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1,335 results on '"Simon, Tabassome"'

151. The recognition of human voice in deaf and hearing infants

Author

Coëz, Arnaud, primary, Loundon, Natalie, additional, Rouillon, Isabelle, additional, Parodi, Marine, additional, Blanchard, Marion, additional, Achard, Sophie, additional, Garabédian, Eréa-Noël, additional, Bizaguet, Eric, additional, Simon, Tabassome, additional, Tessier, Natacha, additional, Denoyelle, Françoise, additional, and Gervain, Judit, additional

Published
2022
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152. Economic evaluation of fractional flow reserve-guided versus angiography-guided multivessel revascularisation in ST-segment elevation myocardial infarction patients in the FLOWER-MI randomised trial

Author

Le Bras, Alicia, primary, Puymirat, Etienne, additional, Rabetrano, Hasina, additional, Cayla, Guillaume, additional, Simon, Tabassome, additional, Steg, Gabriel, additional, Montalescot, Gilles, additional, Varenne, Olivier, additional, Bonello, Laurent, additional, Coste, Pierre, additional, Delarche, Nicolas, additional, Georges, Jean-Louis, additional, Chassaing, Stephan, additional, Letocart, Vincent, additional, Chatellier, Gilles, additional, Danchin, Nicolas, additional, and Durand-Zaleski, Isabelle, additional

Published
2022
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153. Economic evaluation of restrictive vs. liberal transfusion strategy following acute myocardial infarction (REALITY): trial-based cost–effectiveness and cost–utility analyses

Author

Durand-Zaleski, Isabelle, primary, Ducrocq, Gregory, additional, Mimouni, Maroua, additional, Frenkiel, Jerome, additional, Avendano-Solá, Cristina, additional, Gonzalez-Juanatey, Jose R, additional, Ferrari, Emile, additional, Lemesle, Gilles, additional, Puymirat, Etienne, additional, Berard, Laurence, additional, Cachanado, Marine, additional, Arnaiz, Joan Albert, additional, Martínez-Sellés, Manuel, additional, Silvain, Johanne, additional, Ariza-Solé, Albert, additional, Calvo, Gonzalo, additional, Danchin, Nicolas, additional, Paco, Sandra, additional, Drouet, Elodie, additional, Abergel, Helene, additional, Rousseau, Alexandra, additional, Simon, Tabassome, additional, and Steg, Philippe Gabriel, additional

Published
2022
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154. Deleterious synergistic effects of acute heart failure and diabetes mellitus in patients with acute coronary syndrome: Data from the FAST-MI Registries

Author

Dillinger, Jean-Guillaume, primary, Achkouty, Guy, additional, Albert, Franck, additional, Muller, Grégoire, additional, Labèque, Jean-Noël, additional, Moisson, Louis, additional, Morelle, Jean-François, additional, Cottin, Yves, additional, Pezel, Theo, additional, Lim, Pascal, additional, Aissaoui, Nadia, additional, Schiele, François, additional, Ferrières, Jean, additional, Angoulvant, Denis, additional, Henry, Patrick, additional, Puymirat, Etienne, additional, Simon, Tabassome, additional, and Danchin, Nicolas, additional

Published
2022
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158. Cost-effectiveness of ticagrelor in patients with type 2 diabetes and coronary artery disease : a European economic evaluation of the THEMIS trial.

Author

Steg, Philippe Gabriel, Bhatt, Deepak L, James, Stefan, Darlington, Oliver, Hoskin, Louise, Simon, Tabassome, Fox, Kim M, Leiter, Lawrence A, Mehta, Shamir R, Harrington, Robert A, Himmelmann, Anders, Ridderstråle, Wilhelm, Andersson, Marielle, Bueno, Héctor, De Luca, Leonardo, Tank, Amarjeet, Mellström, Carl, McEwan, Phil, Steg, Philippe Gabriel, Bhatt, Deepak L, James, Stefan, Darlington, Oliver, Hoskin, Louise, Simon, Tabassome, Fox, Kim M, Leiter, Lawrence A, Mehta, Shamir R, Harrington, Robert A, Himmelmann, Anders, Ridderstråle, Wilhelm, Andersson, Marielle, Bueno, Héctor, De Luca, Leonardo, Tank, Amarjeet, Mellström, Carl, and McEwan, Phil

Abstract

AIMS: To conduct a health economic evaluation of ticagrelor in patients with type 2 diabetes and coronary artery disease (CAD) from a multinational payer perspective. Cost-effectiveness and cost-utility of ticagrelor were evaluated in the overall effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS) trial population and in the predefined patient group with prior percutaneous coronary intervention. METHODS AND RESULTS: A Markov model was developed to extrapolate patient outcomes over a lifetime horizon. The primary outcome was incremental cost-effectiveness ratios (ICERs), which were compared with conventional willingness-to-pay thresholds [€47 000/quality-adjusted life-year (QALY) in Sweden and €30 000/QALY in other countries].Treatment with ticagrelor resulted in QALY gains of up to 0.045 in the overall population and 0.099 in patients with percutaneous coronary intervention (PCI). Increased costs and benefits translated to ICERs ranged between €27 894 and €42 252/QALY across Sweden, Germany, Italy, and Spain in the overall population. In patients with prior PCI, estimated ICERs improved to €18 449, €20 632, €20 233, and €13 228/QALY in Sweden, Germany, Italy, and Spain, respectively, driven by higher event rates and treatment benefit. CONCLUSION: Based on THEMIS results, ticagrelor plus aspirin compared with aspirin alone may be cost-effective in some European countries in patients with T2DM and CAD and no prior myocardial infarction (MI) or stroke. Additionally, ticagrelor is likely to be cost-effective across European countries in patients with a history of PCI.

