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1. Long-term outcome of risankizumab in Crohn’s disease: a real-world GETAID study

Author

Fumery, Mathurin, primary, Caron, Benedicte, additional, Hébuterne, Xavier, additional, Altwegg, Romain, additional, Roblin, Xavier, additional, Stefanescu, Carmen, additional, Meyer, Antoine, additional, Nachury, Maria, additional, Laharie, David, additional, Le Berre, Catherine, additional, Guillo, Lucas, additional, Biron, Amélie, additional, Caillo, Ludovic, additional, Buisson, Anthony, additional, Nancey, Stephane, additional, Uzzan, Mathieu, additional, Vuitton, Lucine, additional, Gilletta, Cyrielle, additional, Geyl, Sophie, additional, Blain, Antoine, additional, Kirchgesner, Julien, additional, Ah-Soune, Philippe, additional, Duveau, Nicolas, additional, Vidon, Mathias, additional, Abitbol, Vered, additional, Paupard, Thierry, additional, Tran-Minh, My-Linh, additional, Defrance, Antoine, additional, and Peyrin-Biroulet, Laurent, additional

Published
2024
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2. Validation of NIAAAm-CRP criteria to predict alcohol-associated steatohepatitis on liver histology

Author

Stauber, Rudolf E., primary, Rautou, Pierre-Emmanuel, additional, Stefanescu, Horia, additional, Horhat, Adelina, additional, Thiele, Maja, additional, Lackner, Carolin, additional, Davies, Susan, additional, Denk, Helmut, additional, Detlefsen, Sönke, additional, Dienes, Hans Peter, additional, Gnemmi, Viviane, additional, Gouw, Annette S.H., additional, Guido, Maria, additional, Miquel, Rosa, additional, Paradis, Valerie, additional, Rusu, Ioana, additional, Schirmacher, Peter, additional, Terracciano, Luigi, additional, and Tiniakos, Dina, additional

Published
2024
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4. Shape coexistence in 66Se

Author

Elekes, Z., primary, Panin, V., additional, Rodríguez, T.R., additional, Sieja, K., additional, Ahn, D.S., additional, Al-Adili, A., additional, Baba, H., additional, Stefanescu, A.I., additional, Cook, K.J., additional, Dósa, Cs., additional, Fukuda, N., additional, Gao, J., additional, Gibelin, J., additional, Hahn, K.I., additional, Halász, Z., additional, Huang, S.W., additional, Isobe, T., additional, Juhász, M.M., additional, Kim, D., additional, Kobayashi, T., additional, Kondo, Y., additional, Korkulu, Z., additional, Kurihara, A., additional, Kuti, I., additional, Miki, H., additional, Miki, K., additional, Motobayashi, T., additional, Otsu, H., additional, Saastamoinen, A., additional, Sasano, M., additional, Sato, H., additional, Shimada, T., additional, Shimizu, Y., additional, Sobotka, L.G., additional, Stefanescu, I., additional, Stuhl, L., additional, Suzuki, H., additional, Takeda, H., additional, Togano, Y., additional, Tomai, T., additional, Trache, L., additional, Tudor, D., additional, Uesaka, T., additional, Utsuki, Y., additional, Wang, H., additional, Yasuda, A., additional, Yoneda, K., additional, and Yoshitome, Y., additional

Published
2023
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7. Trends in Postpartum Contraceptive Use in 20 U.S. States and Jurisdictions: The Pregnancy Risk Assessment Monitoring System, 2015–2018

Author

Katharine Bruce, Andrei Stefanescu, Lisa Romero, Ekwutosi Okoroh, Shanna Cox, Lyn Kieltyka, and Charlan Kroelinger

Subjects
Health (social science), Maternity and Midwifery, Public Health, Environmental and Occupational Health, Obstetrics and Gynecology
Abstract

In the last decade, state and national programs and policies aimed to increase access to postpartum contraception; however, recent data on population-based estimates of postpartum contraception is limited.Using Pregnancy Risk Assessment Monitoring System data from 20 sites, we conducted multivariable-adjusted weighted multinomial regression to assess variation in method use by insurance status and geographic setting (urban/rural) among people with a recent live birth in 2018. We analyzed trends in contraceptive method use from 2015 to 2018 overall and within subgroups using weighted multinomial logistic regression.In 2018, those without insurance had lower odds of using permanent methods (adjusted odds ratio [AOR], 0.72; 95% confidence interval [CI], 0.53-0.98), long-acting reversible contraception (LARC) (AOR, 0.67; 95% CI, 0.51-0.89), and short-acting reversible contraception (SARC) (AOR, 0.61; 95% CI, 0.47-0.81) than those with private insurance. There were no significant differences in these method categories between public and private insurance. Rural respondents had greater odds than urban respondents of using all method categories: permanent (AOR, 2.15; 95% CI, 1.67-2.77), LARC (AOR, 1.31; 95% CI, 1.04-1.65), SARC (AOR, 1.42; 95% CI, 1.15-1.76), and less effective methods (AOR, 1.38; 95% CI, 1.11-1.72). From 2015 to 2018, there was an increase in LARC use (odds ratio [OR], 1.03; 95% CI, 1.01-1.05) and use of no method (OR, 1.05; 95% CI, 1.02-1.07) and a decrease in SARC use (OR, 0.97; 95% CI, 0.95-0.99). LARC use increased among those with private insurance (OR, 1.05; 95% CI, 1.02-1.08) and in urban settings (OR, 1.04; 95% CI, 1.02-1.07), but not in other subgroups.We found that those without insurance had lower odds of using effective contraception and that LARC use increased among those who had private insurance and lived in urban areas. Strategies to increase access to contraception, including increasing insurance coverage and investigating whether effectiveness of existing initiatives varies by geographic setting, may increase postpartum contraceptive use and address these differences.

