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1. Inferior Vena Cava Filters: A Clinical Review and Future Perspectives

Author

Raffaella Benedetti, Simone Marino, Flavio Tangianu, and Davide Imberti

Subjects
caval filter, pulmonary embolism, deep vein thrombosis, venous thromboembolism, Medicine
Abstract

Anticoagulation represents the first line treatment for venous thromboembolism (VTE). However, inferior vena cava (IVC) filter insertion can be considered as a possible therapeutic strategy when anticoagulant therapy is contraindicated, to avoid embolization from the lower limbs to pulmonary circulation. Other possible indications are debated among experts. Both permanent and retrievable caval filters are available in clinical practice. Retrievable filters can be removed when no longer necessary, as their use may be indicated only for a limited amount of time. Moreover, caval filter insertion is not devoid of possible complications, particularly in cases of permanent or long-dwelling filters. A multidisciplinary approach is recommended to review the appropriateness of caval filter use and to define the best timing for retrieval.

Published
2024
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2. Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry

Author

George Ntaios, Menno V. Huisman, Hans-Christoph Diener, Jonathan L. Halperin, Christine Teutsch, Sabrina Marler, Venkatesh K. Gurusamy, Milla Thompson, Gregory Y.H. Lip, Brian Olshansky, Dzifa Wosornu Abban, Nasser Abdul, Atilio Marcelo Abud, Fran Adams, Srinivas Addala, Pedro Adragão, Walter Ageno, Rajesh Aggarwal, Sergio Agosti, Piergiuseppe Agostoni, Francisco Aguilar, Julio Aguilar Linares, Luis Aguinaga, Jameel Ahmed, Allessandro Aiello, Paul Ainsworth, Jorge Roberto Aiub, Raed Al-Dallow, Lisa Alderson, Jorge Antonio Aldrete Velasco, Dimitrios Alexopoulos, Fernando Alfonso Manterola, Pareed Aliyar, David Alonso, Fernando Augusto Alves da Costa, José Amado, Walid Amara, Mathieu Amelot, Nima Amjadi, Fabrizio Ammirati, Marianna Andrade, Nabil Andrawis, Giorgio Annoni, Gerardo Ansalone, M.Kevin Ariani, Juan Carlos Arias, Sébastien Armero, Chander Arora, Muhammad Shakil Aslam, M. Asselman, Philippe Audouin, Charles Augenbraun, S. Aydin, Ivaneta Ayryanova, Emad Aziz, Luciano Marcelo Backes, E. Badings, Ermentina Bagni, Seth H. Baker, Richard Bala, Antonio Baldi, Shigenobu Bando, Subhash Banerjee, Alan Bank, Gonzalo Barón Esquivias, Craig Barr, Maria Bartlett, Vanja Basic Kes, Giovanni Baula, Steffen Behrens, Alan Bell, Raffaella Benedetti, Juan Benezet Mazuecos, Bouziane Benhalima, Jutta Bergler-Klein, Jean-Baptiste Berneau, Richard A. Bernstein, Percy Berrospi, Sergio Berti, Andrea Berz, Elizabeth Best, Paulo Bettencourt, Robert Betzu, Ravi Bhagwat, Luna Bhatta, Francesco Biscione, Giovanni BISIGNANI, Toby Black, Michael J. Bloch, Stephen Bloom, Edwin Blumberg, Mario Bo, Ellen Bøhmer, Andreas Bollmann, Maria Grazia Bongiorni, Giuseppe Boriani, D.J. Boswijk, Jochen Bott, Edo Bottacchi, Marica Bracic Kalan, Drew Bradman, Donald Brautigam, Nicolas Breton, P.J.A.M. Brouwers, Kevin Browne, Jordi Bruguera Cortada, A. Bruni, Claude Brunschwig, Hervé Buathier, Aurélie Buhl, John Bullinga, Jose Walter Cabrera, Alberto Caccavo, Shanglang Cai, Sarah Caine, Leonardo Calò, Valeria Calvi, Mauricio Camarillo Sánchez, Rui Candeias, Vincenzo Capuano, Alessandro Capucci, Ronald Caputo, Tatiana Cárdenas Rizo, Francisco Cardona, Francisco Carlos da Costa Darrieux, Yan Carlos Duarte Vera, Antonio Carolei, Susana Carreño, Paula Carvalho, Susanna Cary, Gavino Casu, Claudio Cavallini, Guillaume Cayla, Aldo Celentano, Tae-Joon Cha, Kwang Soo Cha, Jei Keon Chae, Kathrine Chalamidas, Krishnan Challappa, Sunil Prakash Chand, Harinath Chandrashekar, Ludovic Chartier, Kausik Chatterjee, Carlos Antero Chavez Ayala, Aamir Cheema, Amjad Cheema, Lin Chen, Shih-Ann Chen, Jyh Hong Chen, Fu-Tien Chiang, Francesco Chiarella, Lin Chih-Chan, Yong Keun Cho, Jong-Il Choi, Dong Ju Choi, Guy Chouinard, Danny Hoi-Fan Chow, Dimitrios Chrysos, Galina Chumakova, Eduardo Julián José Roberto Chuquiure Valenzuela, Nicoleta Cindea Nica, David J. Cislowski, Anthony Clay, Piers Clifford, Andrew Cohen, Michael Cohen, Serge Cohen, Furio Colivicchi, Ronan Collins, Paolo Colonna, Steve Compton, Derek Connolly, Alberto Conti, Gabriel Contreras Buenostro, Gregg Coodley, Martin Cooper, Julian Coronel, Giovanni Corso, Juan Cosín Sales, Yves Cottin, John Covalesky, Aurel Cracan, Filippo Crea, Peter Crean, James Crenshaw, Tina Cullen, Harald Darius, Patrick Dary, Olivier Dascotte, Ira Dauber, Vicente Davalos, Ruth Davies, Gershan Davis, Jean-Marc Davy, Mark Dayer, Marzia De Biasio, Silvana De Bonis, Raffaele De Caterina, Teresiano De Franceschi, J.R. de Groot, José De Horta, Axel De La Briolle, Gilberto de la Pena Topete, Angelo Amato Vicenzo de Paola, Weimar de Souza, A. de Veer, Luc De Wolf, Eric Decoulx, Sasalu Deepak, Pascal Defaye, Freddy Del-Carpio Munoz, Diana Delic Brkljacic, N. Joseph Deumite, Silvia Di Legge, Igor Diemberger, Denise Dietz, Pedro Dionísio, Qiang Dong, Fabio Rossi dos Santos, Elena Dotcheva, Rami Doukky, Anthony D'Souza, Simon Dubrey, Xavier Ducrocq, Dmitry Dupljakov, Mauricio Duque, Dipankar Dutta, Nathalie Duvilla, A. Duygun, Rainer Dziewas, Charles B. Eaton, William Eaves, L.A. Ebels-Tuinbeek, Clifford Ehrlich, Sabine Eichinger-Hasenauer, Steven J. Eisenberg, Adnan El Jabali, Mahfouz El Shahawy, Mauro Esteves Hernandes, Ana Etxeberria Izal, Rudolph Evonich, III, Oksana Evseeva, Andrey Ezhov, Raed Fahmy, Quan Fang, Ramin