Published
2022
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159. Polypill Strategy in Secondary Cardiovascular Prevention

Author

Castellano, Jose M., Pocock, Stuart J., Bhatt, Deepak L., Quesada, Antonio J., Owen, Ruth, Fernandez-Ortiz, Antonio, Sanchez, Pedro L., Ortuño, Francisco Marin, Vazquez Rodriguez, Jose M., Domingo-Fernández, Alexandra, Lozano, Iñigo, Roncaglioni, Maria C., Baviera, Marta, Foresta, Andreana, Ojeda-Fernandez, Luisa, Colivicchi, Furio, Di Fusco, Stefania A., Doehner, Wolfram, Meyer, Antje, Schiele, François, Ecarnot, Fiona, Linhart, Aleš, Lubanda, Jean Claude, Barczi, Gyorgy, Merkely, Bela, Ponikowski, Piotr, Kasprzak, Marta, Fernandez Alvira, Juan M., Andres, Vicente, Bueno, Hector, Collier, Timothy, Van de Werf, Frans, Perel, Pablo, Rodriguez-Manero, Moises, Garcia, Angeles Alonso, Proietti, Marco, Schoos, Mikkel M., Simon, Tabassome, Ferro, Jose Fernandez, Lopez, Nicolas, Beghi, Ettore, Bejot, Yannick, Vivas, David, Cordero, Alberto, Ibañez, Borja, Fuster, Valentin, Castellano, Jose M., Pocock, Stuart J., Bhatt, Deepak L., Quesada, Antonio J., Owen, Ruth, Fernandez-Ortiz, Antonio, Sanchez, Pedro L., Ortuño, Francisco Marin, Vazquez Rodriguez, Jose M., Domingo-Fernández, Alexandra, Lozano, Iñigo, Roncaglioni, Maria C., Baviera, Marta, Foresta, Andreana, Ojeda-Fernandez, Luisa, Colivicchi, Furio, Di Fusco, Stefania A., Doehner, Wolfram, Meyer, Antje, Schiele, François, Ecarnot, Fiona, Linhart, Aleš, Lubanda, Jean Claude, Barczi, Gyorgy, Merkely, Bela, Ponikowski, Piotr, Kasprzak, Marta, Fernandez Alvira, Juan M., Andres, Vicente, Bueno, Hector, Collier, Timothy, Van de Werf, Frans, Perel, Pablo, Rodriguez-Manero, Moises, Garcia, Angeles Alonso, Proietti, Marco, Schoos, Mikkel M., Simon, Tabassome, Ferro, Jose Fernandez, Lopez, Nicolas, Beghi, Ettore, Bejot, Yannick, Vivas, David, Cordero, Alberto, Ibañez, Borja, and Fuster, Valentin

Abstract

BACKGROUND A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting–enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction. METHODS In this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke. RESULTS A total of 2499 patients underwent randomization and were followed for a median of 36 months. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P=0.02). A key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P=0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups. CONCLUSIONS Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care.

Published
2022

160. Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial

Author

Guidet, Bertrand, Leblanc, Guillaume, Simon, Tabassome, Woimant, Maguy, Quenot, Jean-Pierre, Ganansia, Olivier, Maignan, Maxime, Yordanov, Youri, Delerme, Samuel, Doumenc, Benoit, Fartoukh, Muriel, Charestan, Pierre, Trognon, Pauline, Galichon, Bertrand, Javaud, Nicolas, Patzak, Anabela, Garrouste-Orgeas, Maïté, Thomas, Caroline, Azerad, Sylvie, Pateron, Dominique, and Boumendil, Ariane

Published
2017
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161. Impact of Selection Bias on Estimation of Subsequent Event Risk

Author

Hu, Yi-Juan, Schmidt, Amand F., Dudbridge, Frank, Holmes, Michael V., Brophy, James M., Tragante, Vinicius, Li, Ziyi, Liao, Peizhou, Quyyumi, Arshed A., McCubrey, Raymond O., Horne, Benjamin D., Hingorani, Aroon D., Asselbergs, Folkert W., Patel, Riyaz S., Long, Qi, Åkerblom, Axel, Algra, Ale, Allayee, Hooman, Almgren, Peter, Anderson, Jeffrey L., Andreassi, Maria G., Anselmi, Chiara V., Ardissino, Diego, Arsenault, Benoit J., Ballantyne, Christie M., Baranova, Ekaterina V., Behloui, Hassan, Bergmeijer, Thomas O., Bezzina, Connie R., Bjornsson, Eythor, Body, Simon C., Boeckx, Bram, Boersma, Eric (H.), Boerwinkle, Eric, Bogaty, Peter, Braund, Peter S., Breitling, Lutz P., Brenner, Hermann, Briguori, Carlo, Brugts, Jasper J., Burkhardt, Ralph, Cameron, Vicky A., Carlquist, John F., Carpeggiani, Clara, Carruthers, Kathryn F., Casu, Gavino, Condorelli, Gianluigi, Cresci, Sharon, Danchin, Nicolas, de Faire, Ulf, Deanfield, John, Delgado, Graciela, Deloukas, Panos, Direk, Kenan, Doughty, Robert N., Drexel, Heinz, Duarte, Nubia E., Dubé, Marie-Pierre, Dufresne, Line, Engert, James C., Eriksson, Niclas, Fitzpatrick, Natalie, Foco, Luisa, Ford, Ian, Fox, Keith A.A., Gigante, Bruna, Gijsberts, Crystel M., Girelli, Domenico, Gong, Yan, Gudbjartsson, Daniel F., Hagström, Emil, Hartiala, Jaana, Hazen, Stanley L., Held, Claes, Helgadottir, Anna, Hemingway, Harry, Heydarpour, Mahyar, Hoefer, Imo E., Hovingh, Kees, Hubacek, Jaroslav A., James, Stefan, Johnson, Julie A., Wouter Jukema, J., Kaczor, Marcin P., Kaminski, Karol A., Kettner, Jiri, Kiliszek, Marek, Kleber, Marcus, Klungel, Olaf H., Kofink, Daniel, Kohonen, Mika, Kotti, Salma, Kuukasjärvi, Pekka, Lagerqvist, Bo, Lambrechts, Diether, Lang, Chim C., Laurikka, Jari O., Leander, Karin, Lee, Vei-Vei, Lehtimäki, Terho, Leiherer, Andreas, Lenzini, Petra A., Levin, Daniel, Lindholm, Daniel, Lokki, Marja-Liisa, Lotufo, Paulo A., Lyytikäinen, Leo-Pekka, Khan Mahmoodi, B., Maitland-van der Zee, Anke H., Martinelli, Nicola, März, Winfried, Marziliano, Nicola, McPherson, Ruth, Melander, Olle, Mons, Ute, Muehlschlegel, Jochen D., Muhlestein, Joseph B., Nelson, Cristopher P., Newton Cheh, Chris, Olivieri, Oliviero, Opolski, Grzegorz, Palmer, Colin N., Pare, Guillaume, Pasterkamp, Gerard, Pepine, Carl J., Pepinski, Witold, Pereira, Alexandre C., Pilbrow, Anna P., Pilote, Louise, Pitha, Jan, Ploski, Rafal, Mark Richards, A., Saely, Christoph H., Samani, Nilesh J., Samman-Tahhan, Ayman, Sanak, Marek, Sandesara, Pratik B., Sattar, Naveed, Scholz, Markus, Siegbahn, Agneta, Simon, Tabassome, Sinisalo, Juha, Gustav Smith, J., Spertus, John A., Stefansson, Kari, Stewart, Alexandre F.R., Stott, David J., Szczeklik, Wojciech, Szpakowicz, Anna, Tanck, Michael W.T., Tang, Wilson H., Tardif, Jean-Claude, ten Berg, Jur M., Teren, Andrej, Thanassoulis, George, Thiery, Joachim, Thorgeirsson, Gudmundur, Thorleifsson, Gudmar, Thorsteinsdottir, Unnur, Timmis, Adam, Trompet, Stella, van de Werf, Frans, van der Graaf, Yolanda, van der Haarst, Pim, van der Laan, Sander W., Vilmundarson, Ragnar O., Virani, Salim S., Visseren, Frank L.J., Vlachopoulou, Efthymia, Wallentin, Lars, Waltenberger, Johannes, Wauters, Els, and Wilde, Arthur A.M.