Published
2023

9. Integrated proteomics and genomics analysis of paradoxical eczema in psoriasis patients treated with biologics

Author

Al-Janabi, Ali, primary, Martin, Paul, additional, Khan, Adnan R., additional, Foulkes, Amy C., additional, Smith, Catherine H., additional, Griffiths, Christopher E.M., additional, Morris, Andrew P., additional, Eyre, Steve, additional, Warren, Richard B., additional, Ahmed, Shehnaz, additional, Alabas, Oras, additional, Barker, Jonathan, additional, Becher, Gabrielle, additional, Bewley, Anthony, additional, Evans, Ian, additional, Hampton, Philip, additional, Kirby, Brian, additional, Kleyn, Elise, additional, Laws, Philip, additional, Lawson, Linda, additional, Mackenzie, Teena, additional, McElhone, Kathleen, additional, McPherson, Tess, additional, Morrison, Simon, additional, Owen, Caroline, additional, Pearson, Eleanor, additional, Rashid, Amir, additional, Reynolds, Nick, additional, Strangfeld, Anja, additional, Walton, Shernaz, additional, Yiu, Zenas, additional, Gupta, Girish, additional, Strangfeld (chair), Anja, additional, Weller, Richard, additional, Zietemann, Vera, additional, Aldoori, Nadia, additional, Ali, Mahmud, additional, Al-Rusan, Ahmed, additional, Angit, Caroline, additional, Anstey, Alex, additional, Antony, Fiona, additional, Archer, Charles, additional, August, Suzanna, additional, Balasubramaniam, Periasamy, additional, Baudry, David, additional, Baxter, Kay, additional, Bonsall, Alexandra, additional, Brown, Sara, additional, Brown, Victoria, additional, Burden, David, additional, Burova, Ekaterina, additional, Butt, Aamir, additional, Caswell, Mel, additional, Chapman, Anna, additional, Cliff, Sandeep, additional, Costache, Mihaela, additional, Darne, Sharmela, additional, DeGiovanni, Claudia, additional, Desai, Trupti, additional, Diba, Victoria, additional, Domanne, Eva, additional, Duckworth, Michael, additional, Dymond, Harvey, additional, Fahy, Caoimhe, additional, Farwer, Susanne, additional, Ferguson, Leila, additional, Gkini, Maria-Angeliki, additional, Godwin, Alison, additional, Goulding, Jon, additional, Hammonds, Fiona, additional, Haque, Shaheen, additional, Higgins, Caroline, additional, Hood, Sue, additional, Joseph, Teresa, additional, Johnson, Sarah, additional, Kalavala, Manju, additional, Khorshid, Mohsen, additional, Labinoti, Liberta, additional, Lamb, Ruth, additional, Lawson, Nicole, additional, Layton, Alison, additional, Lees, Tara, additional, Levell, Nick, additional, Lewis, Helen, additional, Lovell, Chris, additional, Lyon, Calum, additional, McAteer, Helen, additional, McBride, Sandy, additional, McCormack, Sally, additional, McKenna, Kevin, additional, Mellor, Serap, additional, Meredith, Fiona, additional, Murphy, Ruth, additional, Norris, Paul, additional, Parslew, Richard, additional, Perera, Gay, additional, Ponnambath, Nabil, additional, Popli, Urvi, additional, Powell, James, additional, Ramesh, Raakhee, additional, Ramsay, Helen, additional, Ranasinghe, Aruni, additional, Reeken, Saskia, additional, Rose, Rebecca, additional, Rotarescu, Rada, additional, Salvary, Ingrid, additional, Sands, Kathy, additional, Sinha, Tapati, additional, Schofield, Julia, additional, Shipman, Alexa, additional, Siebert, Stefan, additional, Stefanescu, Simina, additional, Sundararaj, Kavitha, additional, Taghipour, Kathy, additional, Taylor, Michelle, additional, Thomson, Michelle, additional, Topliffe, Joanne, additional, Verdolini, Roberto, additional, Wachsmuth, Rachel, additional, Wade, Martin, additional, Wahie, Shymal, additional, Walsh, Sarah, additional, Wilcox, Louise, additional, Williamson, Diane, additional, and Wright, Andrew, additional

Published
2023
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10. Accuracy of spleen stiffness measurement for the diagnosis of clinically significant portal hypertension in patients with compensated advanced chronic liver disease: a systematic review and individual patient data meta-analysis

Author

Dajti, Elton, primary, Ravaioli, Federico, additional, Zykus, Romanas, additional, Rautou, Pierre-Emmanuel, additional, Elkrief, Laure, additional, Grgurevic, Ivica, additional, Stefanescu, Horia, additional, Hirooka, Masashi, additional, Fraquelli, Mirella, additional, Rosselli, Matteo, additional, Chang, Pik Eu Jason, additional, Piscaglia, Fabio, additional, Reiberger, Thomas, additional, Llop, Elba, additional, Mueller, Sebastian, additional, Marasco, Giovanni, additional, Berzigotti, Annalisa, additional, Colli, Agostino, additional, Festi, Davide, additional, Colecchia, Antonio, additional, Alemanni, Luigina Vanessa, additional, Vestito, Amanda, additional, Renzulli, Matteo, additional, Azzaroli, Francesco, additional, Colecchia, Luigi, additional, Castera, Laurent, additional, Ronot, Maxime, additional, Platon-Lupsor, Monica, additional, Nicoara-Farcau, Oana, additional, Ignat, Mina, additional, Hias, Yoichi, additional, Fichera, Anna, additional, Ooi, Chin Chin, additional, Borghi, Alberto, additional, Bauer, David, additional, Semmler, Georg, additional, Mandorfer, Mattias, additional, Calleja, José Luis, additional, Elshaarawy, Omar, additional, and Romagnoli, Dante, additional

Published
2023
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11. Pregnancies Complicated by Diabetes and Effect on Fetal Growth in Patients With Congenital Heart Disease

