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4. 2 years outcomes in patients with or without ARC-HBR criteria undergoing PCI with polymer-free biolimus coated stents: The Biofreedom France Study

Author

Garot, P., primary, Brunel, P., additional, Dibie, A., additional, Morelle, J.-F., additional, Abdellaoui, M., additional, Levy, R., additional, Carrié, D., additional, Karsenty, B., additional, Robin, C., additional, Berland, J., additional, Copt, S., additional, Sadozai, S., additional, Olroyd, K., additional, Morice, M.-C., additional, and Lipiecki, J., additional

Published
2023
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9. Clinical and genetic spectra of autosomal dominant tubulointerstitial kidney disease due to mutations in UMOD and MUC1

Author

Olinger, E, Hofmann, P, Kidd, K, Dufour, I, Belge, H, Schaeffer, C, Kipp, A, Bonny, O, Deltas, C, Demoulin, N, Fehr, T, Fuster, D G, Gale, D P, Goffin, E, Hodanova, K, Huynh-Do, Uyen, Kistler, Andreas, Morelle, J, Papagregoriou, G, Pirson, Y, Sandford, R, Sayer, J A, Torra, R, Venzin, C, Venzin, R, Vogt, B, Živná, M, Greka, A, Dahan, K, Rampoldi, L, Devuyst, Olivier, et al, University of Zurich, and Olinger, E

Subjects
2727 Nephrology, Nephrology, 570 Life sciences, biology, 610 Medicine & health, 10052 Institute of Physiology
Published
2020

13. Die Abstoßungskrise : Ihre Bedeutung zum Verständnis der Histokompatibilität sowie in der Abwägung der Zweckmäßigkeit einer immunosuppressiven Behandlung

Author

Alexandre, G. P. J., Morelle, J., van Ypersele, Ch., Sokal, G., Coche, E., Allgöwer, M., editor, Bauer, K. H., editor, Block, W., editor, Brunner, A., editor, de la Camp, H. Bürkle, editor, Denk, W., editor, Derra, E., editor, Frey, E. K., editor, Linder, F., editor, v. Seemen, H., editor, and Zenker, R., editor

Published
1969
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20. Test Bench For Converters Reliability Studies For EV and HEV Electrical Vehicle Applications

Author

Bendjedia, M., Berthon, Alain, Gustin, Frédéric, Morelle J., M., Coquery, Gérard, Franche-Comté Électronique Mécanique, Thermique et Optique - Sciences et Technologies (UMR 6174) (FEMTO-ST), Université de Technologie de Belfort-Montbeliard (UTBM)-Ecole Nationale Supérieure de Mécanique et des Microtechniques (ENSMM)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre National de la Recherche Scientifique (CNRS), Laboratoire des Technologies Nouvelles (INRETS/LTN), and Institut National de Recherche sur les Transports et leur Sécurité (INRETS)

Subjects
[SPI.NRJ]Engineering Sciences [physics]/Electric power, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2009

21. Inverter Components Reliability Tests for Hybrid Electrical Vehicles, 6th International Power Electrics and Motion Control

Author

Berthon, Alain, Gustin, Frédéric, Bendjedia, M., Morelle J., M., Coquery, Gérard, Franche-Comté Électronique Mécanique, Thermique et Optique - Sciences et Technologies (UMR 6174) (FEMTO-ST), Université de Technologie de Belfort-Montbeliard (UTBM)-Ecole Nationale Supérieure de Mécanique et des Microtechniques (ENSMM)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre National de la Recherche Scientifique (CNRS), Laboratoire des Technologies Nouvelles (INRETS/LTN), and Institut National de Recherche sur les Transports et leur Sécurité (INRETS)

Subjects
[SPI.NRJ]Engineering Sciences [physics]/Electric power, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2009

22. Die Abstoßungskrise

Author

Alexandre, G. P. J., primary, Morelle, J., additional, van Ypersele, Ch., additional, Sokal, G., additional, and Coche, E., additional