Published
2017
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169. Prevalence of herpesviruses at onset of idiopathic nephrotic syndrome

Author

Dossier, Claire, Sellier-Leclerc, Anne-Laure, Rousseau, Alexandra, Michel, Yanne, Gautheret-Dejean, Agnes, Englender, Mariana, Madhi, Fouad, Charbit, Marina, Ulinski, Tim, Simon, Tabassome, Jacqz-Aigrain, Evelyne, and Deschenes, Georges

Subjects
Steroids (Drugs) -- Complications and side effects -- Research, Herpes -- Distribution -- Demographic aspects -- Research, Nephrotic syndrome -- Development and progression -- Demographic aspects -- Research, Herpesvirus diseases -- Distribution -- Demographic aspects -- Research, Company distribution practices, Health
Abstract

Background Idiopathic nephrotic syndrome (INS) is likely a primary immune disorder, but viruses might also be involved in the mechanisms of the disease. Here, we investigate the link between herpesvirus infection and the first manifestation of INS in children. Methods A prospective, multicentre, and population-based case-control study called NEPHROVIR included 164 patients, aged 6 months to 15 years old, newly diagnosed with INS, and 233 controls matched for gender, age, and period of sample. The analysis was done on 124 patients and 196 controls. Epstein-Barr virus (EBV), cytomegalovirus (CMV), human herpesvirus-6 (HHV-6), and human herpesvirus-7 (HHV-7) DNA prev alence at diagnosis were assessed from whole peripheral blood samples, as well as EBV and CMV viral load and seroprevalence. Results EBV DNA was significantly more prevalent in cases than in controls (50.8 vs 29.1 %; OR=2.6; p=0.0002), with no difference in viral load. A significant difference was also found for CMV (11.3 vs 3.6 %; p=0.02) and HHV-7 (83 vs 72 %; p=0.02) DNA prevalence between cases and controls. There were significantly more EBV and CMV recent infections or reactivations based on VCA-IgM and CMV IgM in cases than controls, while there were no differences in IgG seroprevalence. Conclusion The prevalence of positive EBV DNA detection and recent infection or reactivation is higher in children at onset of INS compared to a population matched for age, gender, and time of sampling. Keywords Epstein-barr virus * Cytomegalovirus * Steroid-sensitive nephroticsyndrome * Proteinuria Nephrovir, Introduction Steroid-sensitive idiopathic nephrotic syndrome (INS) is likely a primary immune disorder since proteinuria is fully sensitive to prednisone, and numerous immunosuppressive drugs have the ability to control the occurrence [...]

Published
2014
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170. Cost–effectiveness of ticagrelor in patients with type 2 diabetes and coronary artery disease: a European economic evaluation of the THEMIS trial

Author

Steg, Philippe Gabriel, primary, Bhatt, Deepak L, additional, James, Stefan K, additional, Darlington, Oliver, additional, Hoskin, Louise, additional, Simon, Tabassome, additional, Fox, Kim M, additional, Leiter, Lawrence A, additional, Mehta, Shamir R, additional, Harrington, Robert A, additional, Himmelmann, Anders, additional, Ridderstråle, Wilhelm, additional, Andersson, Marielle, additional, Bueno, Héctor, additional, De Luca, Leonardo, additional, Tank, Amarjeet, additional, Mellström, Carl, additional, and McEwan, Phil, additional

Published
2022
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171. Determinants of long-term dual antiplatelet therapy use in post myocardial infarction patients: Insights from the TIGRIS registry

Author

Russo, Juan J, primary, Yan, Andrew T, additional, Pocock, Stuart J, additional, Brieger, David, additional, Owen, Ruth, additional, Sundell, Karolina Andersson, additional, Bagai, Akshay, additional, Granger, Christopher B, additional, Cohen, Mauricio G, additional, Yasuda, Satoshi, additional, Nicolau, Jose C, additional, Brandrup-Wognsen, Gunnar, additional, Westermann, Dirk, additional, Simon, Tabassome, additional, and Goodman, Shaun G, additional

Published
2022
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172. Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial

Author

Courties, Alice, primary, Deprouw, Camille, additional, Rousseau, Alexandra, additional, Berard, Laurence, additional, Touati, Amel, additional, Kalsch, Johanna, additional, Villevieille, Margaux, additional, Maheu, Emmanuel, additional, Miquel, Anne, additional, Simon, Tabassome, additional, Berenbaum, Francis, additional, and Sellam, Jeremie, additional

Published
2022
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173. 002 - TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN EROSIVE HAND OSTEOARTHRITIS: RESULTS OF THE ESTIVAL MULTICENTER RANDOMIZED SHAM-CONTROLLED TRIAL

Author

Courties, Alice, Tuffet, Sophie, Cormier, Grégoire, Roux, Christian, Ornetti, Paul, Pers, Yves-Marie, Gottenberg, Jacques-Eric, Lespessailles, Eric, Chapurlat, Roland, Arniaud, Denis, Rannou, François, Wendling, Daniel, Eymard, Florent, Mathieu, Sylvain, Richette, Pascal, Saraux, Alain, Marotte, Hubert, Poursac, Nicolas, rat, Anne-Christine, Bastard, Jean-Philippe, Fellahi, Soraya, Henrotin, Yves, Deprouw, Camille, Nguyen, Christelle, Touati, Amel, Rousseau, Alexandra, Simon, Tabassome, Maheu, Emmanuel, Berenbaum, Francis, and Sellam, Jeremie

Published
2024
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174. Outpatient healthcare and clinical trials in the care pathway: Organisational and regulatory aspects and tools