Author

Lee, Jennifer, primary, Duncan, Madeline E., additional, Economy, Katherine E., additional, Rosenberg, Emily A., additional, Gauvreau, Kimberlee, additional, Joyce, Caitlyn, additional, Lassey, Sarah C., additional, Valente, Anne Marie, additional, Aggarwal, Shivani R., additional, Aldweib, Nael, additional, Alshawabkeh, Laith, additional, Barker, Nancy, additional, Buber, Yonatan, additional, Carabuena, Jean Marie, additional, Carazo, Matthew, additional, Drakeley, Sheila, additional, Duarte, Valeria, additional, Easter, Sarah Rae, additional, Assenza, Gabriele Egidy, additional, Graf, Julia, additional, Gurvitz, Michelle, additional, Halpern, Daniel, additional, Harmon, Amy, additional, Hickey, Kelsey, additional, Hynes, Jenna, additional, Knapp, William P., additional, Landzberg, Michael, additional, Marenco, Anais, additional, Mullen, Mary, additional, Opotowsky, Alexander, additional, Partington, Sara, additional, Rajpal, Saraubh, additional, Rodriguez-Monserrate, Carla P., additional, Rouse, Carrie, additional, Schefter, Zoë J., additional, Shafer, Keri, additional, Singh, Michael N., additional, Stefanescu Schmidt, Ada C., additional, Tsao, Allison L., additional, Upadhyay, Shailendra, additional, and Wu, Fred, additional

Published
2023
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15. When is the optimal time to collect baseline data for calculating the Lille score in severe alcoholic hepatitis?

Author

Ignat, Mina, primary, Horhat, Adelina, additional, Barb, Andreea, additional, Dragomir, Irina, additional, Fodor, Andreea, additional, Petra, Fischer, additional, Nicoara-Farcau, Oana, additional, Gabriela, Indre Madalina, additional, Taru, Vlad, additional, Radu, Corina, additional, Procopet, Bogdan, additional, and Stefanescu, Horia, additional

Published
2023
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16. Accuracy of spleen stiffness measurement for the diagnosis of clinically significant portal hypertension in patients with advanced chronic liver disease: an individual patient meta-analysis

Author

Dajti, Elton, primary, Ravaioli, Federico, additional, Zykus, Romanas, additional, Elkrief, Laure, additional, Rautou, Pierre-Emmanuel, additional, Grgurevic, Ivica, additional, Stefanescu, Horia, additional, Hirooka, Masashi, additional, Mirella, Fraquelli, additional, Rosselli, Matteo, additional, Eu Chang, Jason Pik, additional, Borghi, Alberto, additional, Reiberger, Thomas, additional, Llop, Elba, additional, Mueller, Sebastian, additional, Marasco, Giovanni, additional, Berzigotti, Annalisa, additional, Colli, Agostino, additional, Festi, Davide, additional, and Colecchia, Antonio, additional

Published
2023
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17. Ultrasound predictors of hemodynamic TIPS dysfunction: friends or foes?

Author

Fodor, Andreea, primary, Craciun, Rares, additional, Nicoara-Farcau, Oana, additional, Petra, Fischer, additional, Ignat, Mina, additional, Motofelea, Ionel-Andrei, additional, Buda, Roxana, additional, Radu, Corina, additional, Sparchez, Zeno, additional, Stefanescu, Horia, additional, and Procopet, Bogdan, additional

Published
2023
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18. Recently validated non-invasive tests for liver fibrosis assessment have great performance in identifying NASH patients at risk for decompensation

Author

Taru, Vlad, primary, Taru, Madalina Gabriela, additional, Petrushev, Bobe, additional, Ioana, Rusu, additional, Stefanescu, Horia, additional, Fodor, Andreea, additional, Ignat, Mina Dana, additional, Petra, Fischer, additional, Nicoara-Farcau, Oana, additional, Platon, Monica, additional, and Procopet, Bogdan, additional

Published
2023
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19. 2022 ACC Health Policy Statement on Career Flexibility in Cardiology

Author

Mary Norine Walsh, James A. Arrighi, Joseph G. Cacchione, Anna Lisa Chamis, Pamela S. Douglas, Claire S. Duvernoy, JoAnne M. Foody, Sharonne N. Hayes, Dipti Itchhaporia, Michael S. Parmacek, Ada C. Stefanescu Schmidt, George W. Vetrovec, Thad F. Waites, and John J. Warner

Subjects
Cardiology and Cardiovascular Medicine
Published
2022

20. The threat of carbapenem resistance in Eastern Europe in patients with decompensated cirrhosis admitted to intensive care unit

Author

Petra Fischer, Stanca Pandrea, Mircea Dan Grigorescu, Horia Stefanescu, Cristian Tefas, Adina Hadade, Bogdan Procopet, and Daniela Ionescu

Subjects
Hospitalization, Liver Cirrhosis, Intensive Care Units, Carbapenem-Resistant Enterobacteriaceae, Carbapenems, Enterobacteriaceae, Hepatology, Inosine Monophosphate, Gastroenterology, Humans, Microbial Sensitivity Tests, Anti-Bacterial Agents
Abstract

Multidrug-resistant organisms are an increasing concern in patients with decompensated cirrhosis.We aimed to evaluate the prevalence of infections with carbapenem-resistant Enterobacteriaceae in patients with decompensated cirrhosis.Patients with decompensated cirrhosis admitted to ICU were included. The isolated Enterobacteriaceae strains were tested for carbapenemase-producing genes using the Roche LightMix® Modular VIM/IMP/NDM/GES/KPC/OXA48-carbapenemase detection kit.48 culture-positive infections were registered in 75 patients with acutely decompensated cirrhosis. Thirty patients contracted a second infection. 46% of bacteria isolated at admission and 60% of bacteria responsible for infections identified during ICU-stay were multiresistant. ESBL+ Enterobacteriaceae were predominant at admission, while carbapenem-resistance was dominant in both Enterobacteriaceae and Non-Fermenting-Gram-Negative Bacteria responsible for infections diagnosed during hospitalisation. OXA 48 or KPC type carbapenemases were present in 30% of the analyzed Enterobacteriaceae and in 40% of the phenotypically carbapenem-resistant Klebsiella pneumoniae strains. The length of ICU stay was a risk-factor for a second infection (p=0.04). Previous carbapenem usage was associated with occurence of infections with carbapenem-resistant Gram-negative bacteria during hospitalization (p=0.03).The prevalence of infections with carbapenem-resistant Enterobacteriaceae is high in patients with decompensated cirrhosis admitted to ICU. Carbapenemase-producing genes in Enterobacteriaceae in our center are bla

