x112 px and 128x128px images. Area under the ROC curve (AUC) is higher than 0.7 (threshold for a fair test) for 112x112 and 128x128 images. The best value of AUC (0.72) is obtained for 112x112 px images.
Published: 2023
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3. Effect of weight-adjusted intermediate-dose versus fixed-dose prophylactic anticoagulation with low-molecular-weight heparin on venous thromboembolism among noncritically and critically ill patients with COVID-19: the COVI-DOSE trial, a multicenter, randomised, open-label, phase 4 trial

Author: Zuily, Stéphane, Lefèvre, Benjamin, Sanchez, Olivier, Empis de Vendin, Ombeline, de Ciancio, Guillaume, Arlet, Jean-Benoît, Khider, Lina, Terriat, Béatrice, Greigert, Hélène, Robert, Céline, Louis, Guillaume, Trinh-Duc, Albert, Rispal, Patrick, Accassat, Sandrine, Thiery, Guillaume, Montani, David, Azarian, Réza, Meneveau, Nicolas, Soudet, Simon, Le Mao, Raphaël, Maurier, François, Le Moing, Vincent, Quéré, Isabelle, Yelnik, Cécile, Lefebvre, Nicolas, Martinot, Martin, Delrue, Maxime, Benhamou, Ygal, Parent, Florence, Roy, Pierre-Marie, Presles, Emilie, Goehringer, François, Mismetti, Patrick, Bertoletti, Laurent, Rossignol, Patrick, Couturaud, Francis, Wahl, Denis, Thilly, Nathalie, Laporte, Silvy, Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Adaptation, mesure et évaluation en santé. Approches interdisciplinaires (APEMAC), Université de Lorraine (UL), Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Service de Cardiologie [CHRU Nancy], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHR de Metz-Thionville, Centre Hospitalier Agen-Nérac, Hôpital Bicêtre, Université Paris-Saclay, Centre Hospitalier de Versailles André Mignot (CHV), Department of Cardiology, University Hospital Jean Minjoz, Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC), CHU Amiens-Picardie, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), UNEOS, Département Maladies Infectieuses et Tropicales, Hôpital Universitaire, Montpellier, France, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Lapeyronie [Montpellier] (CHU), Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Université de Lille, CHU Lille, Centre National de Référence des Maladies Auto-Immunes Systémiques Rares du Nord et Nord-Ouest de France (CeRAINO), Facteurs de Risque et Déterminants Moléculaires des Maladies liées au Vieillissement - U 1167 (RID-AGE), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Les Hôpitaux Universitaires de Strasbourg (HUS), Hôpitaux Civils de Colmar, Service d’Hématologie Biologique [CHU Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Endothélium, valvulopathies et insuffisance cardiaque (EnVI), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université d'Angers (UA), CHU d'Angers [Département Urgences], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Université Jean Monnet - Saint-Étienne (UJM), Santé Ingénierie Biologie Saint-Etienne (SAINBIOSE), Centre Ingénierie et Santé (CIS-ENSMSE), École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service des Maladies Infectieuses et Tropicales [CHRU Nancy], Service de Chirurgie Vasculaire [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM), Centre d'Investigation Clinique - Epidémiologie Clinique Saint-Etienne (CIC-EC), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'investigation clinique plurithématique Pierre Drouin [Nancy] (CIC-P), Centre d'investigation clinique [Nancy] (CIC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy] (INI-CRCT), Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu [Nancy], Centre Hospitalier Princesse Grace, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), French Ministry of Health, CAPNET, Grand-Est Region, Grand-Nancy Métropole., and COVI-DOSE investigators: Stéphane Zuily, Francis Couturaud, François Goehringer, Silvy Laporte, Patrick Mismetti, Emilie Presles, Patrick Rossignol, Nathalie Thilly, Denis Wahl, Thomas Lecompte, Emmanuel Oger, Marie-Antoinette Sevestre, Florence Parent, Ygal Benhamou, Pierre-Marie Roy, Tristan Gigante, Morgane Gilg, Pierre-Luc Maclot, Bénédicte Rossignol, Jonathan Udot, Hélène Bouteille, Andréa Buchmuller, Céline Peurière, El Mehdi Siaghy, Valérie Bouaziz, Charlotte Daguin, Benjamin Grosjean, Véronique Saunier, Laurence Verger, Madlyne Jacquot, Nadine Petitpain, Martin Charly, Laurent Tordella, Emilie Presles, Guillaume Baronnet, Elisabeth Baux, Athanase Benetos, Jean-Baptiste Blanvillain, Marie Conrad, Guilhem Courte, Aurélie Cravoisy-Popovic, Virginie Dufrost, Sébastien Gibot, Philippe Guerci, Laure Joly, Antoine Kimmoun, Matthieu Koszutski, Alexandrine Larue, Bruno Levy, Marie-Reine Losser, Mathieu Mattei, Lionel Nace, Emmanuel Novy, Pierre Perez, Jean-Pierre Pertek, Camille Rigaux, Alexis Sauvage, Evelyne Schvoerer, Carine Thivilier, Lev Volkov, Piotr Zieminski, Manil Benlounes, Charles Cheng, Jean-Baptiste de Fréminville, Grégoire Détriché, Emmanuel Flammarion, Guillaume Goudot, Amer Hamdan, Raphaël Hindré, Corina Manoli, Emmanuel Messas, Adrien Michon, Tristan Mirault, Jean Pastré, Marie-Aude Penet, Benjamin Planquette, Geoffroy Volle, Rémy Hamdan, Aline Laubriet-Jazayeri, Vincent Petit, Lionel Piroth, Jean Pierre Quenot, Mélissa Saccu, Damien Barraud, Zoé Cavalli, Rostane Gaci, Mathilde Andreu, Laurent Bertoletti, Andréa Buchmuller, Elodie De Magalhaes, Sophie Bulifon, Athénaïs Boucly, Nathan Ebstein, Marc Humbert, Xavier Jaïs, Mitja Jevnikar, Laurent Savale, Andrei Horia Seferian, Charlotte Colin, Timothée Ganem, Mehdi Roumila, Romain Chopard, Matthieu Besutti, Basile Mouhat, Claire Andrejak, Stéphane Dupas, Gaëlle Le Roy, Santhi Samy-Modeliar, Anne Coste, Alexandre Fauche, David Goetghebeur, Christophe Gut-Gobert, Clément Hoffmann, Baptiste Hourmant, Cécile L'hévéder, Emmanuelle Lemoigne, Olivier Nepveu, Raphaël Paret, Gaël Picart, Saïd Azerkan, Chadia Boudaa, Julien Campagne, Peter Eszto, Benoît Godbert, Jean-François Guichard, Marion Heschung, Antoine Legoff, Jacques Mariot, Pascale Martin, Magalie Mercy, Julie Perrin, Stéphane Raymond, Nathalie Vernier, Pierre Fesler, Pierrick Henneton, Cédric Mercuzot, Nathalie Pansu, Lucas Perez, Loïc Andre, Edgar Bakhache, Marie-Charlotte Chopin, Marie Gilbert, Marc Lambert, Mohammad Ryadh Pokeerbux, François Danion, Yves Hansmann, Estelle Rougier, Yvon Ruch, Dominique Stéphan, Axel Ursenbach, Isabelle Connerade, Simon Gravier, Damien Kayser, Jean-Marc Michel, Mahsa Mohseni, Waël Younes, Ruxandra Burlacu, Amanda Lopes, Stéphane Mouly, Kladoum Nassarmadji, Damien Sène, Virginie Siguret, Alain Stepanian, Cédric Annweiler, Antoine Brangier, Vincent Dubee, Samir Henni, Jeanne Hersant, Jocelyne Loison, Léa Kern, Jean-Baptiste Laine, Claire Neveux-Brecheteau, Lucia Perez, Ruben Benainous, Bénédicte Giroux-Leprieur, Marilucy Lopez-Sublet, Saïda Khaled-Jousselin, Yohann Bernard, Amélie Amiot, Jessica Breistroff, Emilie Detry, Kadidiatou Diallo, Agnès Didier, Nathalie Dumont, Julie Egensperger, Aurélie Emmerich, Nelly François, Fanny Gallo, Valérie George, Quentin Gérome, Aurélie Gutehrle, Laure Lehman, Séverine Petit, Vanessa Piard, Maximilien Saint-Gilles, Olivier Terenzi, Amélie Marquette, Hélène Mortelette, Mathilde Audry, Amélie Cransac, Marine Maillard, Anaïs Boyer, Floriana Gallo, Arielle Urbing, Imane Zahaf, Alexandra Byczko, Amina Chaalal, Georgette Berlier, Corinne Bernabe, Souad Bezzeghoud, Caroline Chaudier, Carole Chauvet, Marina Davier, Carine Labruyere, Estelle Perrin, Michaël Pierre, Claire-Annissa Chekirine, Florence Voivret, Ramdane Meftali, Ouaffa Sabri, Anaïs Beulaygue, Julie Gall, Laure Girard, Soumia Haddaoui, Scheherazade Rami, Auriane Couderc, Aude Le Breton, Marie-Line Perruche, Cindy Claudon, Ludivine Roussel, Aude Barnier, Tiphaine Blanchard, Bénédicte Le Gall, Mélanie Pelouin, Anne-Sophie Veillon, Quam Aquereburu, Charlène Delaygue, Zahoua Ait Idir, Jérémy Drugeon, Déborah Dubrulle, Rabah Tezkratt, Anne-Sophie Frantz, Julie Drouaine, Jacqueline Dubois, Magali Eyriey, Elina Haerrel, Mélinda Beaudenon, Mialy Guenet, Thibaud Lecerf, Stéphanie Marechal-Girault, Sami Rehaiem, Romain Simon, Florence Dangeul-Potier, Morgane Goulvent, Souha Fliss, Fadhila Messani, Béatrice Mizejewski, Brigitte Mugnier, Valérie Opderbeck, Brigitte Risse
Subjects: Anticoagulation, Heparin, [SDV]Life Sciences [q-bio], COVID-19, Venous thromboembolism
Abstract: International audience; Background: Venous thromboembolism is a major complication of coronavirus disease 2019 (COVID-19). We hypothesized that a weight-adjusted intermediate dose of anticoagulation may decrease the risk of venous thromboembolism COVID-19 patients.Methods: In this multicenter, randomised, open-label, phase 4, superiority trial with blinded adjudication of outcomes, we randomly assigned adult patients hospitalised in 20 French centers and presenting with acute respiratory SARS-CoV-2. Eligible patients were randomly assigned (1:1 ratio) to receive an intermediate weight-adjusted prophylactic dose or a fixed-dose of subcutaneous low-molecular-weight heparin during the hospital stay. The primary outcome corresponded to symptomatic deep-vein thrombosis (fatal) pulmonary embolism during hospitalization (COVI-DOSE ClinicalTrials.gov number: NCT04373707).Findings: Between May 2020, and April 2021, 1000 patients underwent randomisation in medical wards (noncritically ill) (80.1%) and intensive care units (critically ill) (19.9%); 502 patients were assigned to receive a weight-adjusted intermediate dose, and 498 received fixed-dose thromboprophylaxis. Symptomatic venous thromboembolism occurred in 6 of 502 patients (1.2%) in the weight-adjusted dose group and in 10 of 498 patients (2.1%) in the fixed-dose group (subdistribution hazard ratio, 0.59; 95% CI, 0.22-1.63; P = 0.31). There was a twofold increased risk of major or clinically relevant nonmajor bleeding: 5.9% in the weight-adjusted dose group and 3.1% in the fixed-dose group (P = 0.034).Interpretation: In the COVI-DOSE trial, the observed rate of thromboembolic events was lower than expected in patients hospitalized for COVID-19 infection, and the study was unable to show a significant difference in the risk of venous thromboembolism between the two low-molecular-weight-heparin regimens.
Published: 2023
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4. Frequency and Predictors for Chronic Thromboembolic Pulmonary Hypertension after a first Unprovoked Pulmonary Embolism: results from PADIS studies