Author

Laviolle, Bruno, Diebolt, Vincent, Duchossoy, Luc, Anglaret, Xavier, Behier, Jehan-Michel, Bertoye, Pierre-Henri, Chapron, Anthony, Comet, Denis, Cornu, Catherine, Fouret, Cécile, Galaup, Anne, Guérin, Aurélie, Hoen, Bruno, Imbert, Patrick, Lang, Marie, Le Louarn, Anne, Mezerette, Bastien, Sénéchal, Sophie, Simon, Tabassome, Traineau, Pierre, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-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 ), CHU Pontchaillou [Rennes], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Sanofi Aventis R&D [Chilly-Mazarin], CHU Bordeaux [Bordeaux], UNICANCER, Axonal-Biostatem [Nanterre], 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), Centre d'Investigation Clinique [Bron] (CIC1407), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupement Hospitalier Est [Bron], Medtronic SNT, Medtronic, Les entreprises du Médicament (LEEM), Pfizer, Institut Pasteur [Paris] (IP), Collège National des Généralistes Enseignants (CNGE), Groupement Interrégionale de Recherche Clinique et d'Innova on - GIRCI Ile-de-France, AstraZeneca [Cambridge, UK], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Centre d'expertises en santé connectée (Catel e-santé)

Subjects
Male, Motivation, Clinical Trials as Topic, Patient, [SDV]Life Sciences [q-bio], Digitisation, Hospitals, Clinical research, Digitalisation, Acceptability, Physicians, Ambulatory Care, Critical Pathways, Training, Humans, Pharmacology (medical), Female, Mobile teams, General practice
Abstract

International audience; Clinical research in outpatient healthcare, particularly in general practice, which is the first line of contact with the population, is now a public health issue. However, this type of research has specific characteristics that differentiate it from clinical research conducted in a hospital setting and requires an adaptation of its conditions of practice: in terms of organisation, the development of research in outpatient healthcare relies on the appropriation of its fundamentals by the investigators, which implies their presentation, upstream, from the initial cycle, and the participation of practitioners in training modules adapted to research in primary care, such as those already organised by several GIRCI (Groupement Inter régional de la Recherche Clinique et de l’Innovation [French Interregional Clusters for Clinical Research and Innovation]). To compensate for the fragmented nature of their location, on the model of the EMRCs (équipes mobiles de recherche clinique [mobile clinical research teams]) in oncology, mobile research teams should enable general medical practices to participate in clinical trials. This presupposes, on the one hand, the allocation of earmarked funding to ensure the sustainability of a base of dedicated personnel and, on the other hand, the impetus of a national dynamic through the setting up of a multi-organisation thematic institute for "research in primary care" associated, at the operational level, with a national scale investigation network supported by a platform of excellence. The use of digital tools and innovations (telemedicine; data collection via connected tools; e-consent; electronic signature) which make it possible to digitise and relocate all or part of the research procedures for both the participant and the investigation teams. An adaptation of the legal framework in order to bring the place of research closer to the patient and not the other way round, which means moving the equipment and investigations closer to the patient. Taking into account the acceptability of the patient, thus limiting the disruption that may be caused by his or her participation in a research protocol and motivating the practitioner by valuing his or her contribution and providing all the guarantees of scientific relevance and independence of practice. In view of the contextual analysis, positive feedback and the availability of organisational and digital support points facilitating the delocalisation and digitisation of the conduct of research activity as close as possible to the patient and his or her doctor, the round table concluded that opportunities exist today which favour the development of clinical research in general practice. It is important to seize this opportunity and make the most of it without delay.

Published
2021

175. Effect of a Diagnostic Strategy Using an Elevated and Age-Adjusted D-Dimer Threshold on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism

Author

Freund, Yonathan, Chauvin, Anthony, Jimenez, Sonia, Philippon, Anne-Laure, Curac, Sonja, Fémy, Florent, Gorlicki, Judith, Chouihed, Tahar, Goulet, Hélène, Montassier, Emmanuel, Dumont, Margaux, Lozano Polo, Laura, Le Borgne, Pierrick, Khellaf, Mehdi, Bouzid, Donia, Raynal, Pierre-Alexis, Abdessaied, Nizar, Laribi, Saïd, Guenezan, Jeremy, Ganansia, Olivier, Bloom, Ben, Miró, Oscar, Cachanado, Marine, Simon, Tabassome, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University of Barcelona, Hôpital Beaujon [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), Hôpital Avicenne [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, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), 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), CHU Tenon [AP-HP], Centre hospitalier universitaire de Nantes (CHU Nantes), Universitat Autònoma de Barcelona (UAB), Les Hôpitaux Universitaires de Strasbourg (HUS), CHU Henri Mondor, 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), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, AP-HP - Hôpital Bichat - Claude Bernard [Paris], CHU Saint-Antoine [AP-HP], Centre Hospitalier de Saint-Denis [Ile-de-France], Université de Tours (UT), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre hospitalier Saint-Joseph [Paris], Barts Health NHS Trust [London, UK], Unité de Recherche Clinique de l’Est Parisien [CHU Saint-Antoine] (URC-EST), Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO)-CHU Tenon [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 Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Direction de la Recherche Clinique et de l'Innovation [AP-HP] (DRCI), and gravez, basile

Subjects
[SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio]
Abstract

International audience; Importance: Uncontrolled studies suggest that pulmonary embolism (PE) can be safely ruled out using the YEARS rule, a diagnostic strategy that uses varying D-dimer thresholds.Objective: To prospectively validate the safety of a strategy that combines the YEARS rule with the pulmonary embolism rule-out criteria (PERC) rule and an age-adjusted D-dimer threshold.Design, settings, and participants: A cluster-randomized, crossover, noninferiority trial in 18 emergency departments (EDs) in France and Spain. Patients (N = 1414) who had a low clinical risk of PE not excluded by the PERC rule or a subjective clinical intermediate risk of PE were included from October 2019 to June 2020, and followed up until October 2020.Interventions: Each center was randomized for the sequence of intervention periods. In the intervention period (726 patients), PE was excluded without chest imaging in patients with no YEARS criteria and a D-dimer level less than 1000 ng/mL and in patients with 1 or more YEARS criteria and a D-dimer level less than the age-adjusted threshold (500 ng/mL if age

Published
2021

177. Effect of a Diagnostic Strategy Using an Elevated and Age-Adjusted D-Dimer Threshold on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism

Author

Freund, Yonathan, primary, Chauvin, Anthony, additional, Jimenez, Sonia, additional, Philippon, Anne-Laure, additional, Curac, Sonja, additional, Fémy, Florent, additional, Gorlicki, Judith, additional, Chouihed, Tahar, additional, Goulet, Hélène, additional, Montassier, Emmanuel, additional, Dumont, Margaux, additional, Lozano Polo, Laura, additional, Le Borgne, Pierrick, additional, Khellaf, Mehdi, additional, Bouzid, Donia, additional, Raynal, Pierre-Alexis, additional, Abdessaied, Nizar, additional, Laribi, Saïd, additional, Guenezan, Jeremy, additional, Ganansia, Olivier, additional, Bloom, Ben, additional, Miró, Oscar, additional, Cachanado, Marine, additional, and Simon, Tabassome, additional