Published
2022

22. Safety and efficacy of cipaglucosidase alfa plus miglustat versus alglucosidase alfa plus placebo in late-onset Pompe disease (PROPEL): an international, randomised, double-blind, parallel-group, phase 3 trial

Author

Sheela Sitaraman, Richard Roxburgh, Kristina Gutschmidt, Ela Stefanescu, Drago Bratkovic, Thomas Burrow, Kornblum Cornelia, Kristl Claeys, Miriam Freimer, Ozlem Goker-Alpan, Srilakshmi Kuchipudi, Alan Pestronk, Wolfgang Löscher, Francoise Bouhour, Maria Judit Molnar, Ans T. van der Ploeg, Halina Bartosik-Psujek, Mitchell Goldman, Robert D. Henderson, Stephanie Dearmey, Colin Quinn, Paula R. Clemens, Priya S. Kishnani, Jennifer B Avelar, Nicola Longo, Shahram Attarian, Robert Hopkin, Tomo Sawada, Blaž Koritnik, George Konstantinos Papadimas, Hideaki Shiraishi, Christopher Lindberg, Jin-Hong Shin, Ivaylo Tarnev, Tahseen Mozaffar, Heather Lau, Michel Tchan, Jozsef Janszky, Tobias Ruck, Sabrina Sacconi, Benedikt Schoser, Hashiguchi Akihiro, Patrick Deegan, Ernest Butler, Nuria Vidal-Fernandez, Antonio Toscano, Tarekegn Hiwot, Gee Kim, Emmanuelle Salort-Campana, Jeff Castelli, Pascal Laforet, Céline Tard, Crystal Eldridge, Aneal Khan, Stephan Wenninger, Simona Fecarotta, Jordi Díaz-Manera, Jorge Alonso-Pérez, Yin-Hsiu Chien, Mark Tarnopolsky, Olimpia Musumeci, Hiroshi Kobayashi, Helio Pedro, Jonathan Cauci, Agnes Sebok, Cynthia Bodkin, Hai Jiang, Julie Berthy, Vescei Laszlo, Derralynn Hughes, David Reyes-Leiva, Aleksandra Dominovic-Kovacevic, Mazen M. Dimachkie, Hernan Amartino, Hani Kushlaf, Barry J. Byrne, Giancarlo Parenti, Henning Andersen, Mark Roberts, Marie Wencel, Jaime Vengoechea, Schoser, B., Roberts, M., Byrne, B. J., Sitaraman, S., Jiang, H., Laforet, P., Toscano, A., Castelli, J., Diaz-Manera, J., Goldman, M., van der Ploeg, A. T., Bratkovic, D., Kuchipudi, S., Mozaffar, T., Kishnani, P. S., Sebok, A., Pestronk, A., Dominovic-Kovacevic, A., Khan, A., Koritnik, B., Tard, C., Lindberg, C., Quinn, C., Eldridge, C., Bodkin, C., Reyes-Leiva, D., Hughes, D., Stefanescu, E., SALORT-CAMPANA, E., Butler, E., Bouhour, F., Kim, G., Konstantinos Papadimas, G., Parenti, G., Bartosik-Psujek, H., Kushlaf, H., Akihiro, H., Lau, H., Pedro, H., Andersen, H., Amartino, H., Shiraishi, H., Kobayashi, H., Tarnev, I., Vengoechea, J., Avelar, J., Shin, J. -H., Cauci, J., Alonso-Perez, J., Janszky, J., Berthy, J., Cornelia, K., Gutschmidt, K., Claeys, K., Judit Molnar, M., Wencel, M., Tarnopolsky, M., Dimachkie, M., Tchan, M., Freimer, M., Longo, N., Vidal-Fernandez, N., Musumeci, O., Goker-Alpan, O., Deegan, P., Clemens, P. R., Roxburgh, R., Henderson, R., Hopkin, R., Sacconi, S., Fecarotta, S., Attarian, S., Wenninger, S., Dearmey, S., Hiwot, T., Burrow, T., Ruck, T., Sawada, T., Laszlo, V., Loscher, W., Chien, Y. -H., and Pediatrics

Subjects
education.field_of_study, medicine.medical_specialty, 1-Deoxynojirimycin, Adolescent, Glycogen Storage Disease Type II, business.industry, Population, alpha-Glucosidases, Enzyme replacement therapy, Placebo, Treatment Outcome, Double-Blind Method, SDG 3 - Good Health and Well-being, Internal medicine, Miglustat, medicine, Clinical endpoint, Humans, Respiratory function, Neurology (clinical), Adverse effect, education, business, Alglucosidase alfa, medicine.drug
Abstract