Farsad, Laurent Fauchier, Stefano Favale, Maxime Fayard, Jose Luis Fedele, Francesco Fedele, Olga Fedorishina, Steven R. Fera, Luis Gustavo Gomes Ferreira, Jorge Ferreira, Claudio Ferri, Anna Ferrier, Hugo Ferro, Alexandra Finsen, Brian First, Stuart Fischer, Catarina Fonseca, Luísa Fonseca Almeida, Steven Forman, Brad Frandsen, William French, Keith Friedman, Athena Friese, Ana Gabriela Fruntelata, Shigeru Fujii, Stefano Fumagalli, Marta Fundamenski, Yutaka Furukawa, Matthias Gabelmann, Nashwa Gabra, Niels Gadsbøll, Michel Galinier, Anders Gammelgaard, Priya Ganeshkumar, Christopher Gans, Antonio Garcia Quintana, Olivier Gartenlaub, Achille Gaspardone, Conrad Genz, Frédéric Georger, Jean-Louis Georges, Steven Georgeson, Evaldas Giedrimas, Mariusz Gierba, Ignacio Gil Ortega, Eve Gillespie, Alberto Giniger, Michael C. Giudici, Alexandros Gkotsis, Taya V. Glotzer, Joachim Gmehling, Jacek Gniot, Peter Goethals, Seth Goldbarg, Ronald Goldberg, Britta Goldmann, Sergey Golitsyn, Silvia Gómez, Juan Gomez Mesa, Vicente Bertomeu Gonzalez, Jesus Antonio Gonzalez Hermosillo, Víctor Manuel González López, Hervé Gorka, Charles Gornick, Diana Gorog, Venkat Gottipaty, Pascal Goube, Ioannis Goudevenos, Brett Graham, G. Stephen Greer, Uwe Gremmler, Paul G. Grena, Martin Grond, Edoardo Gronda, Gerian Grönefeld, Xiang Gu, Ivett Guadalupe Torres Torres, Gabriele Guardigli, Carolina Guevara, Alexandre Guignier, Michele Gulizia, Michael Gumbley, Albrecht Günther, Andrew Ha, Georgios Hahalis, Joseph Hakas, Christian Hall, Bing Han, Seongwook Han, Joe Hargrove, David Hargroves, Kenneth B. Harris, Tetsuya Haruna, Emil Hayek, Jeff Healey, Steven Hearne, Michael Heffernan, Geir Heggelund, J.A. Heijmeriks, Maarten Hemels, I. Hendriks, Sam Henein, Sung-Ho Her, Paul Hermany, Jorge Eduardo Hernández Del Río, Yorihiko Higashino, Michael Hill, Tetsuo Hisadome, Eiji Hishida, Etienne Hoffer, Matthew Hoghton, Kui Hong, Suk keun Hong, Stevie Horbach, Masataka Horiuchi, Yinglong Hou, Jeff Hsing, Chi-Hung Huang, David Huckins, kathy Hughes, A. Huizinga, E.L. Hulsman, Kuo-Chun Hung, Gyo-Seung Hwang, Margaret Ikpoh, Davide Imberti, Hüseyin Ince, Ciro Indolfi, Shujiro Inoue, Didier Irles, Harukazu Iseki, C. Noah Israel, Bruce Iteld, Venkat Iyer, Ewart Jackson-Voyzey, Naseem Jaffrani, Frank Jäger, Martin James, Sung-Won Jang, Nicolas Jaramillo, Nabil Jarmukli, Robert J. Jeanfreau, Ronald D. Jenkins, Carlos Jerjes Sánchez, Javier Jimenez, Robert Jobe, Tomas Joen-Jakobsen, Nicholas Jones, Jose Carlos Moura Jorge, Bernard Jouve, Byung Chun Jung, Kyung Tae Jung, Werner Jung, Mikhail Kachkovskiy, Krystallenia Kafkala, Larisa Kalinina, Bernd Kallmünzer, Farzan Kamali, Takehiro Kamo, Priit Kampus, Hisham Kashou, Andreas Kastrup, Apostolos Katsivas, Elizabeth Kaufman, Kazuya Kawai, Kenji Kawajiri, John F. Kazmierski, P. Keeling, José Francisco Kerr Saraiva, Galina Ketova, AJIT Singh Khaira, Aleksey Khripun, Doo-Il Kim, Young Hoon Kim, Nam Ho Kim, Dae Kyeong Kim, Jeong Su Kim, June Soo Kim, Ki Seok Kim, Jin bae Kim, Elena Kinova, Alexander Klein, James J. Kmetzo, G. Larsen Kneller, Aleksandar Knezevic, Su Mei Angela Koh, Shunichi Koide, Anastasios Kollias, J.A. Kooistra, Jay Koons, Martin Koschutnik, William J. Kostis, Dragan Kovacic, Jacek Kowalczyk, Natalya Koziolova, Peter Kraft, Johannes A. Kragten, Mori Krantz, Lars Krause, B.J. Krenning, F. Krikke, Z. Kromhout, Waldemar Krysiak, Priya Kumar, Thomas Kümler, Malte Kuniss, Jen-Yuan Kuo, Achim Küppers, Karla Kurrelmeyer, Choong Hwan Kwak, Bénédicte Laboulle, Arthur Labovitz, Wen Ter Lai, Andy Lam, Yat Yin Lam, Fernando Lanas Zanetti, Charles Landau, Giancarlo Landini, Estêvão Lanna Figueiredo, Torben Larsen, Karine Lavandier, Jessica LeBlanc, Moon Hyoung Lee, Chang-Hoon Lee, John Lehman, Ana Leitão, Nicolas Lellouche, Malgorzata Lelonek, Radoslaw Lenarczyk, T. Lenderink, Salvador León González, Peter Leong-Sit, Matthias Leschke, Nicolas Ley, Zhanquan Li, Xiaodong Li, Weihua Li, Xiaoming Li, Christhoh Lichy, Ira Lieber, Ramon Horacio Limon Rodriguez, Hailong Lin, Feng Liu, Hengliang Liu, Guillermo Llamas Esperon, Nassip Llerena Navarro, Eric Lo, Sergiy Lokshyn, Amador López, José Luís López-Sendón, Adalberto Menezes Lorga Filho, Richard S. Lorraine, Carlos Alberto Luengas, Robert Luke, Ming Luo, Steven Lupovitch, Philippe Lyrer, Changsheng Ma, Genshan Ma, Irene Madariaga, Koji Maeno, Dominique Magnin, Gustavo Maid, Sumeet K. Mainigi, Konstantinos Makaritsis, Rohit Malhotra, Rickey Manning, Athanasios Manolis, Helard Andres Manrique Hurtado, Ioannis Mantas, Fernando Manzur Jattin, Vicky Maqueda, Niccolo Marchionni, Francisco Marin Ortuno, Antonio Martín Santana, Jorge Martinez, Petra Maskova, Norberto Matadamas Hernandez, Katsuhiro Matsuda, Tillmann Maurer, Ciro Mauro, Erik May, Nolan Mayer, John McClure, Terry McCormack, William McGarity, Hugh McIntyre, Brent McLaurin, Feliz Alvaro Medina Palomino, Francesco Melandri, Hiroshi Meno, Dhananjai Menzies, Marco Mercader, Christian Meyer, Beat j. Meyer, Jacek Miarka, Frank Mibach, Dominik Michalski, Patrik Michel, Rami Mihail Chreih, Ghiath Mikdadi, Milan Mikus, Davor Milicic, Constantin Militaru, Sedi Minaie, Bogdan Minescu, Iveta Mintale, Tristan Mirault, Michael J. Mirro, Dinesh Mistry, Nicoleta Violeta Miu, Naomasa Miyamoto, Tiziano Moccetti, Akber Mohammed, Azlisham Mohd Nor, Michael Mollerus, Giulio Molon, Sergio Mondillo, Patrícia Moniz, Lluis Mont, Vicente Montagud, Oscar Montaña, Cristina Monti, Luciano Moretti, Kiyoo Mori, Andrew Moriarty, Jacek Morka, Luigi Moschini, Nikitas Moschos, Andreas