Published
2021
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178. Atrial fibrillation and clinical outcomes 1 to 3 years after myocardial infarction

Author

Carnicelli, Anthony P, primary, Owen, Ruth, additional, Pocock, Stuart J, additional, Brieger, David B, additional, Yasuda, Satoshi, additional, Nicolau, Jose Carlos, additional, Goodman, Shaun G, additional, Cohen, Mauricio G, additional, Simon, Tabassome, additional, Westermann, Dirk, additional, Hedman, Katarina, additional, Andersson Sundell, Karolina, additional, and Granger, Christopher B, additional

Published
2021
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179. Plasma and genetic determinants of soluble TREM-1 and major adverse cardiovascular events in a prospective cohort of acute myocardial infarction patients. Results from the FAST-MI 2010 study

Author

Ait-Oufella, Hafid, primary, Yu, Mengyao, additional, Kotti, Salma, additional, Georges, Adrien, additional, Vandestienne, Marie, additional, Joffre, Jeremie, additional, Roubille, François, additional, Angoulvant, Denis, additional, Santos-Zas, Icia, additional, Tedgui, Alain, additional, Gibot, Sébastien, additional, Derive, Marc, additional, Danchin, Nicolas, additional, Bouatia-Naji, Nabila, additional, and Simon, Tabassome, additional

Published
2021
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181. Correlates of pre-hospital morphine use in ST-elevation myocardial infarction patients and its association with in-hospital outcomes and long-term mortality: the FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) programme

Author

Puymirat, Etienne, Lamhaut, Lionel, Bonnet, Nicolas, Aissaoui, Nadia, Henry, Patrick, Cayla, Guillaume, Cattan, Simon, Steg, Gabriel, Mock, Laurent, Ducrocq, Gregory, Goldstein, Patrick, Schiele, François, Bonnefoy-Cudraz, Eric, Simon, Tabassome, and Danchin, Nicolas

Published
2016
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182. Clinical Trials Legislation - Preparing for the Revision of the European Directive Scheduled for 2011

Author

Abiteboul, Michel, Bertram, Delphine, Cornu, Catherine, Chassany, Olivier, Demotes-Mainard, Jacques, Demarez, Jean-Paul, Diebolt, Vincent, Dubray, Claude, Ericson, Mats, Orvoen, Elisabeth Frija, Hirsch, François, Juillet, Yves, Lamarque, Véronique, Le Coent, Rémi, Libersa, Christian, Marey, Christine, Marchenay, Brigitte, Mijonnet, Armelle, Plattner, Valérie, Raison, Anne, Rossignol, Patrick, Rusch, Philippe, Simon, Tabassome, Bilbault, Pascal, Belorgey, Chantal, Zannad, Faiez, Golinelli, Danielle, and Pletan, Yannick

Published
2010
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183. Législation des essais cliniques : préparer la révision de la Directive Européenne prévue en 2011

Author

Abiteboul, Michel, Bertram, Delphine, Cornu, Catherine, Chassany, Olivier, Demotes-Mainard, Jacques, Demarez, Jean-Paul, Diebolt, Vincent, Dubray, Claude, Ericson, Mats, Orvoen, Elisabeth Frija, Hirsch, François, Juillet, Yves, Lamarque, Véronique, Le Coent, Rémi, Libersa, Christian, Marey, Christine, Marchenay, Brigitte, Mijonnet, Armelle, Plattner, Valérie, Raison, Anne, Rossignol, Patrick, Rusch, Philippe, Simon, Tabassome, Bilbault, Pascal, Belorgey, Chantal, Zannad, Faiez, Golinelli, Danielle, and Pletan, Yannick

Published
2010
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186. Diuretic vs. placebo in intermediate-risk acute pulmonary embolism: a randomized clinical trial

Author

Lim, Pascal, primary, Delmas, Clément, additional, Sanchez, Olivier, additional, Meneveau, Nicolas, additional, Rosario, Roger, additional, Bouvaist, Helene, additional, Bernard, Anne, additional, Mansourati, Jacques, additional, Couturaud, Francis, additional, Sebbane, Mustapha, additional, Coste, Pierre, additional, Rohel, Gwenole, additional, Tardy, Bernard, additional, Biendel, Caroline, additional, Lairez, Olivier, additional, Ivanes, Fabrice, additional, Gallet, Romain, additional, Dubois-Rande, Jean-Luc, additional, Fard, Damien, additional, Chatelier, Gilles, additional, Simon, Tabassome, additional, Paul, Muriel, additional, Natella, Pierre-André, additional, Layese, Richard, additional, and Bastuji-Garin, Sylvie, additional

Published
2021
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187. Long-term mortality after ST-elevation myocardial infarction in the reperfusion and modern secondary prevention therapy era according to coronary artery disease extent: The FAST-MI registries

Author

Brunet, Thibaud, primary, Bonello, Laurent, additional, Chamandi, Chekrallah, additional, Tea, Victoria, additional, Nallet, Olivier, additional, Lhermusier, Thibault, additional, Gallet, Romain, additional, Labèque, Jean-Noel, additional, Albert, Franck, additional, Schiele, François, additional, Ferrières, Jean, additional, Simon, Tabassome, additional, Danchin, Nicolas, additional, and Puymirat, Etienne, additional

Published
2021
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188. RCT Abstract - Cyclophosphamide added to glucocorticoids in acute exacerbation of idiopathic pulmonary fibrosis (EXAFIP): a randomized, double-blind, placebo-controlled, phase 3 trial

Author

Naccache, Jean-Marc, primary, Jouneau, Stephane, additional, Didier, Morgane, additional, Borie, Raphaël, additional, Cachanado, Marine, additional, Bourdin, Arnaud, additional, Reynaud-Gaubert, Martine, additional, Bonniaud, Philippe, additional, Israel-Biet, Dominique, additional, Prevot, Gregoire, additional, Hirschi, Sandrine, additional, Lebargy, Francois, additional, Marchand-Adam, Sylvain, additional, Bautin, Nathalie, additional, Traclet, Julie, additional, Gomez, Emmanuel, additional, Leroy, Sylvie, additional, Gagnadoux, Frederic, additional, Rivière, Frederic, additional, Bergot, Emmanuel, additional, Gondouin, Anne, additional, Blanchard, Elodie, additional, Parrot, Antoine, additional, Blanc, Francois-Xavier, additional, Chabrol, Alexandre, additional, Dominique, Stephane, additional, Gibelin, Aude, additional, Tazi, Abdellatif, additional, Berard, Laurence, additional, Brillet, Pierre-Yves, additional, Debray, Marie-Pierre, additional, Rousseau, Alexandra, additional, Kerjouan, Malorie, additional, Freynet, Olivia, additional, Dombret, Marie-Christine, additional, Gamez, Anne-Sophie, additional, Nieves, Ana, additional, Beltramo, Guillaume, additional, Pastré, Jean, additional, Le Borgne-Krams, Aurélie, additional, Dégot, Tristan, additional, Launois, Claire, additional, Plantier, Laurent, additional, Wémeau-Stervinou, Lidwine, additional, Cadranel, Jacques, additional, Chenivesse, Cécile, additional, Valeyre, Dominique, additional, Crestani, Bruno, additional, Cottin, Vincent, additional, Simon, Tabassome, additional, and Nunes, Hilario, additional