Author: Alexandre Fauché, Emilie Presles, Olivier Sanchez, Xavier Jaïs, Raphael Le Mao, Philippe Robin, Gilles Pernod, Laurent Bertoletti, Patrick Jego, Florence Parent, Catherine A. Lemarié, Florent Leven, Pierre‐Yves Le Roux, Pierre‐Yves Salaun, Michel Nonent, Philippe Girard, Karine Lacut, Laurent Savale, Solen Mélac, Marie Guégan, Patrick Mismetti, Silvy Laporte, Christophe Leroyer, David Montani, Francis Couturaud, Cécile Tromeur, Guy Meyer, Elisabeth Duhamel, Karine Provost, Dominique Mottier, Aurélia Le Hir, Stéphane Lenoir, Christian Lamer, Jean François Bergmann, Denis Wahl, Ludovic Drouet, Patrick Chevarier, Nicolas Monte, Florence Morvan, Véronique Kouassi, Nabahats Ibrir, Gaid El Asri, Pierre Yves Salaun, Pierre Yves Le Roux, Luc Bressollette, Philippe Quéhé, Simon Gestin, Jérôme Bahuon, Lucille Deloire, Benjamin Planquette, Yannick Jobic, Yves Etienne, Romain Didier, Loic Leroux, Hubert Galinat, Cédric Le Maréchal, Lénaïck Gourhant, Fanny Mingant, Emmanuelle Lemoigne, Luc De Saint Martin, Aurélien Delluc, Grégoire Le Gal, Nicolas Paleiron, Raphaël Le Mao, Christophe Pison, Philippe Guéret, Hervé Décousus, Sandrine Accassat, CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), INSERM U1059, SAINBIOSE - Santé, Ingénierie, Biologie, Saint-Etienne (SAINBIOSE-ENSMSE), Centre Ingénierie et Santé (CIS-ENSMSE), École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Etienne, F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Innovations thérapeutiques en hémostase (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Hôpital Bicêtre, Pôle des Cardiopathies Congénitales du Nouveau-Né à L'adulte - Centre Constitutif Cardiopathies Congénitales Complexes M3C, Groupe Hospitalier Paris Saint-Joseph, Hôpital Marie-Lannelongue, Inserm U999, Université Paris-Saclay, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), CHU Grenoble, Université Grenoble Alpes (UGA), CIC Saint Etienne, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Nord (Saint Etienne), Université de Rennes (UR), CHU Pontchaillou [Rennes], Institut Mutualiste de Montsouris (IMM), PADIS-PE Investigators: Francis Couturaud, Patrick Mismetti, Christophe Leroyer, Guy Meyer, Olivier Sanchez, Patrick Jego, Gilles Pernod, Elisabeth Duhamel, Karine Provost, Florence Parent, Laurent Bertoletti, Cécile Tromeur, Dominique Mottier, Marie Guégan, Solen Mélac, Aurélia Le Hir, Philippe Girard, Stéphane Lenoir, Christian Lamer, Jean François Bergmann, Denis Wahl, Ludovic Drouet, Emilie Presles, Silvy Laporte, Patrick Chevarier, Nicolas Monte, Florence Morvan, Véronique Kouassi, Nabahats Ibrir, Gaid El Asri, Pierre Yves Salaun, Philippe Robin, Pierre Yves Le Roux, Luc Bressollette, Philippe Quéhé, Simon Gestin, Michel Nonent, Jérôme Bahuon, Lucille Deloire, Benjamin Planquette, Yannick Jobic, Yves Etienne, Romain Didier, Florent Leven, Loic Leroux, Hubert Galinat, Cédric Le Maréchal, Lénaïck Gourhant, Fanny Mingant, Karine Lacut, Emmanuelle Lemoigne, Luc De Saint Martin, Aurélien Delluc, Grégoire Le Gal, Nicolas Paleiron, Raphaël Le Mao, Christophe Pison, Philippe Guéret, Hervé Décousus, Sandrine Accassat, Jonchère, Laurent, Santé Ingénierie Biologie Saint-Etienne (SAINBIOSE), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis (IThEM - U1140), Centre d'Investigation Clinique - Epidémiologie Clinique Saint-Etienne (CIC-EC), and Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: [SDV] Life Sciences [q-bio], Pulmonary Hypertension, Risk Factors, Hypertension, Pulmonary, Incidence, [SDV]Life Sciences [q-bio], Chronic Disease, Clinical Studies, Humans, Anticoagulants, Hematology, Pulmonary Embolism, Aged
Abstract: International audience; Background: Chronic thromboembolic pulmonary hypertension (CTEPH) is a life-threatening pulmonary embolism's (PE) complication whose incidence and predictors are not precisely determined.Objective: To determine the frequency and predictors for CTEPH after a first unprovoked PE.Patients/methods: In a randomized trial comparing an additional 18-month warfarin versus placebo in patients after a first unprovoked PE initially treated with vitamin K antagonist for 6 months, we applied recommended CTEPH screening strategies through 8-year follow-up to determine cumulative incidence of CTEPH. CTEPH predictors were estimated using Cox models. Pulmonary vascular obstruction (PVO) and systolic pulmonary arterial pressure (sPAP) at PE diagnosis and 6 months were studied by receiver operating curves analysis. All CTEPH cases and whether they were incident or prevalent were adjudicated.Results: During a median follow-up of 8.7 years, 9 CTEPH cases were diagnosed among 371 patients, with a cumulative incidence of 2.8% (95% confidence interval [CI], 0.95-4.64), and of 1.31% (95%CI, 0.01-2.60) after exclusion of 5 cases adjudicated as prevalent. At PE diagnosis, PVO>45% and sPAP>56mmHg were associated with CTEPH with a hazard ratio (HR) of 33.00 (95%CI 1.64-667.00, p=0.02) and 12.50 (95%CI 2.10-74.80, p65 years, lupus anticoagulant antibodies and non-O blood groups were also predictive of CTEPH. PVO>14% and sPAP>34mmHg at 6-month were associated with CTEPH (HRs 63.90 [95%CI, 3.11-1310.00, p
Published: 2022
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5. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study