Mügge, Thomas J. Mulhearn, Carmen Muresan, Michela Muriago, Wlodzimierz Musial, Carl W. Musser, Francesco Musumeci, Thuraia Nageh, Hidemitsu Nakagawa, Yuichiro Nakamura, Toru Nakayama, Gi-Byoung Nam, Michele Nanna, Indira Natarajan, Hemal M. Nayak, Stefan Naydenov, Jurica Nazli, Alexandru Cristian Nechita, Libor Nechvatal, Sandra Adela Negron, James Neiman, Fernando Carvalho Neuenschwander, David Neves, Anna Neykova, Ricardo Nicolás Miguel, George Nijmeh, Alexey Nizov, Rodrigo Noronha Campos, Janko Nossan, Tatiana Novikova, Ewa Nowalany-Kozielska, Emmanuel Nsah, Juan Carlos Nunez Fragoso, Svetlana Nurgalieva, Dieter Nuyens, Ole Nyvad, Manuel Odin de Los Rios Ibarra, Philip O'Donnell, Martin O'Donnell, Seil Oh, Yong Seog Oh, Dongjin Oh, Gilles O'Hara, Kostas Oikonomou, Claudia Olivares, Richard Oliver, Rafael Olvera Ruiz, Christoforos Olympios, Anna omaszuk-Kazberuk, Joaquín Osca Asensi, eena Padayattil jose, Francisco Gerardo Padilla Padilla, Victoria Padilla Rios, Giuseppe Pajes, A. Shekhar Pandey, Gaetano Paparella, F. Paris, Hyung Wook Park, Jong Sung Park, Fragkiskos Parthenakis, Enrico Passamonti, Rajesh J. Patel, Jaydutt Patel, Mehool Patel, Janice Patrick, Ricardo Pavón Jimenez, Analía Paz, Vittorio Pengo, William Pentz, Beatriz Pérez, Alma Minerva Pérez Ríos, Alejandro Pérez-Cabezas, Richard Perlman, Viktor Persic, Francesco Perticone, Terri K. Peters, Sanjiv Petkar, Luis Felipe Pezo, Christian Pflücke, David N. Pham, Roland T. Phillips, Stephen Phlaum, Denis Pieters, Julien Pineau, Arnold Pinter, Fausto Pinto, R. Pisters, Nediljko Pivac, Darko Pocanic, Cristian Podoleanu, Alessandro Politano, Zdravka Poljakovic, Stewart Pollock, Jose Polo Garcéa, Holger Poppert, Maurizio Porcu, Antonio Pose Reino, Neeraj Prasad, Dalton Bertolim Précoma, Alessandro Prelle, John Prodafikas, Konstantin Protasov, Maurice Pye, Zhaohui Qiu, Jean-Michel Quedillac, Dimitar Raev, Carlos Antonio Raffo Grado, Sidiqullah Rahimi, Arturo Raisaro, Bhola Rama, Ricardo Ramos, Maria Ranieri, Nuno Raposo, Eric Rashba, Ursula Rauch-Kroehnert, Ramakota Reddy, Giulia Renda, Shabbir Reza, Luigi Ria, Dimitrios Richter, Hans Rickli, Werner Rieker, Tomas Ripolil Vera, Luiz Eduardo Ritt, Douglas Roberts, Ignacio Rodriguez Briones, Aldo Edwin Rodriguez Escudero, Carlos Rodríguez Pascual, Mark Roman, Francesco Romeo, E. Ronner, Jean-Francois Roux, Nadezda Rozkova, Miroslav Rubacek, Frank Rubalcava, Andrea M. Russo, Matthieu Pierre Rutgers, Karin Rybak, Samir Said, Tamotsu Sakamoto, Abraham Salacata, Adrien Salem, Rafael Salguero Bodes, Marco A. Saltzman, Alessandro Salvioni, Gregorio Sanchez Vallejo, Marcelo Sanmartín Fernández, Wladmir Faustino Saporito, Kesari Sarikonda, Taishi Sasaoka, Hamdi Sati, Irina Savelieva, Pierre-Jean Scala, Peter Schellinger, Carlos Scherr, Lisa Schmitz, Karl-Heinz Schmitz, Bettina Schmitz, Teresa Schnabel, Steffen Schnupp, Peter Schoeniger, Norbert Schön, Peter Schwimmbeck, Clare Seamark, Greg Searles, Karl-Heinz Seidl, Barry Seidman, Jaroslaw Sek, Lakshmanan Sekaran, Carlo SERRATI, Neerav Shah, Vinay Shah, Anil Shah, Shujahat Shah, Vijay Kumar Sharma, Louise Shaw, Khalid H. Sheikh, Naruhito Shimizu, Hideki Shimomura, Dong-Gu Shin, Eun-Seok Shin, Junya Shite, Gerolamo Sibilio, Frank Silver, Iveta Sime, Tim A. Simmers, Narendra Singh, Peter Siostrzonek, Didier Smadja, David W. Smith, Marcelo Snitman, Dario Sobral Filho, Hassan Soda, Carl Sofley, Adam Sokal, Yannie Soo Oi Yan, Rodolfo Sotolongo, Olga Ferreira de Souza, Jon Arne Sparby, Jindrich Spinar, David Sprigings, Alex C. Spyropoulos, Dimitrios Stakos, Clemens Steinwender, George Stergiou, Ian Stiell, Marcus Stoddard, Anastas Stoikov, Witold Streb, Ioannis Styliadis, Guohai Su, Xi Su, Wanda Sudnik, Kai Sukles, Xiaofei Sun, H. Swart, Janko Szavits-Nossan, Jens Taggeselle, Yuichiro Takagi, Amrit Pal Singh Takhar, Angelika Tamm, Katsumi Tanaka, Tanyanan Tanawuttiwat, Sherman Tang, Aylmer Tang, Giovanni Tarsi, Tiziana Tassinari, Ashis Tayal, Muzahir Tayebjee, J.M. ten Berg, Dan Tesloianu, Salem H.K. The, Dierk Thomas, Serge Timsit, Tetsuya Tobaru, Andrzej R. Tomasik, Mikhail Torosoff, Emmanuel Touze, Elina Trendafilova, W. Kevin Tsai, Hung Fat Tse, Hiroshi Tsutsui, Tian Ming Tu, Ype Tuininga, Minang Turakhia, Samir Turk, Wayne Tcurner, Arnljot Tveit, Richard Tytus, C. Valadão, P.F.M.M. van Bergen, Philippe van de Borne, B.J. van den Berg, C. van der Zwaan, M. Van Eck, Peter Vanacker, Dimo Vasilev, Vasileios Vasilikos, Maxim Vasilyev, Srikar Veerareddy, Mario Vega Miño, Asok Venkataraman, Paolo Verdecchia, Francesco Versaci, Ernst Günter Vester, Hubert Vial, Jason Victory, Alejandro Villamil, Marc Vincent, Anthony Vlastaris, Jürgen vom Dahl, Kishor Vora, Robert B. Vranian, Paul Wakefield, Ningfu Wang, Mingsheng Wang, Xinhua Wang, Feng Wang, Tian Wang, Alberta L. Warner, Kouki Watanabe, Jeanne Wei, Christian Weimar, Stanislav Weiner, Renate Weinrich, Ming-Shien Wen, Marcus Wiemer, Preben Wiggers, Andreas Wilke, David Williams, Marcus L. Williams, Bernhard Witzenbichler, Brian Wong, Ka Sing Lawrence Wong, Beata Wozakowska-Kaplon, Shulin Wu, Richard C. Wu, Silke Wunderlich, Nell Wyatt, John (Jack) Wylie, Yong Xu, Xiangdong Xu, Hiroki Yamanoue, Takeshi Yamashita, Ping Yen Bryan Yan, Tianlun Yang, Jing Yao, Kuo-Ho Yeh, Wei Hsian Yin, Yoto Yotov, Ralf Zahn, Stuart Zarich, Sergei Zenin, Elisabeth Louise Zeuthen, Huanyi Zhang, Donghui Zhang, Xingwei Zhang, Ping Zhang, Jun Zhang, Shui Ping Zhao, Yujie Zhao, Zhichen Zhao, Yang Zheng, Jing Zhou, Sergio Zimmermann, Andrea Zini, Steven Zizzo, Wenxia Zong, and L Steven Zukerman