Published
1969
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25. Reliability study under DC stress on mmW LNA, Mixer and VCO

Author

Ighilahriz, S., primary, Cacho, F., additional, Moquillon, L., additional, Razafimandimby, S., additional, Blanchet, F., additional, Morelle, J., additional, Corrao, N., additional, Huard, V., additional, Garcia, P., additional, Arnaud, C., additional, Fournier, J.M., additional, and Benech, P., additional

Published
2012
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40. Fast [<SUP>18</SUP>F]FDG synthesis by alkaline hydrolysis on a low polarity solid phase support<FNR HREF="fn1"></FNR> <FN ID="fn1">Parts of this work was presented at the XIIth International Symposium on Radiopharmaceutical Chemistry Uppsala, Sweden, June 15–19, 1997</FN>

Author

Lemaire, C., Damhaut, Ph., Lauricella, B., Mosdzianowski, C., Morelle, J.-L, Monclus, M., Naemen, J. Van, Mulleneers, E., Aerts, J., Plenevaux, A., Brihaye, C., and Luxen, A.

Abstract

The synthesis of 2-deoxy-2-[18F]fluoro-D-glucose ([18F]FDG) has been simplified by the use of a tC18 Sep Pak cartridge to effect purification and hydrolysis of the tetraacetylated [18F]fluoro-glucose compound ([18F]TAG). After radiolabelling, this derivative was trapped on a solid phase extraction (SPE) cartridge and the residual reaction solvent (CH3CN), reagents (K222, K2CO3,…) and by-products removed by washing the support with water. After this cleaning step, the acetyl groups were cleaved on the same tC18 column using 2N sodium hydroxide. This fast reaction proceeded near quantitatively (>98%) at room temperature in less than 2 min. The [18F]FDG was then recovered with a small amount of water, neutralized with a slight excess of 2N hydrochloric acid, buffered for pH with a citrate solution and finally purified on a neutral alumina oxide and a second tC18 column. After filtration, the radiochemical yield of this [18F]FDG isotonic solution after more than 100 production runs was found to be very reliable and reproducible (70±6% decay corrected). The synthesis time was about 22 min. Quality controls showed that the radiochemical purity was higher than 98% and in any case no [18F]FDM was detected. Only traces of 2-chloro-2-deoxy-glucose (ClDG) were found in the final sample (64±9 μg/ batch of 16 ml). [18F]FDG specific activity averaged between 1 and 20 Ci/µmol (EOS). No evaporation and use of ion retardation resin (AG11A8) are required. Moreover, this new approach is suitable for complete remote operation using available single use medical components. Copyright © 2002 John Wiley & Sons, Ltd.

Published
2002
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47. Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults

Author

Thomas Barbour, Marie Scully, Gema Ariceta, Spero Cataland, Katherine Garlo, Nils Heyne, Yosu Luque, Jan Menne, Yoshitaka Miyakawa, Sung-Soo Yoon, David Kavanagh, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Josep M. Campistol, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Eric Rondeau, Hermann Haller, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Barbour T., Scully M., Ariceta G., Cataland S., Garlo K., Heyne N., Luque Y., Menne J., Miyakawa Y., Yoon S.-S., Kavanagh D., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Campistol J.M., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Le Quintrec M., Jeantet G., Fumie I., Rondeau E., Haller H., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., Wong E.K.S., Institut Català de la Salut, [Barbour T] Kidney Care, The Royal Melbourne Hospital, Melbourne, Australia. [Scully M] Department of Haematology, University College London Hospitals, London, UK. [Ariceta G] Servei de Nefrologia Pediàtrica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Cataland S] Division of Hematology, The Ohio State University Medical Center, Columbus, Ohio, USA. [Garlo K] Clinical Development, Alexion Pharmaceuticals, Inc., Boston, Massachusetts, USA. [Heyne N] Section of Nephrology and Hypertension, Tübingen University Hospital, Tübingen, Germany, Vall d'Hebron Barcelona Hospital Campus, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, The Royal Melbourne Hospital, University College London Hospitals (UCLH), Vall d'Hebron University Hospital [Barcelona], Ohio State University [Columbus] (OSU), Universitätsklinikum Tübingen - University Hospital of Tübingen, Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU), Seoul National University Hospital, and Newcastle University [Newcastle]