Author: Righini, Marc, Robert‐Ebadi, Helia, Cremonesi, Alessio, Elias, Antoine, Sanchez, Olivier, Le Moigne, Emmanuelle, Schmidt, Jeannot, Le Gall, Catherine, Cornuz, Jacques, Aujesky, Drahomir, Roy, Pierre‐Marie, Chauleur, Céline, Rouyer, Frédéric, Poletti, Pierre‐Alexandre, Moreau, Caroline, Le Gal, Grégoire, CT-PE-Pregnancy group, Faculté de médecine [Genève], Geneva University Hospitals and Geneva University, University Children’s Hospital Zurich, Universität Zürich [Zürich] = University of Zurich (UZH), Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse, Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Centre hospitalier Argenteuil (CH Argenteuil), Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Bern University Hospital [Berne] (Inselspital), University of Bern, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Biologie Intégrative du Tissu Osseux (LBTO), Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Canadian Institutes of Health Research [Ottawa, Canada] (CIHR), Schweizerischer Nationalfonds zur Forderung der Wissenschaftlichen Forschung [FNS32003B-120760], University of Zurich, Innovations thérapeutiques en hémostase (IThEM - U1140), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Biologie intégrative du tissu osseux, and Jonchère, Laurent
Subjects: diagnosis, [SDV]Life Sciences [q-bio], Infant, Newborn, Female, Humans, Pregnancy, Pulmonary Embolism/epidemiology, Prospective Studies, Angiography/methods, Outcome Assessment, Health Care, Hypothyroidism/epidemiology, Thyrotropin, Guthrie test, hypothyroidism, pregnancy, pulmonary embolism, Angiography, 610 Medicine & health, Hematology, [SDV] Life Sciences [q-bio], Hypothyroidism, 10036 Medical Clinic, Pulmonary Embolism
Abstract: International audience; Background Neonatal hypothyroidism is often raised as a potential concern for the use of computed tomography pulmonary angiography (CTPA) in pregnant women with suspected pulmonary embolism (PE). Objectives To assess the incidence of neonatal hypothyroidism among newborns from mothers exposed to CTPA. Patients/Methods Pregnant women with clinically suspected PE were included in a multicenter, multinational prospective diagnostic management outcome study, based on pretest clinical probability assessment, high-sensitivity D-dimer testing, bilateral lower limb venous compression ultrasonography, and CTPA. Results of Guthrie tests were systematically collected for newborns of all women who required CTPA as part of the diagnostic strategy. A thyroid-stimulating hormone (TSH) level above 15 U/ml was used to define hypothyroidism. Results Out of the 166 women included in the Swiss participating centers, 149 underwent a CTPA including 14 with twin pregnancies. Eight women suffered a pregnancy loss and results of the Guthrie test could not be retrieved for four newborns. All TSH levels were reported as being below 15 U/ml. The incidence of neonatal hypothyroidism was 0/151 (0.0%, 95% confidence interval: 0.0%-2.5%). Conclusions We did not identify any cases of neonatal hypothyroidism in our cohort of 149 pregnant women investigated for suspected PE using a CTPA. Along with previous literature data, this provides further reassuring data regarding the use of CTPA in this indication.
Published: 2022
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6. Intramuscular Vaccination in Adults with Therapeutic Anticoagulation in the Era of COVID-19 Vaccines Outbreak: A Practical Review

Author: Tristan Mirault, David Lebeaux, Nicolas Gendron, Christine Le Beller, Brigitte Sabatier, Luc Darnige, Benjamin Planquette, Agnès Lillo-Le Louët, Olivier Sanchez, Lina Khider, Germain Perrin, David M. Smadja, GHU AP-HP Centre Université de Paris, Université de Paris (UP), Physiopathologie et Epidémiologie des Maladies Respiratoires (PHERE (UMR_S_1152 / U1152)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Innovations thérapeutiques en hémostase (IThEM - U1140), Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Université Paris Cité (UPCité), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), and PERRIN, Germain
Subjects: medicine.medical_specialty, 2019-20 coronavirus outbreak, [SDV.IMM] Life Sciences [q-bio]/Immunology, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), MEDLINE, Outbreak, 030204 cardiovascular system & hematology, 3. Good health, Vaccination, 03 medical and health sciences, 0302 clinical medicine, RC666-701, medicine, [SDV.IMM]Life Sciences [q-bio]/Immunology, Diseases of the circulatory (Cardiovascular) system, 030212 general & internal medicine, Intensive care medicine, business, Letter to the Editor, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2021
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7. Diuretic vs. placebo in intermediate-risk acute pulmonary embolism: a randomized clinical trial