Summary Background Pompe disease is a rare disorder characterised by progressive loss of muscle and respiratory function due to acid α-glucosidase deficiency. Enzyme replacement therapy with recombinant human acid α-glucosidase, alglucosidase alfa, is the first approved treatment for the disease, but some patients do not respond, and many do not show a sustained benefit. We aimed to assess the safety and efficacy of an investigational two-component therapy (cipaglucosidase alfa, a novel recombinant human acid α-glucosidase, plus miglustat, an enzyme stabiliser) for late-onset Pompe disease. Methods We did a randomised, double-blind, parallel-group, phase 3 trial at 62 neuromuscular and metabolic medical centres in 24 countries in the Americas, Asia-Pacific, and Europe. Eligible participants were aged 18 years or older with late-onset Pompe disease, and had either been receiving alglucosidase alfa for at least 2 years or were enzyme replacement therapy-naive. Participants were randomly assigned (2:1) using interactive response technology software, stratified by 6-min walk distance and previous enzyme replacement therapy status, to intravenous cipaglucosidase alfa (20 mg/kg) plus oral miglustat or to intravenous alglucosidase alfa (20 mg/kg) plus oral placebo once every 2 weeks for 52 weeks. Patients, investigators, and outcome assessors were masked to treatment assignment. The primary endpoint was change from baseline to week 52 in 6-min walk distance, assessed using a mixed-effect model for repeated measures analysis for comparison of superiority in the intention-to-treat population (all patients who received at least one dose of study drug). This study is now complete and is registered with ClinicalTrials.gov , NCT03729362 . Findings Between Dec 3, 2018, and Nov 26, 2019, 130 patients were screened for eligibility and 125 were enrolled and randomly assigned to receive cipaglucosidase alfa plus miglustat (n=85) or alglucosidase alfa plus placebo (n=40). Two patients in the alglucosidase alfa plus placebo group did not receive any dose due to absence of genotype confirmation of late-onset Pompe disease and were excluded from analysis. Six patients discontinued (one in the alglucosidase alfa plus placebo group, five in the cipaglucosidase alfa plus miglustat group), and 117 completed the study. At week 52, mean change from baseline in 6-min walk distance was 20·8 m (SE 4·6) in the cipaglucosidase alfa plus miglustat group versus 7·2 m (6·6) in the alglucosidase alfa plus placebo group using last observation carried forward (between-group difference 13·6 m [95% CI −2·8 to 29·9]). 118 (96%) of 123 patients experienced at least one treatment-emergent adverse event during the study; the incidence was similar between the cipaglucosidase alfa plus miglustat group (n=81 [95%]) and the alglucosidase alfa plus placebo group (n=37 [97%]). The most frequently reported treatment-emergent adverse events were fall (25 [29%] patients in the cipaglucosidase alfa plus miglustat group vs 15 [39%] in the alglucosidase alfa plus placebo group), headache (20 [24%] vs 9 [24%]), nasopharyngitis (19 [22%] vs 3 [8%]), myalgia (14 [16%] vs 5 [13%]), and arthralgia (13 [15%]) vs 5 [13%]). 12 serious adverse events occurred in eight patients in the cipaglucosidase alfa plus miglustat group; only one event (anaphylaxis) was deemed related to study drug. One serious adverse event (stroke) occurred in the alglucosidase alfa plus placebo group, which was deemed unrelated to study drug. There were no deaths. Interpretation Cipaglucosidase alfa plus miglustat did not achieve statistical superiority to alglucosidase alfa plus placebo for improving 6-min walk distance in our overall population of patients with late-onset Pompe disease. Further studies should investigate the longer-term safety and efficacy of cipaglucosidase alfa plus miglustat and whether this investigational two-component therapy might provide benefits, particularly in respiratory function and in patients who have been receiving enzyme replacement therapy for more than 2 years, as suggested by our secondary and subgroup analyses. Funding Amicus Therapeutics.

Published
2021

26. Obesity in adult patients with inflammatory bowel disease: Clinical features and impact on disability. A cross-sectional survey from the GETAID

Author

Bacha, Rose Al, primary, Bouhnik, Yoram, additional, Serrero, Melanie, additional, Filippi, Jerome, additional, Roblin, Xavier, additional, Bourrier, Anne, additional, Bouguen, Guillaume, additional, Franchimont, Denis, additional, Savoye, Guillaume, additional, Buisson, Anthony, additional, Louis, Edouard, additional, Nancey, Stephane, additional, Abitbol, Vered, additional, Reimund, Jean-Marie, additional, DeWit, Olivier, additional, Vuitton, Lucine, additional, Mathieu, Nicolas, additional, Peyrin-Biroulet, Laurent, additional, Gilletta, Cyrielle, additional, Allez, Matthieu, additional, Viennot, Stephanie, additional, Berre, Catherine Le, additional, Laharie, David, additional, Nachury, Maria, additional, Amiot, Aurelien, additional, Tadbiri, Sara, additional, Gagniere, Charlotte, additional, Tannoury, Jenny, additional, Pariente, Benjamin, additional, Wils, Pauline, additional, Stefanescu, Carmen, additional, Treton, Xavier, additional, Martins, Carole, additional, Uzzan, Mathieu, additional, Hébuterne, Xavier, additional, Arab, Nadia, additional, Cluzeau, Virginie, additional, Tedesco, Emilie Del, additional, Beaugerie, Laurent, additional, Seksik, Philippe, additional, Landmann, Cecilia, additional, Kirchgesner, Julien, additional, Sokol, Harry, additional, Siproudhis, Laurent, additional, DeWitte, Marie, additional, Reenaers, Catherine, additional, Boschetti, Gilles, additional, Gay, Claire, additional, Danion, Pauline, additional, Flourié, Bernard, additional, Malamut, Georgia, additional, Caron, Benedicte, additional, DeWitt, Olivier, additional, Pestour, Sandie, additional, Chateau, Thomas, additional, Zallot, Camille, additional, Gornet, Jean-Marc, additional, Baudry, Clotilde, additional, Bourreille, Arnaud, additional, Trang-Poisson, Caroline, additional, Dib, Nina, additional, Brixi, Hedi, additional, Cadiot, Guillaume, additional, Boualit, Medina, additional, Painchart, Claire, additional, Plastaras, Laurianne, additional, Altwegg, Romain, additional, Boivineau, Lucile, additional, Fumery, Mathurin, additional, Caillo, Ludovic, additional, Riviere, Pauline, additional, Poullenot, Florian, additional, Coffin, Benoit, additional, Duboc, Henri, additional, Nahon, Stephane, additional, Tavernier, Noemie, additional, Simon, Marion, additional, Coulibaly, Baya, additional, Amil, Morgane, additional, Nicolas, Duveau, additional, Khater, Sherine, additional, Kaassis, Mehdi, additional, Goutorbe, Felix, additional, Moussata, Driffa, additional, and Picon, Laurence, additional