Subjects
medicine.medical_specialty, Thrombotic microangiopathy, [SDV]Life Sciences [q-bio], Hemic and Lymphatic Diseases::Hematologic Diseases::Anemia::Anemia, Hemolytic::Hemolytic-Uremic Syndrome::Hemic and Lymphatic Diseases::Hematologic Diseases::Atypical Hemolytic Uremic Syndrome [DISEASES], 030232 urology & nephrology, Renal function, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], 030204 cardiovascular system & hematology, Other subheadings::Other subheadings::/drug therapy [Other subheadings], 03 medical and health sciences, 0302 clinical medicine, afecciones patológicas, signos y síntomas::procesos patológicos::atributos de la enfermedad::enfermedades raras [ENFERMEDADES], Clinical Research, Internal medicine, Atypical hemolytic uremic syndrome, Medicine, complement, Adverse effect, Complement component 5, business.industry, Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Rare Diseases [DISEASES], atypical hemolytic uremic syndrome, Acute kidney injury, diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], medicine.disease, Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], ravulizumab, Diseases of the genitourinary system. Urology, 3. Good health, enfermedades hematológicas y linfáticas::enfermedades hematológicas::anemia::anemia hemolítica::síndrome hemolítico-urémico::enfermedades hematológicas y linfáticas::enfermedades hematológicas::síndrome hemolítico urémico atípico [ENFERMEDADES], kidney failure, thrombotic microangiopathy, Clinical trial, Nephrology, Avaluació de resultats (Assistència sanitària), hemolytic uremic syndrome, RC870-923, Síndrome hemolíticourèmica - Tractament, Malalties rares, business, Kidney disease
Abstract

Hemolytic uremic syndrome; Kidney failure; Ravulizumab Síndrome hemolítico urémico; Insuficiencia renal; Ravulizumab Síndrome hemolític urèmic; Insuficiència renal; Ravulizumab Introduction Atypical hemolytic uremic syndrome (aHUS) is a rare, complex, multisystem disease of dysregulated complement activity, characterized by progressive thrombotic microangiopathy (TMA), acute kidney injury, and multiorgan dysfunction, which often progresses to chronic kidney disease. Results from the prospective clinical trial of ravulizumab (NCT02949128) reveal rapid resolution of TMA in patients with aHUS, with sustained efficacy and safety in a 26-week initial evaluation period. Methods The aim of this analysis was to characterize the long-term efficacy and the safety profile of ravulizumab in adults with aHUS who had completed the initial evaluation period of the trial. Complete TMA response, hematologic and kidney functions, and safety were evaluated for all patients available for follow-up in the extension period (median follow-up: 76.7 weeks; range: 0.6–118.3). This trial included a total of 58 patients, 49 of whom entered the extension period. Results A total of 4 additional patients achieved complete TMA response during the follow-up period. Normalization of platelet count, serum lactate dehydrogenase (LDH), and hemoglobin observed in the 26-week initial evaluation period was sustained until the last available follow-up, as were the improvements in the estimated glomerular filtration rate (eGFR) and patient quality of life. All efficacy endpoints were correlated with the sustained inhibition of complement C5. Most adverse events (AEs) occurred early during the initial evaluation period and decreased substantially during the extension period. No patient developed a meningococcal infection or died during the extension period. Conclusion This analysis reveals that ravulizumab administered every 8 weeks is efficacious with an acceptable safety profile for the long-term treatment of adults with aHUS and provides additional clinical benefit beyond 6 months of treatment.