Author: Roger Rosario, Jacques Mansourati, Clément Delmas, Gwénolé Rohel, Pierre-André Natella, Sylvie Bastuji-Garin, Muriel Paul, Pascal Lim, Jean-Luc Dubois-Randé, Anne Bernard, Olivier Lairez, Bernard Tardy, Olivier Sanchez, Caroline Biendel, Nicolas Meneveau, Romain Gallet, Tabassome Simon, Pierre Coste, Hélène Bouvaist, Gilles Chatelier, Mustapha Sebbane, Fabrice Ivanes, Damien Fard, Richard Layese, Francis Couturaud, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Department of Cardiology, University Hospital Jean Minjoz, Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920) (PCVP / CARDIO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Departement de Cardiologie [Hôpital Saint-Joseph - Marseille], Aix Marseille Université (AMU)-Hôpital Saint-Joseph [Marseille], CHU Grenoble, Institut de neurophysiopathologie (INP), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Université de Brest (UBO), Département de Médecine Interne et Pneumologie [Brest] (DMIP - Brest), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), CHU Bordeaux [Bordeaux], Université de Bordeaux (UB), Santé Ingénierie Biologie Saint-Etienne (SAINBIOSE), Centre Ingénierie et Santé (CIS-ENSMSE), École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-École des Mines de Saint-Étienne (Mines Saint-Étienne MSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Cardiologie [CHU Toulouse], Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), EA4245 - Transplantation, Immunologie, Inflammation [Tours] (T2i), Université de Tours (UT), CHU Henri Mondor [Créteil], Hôpital Henri Mondor, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), CIC - HEGP (CIC 1418), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Clinical Research Unit (URC Mondor), Hôpitaux Universitaires Henri-Mondor AP-HP, IMRB - CEPIA/'Clinical Epidemiology And Ageing : Geriatrics, Primary Care and Public Health' [Créteil] (U955 Inserm - UPEC), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), INSERM U1059, SAINBIOSE - Santé, Ingénierie, Biologie, Saint-Etienne (SAINBIOSE-ENSMSE), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Cardiology, Hôpital Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], CHU Toulouse [Toulouse], and CHU Henri Mondor
Subjects: Randomization, medicine.medical_treatment, Ventricular Dysfunction, Right, [SDV]Life Sciences [q-bio], Critical Care and Intensive Care Medicine, Placebo, law.invention, Randomized controlled trial, Double-Blind Method, law, Furosemide, medicine, Humans, Diuretics, business.industry, General Medicine, medicine.disease, Pulmonary embolism, Blood pressure, Treatment Outcome, Anesthesia, Acute Disease, Diuretic, Bolus (digestion), Cardiology and Cardiovascular Medicine, business, Pulmonary Embolism, medicine.drug
Abstract: Aims The role of diuretics in patients with intermediate-risk pulmonary embolism (PE) is controversial. In this multicentre, double-blind trial, we randomly assigned normotensive patients with intermediate-risk PE to receive either a single 80 mg bolus of furosemide or a placebo. Methods and results Eligible patients had at least a simplified PE Severity Index (sPESI) ≥1 with right ventricular dysfunction. The primary efficacy endpoint assessed 24 h after randomization included (i) absence of oligo-anuria and (ii) normalization of all sPESI items. Safety outcomes were worsening renal function and major adverse outcomes at 48 hours defined by death, cardiac arrest, mechanical ventilation, or need of catecholamine. A total of 276 patients underwent randomization; 135 were assigned to receive the diuretic, and 141 to receive the placebo. The primary outcome occurred in 68/132 patients (51.5%) in the diuretic and in 49/132 (37.1%) in the placebo group (relative risk = 1.30, 95% confidence interval 1.04–1.61; P = 0.021). Major adverse outcome at 48 h occurred in 1 (0.8%) patients in the diuretic group and 4 patients (2.9%) in the placebo group (P = 0.19). Increase in serum creatinine level was greater in diuretic than placebo group [+4 µM/L (−2; 14) vs. −1 µM/L (−11; 6), P Conclusion In normotensive patients with intermediate-risk PE, a single bolus of furosemide improved the primary efficacy outcome at 24 h and maintained stable renal function. In the furosemide group, urine output increased, without a demonstrable improvement in heart rate, systolic blood pressure, or arterial oxygenation. ClinicalTrials.gov identifier NCT02268903.
Published: 2022
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8. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial

Author: Pierre-Marie Roy, Raphaëlle Lopez, Mustapha Sebbane, Charlotte Steinier, Benjamin Planquette, Nicolas Falvo, Tali-Anne Szwebel, Olivier Hugli, Ygal Benhamou, Jeannot Schmidt, Nicolas Dublanchet, Magali Bartiaux, Alexandre Ghuysen, Delphine Douillet, Antoine Elias, Luc-Marie Joly, Isabelle Mahé, Nicolas Javaud, Laura M. Faber, Francis Couturaud, Isabelle Quéré, Jerome Bokobza, Karine Montaclair, Menno V. Huisman, Damien Viglino, Rosen Cren, Armelle Arnoux, Andrea Penaloza, Gilles Chatellier, Frits I. Mulder, Henry Juchet, Stephan V. Hendriks, Frederikus A. Klok, François-Xavier Lapébie, Thomas Moumneh, Marie Daoud-Elias, Guy Meyer, Gilles Pernod, David Jiménez, Olivier Sanchez, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), SFR UA 4208 Interactions Cellulaires et Applications Thérapeutiques (ICAT), Université d'Angers (UA), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), Université Catholique de Louvain = Catholic University of Louvain (UCL), Cliniques Universitaires Saint-Luc [Bruxelles], Lausanne University Hospital, Leiden University Medical Center (LUMC), Universiteit Leiden, CIC - HEGP (CIC 1418), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Services des urgences [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), University Hospital Sart Tilman [Liège, Belgium], Rode Kruis Hospital Beverwijk, Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hypoxie et PhysioPathologie (HP2), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), CHU Grenoble, Pôle Urgences [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Université Clermont Auvergne (UCA), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hôpital Louis Mourier - AP-HP [Colombes], Hôpital Saint-Pierre, Bruxelles, CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), CIC Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Le Mans (CH Le Mans), Hôpital Charles Nicolle [Rouen], Normandie Université (NU)-Normandie Université (NU), Endothélium, valvulopathies et insuffisance cardiaque (EnVI), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Cochin [AP-HP], Translational Innovation in Medicine and Complexity / Recherche Translationnelle et Innovation en Médecine et Complexité - UMR 5525 (TIMC ), VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), Université Grenoble Alpes (UGA), Techniques pour l'Evaluation et la Modélisation des Actions de la Santé (TIMC-ThEMAS ), Université Grenoble Alpes (UGA)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), CHU Clermont-Ferrand, Hôpital Lapeyronie [Montpellier] (CHU), Université de Montpellier (UM), Universidad de Alcalá de Henares (UAH), Graduate School, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, ARD - Amsterdam Reproduction and Development, HOME-PE Study Group, Feral, A.L., Pastré, J., Roche, A., Cornand, D., Martinez, P., Poggi, J.N., Rezkallah, S., Belizna, C., Bigou, Y., Carraro, Q., Friou, E., Gourdier, A.S., Palous, C., Goetghebeur, D., Armengol, G., Tzebia, C., Dumas, F., Maignan, M., Moustafa, F., Charpentier, S., Bura-Rivière, A., Maillet, F., Plaisance, L., Galanaud, J.P., Henneton, P., Jreige, R., Lehodey, B., Honnart, D., Tfifha, R., Schotte, T., Al Dandachi, G., Simoneau, G., Le Coat, A., Casarin, C., Cismas, A., Germeau, B., Grégoire, C., Hainaut, P., Hermans, C., Lambert, C., Steenebrugge, F., Muriel, M., Moonen, S., Gabrovska, M., Kreps, B., de Longueville, D., Mols, P., Delvaux, P., Van Nuffelen, M., Motte, S., Kamphuisen, P.W., Bresser, C., Hendriks, S., Mairuhu, ATA, van der Pol, L., Fogteloo, A.J., Nijkeuter, M., de Winter, M., Chatellier, G., Hugli, O., Huisman, M., Jimenez, D., Klok, F.A., Meyer, G., Penaloza, A., Roy, P.M., Sanchez, O., Girard, P., den Exter, P., Parent, F., Aujesky, D., Bounameaux, H., Laporte, S., Ten Cate, H., Gable, B., Augereau, C., Chrétien, J.M., Goraguer, A., Houssin, E., Leconte, L., Smii, S., Lasri, F., Haton, C., Marquette, A., Mercier, M., Abello, M., Mitri, F., Leclerq, C., Giansily, D., Aubert, C., Ragueneau, C., Baty, N., Veillon, A.S., Le Gall, B., Bulte, C., Pontdemé, G., Chibah, A., Atia, Y., Makele, P.M., Bouchafa, F., Camminada, C., Hebrard, M., Pelvet, B., Baudoin, D., Pinson, M., Helfer, H., Lefebvre, S., Pontal, D., Lextreyt, B., Bernard, C., Robert, A., Pichon, I., Beuvard, E., Dekeister, A.C., Leon, C., Gerhard-Donnet, H., Moll, S., and de Bruijn, M.
Subjects: medicine.medical_specialty, Randomization, Cardiologie et circulation, Population, Severity of Illness Index, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, law.invention, Randomized controlled trial, Clinical Research, law, medicine, Humans, AcademicSubjects/MED00200, education, Risk assessment, education.field_of_study, Intention-to-treat analysis, business.industry, Emergency department, Acute Disease, Patient Discharge, Prognosis, Pulmonary Embolism/drug therapy, Risk Assessment, Clinical decision-making, Home treatment, Pulmonary embolism, Absolute risk reduction, medicine.disease, Hospitals, Thrombosis and Antithrombotic Treatment, Hospitalization, Embolism, Emergency medicine, Cardiology and Cardiovascular Medicine, business
Abstract: 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., SCOPUS: ar.j, info:eu-repo/semantics/published
Published: 2021
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9. Management of Cancer-Associated Thrombosis in France: A National Survey among Vascular Disease and Supportive Care Specialists