Published
2023
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30. O-25 ASSESSMENT OF MODELS FOR PREDICTING RESPONSE TO CORTICOIDS TREATMENT IN ALCOHOL-ASSOCIATED HEPATITIS: A GLOBAL COHORT STUDY

Author

Idalsoaga, Francisco, primary, Díaz, Luis Antonio, additional, Ayares, Gustavo, additional, Arnold, Jorge, additional, Dunn, Winston, additional, Li, Yanming, additional, Singal, Ashwani, additional, Simonetto, Doug, additional, Ayala-Valverde, María, additional, Perez, Diego, additional, Gomez, Jaime, additional, Escarate, Rodrigo, additional, Fuentes-López, Eduardo, additional, Ramirez, Carolina A, additional, Morales-Arraez, Dalia, additional, Zhang, Wei, additional, Qian, Steve, additional, Ahn, Joseph, additional, Buryska, Seth, additional, Mehta, Heer, additional, Waleed, Muhammad, additional, Stefanescu, Horia, additional, Horhat, Adelina, additional, Bumbu, Andreea, additional, Attar, Bashar, additional, Grawal, Rohit, additional, Cabezas, Joaquín, additional, García-Carrera, Inés, additional, Cuyàs, Berta, additional, Poca, Maria, additional, Pastor, German Soriano, additional, Sarin, Shiv K, additional, Maiwall, Rakhi, additional, Jalal, Prasun K, additional, Tijera, María Fátima Higuera-De La, additional, Kulkarni, Anand, additional, Rao P, Nagaraja, additional, Salazar, Patricia Guerra, additional, Skladaný, Lubomir, additional, Bystrianska, Natália, additional, Prado, Veronica, additional, Clemente-Sanchez, Ana, additional, Rincón, Diego, additional, Haider, Tehseen, additional, Chacko, Kristina R, additional, Romero, Gustavo A, additional, Pollarsky, Florencia D, additional, Restrepo, Juan Carlos, additional, Toro, Luis G, additional, Yaquich, Pamela, additional, Mendizabal, Manuel, additional, Garrido, Maria Laura, additional, Marciano, Sebastian, additional, Dirchwolf, Melisa, additional, Vargas, Victor, additional, Jimenez, Cesar, additional, García-Tsao, Guadalupe, additional, Ortiz, Guillermo, additional, Abraldes, Juan G, additional, Kamath, Patrick, additional, Arrese, Marco, additional, Shah, Vijay, additional, Bataller, Ramon, additional, and Arab, Juan Pablo, additional

Published
2023
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32. Outcomes of Patent Foramen Ovale Transcatheter Closure

Author

Stefanescu Schmidt, Ada C., primary, Abrahamyan, Lusine, additional, Muthuppalaniappan, Annamalar, additional, Gorocica Romero, Ricardo, additional, Ephrem, Georges, additional, Everett, Karl, additional, Lee, Douglas S., additional, Osten, Mark, additional, Benson, Leland N., additional, and Horlick, Eric M., additional

Published
2023
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34. Risk of SARS-CoV-2 infection in healthcare workers with inflammatory bowel disease: a case-control study

Author

Amiot, Aurelien, primary, Bourrier, Anne, additional, Gornet, Jean-Marc, additional, Dewit, Olivier, additional, Nancey, Stephane, additional, Altwegg, Romain, additional, Abitbol, Vered, additional, Laharie, David, additional, Reenaers, Catherine, additional, Gagnière, Charlotte, additional, Buisson, Anthony, additional, Nachury, Maria, additional, Viennot, Stephanie, additional, Vuitton, Lucine, additional, Stefanescu, Carmen, additional, Marteau, Philippe, additional, Bouguen, Guillaume, additional, and Seksik, Philippe, additional

Published
2023
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36. Obesity in adult patients with inflammatory bowel disease: Clinical features and impact on disability. A cross-sectional survey from the GETAID

Author

Rose Al Bacha, Yoram Bouhnik, Melanie Serrero, Jerome Filippi, Xavier Roblin, Anne Bourrier, Guillaume Bouguen, Denis Franchimont, Guillaume Savoye, Anthony Buisson, Edouard Louis, Stephane Nancey, Vered Abitbol, Jean-Marie Reimund, Olivier DeWit, Lucine Vuitton, Nicolas Mathieu, Laurent Peyrin-Biroulet, Cyrielle Gilletta, Matthieu Allez, Stephanie Viennot, Catherine Le Berre, David Laharie, Maria Nachury, Aurelien Amiot, Sara Tadbiri, Charlotte Gagniere, Jenny Tannoury, Benjamin Pariente, Pauline Wils, Carmen Stefanescu, Xavier Treton, Carole Martins, Mathieu Uzzan, Xavier Hébuterne, Nadia Arab, Virginie Cluzeau, Emilie Del Tedesco, Laurent Beaugerie, Philippe Seksik, Cecilia Landmann, Julien Kirchgesner, Harry Sokol, Laurent Siproudhis, Marie DeWitte, Catherine Reenaers, Gilles Boschetti, Claire Gay, Pauline Danion, Bernard Flourié, Georgia Malamut, Benedicte Caron, Olivier DeWitt, Sandie Pestour, Thomas Chateau, Camille Zallot, Jean-Marc Gornet, Clotilde Baudry, Arnaud Bourreille, Caroline Trang-Poisson, Nina Dib, Hedi Brixi, Guillaume Cadiot, Medina Boualit, Claire Painchart, Laurianne Plastaras, Romain Altwegg, Lucile Boivineau, Mathurin Fumery, Ludovic Caillo, Pauline Riviere, Florian Poullenot, Benoit Coffin, Henri Duboc, Stephane Nahon, Noemie Tavernier, Marion Simon, Baya Coulibaly, Morgane Amil, Duveau Nicolas, Sherine Khater, Mehdi Kaassis, Felix Goutorbe, Driffa Moussata, Laurence Picon, AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Nord [CHU - APHM], Immunité muqueuse et vaccination, Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-IFR50-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Côte d'Azur (UCA), Service de Gastro-entérologie et Hépatologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Pontchaillou [Rennes], Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Erasme [Bruxelles] (ULB), Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), CHU Rouen, Normandie Université (NU), CHU Clermont-Ferrand, Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Centre Hospitalier Universitaire de Liège (CHU-Liège), Hospices Civils de Lyon (HCL), Hôpital Cochin [AP-HP], Voies de Signalisation du Développement et du Stress Cellulaire dans les Cancers Digestifs et Urologiques, Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), Service de Gastro-Entérologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Grenoble, Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hopital Saint-Louis [AP-HP] (AP-HP), CHU Amiens-Picardie, Périnatalité et Risques Toxiques - UMR INERIS_I 1 (PERITOX), Institut National de l'Environnement Industriel et des Risques (INERIS)-Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, Groupe d’Étude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID), and This study was supported by Abbvie.