Published
2021
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189. Combined use of a broad-panel respiratory multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe community-acquired pneumonia (MULTI-CAP): a multicentre, parallel-group, open-label, individual randomised trial conducted in French intensive care units

Author

Voiriot, Guillaume, primary, Fartoukh, Muriel, additional, Durand-Zaleski, Isabelle, additional, Berard, Laurence, additional, Rousseau, Alexandra, additional, Armand-Lefevre, Laurence, additional, Verdet, Charlotte, additional, Argaud, Laurent, additional, Klouche, Kada, additional, Megarbane, Bruno, additional, Patrier, Juliette, additional, Richard, Jean-Christophe, additional, Reignier, Jean, additional, Schwebel, Carole, additional, Souweine, Bertrand, additional, Tandjaoui-Lambiotte, Yacine, additional, Simon, Tabassome, additional, and Timsit, Jean-François, additional

Published
2021
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190. Economic evaluation of restrictive vs. liberal transfusion strategy following acute myocardial infarction (REALITY): trial-based cost–effectiveness and cost–utility analyses

Author

Durand-Zaleski, Isabelle, Ducrocq, Gregory, Mimouni, Maroua, Frenkiel, Jerome, Avendano-Solá, Cristina, Gonzalez-Juanatey, Jose R, Ferrari, Emile, Lemesle, Gilles, Puymirat, Etienne, Berard, Laurence, Cachanado, Marine, Arnaiz, Joan Albert, Martínez-Sellés, Manuel, Silvain, Johanne, Ariza-Solé, Albert, Calvo, Gonzalo, Danchin, Nicolas, Paco, Sandra, Drouet, Elodie, Abergel, Helene, Rousseau, Alexandra, Simon, Tabassome, and Steg, Philippe Gabriel

Abstract

Graphical AbstractCost utility of restrictive vs liberal transfusion.

Published
2023
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191. Outcome associated with prescription of cardiac rehabilitation according to predicted risk after acute myocardial infarction: Insights from the FAST-MI registries

Author

Debiec, Hanna, Dossier, Claire, Letouzé, Eric, Gillies, Christopher, Vivarelli, Marina, Putler, Rosemary, Ars, Elisabet, Jacqz-Aigrain, Evelyne, Elie, Valery, Colucci, Manuela, Debette, Stéphanie, Amouyel, Philippe, Elalaoui, Siham, Sefiani, Abdelaziz, Dubois, Valérie, Kretzler, Matthias, Ballarin, Jose, Emma, Francesco, Sampson, Matthew, Deschênes, Georges, Ronco, Pierre, Ederhy, Stephane, Cohen, Ariel, Boccara, Franck, Aissaoui, Nadia, Elbaz, Meyer, Bonnefoy-Cudraz, Eric, Druelles, Philipe, Andrieu, Stéphane, Angoulvant, Denis, Furber, Alain, Cottin, Yves, Puymirat, Etienne, Bonaca, Marc, Iliou, Marie-Christine, Tea, Victoria, Ducrocq, Grégory, Douard, Hervé, Labrunee, Marc, Plastaras, Philoktimon, Chevallereau, Pierre, Taldir, Guillaume, Bataille, Vincent, Ferrières, Jean, Schiele, François, Simon, Tabassome, Danchin, Nicolas, Centre de Ressources Biologiques APHP-SU (PASS-CRB-APHP-SU), Unité Mixte de Service Production et Analyse de données en Sciences de la vie et en Santé (PASS), and Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, Time Factors, MESH: Registries, health care facilities, manpower, and services, [SDV]Life Sciences [q-bio], medicine.medical_treatment, Cardiac rehabilitation, 030204 cardiovascular system & hematology, MESH: Risk Assessment, MESH: Aged, 80 and over, 0302 clinical medicine, Risk Factors, MESH: Risk Factors, Medicine, Registries, MESH: Cardiac Rehabilitation, 030212 general & internal medicine, Myocardial infarction, Atherothrombotic risk stratification, Non-ST Elevated Myocardial Infarction, health care economics and organizations, Cancer, MESH: Treatment Outcome, Aged, 80 and over, MESH: Aged, education.field_of_study, MESH: Middle Aged, Framingham Risk Score, Rehabilitation, nephrotic syndrome, MESH: Polymorphism, Single Nucleotide, Hazard ratio, Score, genetic renal disease, General Medicine, Middle Aged, MESH: Recovery of Function, 3. Good health, In-hospital mortality, Treatment Outcome, Stratification risque athérothrombotique, cardiovascular system, Female, France, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, pediatrics, education, Population, Infarctus du myocarde, Acute myocardial infarction, Mortalité, MESH: Phenotype, Risk Assessment, 03 medical and health sciences, Intensive care, Internal medicine, MESH: Spain, Humans, cardiovascular diseases, Mortality, Réadaptation cardiaque, MESH: ST Elevation Myocardial Infarction, Medical prescription, Aged, focal segmental glomerulosclerosis, genome-wide association study, MESH: Humans, business.industry, MESH: Time Factors, MESH: Italy, Recovery of Function, medicine.disease, MESH: Male, MESH: Quantitative Trait Loci, MESH: Steroids, Confidence interval, MESH: France, MESH: Non-ST Elevated Myocardial Infarction, gene expression, Mortalité hospitalière, ST Elevation Myocardial Infarction, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Nephrotic Syndrome, business, MESH: Female
Abstract