Author: Isabelle Mahé, Céline Chapelle, Ludovic Plaisance, Laurent Bertoletti, Patrick Mismetti, Didier Mayeur, Guillaume Mahé, Francis Couturaud, Université Paris Cité (UPCité), Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Biologie Intégrative du Tissu Osseux (LBTO), Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire Mouvement Sport Santé (M2S), Université de Rennes (UR)-École normale supérieure - Rennes (ENS Rennes)-Université de Brest (UBO)-Université de Rennes 2 (UR2)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), BAYER [FR01902036138N], Jonchère, Laurent, Innovations thérapeutiques en hémostase (IThEM - U1140), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), and Biologie intégrative du tissu osseux
Subjects: [SDV] Life Sciences [q-bio], anticoagulants, Cancer Research, Oncology, [SDV]Life Sciences [q-bio], venous thromboembolism, cancer, treatment guidelines, survey
Abstract: International audience; Low molecular weight heparins (LMWHs) are recommended by international guidelines for at least 6 months in patients with cancer-associated thromboembolism (CAT). Direct oral anticoagulants (DOACs) have been proposed as an alternative to LMWH. In clinical practice, the specialists in charge of CAT have to decide which anticoagulant to prescribe. An electronic survey tool, including vignettes and questions, was sent to members of the French Society of Vascular Medicine, the French-speaking association for supportive care in oncology and the Investigation Network On Venous Thrombo-Embolism. Among the 376 respondents, LMWHs were reported as the first choice by most specialists. The prescription of DOACs within the first 3 weeks of CAT diagnosis was highly dependent on the cancer site: 5.9%, 18.6% and 24.5% in patients with locally advanced colorectal, lung and breast cancer, respectively. The determinants were mostly related to cancer (site and stage or evolution) and to anticancer treatments. For 61% of physicians, some anticancer treatments were contraindications to DOACs. However, almost 90% of physicians considered switching to DOAC after a median 3-month period of LMWHs. In daily practice, LMWHs and DOACs are now considered by specialists of CAT; the decision is mostly driven by the site of cancer. The role of anticancer treatments in the decision remains to be investigated.
Published: 2022
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10. Prevention of venous thromboembolism and haemostasis monitoring in patients with COVID-19: Updated proposals (April 2021)

Author: Alexandre Godon, Charles Ambroise Tacquard, Alexandre Mansour, Delphine Garrigue, Philippe Nguyen, Dominique Lasne, Sophie Testa, Jerrold H. Levy, Pierre Albaladejo, Yves Gruel, Sophie Susen, Anne Godier, P. Albaladejo, N. Blais, F. Bonhomme, A. Borel-Derlon, A. Cohen, J.-P. Collet, E. de Maistre, P. Fontana, D. Garrigue Huet, A. Godier, Y. Gruel, A. Godon, B. Ickx, S. Laporte, D. Lasne, J. Llau, G. Le Gal, T. Lecompte, S. Lessire, J.H. Levy, D. Longrois, S. Madi-Jebara, A. Mansour, M. Mazighi, P. Mismetti, P.E. Morange, S. Motte, F. Mullier, N. Nathan, P. Nguyen, G. Pernod, N. Rosencher, S. Roullet, P.M. Roy, S. Schlumberger, P. Sié, A. Steib, S. Susen, C.A. Tacquard, S. Testa, A. Vincentelli, P. Zufferey, E Boissier, B Dumont, C James, V. Siguret, BrainTech Laboratory [CHU Grenoble Alpes - Inserm U1205] (Brain Tech Lab ), CHU Grenoble-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Service d'Anesthésie-Réanimation [Strasbourg], Nouvel Hôpital Civil [Strasbourg], CHU Strasbourg-CHU Strasbourg, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Universitaire de Reims (CHU Reims), Hémostase, Inflammation, Thrombose (HITH - U1176 Inserm - CHU Bicêtre), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)-Université Paris-Saclay, Istituti Ospitalieri di Cremona, Duke University [Durham], CHU Grenoble, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble, CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Lille, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre Hospitalier Universitaire (CHU), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Saint-Antoine [AP-HP], Institut de cardiologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Hôpitaux Universitaires de Genève (HUG), Université de Genève = University of Geneva (UNIGE), CHU UCL Namur, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Cité (UPCité), Fondation Ophtalmologique Adolphe de Rothschild [Paris], Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Hôpital Lariboisière-Fernand-Widal [APHP], FHU NeuroVasc [Site Sainte-Anne, Paris] (GHU-PPN), Centre Hospitalier Sainte Anne [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), Biologie Intégrative du Tissu Osseux (LBTO), Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique - Epidémiologie Clinique Saint-Etienne (CIC-EC), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), F-Crin Innovte [CHU Saint-Etienne], Service d’Hématologie Biologique [CHU Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Roche, and Sanofi
Subjects: medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, [SDV]Life Sciences [q-bio], COVID-19, Retrospective cohort study, General Medicine, Perioperative, Critical Care and Intensive Care Medicine, medicine.disease, Thrombosis, Article, Anticoagulation, Thrombotic risk, Anesthesiology and Pain Medicine, Intensive care, Bleeding risk, Epidemiology, Medicine, In patient, business, Intensive care medicine, Thromboprophylaxis, Venous thromboembolism
Abstract: In April 2020, in response to the high thrombotic risk associated with COVID-19, the GIHP and GFHT published proposals for the prevention of venous thromboembolism (VTE) and haemostasis monitoring in patients with COVID-19 [1]. In February 2021, six authors from the proposals (CT, AM, AlG, AnG, SS, YG, PA) decided to update them. This update was justified by several points: - The epidemiology of thrombotic complications has been described. - Different anticoagulation regimens have been reported, and retrospective studies have suggested that higher-than-standard prophylactic anticoagulation may be beneficial. - Initially underestimated, bleeding complications have emerged as a limitation of increased-dose anticoagulation and occur later than thrombotic events. - The first results of large-scale randomised controlled studies on increased doses of anticoagulation have been published. - Immunomodulatory therapies (corticosteroids, interleukin-6 receptor antagonists) are now widely used, but their effect on the thrombotic risk is unknown. - Despite improved survival, thrombotic complications remain a concern [2].
Published: 2021
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11. Compared to randomized studies, observational studies may overestimate the effectiveness of DOACs: a metaepidemiological approach