Subjects
Crohn's disease, Disability, Ulcerative colitis, Hepatology, Gastroenterology, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Fatigue, Inflammatory bowel disease, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Background: In recent years, an increasing prevalence of obesity in inflammatory bowel disease (IBD) has been observed. However, only a few studies have focused on the impact of overweight and obesity on IBD-related disability.Aims: To identify the factors associated with obese and overweight patients with IBD, including IBD-related disability.Patients and methods: In this cross-sectional study, we included 1704 consecutive patients with IBD in 42 centres affiliated with the Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif (GETAID) using a 4-page questionnaire. Factors associated with obesity and overweight were assessed using univariate and multivariate analyses (odds ratios (ORs) are provided with 95% confidence intervals).Results: The prevalence rates of overweight and obesity were 24.1% and 12.2%, respectively. Multivariable analyses were stratified by age, sex, type of IBD, clinical remission and age at diagnosis of IBD. Overweight was significantly associated with male sex (OR = 0.52, 95% CI [0.39-0.68], p < 0.001), age (OR = 1.02, 95% CI [1.01-1.03], p < 0.001) and body image subscore (OR = 1.15, 95% CI [1.10-1.20], p < 0.001) (Table 2). Obesity was significantly associated with age (OR = 1.03, 95% CI [1.02-1.04], p < 0.001), joint pain subscore (OR = 1.08, 95% CI [1.02-1.14], p < 0.001) and body image subscore (OR = 1.25, 95% CI [1.19-1.32], p < 0.001) (Table 3).Conclusion: The increasing prevalence of overweight and obesity in patients with IBD is associated with age and poorer body image. A holistic approach to IBD patient care should be encouraged to improve IBD-related disability and to prevent rheumatological and cardiovascular complications.

Published
2023

38. Kidney function monitoring in inflammatory bowel disease: The MONITORED consensus

Author

Lucas Guillo, Pierre Delanaye, Martin Flamant, Lucile Figueres, Sabine Karam, Sandrine Lemoine, Alban Benezech, Anne-Laure Pelletier, Aurélien Amiot, Bénédicte Caron, Carmen Stefanescu, Gilles Boschetti, Guillaume Bouguen, Jean-François Rahier, Jean-Marc Gornet, Jean-Pierre Hugot, Joëlle Bonnet, Lucine Vuitton, Maria Nachury, Mathias Vidon, Mathieu Uzzan, Mélanie Serrero, Nina Dib, Philippe Seksik, Xavier Hebuterne, Jean-Philippe Bertocchio, Christophe Mariat, Laurent Peyrin-Biroulet, CHU Marseille, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Early detection of Colon Cancer using Molecular Markers and Microbiota (EA 7375) (EC2M3), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CRHU Nancy, Centre International de Recherche en Infectiologie - UMR (CIRI), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Pontchaillou [Rennes], Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU UCL Namur, AP-HP Hôpital universitaire Robert-Debré [Paris], Hopital Saint-Louis [AP-HP] (AP-HP), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institute for Translational Research in Inflammation - U 1286 (INFINITE (Ex-Liric)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHI Créteil, Hôpital Beaujon [AP-HP], Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques (HIFIH), Université d'Angers (UA), Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [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), Centre Hospitalier Universitaire de Nice (CHU Nice), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), No funding, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, and UCL - (MGD) Service de gastro-entérologie

Subjects
Kidney diseases, Consensus, Monitoring, Hepatology, [SDV]Life Sciences [q-bio], Gastroenterology, Inflammatory bowel diseases, Inflammatory Bowel Diseases, Kidney, Kidney Function Tests, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Practice Guidelines as Topic, Humans, Kidney Diseases, 030211 gastroenterology & hepatology
Abstract

International audience; BACKGROUND AND AIMS: Patients with inflammatory bowel diseases (IBD) are exposed to drug-related nephrotoxicity and kidney-related extra-intestinal manifestations (EIMs). Patients should be monitored but guidance is lacking in current international recommendations. The objective of the Kidney Function Monitoring in Inflammatory Bowel Disease (MONITORED) initiative was to achieve an expert consensus about monitoring kidney function in IBD. METHODS: A literature review was first conducted. Then, an expert consensus meeting, involving 28 attendees representing French-speaking gastroenterologists and nephrologists, was held as part of an academic initiative on May 28, 2021. An anonymous Delphi process was used to discuss and vote on statements. Agreement was defined as at least 75% of participants voting for any one statement. RESULTS: Experts reached consensus on 11 criteria for referral to the nephrologist. Concerning kidney function monitoring, participants unanimously validated the use of serum creatinine with estimation of the glomerular filtration rate via the MDRD or CKD-EPI equations. A blood ionogram and a urine sample with measurement of a protein-to-creatinine ratio were also broadly agreed validated. Experts recommended performing this monitoring at IBD diagnosis, prior introducing a new treatment, and annually for EIMs screening and evaluation of treatment tolerance. An evaluation 3 months after starting mesalamine and then every 6 months was felt necessary, while for biologics an annually monitoring was deemed sufficient. CONCLUSION: The MONITORED consensus proposed guidelines on how to monitor kidney function in IBD. These recommendations should be considered in clinical practice to preserve kidney function and ensure the best approach to our patients.