Cardiac rehabilitation is strongly recommended in patients after acute myocardial infarction.To assess cardiac rehabilitation prescription after acute myocardial infarction according to predicted risk, and its association with 1-year mortality, using the FAST-MI registries.We used data from three 1-month French nationwide registries, conducted 5 years apart from 2005 to 2015, including 13130 patients with acute myocardial infarction admitted to coronary or intensive care units. Atherothrombotic risk stratification was performed using the Thrombolysis In Myocardial Infarction Risk Score for Secondary Prevention (TRS-2P). Patients were classified into three categories: Group 1 (low risk; no or one risk indicator; score of 0 or 1); Group 2 (intermediate risk; two risk indicators; score of 2); and Group 3 (high risk; at least three risk indicators; score of≥3).Among the 12291 patients, cardiac rehabilitation prescription was 43.6% (49.9% in Group 1; 43.0% in Group 2; 35.2% in Group 3). Using Cox multivariable analysis, cardiac rehabilitation prescription was associated with lower mortality at 1 year in the overall population (3.8% vs. 8.2%; hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.61-0.85; P0.001). Cardiac rehabilitation was associated with improved 1-year mortality, with homogeneous relative risk reductions in low- and intermediate-risk categories (HR 0.70, 95% CI 0.51-0.94) compared with high-risk patients (HR 0.72, 95% CI 0.59-0.88). In absolute terms, however, mortality decrease associated with cardiac rehabilitation was positively correlated with risk level (Group 1, 0.9% vs. 2.4%; Group 2, 3.0% vs. 4.2%; Group 3, 10.5% vs. 17.3%).Cardiac rehabilitation prescription was inversely correlated with patient risk. A positive association between cardiac rehabilitation and 1-year survival after acute myocardial infarction was present whatever the risk level, but the greatest mortality reduction was observed in high-risk patients.

Published
2019

192. Collections of Human Biological Samples for Scientific Purposes. Why do Current Regulation Need to be Clarified and How?

Author

Barraud, Béatrice, Benessiano, Joëlle, Callies, Ingrid, Caplain, Henri, Clément, Bruno, Dagher, Georges, Demerville, Lauren, Duguet, Anne-Marie, Durette, Catherine, Figarella-Branger, Dominique, Fluckiger, Laurence, Frija-Orvoen, Elisabeth, Gadras, Coraline, Gelé, Patrick, Laurent-Vo, Jean-Marc, Lemaire, François, Libersa, Christian, Llau, Marie-Élise, Louvet, Olivier, Merlio, Jean-Philippe, Mijonnet, Armelle, Petitpré, Jean, Pierré, Alain, Pinachyan, Karen, Reynier, Jean-Charles, Sailly, Anabelle, Schiavi, Pierre, Simon, Tabassome, Vidal, Anne, Deplanque, Dominique, Birraux, Guillaume, Bertoye, Pierre-Henri, and Postaire, Éric

Published
2009
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194. Collections d’échantillons biologiques humains à visée scientifique. Pourquoi et comment clarifier la réglementation actuelle ?

Author

Barraud, Béatrice, Benessiano, Joëlle, Callies, Ingrid, Caplain, Henri, Clément, Bruno, Dagher, Georges, Demerville, Lauren, Duguet, Anne Marie, Durette, Catherine, Figarella-Branger, Dominique, Fluckiger, Laurence, Frija-Orvoen, Élisabeth, Gadras, Coraline, Gelé, Patrick, Laurent-Vo, Jean-Marc, Lemaire, François, Libersa, Christian, Llau, Marie-Élise, Louvet, Olivier, Merlio, Jean-Philippe, Mijonnet, Armelle, Petitpré, Jean, Pierré, Alain, Pinachyan, Karen, Reynier, Jean-Charles, Sailly, Anabelle, Schiavi, Pierre, Simon, Tabassome, Vidal, Anne, Deplanque, Dominique, Birraux, Guillaume, Bertoye, Pierre-Henri, and Postaire, Éric

Published
2009
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195. Atherothrombotic risk stratification after acute myocardial infarction: The Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention in the light of the French Registry of Acute ST Elevation or non‐ST Elevation Myocardial Infarction registries

Author

Puymirat, Etienne, Bonaca, Marc, Fumery, Maxime, Tea, Victoria, Aissaoui, Nadia, Lemesles, Gilles, Bonello, Laurent, Ducrocq, Grégory, Cayla, Guillaume, Ferrières, Jean, Schiele, François, Simon, Tabassome, and Danchin, Nicolas

Subjects
Male, Time Factors, Coronary Thrombosis, Incidence, Clinical Investigations, acute myocardial infarction, Middle Aged, mortality, Risk Assessment, Electrocardiography, prevention, Risk Factors, Secondary Prevention, score, Humans, ST Elevation Myocardial Infarction, Female, Thrombolytic Therapy, France, Registries, Non-ST Elevated Myocardial Infarction, Aged, Follow-Up Studies, Retrospective Studies
Abstract

Background Guidelines recommend using risk stratification tools in acute myocardial infarction (AMI) to assist decision‐making. The Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS‐2P) has been recently developed to characterize long‐term risk in patients with MI. Hypothesis We aimed to assess the TRS‐2P in the French Registry of Acute ST Elevation or non‐ST elevation MI registries. Methods We used data from three 1‐month French registries, conducted 5 years apart, from 2005 to 2015, including 13 130 patients with AMI (52% ST‐elevation myocardial infarction [STEMI]). Atherothrombotic risk stratification was performed using the TRS‐2P score. Patients were divided in to three categories: G1 (low‐risk, TRS‐2P = 0/1); G2 (intermediate‐risk, TRS‐2P = 2); and G3 (high‐risk, TRS‐2P ≥ 3). Baseline characteristics and outcomes were analyzed according to TRS‐2P categories. Results A total of 12 715 patients (in whom TRS‐2P was available) were included. Prevalence of G1, G2, and G3 was 43%, 24%, and 33% respectively. Clinical characteristics and management significantly differed according to TRS‐2P categories. TRS‐2P successfully defined residual risk of death at 1 year (C‐statistic 0.78): 1‐year survival was 98% in G1, 94% in G2, and 78.5% in G3 (P < 0.001). Using Cox multivariate analysis, G3 was independently associated with higher risk of death at 1 year (hazard ratio [HR] 4.61; 95% confidence interval [CI]: 3.61‐5.89), as G2 (HR 2.08; 95% CI: 1.62‐2.65) compared with G1. The score appeared robust and correlated well with mortality in STEMI and NSTEMI populations, as well as in each cohort separately. Conclusions The TRS‐2P appears to be a robust risk score, identifying patients at high risk after AMI irrespective of the type of MI and historical period.