Author: Michel Cucherat, Cyril Ferdynus, Laurent Bertoletti, Edouard Ollier, Patrick Mismetti, Silvy Laporte, Céline Chapelle, Maissa Safieddine, Unité de Soutien Méthodologique [CHU La Réunion] (USM), Centre Hospitalier Universitaire de La Réunion (CHU La Réunion), Biologie intégrative du tissu osseux, Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), CHU Saint-Etienne, Centre d'Investigation Clinique de La Réunion - INSERM (CIC 1410), Université de La Réunion (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de La Réunion (CHU La Réunion), Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), CCSD, Accord Elsevier, Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), and Biologie Intégrative du Tissu Osseux (LBTO)
Subjects: Male, medicine.medical_specialty, Biomedical Research, Ratio of hazard ratio, Epidemiology, [SDV]Life Sciences [q-bio], Population, Guidelines as Topic, law.invention, Direct oral anticoagulants, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Humans, Overestimation, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, education, Observational studies, Proportional Hazards Models, Randomized Controlled Trials as Topic, Retrospective Studies, education.field_of_study, business.industry, Data Collection, Confounding, Hazard ratio, Anticoagulants, Retrospective cohort study, Venous Thromboembolism, Metaepidemiological study, Middle Aged, 3. Good health, [SDV] Life Sciences [q-bio], Observational Studies as Topic, Treatment Outcome, Research Design, Residual confounding, Female, Observational study, business, 030217 neurology & neurosurgery, Cohort study
Abstract: Background and Objectives Randomized controlled trials (RCTs) are criticized for including patients who are overselected. Health authorities consequently encourage “real-world” postmarketing cohort studies. Our objective was to determine the differences between RCTs and observational studies as regards their populations and efficacy/safety results. Methods A systematic review was conducted to identify RCTs and observational studies including patients with venous thromboembolism receiving direct oral anticoagulants or conventional treatment. Ratios of hazard ratio (RHR) comparing epidemiological studies (prospective and retrospective cohort studies and studies using living databases) with RCTs were computed. Results Six RCTs (27,121 patients) and twenty observational studies (248,971 patients) were identified and analyzed. Prospective cohort studies seemed to recruit patients who were no less selected than those of RCTs whereas other types of observational studies may reflect the population treated in real life. Among observational studies, prospective cohort studies yielded the most favorable estimates of treatment effect compared with RCTs. These studies were associated with a nonsignificant 33% increase in efficacy estimate (RHR 0.67, [95% CI, 0.39–1.18]) but no effect on safety estimate. Studies using living databases were associated with nonsignificant trends toward a greater effect on efficacy (RHR 0.82, [0.66–1.01]) and a smaller effect on safety (RHR 1.33, [0.96–1.84]). Discussion Overall, in this clinical setting, an exaggeration of the treatment efficacy estimate was seen with observational studies compared with RCTs. Conclusions As the presence of residual confounding cannot be excluded, these results should be interpreted cautiously.
Published: 2021
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12. Prevalence and characteristics of pulmonary embolism in 1042 COVID-19 patients with respiratory symptoms: A nested case-control study

Author: Hélène Beaussier, Nassim Mohamedi, David M. Smadja, Olivier Sanchez, Isabelle Lazareth, Lina Khider, Marc Zins, Joseph Emmerich, Alexandra Yannoutsos, Laure Fournier, Gilles Chatelier, Cédric Bruel, Guillaume Goudot, Stéphane Jouveshomme, Benjamin Planquette, Jean Luc Diehl, Tristan Mirault, Jean-Jacques Mourad, Marie de Torcy, Nicolas Gendron, Emmanuel Messas, Alice Le Berre, Guy Meyer, Pascal Priollet, Innovations thérapeutiques en hémostase (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Fondation Alain Carpentier - (Centre Médical International) [Paris] (FAC - CMI), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre hospitalier Saint-Joseph [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Physique pour la médecine (PhysMed Paris), Ecole Superieure de Physique et de Chimie Industrielles de la Ville de Paris (ESPCI Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), CIC - HEGP (CIC 1418), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), CCSD, Accord Elsevier, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Physique pour la médecine (UMR 8063, U1273), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Ecole Superieure de Physique et de Chimie Industrielles de la Ville de Paris (ESPCI Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)
Subjects: Male, Chest Pain, medicine.medical_specialty, Computed Tomography Angiography, [SDV]Life Sciences [q-bio], Population, 030204 cardiovascular system & hematology, Article, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, 0302 clinical medicine, Tachycardia, Internal medicine, D-dimer, Prevalence, medicine, Humans, Thrombophilia, CTPA, education, Aged, Retrospective Studies, education.field_of_study, business.industry, Pulmonary embolism, Case-control study, COVID-19, Retrospective cohort study, Hematology, Odds ratio, Middle Aged, medicine.disease, Combined Modality Therapy, Respiration, Artificial, Confidence interval, COVID-19 Drug Treatment, 3. Good health, [SDV] Life Sciences [q-bio], Case-Control Studies, 030220 oncology & carcinogenesis, Nested case-control study, Female, France, Symptom Assessment, Tomography, X-Ray Computed, business
Abstract: Introduction Coronavirus disease 2019 (COVID-19) has been associated with cardiovascular complications and coagulation disorders. Previous studies reported pulmonary embolism (PE) in severe COVID-19 patients. Aim of the study was to estimate the prevalence of symptomatic PE in COVID-19 patients and to identify the clinical, radiological or biological characteristics associated with PE. Patients/methods We conducted a retrospective nested case-control study in 2 French hospitals. Controls were matched in a 1:2 ratio on the basis of age, sex and center. PE patients with COVID-19 were compared to patients in whom PE was ruled out (CTPA controls) and in whom PE has not been investigated (CT controls). Results PE was suspected in 269 patients among 1042 COVID-19 patients, and confirmed in 59 patients (5.6%). Half of PE was diagnosed at COVID-19 diagnosis. PE patients did not differ from CT and CTPA controls for thrombosis risk factors. PE patients more often required invasive ventilation compared to CTPA controls (odds ratio (OR) 2.79; 95% confidence interval (CI) 1.33–5.84) and to CT controls (OR 8.07; 95% CI 2.70–23.82). PE patients exhibited more extensive parenchymal lesions (>50%) than CT controls (OR 3.90; 95% CI 1.54–9.94). D-dimer levels were 5.1 (95% CI 1.90–13.76) times higher in PE patients than CTPA controls. Conclusions Our results suggest a PE prevalence in COVID-19 patients close to 5% in the whole population and to 20% of the clinically suspected population. PE seems to be associated with more extensive lung damage and to require more frequently invasive ventilation., Highlights • Pulmonary embolism is highly prevalent in patients with COVID-19 pneumonia. • In 1 out of 2 cases, pulmonary embolism was diagnosed on hospital admission. • COVID-19 patients admitted to ICU were at high risk for pulmonary embolism. • Pulmonary embolism was correlated with extension of COVID-19 lesions on CT scan.
Published: 2021
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13. Implementation of a systematic comprehensive geriatric assessment for elderly patients suspected of pulmonary hypertension