Subjects
SAMe-TT2R2, atrial fibrillation, non-vitamin-K antagonist oral anticoagulants, vitamin-K-antagonist oral anticoagulants, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Aim: The SAMe-TT2R2 score helps identify patients with atrial fibrillation (AF) likely to have poor anticoagulation control during anticoagulation with vitamin K antagonists (VKA) and those with scores >2 might be better managed with a target-specific oral anticoagulant (NOAC). We hypothesized that in clinical practice, VKAs may be prescribed less frequently to patients with AF and SAMe-TT2R2 scores >2 than to patients with lower scores. Methods and results: We analyzed the Phase III dataset of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF), a large, global, prospective global registry of patients with newly diagnosed AF and ≥1 stroke risk factor. We compared baseline clinical characteristics and antithrombotic prescriptions to determine the probability of the VKA prescription among anticoagulated patients with the baseline SAMe-TT2R2 score >2 and ≤ 2. Among 17,465 anticoagulated patients with AF, 4,828 (27.6%) patients were prescribed VKA and 12,637 (72.4%) patients an NOAC: 11,884 (68.0%) patients had SAMe-TT2R2 scores 0-2 and 5,581 (32.0%) patients had scores >2. The proportion of patients prescribed VKA was 28.0% among patients with SAMe-TT2R2 scores >2 and 27.5% in those with scores ≤2. Conclusions: The lack of a clear association between the SAMe-TT2R2 score and anticoagulant selection may be attributed to the relative efficacy and safety profiles between NOACs and VKAs as well as to the absence of trial evidence that an SAMe-TT2R2-guided strategy for the selection of the type of anticoagulation in NVAF patients has an impact on clinical outcomes of efficacy and safety. The latter hypothesis is currently being tested in a randomized controlled trial. Clinical trial registration: URL: https://www.clinicaltrials.gov//Unique identifier: NCT01937377, NCT01468701, and NCT01671007.