Published
2021

48. Clinical and Genetic Spectra of Autosomal Dominant Tubulointerstitial Kidney Disease due to Mutations in UMOD and MUC1

Author

Nathalie Demoulin, Eric Goffin, Yves Pirson, Anna Greka, Patrick Hofmann, Uyen Huynh-Do, Olivier Devuyst, Olivier Bonny, Johann Morelle, Gregory Papagregoriou, Roser Torra, Karin Dahan, Hendrica Belge, Bruno Vogt, Constantinos Deltas, John A. Sayer, Anthony J. Bleyer, Céline Schaeffer, Kendrah Kidd, Daniel Guido Fuster, Luca Rampoldi, Eric Olinger, Stanislav Kmoch, Kateřina Hodaňová, Anne Kipp, Inès Dufour, Reto Martin Venzin, Thomas Fehr, Andreas D. Kistler, Christina Venzin, Martina Živná, Daniel P. Gale, Richard Sandford, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, Olinger, E, Hofmann, P, Kidd, K, Dufour, I, Belge, H, Schaeffer, C, Kipp, A, Bonny, O, Deltas, C, Demoulin, N, Fehr, T, Fuster, Dg, Gale, Dp, Goffin, E, Hodanova, K, Hyunh-Do, U, Kistler, Ad, Morelle, J, Papagregoriou, G, Pirson, Y, Sandford, R, Sayer, Ja, Torra, R, Venzin, C, Venzin, R, Vogt, B, Živná, M, Greka, A, Dahan, K, Rampoldi, L, Kmoch, S, Bleyer AJ, Sr, and Devuyst, O

Subjects
0301 basic medicine, Nephrology, medicine.medical_specialty, Tamm–Horsfall protein, Gout, Urinary system, 030232 urology & nephrology, 610 Medicine & health, medicine.disease_cause, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Diagnostic score, Internal medicine, Uromodulin, Humans, Medicine, Genetic Testing, Genetic testing, Mutation, Kidney, medicine.diagnostic_test, biology, business.industry, Mucin-1, Middle Aged, Polycystic Kidney, Autosomal Dominant, medicine.disease, Dominant kidney disease, Europe, 030104 developmental biology, medicine.anatomical_structure, biology.protein, business, Kidney disease
Abstract

Autosomal dominant tubulointerstitial kidney disease (ADTKD) is an increasingly recognized. cause of end-stage kidney disease, primarily due to mutations in UMOD and MUC1. The lack of clinical recognition and the small size of cohorts have slowed the understanding of disease ontology and development of diagnostic algorithms. To expand on this, we analyzed two registries from Europe and the United States to define genetic and clinical characteristics of ADTKD-UMOD and ADTKD-MUC1 and develop a practical score to guide genetic testing. Our study encompassed 726 patients from 585 families with a presumptive diagnosis of ADTKD along with clinical, biochemical, genetic and radiologic data. Collectively, 106 different UMOD mutations were detected in 216/562 (38.4%) of families with ADTKD (303 patients), and 4 different MUC1 mutations in 72/205 (35.1%) of the families that are UMOD-negative (83 patients). The median kidney survival was significantly shorter in patients with ADTKD-MUC1 compared to ADTKD-UMOD (46 vs. 54 years respectively), whereas the median gout-free survival was dramatically reduced in patients with ADTKD-UMOD compared to ADTKD-MUC1 (30 vs. 67 years respectively). In contrast to patients with ADTKD-UMOD, patients with ADTKD-MUC1 had normal urinary excretion of uromodulin and distribution of uromodulin in tubular cells. A diagnostic algorithm based on a simple score coupled with urinary uromodulin measurements separated patients with ADTKD-UMOD from those with ADTKD-MUC1 with a sensitivity of 94.1%, a specificity of 74.3% and a positive predictive value of 84.2% for a UMOD mutation. Thus, ADTKD-UMOD is more frequently diagnosed than ADTKD-MUC1, ADTKD subtypes present with distinct clinical features, and a simple score coupled with urine uromodulin measurements may help prioritizing genetic testing.