Author: Laurent Bertoletti, Paul-Benoit Poble, Sandrine Accassat, Ludovic Lafaie, Cécile Duvillard, Pierre-Benoît Bonnefoy, Thomas Celarier, Claire Tulane, Souad Bezzeghoud, Elodie De Magalhaers, Biologie intégrative du tissu osseux, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Jean Monnet [Saint-Étienne] (UJM), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC Saint Etienne, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Nord (Saint Etienne), Université Jean Monnet [Saint-Étienne] (UJM), F-Crin Innovte [CHU Saint-Etienne], and CCSD, Accord Elsevier
Subjects: Male, Pulmonary and Respiratory Medicine, Pediatrics, medicine.medical_specialty, Hypertension, Pulmonary, [SDV]Life Sciences [q-bio], Diagnostic Techniques, Cardiovascular, Functional impact, 030204 cardiovascular system & hematology, Risk Assessment, Pulmonary hypertension, Diagnosis, Differential, 03 medical and health sciences, Elderly, 0302 clinical medicine, Humans, Medicine, In patient, Age of Onset, Intensive care medicine, Aged, Implementation Science, Aged, 80 and over, Geriatrics, business.industry, Cancer, Geriatric assessment, Mean age, Reference Standards, medicine.disease, 3. Good health, [SDV] Life Sciences [q-bio], 030220 oncology & carcinogenesis, Female, France, business
Abstract: International audience; Background: The phenotype of patients seen for a suspicion of pulmonary hypertension has changed, with an increasing age and frequency of comorbidities. Selection of elderly patients, in whom a classical work-up is mandatory, is challenging. Comprehensive geriatric assessment (CGA) has modified the management of elderly patients with cancer. Pulmonary hypertension (PH) shares with cancer a functional impact and may evolve rapidly, depending on the group of PH. We assessed the impact of a systematic CGA in patients over 70 years old referred for a suspicion of PH.Methods: A standardised CGA was performed on every patient older than 70 years old, referred for a PH suspicion, before considering invasive tests for diagnosis and treatment, between July 2014 and May 2019. Our primary aim was to describe the impact of CGA on the decision to stop or pursue the recommended diagnostic work-up for PH.Results: Among the thirty-one patients evaluated [mean age 81,5 (72-91) years], a negative CGA leads to stop the diagnostic work-up in eleven patients. Among the nineteen remaining patients, sixteen had confirmed PH, with half being chronic thromboembolic pulmonary hypertension.Conclusions: Our study indicates that comprehensive geriatric assessment could be an excellent first screen for elderly patients referred for a PH suspicion. Involving a geriatric physician stopped the investigations in one third of patients. In patients with a favourable CGA, PH was confirmed in most of the cases, with chronic thromboembolic pulmonary hypertension being the first cause of PH.
Published: 2020
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14. Twice- or Once-Daily Dosing of Direct Oral Anticoagulants, a systematic review and meta-analysis

Author: S. Provencher, Patrice Nony, Silvy Laporte, Guillaume Grenet, Sabine Mainbourg, Laurent Bertoletti, Patrick Mismetti, Claire Grange, R. Kilo, François Gueyffier, Jean-Christophe Lega, Michel Cucherat, I. Durieu, Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Biologie intégrative du tissu osseux, Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Université Laval [Québec] (ULaval), Biologie Intégrative du Tissu Osseux (LBTO), Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Centre d'Investigation Clinique - Epidémiologie Clinique Saint-Etienne (CIC-EC), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), F-Crin Innovte [CHU Saint-Etienne], CHU Saint-Etienne, CIC Saint Etienne, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Nord (Saint Etienne), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), and CCSD, Accord Elsevier
Subjects: Acute coronary syndrome, medicine.medical_specialty, Pyridones, Deep vein, [SDV]Life Sciences [q-bio], Administration, Oral, Hemorrhage, 030204 cardiovascular system & hematology, Major bleeding, Dabigatran, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Rivaroxaban, Edoxaban, Internal medicine, Atrial Fibrillation, Medicine, Humans, Risk of thrombosis, Dosing regimen, business.industry, Darexaban, Anticoagulants, Hematology, medicine.disease, 3. Good health, [SDV] Life Sciences [q-bio], Stroke, Regimen, Meta-analysis, medicine.anatomical_structure, Treatment Outcome, chemistry, 030220 oncology & carcinogenesis, Apixaban, business, medicine.drug, Direct oral anticoagulant
Abstract: International audience; Aim: The direct oral anticoagulants (DOAC) have similar half-lives, but the dosing regimen varies between once daily (QD) or twice daily (BID). For some prescribers, the QD regimen improves compliance. Others prefer BID regimens to promote better stability of plasma concentrations, particularly in the event of missed doses. Limited level of evidence provides guidance about the best treatment strategy. The purpose of this study was to compare the treatment effect of QD vs. BID administration of DOACs in major orthopedic surgery (MOS), non-valvular atrial fibrillation (NVAF), venous thromboembolism (VTE), and acute coronary syndrome (ACS).Methods: We conducted a systematic review up to April 2020. We included phase II clinical trials comparing DOAC QD vs BID with same daily dose. We extracted data for the occurrence of major thrombosis (proximal deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke) and major hemorrhage (ISTH criteria and recommendations of the European Medicines Agency for surgical patients). Relative risks (RR) were combined using a fixed and random effects weighted meta-analysis.Results: Twelve randomized, controlled, phase II trials were included (10,716 patients), representing 24 dosing regimen comparisons of apixaban, darexaban, edoxaban, rivaroxaban, letaxaban, and dabigatran. There was no difference for major thrombotic event (RRBID/QD = 1.06, 95%IC 0.86-1.30) nor for major bleeding (RRBID/QD = 1.02, 95%IC 0.84-1.23) between the BID vs QD regimens, without heterogeneity (I2 = 0%).Conclusion: Our study does not support a global difference in term of efficacy and safety of the BID and QD regimens of DOAC in MOS, NVAF, VTE and ACS.
Published: 2020
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15. Early detection of the existence or absence of the treatment effect: A cumulative meta-analysis

Author: Silvy Laporte, Edouard Ollier, Guy Meyer, Laurent Bertoletti, Jane-Chloé Trone, Céline Chapelle, Patrick Mismetti, Maissa Safieddine, Philippe Girard, Michel Cucherat, Biologie intégrative du tissu osseux, Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Hôpital Nord (Saint Etienne), F-Crin Innovte [CHU Saint-Etienne], Institut de Cancérologie Lucien Neuwirth, CHU Saint-Etienne, Institut Mutualiste de Montsouris (IMM), Université Paris Cité (UPCité), Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Hospices Civils de Lyon (HCL), CCSD, Accord Elsevier, Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Paris (UP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Biologie Intégrative du Tissu Osseux (LBTO), and Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)
Subjects: Oncology, medicine.medical_specialty, Survival, Epidemiology, medicine.drug_class, [SDV]Life Sciences [q-bio], Early detection, Low molecular weight heparin, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Neoplasms, medicine, Humans, Treatment effect, 030212 general & internal medicine, Cancer, Randomized Controlled Trials as Topic, business.industry, Anticoagulants, Venous Thromboembolism, Heparin, Low-Molecular-Weight, medicine.disease, Survival Analysis, Confidence interval, 3. Good health, [SDV] Life Sciences [q-bio], Treatment Outcome, Meta-analysis, p-hacking, business, 030217 neurology & neurosurgery, Cumulative meta-analysis
Abstract: International audience; Objectives: An unexpected promising effect of low molecular weight heparins (LMWHs) on survival in patients with cancer was observed in early trials in post hoc subgroup analyses but not found in more recent trials. To highlight a possible regression over time toward the lack of the antitumoral effect of LMWHs, we performed a cumulative meta-analysis of survival data from randomized controlled trials (RCTs).Study design and setting: Medical databases were searched to identify RCTs comparing, in patients with cancer, LMWHs with placebo or no treatment in patients free of venous thromboembolism (VTE), or to vitamin K antagonists in patients who experienced an acute VTE in overall survival. The cumulative hazard ratio (HR) was estimated after each study inclusion in chronological order.Results: Twenty-three studies (12,970 patients) were included. The cumulative meta-analysis of the earlier trials showed a significant improvement in overall survival with LMWHs. This apparent benefit then gradually regressed over time toward an absence of the effect of LMWHs on survival (HR: 0.98 [95% confidence interval, 0.93; 1.03]).Conclusion: Despite supportive experimental data and early clinical findings, the promising antitumoral effect of LMWHs in patients with cancer gradually vanished over time toward a lack of impact on overall survival. This result suggests 'p-hacking' and selective reporting of the positive results from post hoc subgroup analyses in the early studies.
Published: 2019
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16. French vascular physicians’ practices in indicating antiplatelet and anticoagulation therapy in venous thromboembolism