Published
2021
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3. Evaluation of unmet clinical needs in prophylaxis and treatment of venous thromboembolism in at-risk patient groups: pregnancy, elderly and obese patients

Author

Benjamin Brenner, Roopen Arya, Jan Beyer-Westendorf, James Douketis, Russell Hull, Ismail Elalamy, Davide Imberti, and Zhenguo Zhai

Subjects
Venous thromboembolism, Elderly, Pregnant, Pregnancy, Obese, Obesity, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Abstract Background Venous thromboembolism (VTE) accounts for an estimated 900,000 cases per year in the US alone and constitutes a considerable burden on healthcare systems across the globe. Objective To understand why the burden is so high, qualitative and quantitative research was carried out to gain insights from experts, guidelines and published studies on the unmet clinical needs and therapeutic strategies in VTE prevention and treatment in three populations identified as being at increased risk of VTE and in whom VTE prevention and treatment were regarded as suboptimal: pregnant women, the elderly and obese patients. Methodology A gap analysis methodology was created to highlight unmet needs in VTE management and to discover the patient populations considered most at risk. A questionnaire was devised to guide qualitative interviews with 44 thrombosis and haemostasis experts, and a review of the literature on VTE in the specific patient groups from 2015 to 2017 was completed. This was followed by a Think Tank meeting where the results from the research were discussed. Results This review highlights the insights gained and examines in detail the unmet needs with regard to VTE risk-assessment tools, biomarkers, patient stratification methods, and anticoagulant and dosing regimens in pregnant women, the elderly and obese patients. Conclusions Specifically, in pregnant women at high risk of VTE, low-molecular-weight heparin (LMWH) is the therapy of choice, but it remains unclear how to use anticoagulants when VTE risk is intermediate. In elderly patients, evaluation of the benefit of VTE prophylaxis against the bleeding risk is particularly important, and a head-to-head comparison of efficacy and safety of LMWH versus direct oral anticoagulants is needed. Finally, in obese patients, lack of guidance on anticoagulant dose adjustment to body weight has emerged as a major obstacle in effective prophylaxis and treatment of VTE.

Published
2019
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4. Management and Outcomes of Isolated Distal Deep Vein Thromboses: A Questionable Trend toward Long-Lasting Anticoagulation Treatment. Results from the START-Register

Author

Gualtiero Palareti, Cristina Legnani, Emilia Antonucci, Sophie Testa, Daniela Mastroiacovo, Benilde Cosmi, Daniela Poli, Eugenio Bucherini, Francesco Dentali, Andrea Fontanella, Nicola Mumoli, Davide Imberti, Anna Falanga, Walter Ageno, and Fulvio Pomero

Subjects
isolated distal deep vein thrombosis, oral anticoagulant, bleeding, duration of treatment, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background Isolated distal deep vein thromboses (IDDVT) are frequently diagnosed; however, their natural history and real risk of complications are still uncertain. Though treatment is still not well standardized, international guidelines recommend no more than 3 months of anticoagulation therapy. We investigated how Italian clinicians treat IDDVT patients in their real life in our country. Methods Baseline characteristics and clinical history of the patients enrolled in the prospective, observational, multicenter START-Register for a first IDDVT or proximal DVT (PDVT) were analyzed. Results Overall, 412 IDDVT patients were significantly younger, with better renal function, and more frequent major transient risk factors, when compared with 1,173 PDVT patients. The anticoagulation duration was >180 days in 52.7% of IDDVT patients (70.7% in PDVT). During treatment, bleeding occurred in 5.6 and 2.8% patient-years in IDDVT and PDVT, respectively (p = 0082). Bleeding was more frequent in IDDVT than PDVT patients treated with warfarin (6.8 vs. 3.2 patient-years, p = 0.0228, respectively). Thrombotic complications occurred in 1.1 and 2.4% patient-years in IDDVT and PDVT patients, respectively. Analyzing together the two groups, 66.1% of bleeds and 86.1% thrombotic complications occurred after 90 days anticoagulation treatment. Conclusion The large majority of IDDVT patients received anticoagulation for more than 3 months. Most bleeding and thrombotic complications occurred after the first 90 days of anticoagulation therapy. These results indicate that an extended anticoagulation beyond 90 days in IDDVT patients is associated with increased risk of complications. Whether an extended treatment may lower recurrences after anticoagulation withdrawal should be assessed by specifically designed studies.