Published
2020

49. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial

Author

Pascal Vranckx, Marco Valgimigli, Peter Jüni, Christian Hamm, Philippe Gabriel Steg, Dik Heg, Gerrit Anne van Es, Eugene P McFadden, Yoshinobu Onuma, Cokky van Meijeren, Ply Chichareon, Edouard Benit, Helge Möllmann, Luc Janssens, Maurizio Ferrario, Aris Moschovitis, Aleksander Zurakowski, Marcello Dominici, Robert Jan Van Geuns, Kurt Huber, Ton Slagboom, Patrick W Serruys, Stephan Windecker, Mohamed Abdellaoui, David Adlam, Ibrahim Akin, Agustin Albarran Gonzalez-Trevilla, Manuel Almeida, Pedro Alves Lemos Neto, Adel Aminian, Richard Anderson, Rick Andreae, Michael Angioi, Taku Asano, Emanuele Barbato, Peter Barlis, Pascal Barraud, Olivier Bertrand, Farzin Beygui, Leonardo Bolognese, Roberto Botelho, Coby Bouwman, Marco Bressers, Philippe Brunel, Pawel Buszman, Ian Buysschaert, Pedro Canas da Silva, Didier Carrie, Angel Cequier, Chun Chin Chang, Saqib Chowdhary, Carlos Collet, Antonio Colombo, James Cotton, Rui Cruz Ferreira, Salvatore Curello, Nick Curzen, Judith de Bot, Tone de Vreede, Georg Delle Karth, Lynn Dijksma, István Édes, Eric Eeckhout, Ingo Eitel, József Faluközy, Farzin Fath-Ordoubadi, Geza Fontos, Jose Francisco Diaz, Edgard Freitas Quintella, Bernhard Frey, Guy Friedrich, Gavin Galasko, Grzegorz Galuszka, Vasco Gama Ribeiro, Scot Garg, Giuseppe Gargiulo, Tobias Geisler, Valeri Gelev, Art Ghandilyan, Javier Goicolea, Tommaso Gori, Felice Gragnano, Ana Guimarães, Michael Haude, Pieter Heijke, Rosa Ana Hernández Antolin, David Hildick-Smith, Dorien Hillen, Ina Hoekman, Sjoerd Hofma, Lene Holmvang, Stephen Hoole, Iván Horváth, Annemarie Hugense, Karim Ibrahim, Andres Iñiguez, Karl Isaaz, Zoltán Jambrik, Pawel Jasionowicz, Judith Jonk, Werner Jung, Yuki Katagiri, Norihiro Kogame, Tian Hai Koh, René Koning, Mariana Konteva, Zsolt Kőszegi, Florian Krackhardt, Yvonne Kreuger, Neville Kukreja, Boudijn Ladan, Pierre Lantelme, Sergio Leandro, Gregor Leibundgut, Christoph Liebetrau, Wietze Lindeboom, Carlos Macaya Miguel, François Mach, Michael Magro, Luc Maillard, Negar Manavifar, Laura Mauri, Eugene McFadden, Bela Merkely, Yosuke Miyazaki, Adam Młodziankowski, Tiziano Moccetti, Rodrigo Modolo, Helge Möllman, Jean-François Morelle, Michael Munndt Ottesen, Martin Muurling, Christoph Kurt Naber, Franz-Josef Neumann, Keith Oldroyd, Paul Ong, Sanne Palsrok, Ivo Petrov, Sylvain Plante, Janusz Prokopczuk, Tessa Rademaker-Havinga, Christopher Raffel, Benno Rensing, Marco Roffi, Kees-Jan Royaards, Manel Sabate, Volker Schächinger, Tim Seidler, Antonio Serra Peñaranda, Patrick Serruys, Lali Sikarulidze, Osama I Soliman, Amanda Sousa, Ernest Spitzer, Rod Stables, Gabriel Steg, Clemens Steinwender, Eduardas Subkovas, Harry Suryapranata, Kuniaki Takahashi, Suneel Talwar, Emmanuel Teiger, Addy ter Weele, Eva Teurlings, Attila Thury, Jan Tijssen, Gincho Tonev, Diana Trendafilova-Lazarova, Carlo Tumscitz, Victor Umans, Imre Ungi, Veselin Valkov, Pim van der Harst, Robert Jan van Geuns, Dobrin Vassilev, Vasil