Published
2022

39. Anticoagulation improves survival in patients with cirrhosis and portal vein thrombosis: The IMPORTAL competing-risk meta-analysis

Author

Guerrero, Antonio, primary, Campo, Laura del, additional, Piscaglia, Fabio, additional, Scheiner, Bernhard, additional, Han, Guohong, additional, Violi, Francesco, additional, Ferreira, Carlos-Noronha, additional, Téllez, Luis, additional, Reiberger, Thomas, additional, Basili, Stefania, additional, Zamora, Javier, additional, Albillos, Agustín, additional, Valla, Dominique, additional, Durand, Francois, additional, Artaza, Tomás, additional, García-Pagán, Juan Carlos, additional, Magaz, Marta, additional, La Mura, Vincenzo, additional, Primignani, Massimo, additional, Luca, Angelo, additional, Stanciu, Carol, additional, Senzolo, Marco, additional, Amitrano, Lucio, additional, Stefanescu, Horia, additional, Nery, Filipe, additional, Chevret, Sylvie, additional, and Girleanu, Irina, additional

Published
2023
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43. Adalimumab in Biologic-naïve Patients With Crohn’s Disease After Resolution of an Intra-abdominal Abscess: A Prospective Study From the GETAID

Author

Bouhnik, Yoram, primary, Pineton de Chambrun, Guillaume, additional, Lambert, Jérôme, additional, Nachury, Maria, additional, Seksik, Philippe, additional, Altwegg, Romain, additional, Vuitton, Lucine, additional, Stefanescu, Carmen, additional, Nancey, Stéphane, additional, Aubourg, Alexandre, additional, Serrero, Mélanie, additional, Filippi, Jérôme, additional, Desseaux, Kristell, additional, Viennot, Stéphanie, additional, Abitbol, Vered, additional, Boualit, Madina, additional, Bourreille, Arnaud, additional, Giletta, Cyrielle, additional, Buisson, Anthony, additional, Roblin, Xavier, additional, Dib, Nina, additional, Malamut, Georgia, additional, Amiot, Aurélien, additional, Fumery, Mathurin, additional, Louis, Edouard, additional, Elgharabawy, Yasmine, additional, Peyrin-Biroulet, Laurent, additional, Moreau, Jacques, additional, Treton, Xavier, additional, Mailhat, Charlotte, additional, Pollet, Justine, additional, Martins, Carole, additional, Savoye, Guillaume, additional, Tavernier, Noémie, additional, Mary, Jean-Yves, additional, Zappa, Magali, additional, and Painchart, Claire, additional

Published
2023
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46. Anticoagulation improves survival in patients with cirrhosis and portal vein thrombosis: The IMPORTAL competing-risk meta-analysis

Author

Antonio Guerrero, Laura del Campo, Fabio Piscaglia, Bernhard Scheiner, Guohong Han, Francesco Violi, Carlos-Noronha Ferreira, Luis Téllez, Thomas Reiberger, Stefania Basili, Javier Zamora, Agustín Albillos, Dominique Valla, Francois Durand, Tomás Artaza, Juan Carlos García-Pagán, Marta Magaz, Vincenzo La Mura, Massimo Primignani, Angelo Luca, Carol Stanciu, Marco Senzolo, Lucio Amitrano, Horia Stefanescu, Filipe Nery, Sylvie Chevret, Irina Girleanu, and Repositório da Universidade de Lisboa

Subjects
Anticoagulation, Cirrhosis, Hepatology, Portal vein, Thrombosis
Abstract

© 2023 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved, Background & aims: Previous meta-analyses demonstrated the safety and efficacy of anticoagulation in the recanalization of portal vein thrombosis in patients with cirrhosis. Whether this benefit translates into improved survival is unknown. We conducted an individual patient data (IPD) meta-analysis to assess the effect of anticoagulation on all-cause mortality in patients with cirrhosis and portal vein thrombosis. Methods: In this IPD meta-analysis, we selected studies comparing anticoagulation vs. no treatment in patients with cirrhosis and portal vein thrombosis from PubMed, Embase, and Cochrane databases (until June 2020) (PROSPERO no.: CRD42020140026). IPD were subsequently requested from authors. The primary outcome - the effect of anticoagulation on all-cause mortality - was assessed by a one-step meta-analysis based on a competing-risk model with liver transplantation as the competing event. The model was adjusted for clinically relevant confounders. A multilevel mixed-effects logistic regression model was used to determine the effect of anticoagulation on recanalization. Results: Individual data on 500 patients from five studies were included; 205 (41%) received anticoagulation and 295 did not. Anticoagulation reduced all-cause mortality (adjusted subdistribution hazard ratio 0.59; 95% CI 0.49-0.70), independently of thrombosis severity and recanalization. The effect of anticoagulation on all-cause mortality was consistent with a reduction in liver-related mortality. The recanalization rate was higher in the anticoagulation arm (adjusted odds ratio 3.45; 95% CI 2.22-5.36). The non-portal-hypertension-related bleeding rate was significantly greater in the anticoagulation group. Conclusions: Anticoagulation reduces all-cause mortality in patients with cirrhosis and portal vein thrombosis independently of recanalization, but at the expense of increasing non-portal hypertension-related bleeding. Prospero registration number: CRD42020140026. Impact and implications: Anticoagulation is effective in promoting recanalization of portal vein thrombosis in patients with cirrhosis, but whether this benefit translates into improved survival is controversial. Our individual patient data meta-analysis based on a competing-risk model with liver transplantation as the competing event shows that anticoagulation reduces all-cause mortality in patients with cirrhosis and portal vein thrombosis independently of recanalization. According to our findings, portal vein thrombosis may identify a group of patients with cirrhosis that benefit from long-term anticoagulation.

Published
2023

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