Published
2021
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5. Evaluation of unmet clinical needs in prophylaxis and treatment of venous thromboembolism in high-risk patient groups: cancer and critically ill

Author

Benjamin Brenner, Russell Hull, Roopen Arya, Jan Beyer-Westendorf, James Douketis, Ismail Elalamy, Davide Imberti, and Zhenguo Zhai

Subjects
Venous thromboembolism, Cancer, Critically ill, Anticoagulants, Low-molecular-weight heparin, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Abstract Background Clinical practice shows that venous thromboembolism (VTE) presents a substantial burden in medical patients, and awareness and advocacy for its primary and secondary prevention remains inadequate. Specific patient populations, such as those with cancer and the critically ill, show elevated risk for VTE, bleeding or both, and significant gaps in VTE prophylaxis and treatment exist in these groups. Objective To present current expert insights and evidence on the unmet needs in thromboprophylaxis, and on the treatment of VTE in two high-risk patient groups: patients with cancer and the critically ill. Methodology To identify specific unmet needs in the management of VTE, a methodology was designed and implemented that assessed gaps in prophylaxis and treatment of VTE through interviews with 44 experts in the field of thrombosis and haemostasis, and through a review of current guidelines and seminal studies to substantiate the insights provided by the experts. The research findings were then analysed, discussed and consolidated by a multidisciplinary group of experts. Results The gap analysis methodology identified shortcomings in the VTE risk assessment tools, patient stratification approaches for prophylaxis, and the suboptimal use of anticoagulants for primary prophylaxis and treatment. Conclusions Specifically, patients with cancer need better VTE risk assessment tools to tailor primary thromboprophylaxis to tumour types and disease stages, and the potential for drug–drug interactions needs to be considered. In critically ill patients, unfractionated heparin is not advised as a first-line treatment option, low-molecular weight heparins remain the first choice for prophylaxis in critically ill and cancer patients due to their safety and efficacy profile, and the strength of evidence is increasing for direct oral anticoagulants as a treatment option over low-molecular-weight heparins. Herein we present novel insights and consolidated evidence collected from experts, clinical practice guidelines and original studies on the unmet needs in thromboprophylaxis, and on the treatment of VTE in patients with cancer and the critically ill.

Published
2019
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6. The introduction of biosimilars of low molecular weight heparins in Europe: a critical review and reappraisal endorsed by the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV)

Author

Davide Imberti, Marco Marietta, Hernan Polo Friz, and Claudio Cimminiello

Subjects
Low molecular weight heparin, Biosimilar pharmaceuticals, Evidence-based practice, Therapeutic equivalency, Venous Thromboembolism, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Abstract Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane® and Inhixa®, biosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin. The authorization path is considerably different from the guidelines published by the EMA in 2009, as well as from the recommendations from the International Society on Thrombosis and Haemostasis published in 2013. Indeed, both of them recommended that LMWHs biosimilars therapeutic equivalence should be demonstrated in at least one adequately designed clinical trial. Shortly after enoxaparin biosimilars approval, EMA published a revised version of its guideline, no longer requiring the execution of a clinical study in patients at risk of venous thromboembolism. Also the assessment of safety shows some relevant flaws, as it relies only on a 20 healthy volunteers study, clearly underpowered to draw any conclusions about the safety profile of the drug. In our opinion, the approach taken by EMA for approval of enoxaparin biosimilars raises serious concerns about their actual, clinical “similarity”. On these grounds, with the endorsement of the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV), we elaborated the present document aimed at reviewing and reappraising some critical points regarding the introduction of biosimilars of LMWH in Europe. Moreover, we would strongly advise the Italian National Health Authorities not to entrust safety assessment to the post-marketing surveillance only, but to promote well designed and powered studies aimed at establish the actual efficacy and safety of LMWH biosimilars.

Published
2017
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7. Hemorrhagic Transformation in Patients With Acute Ischemic Stroke and Atrial Fibrillation: Time to Initiation of Oral Anticoagulant Therapy and Outcomes

Author

Maurizio Paciaroni, Fabio Bandini, Giancarlo Agnelli, Georgios Tsivgoulis, Shadi Yaghi, Karen L. Furie, Prasanna Tadi, Cecilia Becattini, Marialuisa Zedde, Azmil H. Abdul‐Rahim, Kennedy R. Lees, Andrea Alberti, Michele Venti, Monica Acciarresi, Cataldo D'Amore, Maria Giulia Mosconi, Ludovica Anna Cimini, Riccardo Altavilla, Giacomo Volpi, Paolo Bovi, Monica Carletti, Alberto Rigatelli, Manuel Cappellari, Jukka Putaala, Liisa Tomppo, Turgut Tatlisumak, Simona Marcheselli, Alessandro Pezzini, Loris Poli, Alessandro Padovani, Luca Masotti, Vieri Vannucchi, Sung‐Il Sohn, Gianni Lorenzini, Rossana Tassi, Francesca Guideri, Maurizio Acampa, Giuseppe Martini, George Ntaios, George Athanasakis, Konstantinos Makaritsis, Efstathia Karagkiozi, Konstantinos Vadikolias, Chrissoula Liantinioti, Maria Chondrogianni, Nicola Mumoli, Domenico Consoli, Franco Galati, Simona Sacco, Antonio Carolei, Cindy Tiseo, Francesco Corea, Walter Ageno, Marta Bellesini, Giovanna Colombo, Giorgio Silvestrelli, Alfonso Ciccone, Alessia Lanari, Umberto Scoditti, Licia Denti, Michelangelo Mancuso, Miriam Maccarrone, Leonardo Ulivi, Giovanni Orlandi, Nicola Giannini, Gino Gialdini, Tiziana Tassinari, Maria Luisa De Lodovici, Giorgio Bono, Christina Rueckert, Antonio Baldi, Sebastiano D'Anna, Danilo Toni, Federica Letteri, Martina Giuntini, Enrico Maria Lotti, Yuriy Flomin, Alessio Pieroni, Odysseas Kargiotis, Theodore Karapanayiotides, Serena Monaco, Mario Maimone Baronello, Laszló Csiba, Lilla Szabó, Alberto Chiti, Elisa Giorli, Massimo Del Sette, Davide Imberti, Dorjan Zabzuni, Boris Doronin, Vera Volodina, Patrik Michel, Peter Vanacker, Kristian Barlinn, Lars‐Peder Pallesen, Jessica Barlinn, Dirk Deleu, Gayane Melikyan, Faisal Ibrahim, Naveed Akhtar, Vanessa Gourbali, and Valeria Caso