Velchev, Esther Velthuizen, Freek Verheugt, Natalia Vlcek, Jürgen vom Dahl, Mathias Vrolix, Simon Walsh, Nikos Werner, Maarten Witsenburg, Azfar Zaman, Krzysztof Żmudka, Bernhard Zrenner, Robert Zweiker, University of Zurich, Serruys, Patrick W, Cardiology, Vranckx, P., Valgimigli, M., Juni, P., Hamm, C., Steg, P. G., Heg, D., van Es, G. A., Mcfadden, E. P., Onuma, Y., van Meijeren, C., Chichareon, P., Benit, E., Mollmann, H., Janssens, L., Ferrario, M., Moschovitis, A., Zurakowski, A., Dominici, M., Van Geuns, R. J., Huber, K., Slagboom, T., Serruys, P. W., Windecker, S., Abdellaoui, M., Adlam, D., Akin, I., Albarran Gonzalez-Trevilla, A., Almeida, M., Alves Lemos Neto, P., Aminian, A., Anderson, R., Andreae, R., Angioi, M., Asano, T., Barbato, E., Barlis, P., Barraud, P., Bertrand, O., Beygui, F., Bolognese, L., Botelho, R., Bouwman, C., Bressers, M., Brunel, P., Buszman, P., Buysschaert, I., Canas da Silva, P., Carrie, D., Cequier, A., Chin Chang, C., Chowdhary, S., Collet, C., Colombo, A., Cotton, J., Cruz Ferreira, R., Curello, S., Curzen, N., de Bot, J., de Vreede, T., Delle Karth, G., Dijksma, L., Edes, I., Eeckhout, E., Eitel, I., Falukozy, J., Fath-Ordoubadi, F., Fontos, G., Francisco Diaz, J., Freitas Quintella, E., Frey, B., Friedrich, G., Galasko, G., Galuszka, G., Gama Ribeiro, V., Garg, S., Gargiulo, G., Geisler, T., Gelev, V., Ghandilyan, A., Goicolea, J., Gori, T., Gragnano, F., Guimaraes, A., Haude, M., Heijke, P., Hernandez Antolin, R. A., Hildick-Smith, D., Hillen, D., Hoekman, I., Hofma, S., Holmvang, L., Hoole, S., Horvath, I., Hugense, A., Ibrahim, K., Iniguez, A., Isaaz, K., Jambrik, Z., Jasionowicz, P., Jonk, J., Jung, W., Katagiri, Y., Kogame, N., Koh, T. H., Koning, R., Konteva, M., Koszegi, Z., Krackhardt, F., Kreuger, Y., Kukreja, N., Ladan, B., Lantelme, P., Leandro, S., Leibundgut, G., Liebetrau, C., Lindeboom, W., Macaya Miguel, C., Mach, F., Magro, M., Maillard, L., Manavifar, N., Mauri, L., Mcfadden, E., Merkely, B., Miyazaki, Y., Mlodziankowski, A., Moccetti, T., Modolo, R., Mollman, H., Morelle, J. -F., Munndt Ottesen, M., Muurling, M., Naber, C. K., Neumann, F. -J., Oldroyd, K., Ong, P., Palsrok, S., Petrov, I., Plante, S., Prokopczuk, J., Rademaker-Havinga, T., Raffel, C., Rensing, B., Roffi, M., Royaards, K. -J., Sabate, M., Schachinger, V., Seidler, T., Serra Penaranda, A., Serruys, P., Sikarulidze, L., Soliman, O. I., Sousa, A., Spitzer, E., Stables, R., Steg, G., Steinwender, C., Subkovas, E., Suryapranata, H., Takahashi, K., Talwar, S., Teiger, E., ter Weele, A., Teurlings, E., Thury, A., Tijssen, J., Tonev, G., Trendafilova-Lazarova, D., Tumscitz, C., Umans, V., Ungi, I., Valkov, V., van der Harst, P., van Geuns, R. J., Vassilev, D., Velchev, V., Velthuizen, E., Verheugt, F., Vlcek, N., vom Dahl, J., Vrolix, M., Walsh, S., Werner, N., Witsenburg, M., Zaman, A., Zmudka, K., Zrenner, B., Zweiker, R., ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Graduate School, ACS - Heart failure & arrhythmias, and ACS - Amsterdam Cardiovascular Sciences