Published
2018

198. Effect of a Restrictive vs Liberal Blood Transfusion Strategy on Major Cardiovascular Events Among Patients With Acute Myocardial Infarction and Anemia

Author

Ducrocq, Gregory, Gonzalez-Juanatey, Jose, Puymirat, Etienne, Lemesle, Gilles, Cachanado, Marine, Durand-Zaleski, Isabelle, Arnaiz, Joan Albert, Martínez-Sellés, Manuel, Silvain, Johanne, Ariza-Solé, Albert, Ferrari, Emile, Calvo, Gonzalo, Danchin, Nicolas, Avendaño-Solá, Cristina, Frenkiel, Jerome, Rousseau, Alexandra, Vicaut, Eric, Simon, Tabassome, Steg, Philippe Gabriel, Alliance française pour les essais cliniques cardio-vasculaires - French Alliance for Cardiovascular Trials (FACT), 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, Universidade de Santiago de Compostela [Spain] (USC ), 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), Institut Coeur Poumon [CHU Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Récepteurs Nucléaires, Maladies Métaboliques et Cardiovasculaires - U1011 (RNMCD), 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), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Hôtel-Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), 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), Clinic Barcelona Hospital Universitari, Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), 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], Groupe Action, 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), Bellvitge University Hospital [Barcelona, Spain], Université Côte d'Azur (UCA), Hôpital Pasteur [Nice] (CHU), University of Barcelona, Hospital Universitario Puerta de Hierro-Majadahonda [Madrid, Spain], Université Paris Diderot - Paris 7 (UPD7), Université Sorbonne Paris Cité (USPC), Hôpital Lariboisière-Fernand-Widal [APHP], Sorbonne Université (SU), and Imperial College London

Subjects
[SDV]Life Sciences [q-bio]
Abstract

International audience; Importance: The optimal transfusion strategy in patients with acute myocardial infarction and anemia is unclear.Objective: To determine whether a restrictive transfusion strategy would be clinically noninferior to a liberal strategy.Design, setting, and participants: Open-label, noninferiority, randomized trial conducted in 35 hospitals in France and Spain including 668 patients with myocardial infarction and hemoglobin level between 7 and 10 g/dL. Enrollment could be considered at any time during the index admission for myocardial infarction. The first participant was enrolled in March 2016 and the last was enrolled in September 2019. The final 30-day follow-up was accrued in November 2019.Interventions: Patients were randomly assigned to undergo a restrictive (transfusion triggered by hemoglobin ≤8; n = 342) or a liberal (transfusion triggered by hemoglobin ≤10 g/dL; n = 324) transfusion strategy.Main outcomes and measures: The primary clinical outcome was major adverse cardiovascular events (MACE; composite of all-cause death, stroke, recurrent myocardial infarction, or emergency revascularization prompted by ischemia) at 30 days. Noninferiority required that the upper bound of the 1-sided 97.5% CI for the relative risk of the primary outcome be less than 1.25. The secondary outcomes included the individual components of the primary outcome.Results: Among 668 patients who were randomized, 666 patients (median [interquartile range] age, 77 [69-84] years; 281 [42.2%] women) completed the 30-day follow-up, including 342 in the restrictive transfusion group (122 [35.7%] received transfusion; 342 total units of packed red blood cells transfused) and 324 in the liberal transfusion group (323 [99.7%] received transfusion; 758 total units transfused). At 30 days, MACE occurred in 36 patients (11.0% [95% CI, 7.5%-14.6%]) in the restrictive group and in 45 patients (14.0% [95% CI, 10.0%-17.9%]) in the liberal group (difference, -3.0% [95% CI, -8.4% to 2.4%]). The relative risk of the primary outcome was 0.79 (1-sided 97.5% CI, 0.00-1.19), meeting the prespecified noninferiority criterion. In the restrictive vs liberal group, all-cause death occurred in 5.6% vs 7.7% of patients, recurrent myocardial infarction occurred in 2.1% vs 3.1%, emergency revascularization prompted by ischemia occurred in 1.5% vs 1.9%, and nonfatal ischemic stroke occurred in 0.6% of patients in both groups.Conclusions and relevance: Among patients with acute myocardial infarction and anemia, a restrictive compared with a liberal transfusion strategy resulted in a noninferior rate of MACE after 30 days. However, the CI included what may be a clinically important harm.Trial registration: ClinicalTrials.gov Identifier: NCT02648113.

Published
2021

199. Health-related quality of life 1-3 years post-myocardial infarction: its impact on prognosis

Author

Pocock, Stuart, Brieger, David B, Owen, Ruth, Chen, Jiyan, Cohen, Mauricio G, Goodman, Shaun, Granger, Christopher B, Nicolau, José C, Simon, Tabassome, Westermann, Dirk, Yasuda, Satoshi, Hedman, Katarina, Mellström, Carl, Andersson Sundell, Karolina, and Grieve, Richard

Abstract

OBJECTIVE: To assess associations of health-related quality of life (HRQoL) with patient profile, resource use, cardiovascular (CV) events and mortality in stable patients post-myocardial infarction (MI). METHODS: The global, prospective, observational TIGRIS Study enrolled 9126 patients 1-3 years post-MI. HRQoL was assessed at enrolment and 6-month intervals using the patient-reported EuroQol-5 dimension (EQ-5D) questionnaire, with scores anchored at 0 (worst possible) and 1 (perfect health). Resource use, CV events and mortality were recorded during 2-years' follow-up. Regression models estimated the associations of index score at enrolment with patient characteristics, resource use, CV events and mortality over 2-years' follow-up. RESULTS: Among 8978 patients who completed the EQ-5D questionnaire, 52% reported 'some' or 'severe' problems on one or more health dimensions. Factors associated with a lower index score were: female sex, older age, obesity, smoking, higher heart rate, less formal education, presence of comorbidity (eg, angina, stroke), emergency room visit in the previous 6 months and non-ST-elevation MI as the index event. Compared with an index score of 1 at enrolment, a lower index score was associated with higher risk of all-cause death, with an adjusted rate ratio of 3.09 (95% CI 2.20 to 4.31), and of a CV event, with a rate ratio of 2.31 (95% CI 1.76 to 3.03). Patients with lower index score at enrolment had almost two times as many hospitalisations over 2-years' follow-up. CONCLUSIONS: Clinicians managing patients post-acute coronary syndrome should recognise that a poorer HRQoL is clearly linked to risk of hospitalisations, major CV events and death. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT01866904) (https://clinicaltrials.gov).

Published
2021

200. Incidence, Characteristics, and Outcomes of Ventricular Fibrillation Complicating Acute Myocardial Infarction in Women Admitted Alive in the Hospital.

Author

Weizman, Orianne, Marijon, Eloi, Narayanan, Kumar, Boveda, Serge, Defaye, Pascal, Martins, Raphael, Deharo, Jean-Claude, Laurent, Gabriel, Klug, Didier, Sadoul, Nicolas, Hocini, Meleze, Mansencal, Nicolas, Anselme, Frédéric, Da Costa, Antoine, Maury, Philippe, Ferrières, Jean, Schiele, François, Simon, Tabassome, Danchin, Nicolas, and FAST‐MI Program Investigators

Published
2022
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