Subjects
atrial fibrillation, hemorrhagic transformation, stroke, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background In patients with acute ischemic stroke and atrial fibrillation, early anticoagulation prevents ischemic recurrence but with the risk of hemorrhagic transformation (HT). The aims of this study were to evaluate in consecutive patients with acute stroke and atrial fibrillation (1) the incidence of early HT, (2) the time to initiation of anticoagulation in patients with HT, (3) the association of HT with ischemic recurrences, and (4) the association of HT with clinical outcome at 90 days. Methods and Results HT was diagnosed by a second brain computed tomographic scan performed 24 to 72 hours after stroke onset. The incidence of ischemic recurrences as well as mortality or disability (modified Rankin Scale scores >2) were evaluated at 90 days. Ischemic recurrences were the composite of ischemic stroke, transient ischemic attack, or systemic embolism. Among the 2183 patients included in the study, 241 (11.0%) had HT. Patients with and without HT initiated anticoagulant therapy after a mean 23.3 and 11.6 days, respectively, from index stroke. At 90 days, 4.6% (95% confidence interval, 2.3–8.0) of the patients with HT had ischemic recurrences compared with 4.9% (95% confidence interval, 4.0–6.0) of those without HT; 53.1% of patients with HT were deceased or disabled compared with 35.8% of those without HT. On multivariable analysis, HT was associated with mortality or disability (odds ratio, 1.71; 95% confidence interval, 1.24–2.35). Conclusions In patients with HT, anticoagulation was initiated about 12 days later than patients without HT. This delay was not associated with increased detection of ischemic recurrence. HT was associated with increased mortality or disability.

Published
2018
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8. Direct oral anticoagulants for secondary prevention in patients with non-valvular atrial fibrillation

Author

Luca Masotti, Mario Di Napoli, Walter Ageno, Davide Imberti, Cecilia Becattini, Maurizio Paciaroni, Daniel Augustin Godoy, Roberto Cappelli, Giancarlo Landini, Grazia Panigada, Ido Iori, Domenico Prisco, and Giancarlo Agnelli

Subjects
atrial fibrillation, warfarin, stroke, prophylaxis, dabigatran, rivaroxaban, apixaban., Medicine
Abstract

The patients with non-valvular atrial fibrillation (NVAF), both permanent and paroxysmal, and history of previous transient ischemic attack (TIA) or stroke represent a category of patients at high risk of new embolic events, independently of the presence of other risk factors. In these patients, national and international guidelines recommend oral anticoagulants as first choice for antithrombotic prevention. Direct oral anticoagulants (DOACs) have been demonstrated to be not inferior to warfarin for many end points in NVAF patients in terms of efficacy and safety. The post hoc analysis in selected subgroups of patients enrolled in the three mega trials of phase III comparing DOACs (RE-LY, ROCKET-AF and ARISTOTLE) with warfarin help to evaluate whether superiority and non-inferiority persist in these subgroups. Here, patients with NVAF and history of previous TIA/stroke receiving DOACs as secondary prevention are compared with patients with the same characteristics receiving warfarin. An analysis of these patients has been recently published (separately for each of three DOACs). This analysis shows that DOACs maintain their non-inferiority when compared with warfarin in secondary prevention, representing a real alternative in this context of patients at high risk for ischemic and bleeding events.

Published
2013
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9. How to manage new oral anticoagulants in case of surgery

Author

Davide Imberti

Subjects
new oral anticoagulants, low molecular weight heparins, surgery, bleeding risk, thrombosis., Medicine
Abstract

When a patient receiving new oral anticoagulants (NOACs) requires an invasive procedure, the consequences of bleeding if anticoagulation is continued and the risk of thrombosis if it is omitted need to be carefully considered. In addition to the bleeding risk of the procedure, it is of paramount importance to evaluate the renal function, especially for dabigatran that is eliminated predominantly via the renal pathway. NOAC therapy should be stopped for at least 24 h before the intervention, and a longer interruption should be considered in cases of high bleeding risk procedures and/or renal failure. A base-line assessment of coagulation should be performed and intervention should be postponed (if possible) if high levels of anticoagulation parameters are found. In the post-surgical period, if oral anticoagulant therapy cannot be re-started, patients should temporarily receive low molecular weight heparins and re-start NOACs as soon as possible.