Subjects
medicine.medical_specialty, Aspirin, Acute coronary syndrome, business.industry, medicine.medical_treatment, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Percutaneous coronary intervention, 610 Medicine & health, General Medicine, 2700 General Medicine, 030204 cardiovascular system & hematology, medicine.disease, Clopidogrel, 11171 Cardiocentro Ticino, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Drug-eluting stent, Internal medicine, medicine, 030212 general & internal medicine, Myocardial infarction, business, Ticagrelor, medicine.drug
Abstract

Background We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. Methods GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with followup completed. Findings Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3.81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0. 75-1. 01]; p=0.073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0. 78-1. 20]; p=0.77). Interpretation Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. Copright (C) 2018 Elsevier Ltd. All rights reserved. European Clinical Research Institute; Biosensors International; AstraZeneca; Medicines Company; Canada Research Chairs Programme

Published
2018

50. Corrigendum to 'Rondeau E, Scully M, Ariceta G, Barbour T, Cataland S, Heyne N, Miyakawa Y, Ortiz S, Swenson E, Vallee M, Yoon S-S, Kavanagh D and Haller H; on behalf of the 311 Study Group. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment.' Kidney Int. 2020;97:1287–1296

Author

Eric Rondeau, Marie Scully, Gema Ariceta, Tom Barbour, Spero Cataland, Nils Heyne, Yoshitaka Miyakawa, Stephan Ortiz, Eugene Swenson, Marc Vallee, Sung-Soo Yoon, David Kavanagh, Hermann Haller, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Josep M. Campistol, Miquel Blasco, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Giorgia Comai, Maria Cappuccilli, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Yosu Luque, Jan Menne, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Elena Gutierréz, Paola Rodriguez, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Rondeau E., Scully M., Ariceta G., Barbour T., Cataland S., Heyne N., Miyakawa Y., Ortiz S., Swenson E., Vallee M., Yoon S.-S., Kavanagh D., Haller H., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Campistol J.M., Blasco M., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Comai G., Cappuccilli M., Le Quintrec M., Jeantet G., Fumie I., Luque Y., Menne J., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Gutierrez E., Rodriguez P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., and Wong E.K.S.

Subjects
Kidney, medicine.medical_specialty, Adult patients, business.industry, INT, medicine.disease, Gastroenterology, Complement inhibitor, medicine.anatomical_structure, Long acting, Nephrology, Internal medicine, Atypical hemolytic uremic syndrome, Medicine, Ravulizumab, Thrombotic microangiopathy, Pregnancy microangiopathies, Atypical hemolytic uremic syndrome, business
Abstract

The authors regret that 2 investigators were not included in the 311 Study Group. Members of the 311 Study Group are listed in the Appendix. The authors would like to apologize for any inconvenience caused.

Published
2021

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