Author: Antoine Fayol, Guillaume Mahé, Clément Hoffmann, Damien Lanéelle, Isabelle Mahé, Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), CHU Pontchaillou [Rennes], Innovations thérapeutiques en hémostase (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), CIC Saint Etienne, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Nord (Saint Etienne), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), HULOT, Jean-Sébastien, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)
Subjects: medicine.medical_specialty, medicine.drug_class, 030204 cardiovascular system & hematology, antiplatelet therapy, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, law, medicine, Humans, Thrombolytic Therapy, 030212 general & internal medicine, Prospective Studies, anticoagulation, Vascular Medicine, Response rate (survey), business.industry, Anticoagulant, Anticoagulants, Venous Thromboembolism, venous thromboembolism disease, 3. Good health, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Emergency medicine, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Cardiology and Cardiovascular Medicine, business, Venous thromboembolism, Platelet Aggregation Inhibitors
Abstract: Summary. Background: As antiplatelet therapy becomes widespread, physicians face the issue patients being treated with antiplatelet agents (APA) and anticoagulants for venous thromboembolism (VTE). Bleeding risk of this combination is increased 1.5–2.5-fold. The aim of this survey is to assess French vascular physician’s management of this combination at the beginning of the treatment and at 6 months of treatment for VTE. Patients and methods: French vascular physicians were surveyed between September and December 2017, using 4 fictional scenarios regarding a VTE event diagnosed in a patient under antiplatelet therapy plus isolated questions in an online questionnaire, sent by the French Society of Vascular Medicine to its members. Out of 1812 physicians, 179 returned valid questionnaires: the response rate was 9.9%. Results: Firstly 97.2% of respondents acknowledged extra risk with this combination; and 63% ceased antiplatelet therapy when initiating anticoagulants; while 36% did not. Secondly, four strategies emerged: 31.4% ceased APA and prescribed full-dose anticoagulants at initiation and at 6 months; 32% associated reduced-dose anticoagulation with APA at 6 months, regardless of what they decided at initiation; 16.5% prescribed isolated full-dose anticoagulants at initiation and reduced-dose at 6 months; lastly 11.2% associated full-dose anticoagulant with antiplatelet therapy at initiation and at 6 months. Conclusions: French vascular physicians adopted different strategies according to estimated risk/benefit ratio. Prospective randomized controlled trials should compare these strategies in order to make recommendations.
Published: 2019
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17. Low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy: Rationale and design of the Highlow study, a randomised trial of two doses.

Author: Bleker SM, Buchmüller A, Chauleur C, Ní Áinle F, Donnelly J, Verhamme P, Jacobsen AF, Ganzevoort W, Prins M, Beyer-Westendorf J, DeSancho M, Konstantinides S, Pabinger I, Rodger M, Decousus H, and Middeldorp S
Subjects: Adult, Anticoagulants administration & dosage, Anticoagulants adverse effects, Female, Hemorrhage chemically induced, Heparin, Low-Molecular-Weight administration & dosage, Heparin, Low-Molecular-Weight adverse effects, Humans, Postpartum Period, Pregnancy, Recurrence, Secondary Prevention, Treatment Outcome, Young Adult, Anticoagulants therapeutic use, Heparin, Low-Molecular-Weight therapeutic use, Pregnancy Complications, Cardiovascular prevention & control, Venous Thromboembolism prevention & control
Abstract: Background: Women with a history of venous thromboembolism (VTE) have a 2% to 10% absolute risk of VTE recurrence during subsequent pregnancies. Therefore, current guidelines recommend that all pregnant women with a history of VTE receive pharmacologic thromboprophylaxis. The optimal dose of low-molecular-weight heparin (LMWH) for thromboprophylaxis is unknown. In the Highlow study (NCT 01828697; www.highlowstudy.org), we compare a fixed low dose of LMWH with an intermediate dose of LMWH for the prevention of pregnancy-associated recurrent VTE. We present the rationale and design features of this study., Methods: The Highlow study is an investigator-initiated, multicentre, international, open-label, randomised trial. Pregnant women with a history of VTE and an indication for ante- and postpartum pharmacologic thromboprophylaxis are included before 14weeks of gestation. The primary efficacy outcome is symptomatic recurrent VTE during pregnancy and 6weeks postpartum. The primary safety outcomes are clinically relevant bleeding, blood transfusions before 6weeks postpartum and mortality. Patients are closely monitored to detect cutaneous reactions to LMWH and are followed for 3months after delivery. A central independent adjudication committee adjudicates all suspected outcome events., Conclusion: The Highlow study is the first large randomised controlled trial in pregnancy that will provide high-quality evidence on the optimal dose of LWMH thromboprophylaxis for the prevention of recurrent VTE in pregnant women with a history of VTE., (Copyright © 2016 Elsevier Ltd. All rights reserved.)
Published: 2016
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17 results on '"F-Crin Innovte [CHU Saint-Etienne]"'

1. Evaluation of the 'hemoptysis' item in clinical decision rules for the diagnosis of pulmonary embolism in the emergency department

2. Pulmonary embolism detection on venous thrombosis ultrasound images with bi-dimensional entropy measures: preliminary results

3. Effect of weight-adjusted intermediate-dose versus fixed-dose prophylactic anticoagulation with low-molecular-weight heparin on venous thromboembolism among noncritically and critically ill patients with COVID-19: the COVI-DOSE trial, a multicenter, randomised, open-label, phase 4 trial

4. Frequency and Predictors for Chronic Thromboembolic Pulmonary Hypertension after a first Unprovoked Pulmonary Embolism: results from PADIS studies

5. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study

6. Intramuscular Vaccination in Adults with Therapeutic Anticoagulation in the Era of COVID-19 Vaccines Outbreak: A Practical Review

7. Diuretic vs. placebo in intermediate-risk acute pulmonary embolism: a randomized clinical trial

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

9. Management of Cancer-Associated Thrombosis in France: A National Survey among Vascular Disease and Supportive Care Specialists

10. Prevention of venous thromboembolism and haemostasis monitoring in patients with COVID-19: Updated proposals (April 2021)

11. Compared to randomized studies, observational studies may overestimate the effectiveness of DOACs: a metaepidemiological approach

12. Prevalence and characteristics of pulmonary embolism in 1042 COVID-19 patients with respiratory symptoms: A nested case-control study

13. Implementation of a systematic comprehensive geriatric assessment for elderly patients suspected of pulmonary hypertension

14. Twice- or Once-Daily Dosing of Direct Oral Anticoagulants, a systematic review and meta-analysis

15. Early detection of the existence or absence of the treatment effect: A cumulative meta-analysis

16. French vascular physicians’ practices in indicating antiplatelet and anticoagulation therapy in venous thromboembolism

17. Low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy: Rationale and design of the Highlow study, a randomised trial of two doses.

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