Published
2013
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10. The treatment of venous thromboembolism with new oral anticoagulants

Author

Davide Imberti

Subjects
venous thromboembolism, new oral anticoagulants, rivaroxaban, apixaban, dabigatran, traditional therapy., Medicine
Abstract

Traditional anticoagulants, such as low molecular weight heparin, unfractionated heparin, fondaparinux and vitamin K antagonists, have been the mainstay of treatment of venous thromboembolism (VTE) in the clinical hospital setting and after discharge. These anticoagulants are effective, but are associated with some limitations that may lead to their underuse in many settings. Based on the results of large, randomized clinical trials, new oral anticoagulants have been validated for the treatment of acute deep vein thrombosis and pulmonary embolism, and for the prevention of recurrent VTE. These drugs represent a landmark shift in anticoagulation care and may overcome some of the limitations of traditional agents, with the potential of improving adherence to anticoagulation therapy.

Published
2013
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11. Prevention of VTE in orthopedic surgery patients

Author

Federico Spandonaro, Rossella Letizia Mancusi, Lorenzo Terranova, Diana Giannarelli, Paolo Grossi, Davide Imberti, and Emilio Mazza

Subjects
new oral anticoagulants, deep vein thrombosis, hta, low molecular weight heparin, Medicine (General), R5-920
Abstract

Venous thromboembolism (VTE) is defined as the obstruction, partial or complete, of one or more veins of deep circulation. It is a condition that can lead to a deterioration in his state of health until death, manifesting as deep vein thrombosis (DVT) or pulmonary embolism (PE). The major orthopedic surgery and the surgical oncology are frequently associated with thromboembolic complications, because of conditions that are often critical in these patients. It is estimated that in Italy DVT has an incidence that varies between 50 and 150 new cases per 100,000 population, while the prevalence would be between 2.5 and 5%. In the absence of thromboprophylaxis, the orthopedic surgery lead to a high increased risk of VTE. In elective hip replacement, in the absence of prophylaxis, the incidence of DVT and of fatal PE is about 50% and 2% respectively. In elective knee arthroplasty the risk of venous thromboembolic complications is even higher. It is estimated that 56.2% of the costs of prophylaxis with Low Molecular Weight Heparin (LMWH) in patients undergoing major orthopedic surgery are attributable to the cost of drugs (about € 200), followed (with 44.8%) by the cost of administration (approximately € 159). The average total cost/day was estimated at € 8 per patient. In Italy, it has been estimated an annual cost for new cases between 215 and 260 million €. The clinical advantages of the New Oral Anticoagulants (NOA) appear to be substantially clear, the major concern with regard to their reimbursement is therefore linked to the financial impact, due to the higher cost per day of the NOA compared with LMWH. To this end, it was built a model of budget impact, in the perspective of the Italian NHS, from the data related to cases of major surgical orthopedic procedures and a meta-analysis on the pivotal RCT, which aims to measure the differential effects in terms of prevention of VTE. The results show that the financial impact of the NOA in the prophylaxis of major orthopedic surgery is not particularly relevant. In fact, the major pharmaceutical costs that, at national level, amount to € 10.8 mil. (€ 15.2 mil. in the case of prolonged prophylaxis in knee operations) would be more than offset by savings in terms of fewer treatments of VTE, which is based on the assumption of more than 4,000 cases, up to about 6,600 in hypothesis best efficacy.

Published
2013
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12. REACH, PATHOS and SIRIO: indications for managing atherothrombosis

Author

Davide Imberti, Matteo Giorgi Pierfranceschi, Enrico Sverzellati, and Sergio Orlando

Subjects
Atherothrombosis, Risk factors, Diagnosis, Treatment, Prognosis., Medicine
Abstract

BACKGROUND Atherothrombosis includes a broad spectrum of clinical manifestations (coronary artery disease, cerebrovascular disease and peripheral artery disease) and is associated with the main causes of morbility and mortality on a world-wide scale. Thus far, most of the available information on atherothrombosis has been derived especially from randomized clinical trials (RCTs). Due to their strict inclusion and exclusion criteria, RCTs not always provide an accurate view of the entire spectrum of atherosclerotic clinical syndromes and are not fully representative of the real-world situation. Recently, three important observational clinical studies performed in unselected populations (REACH, PATHOS, SIRIO) have described the demographic characteristics, risk profiles, management and prognosis of a very large cohort of patients suffering from atherothrombosis. AIM OF THE STUDY In this article we focus on the description of the main results of REACH, PATHOS and SIRIO studies and we discuss about their relevance in the daily clinical practice.

Published
2013
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13. Agranulocytosis: an adverse effect of allopurinol treatment

Author

Elisa Mari, Franco Ricci, Davide Imberti, and Massimo Gallerani

Subjects
Allopurinol, Agranulocytosis, Hyperuricaemia., Medicine
Abstract

Introduction: Allopurinol is a xanthine oxidase inhibitor that is primarily used to treat hyperuricemia and its complications. The drug is rarely associated with adverse effects, but those that occur can be significant. Hematologic side effects, including bone marrow suppression, severe anemia, thrombocytopenia, and leukopenia, have been reported in 0.2-0.6% of treated patients. Materials and methods: We report a case of agranulocytosis associated with allopurinol therapy in a patient admitted for fever.

Published
2013
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14. Efficacy and safety of new oral anticoagulants compared with warfarin in cardioembolic prophylaxis of patients with non valvular atrial fibrillation. More lights than shadows

Author

Luca Masotti, Mario Di Napoli, Walter Ageno, Davide Imberti, Daniel Godoy, Grazia Panigada, Niccolò Napoli, Giancarlo Landini, Roberto Cappelli, Ido Iori, Domenico Prisco, and Giancarlo Agnelli

Subjects
Atrial fibrillation, Stroke, Dabigatran, Rivaroxaban, Apixaban, Medicine
Abstract

IntroductionThe prophylaxis of thromboembolic events represents a key point in the modern management of patients with non valvular atrial fibrillation (AF), both paroxysmal and persistent/permanent. Up to now, vitamin K antagonist (VKA) drugs are the first choice in thromboembolic prophylaxis. Their treatment limitations have lead to development and clinical experimental use of new molecules aimed to overcome their limits. The new oral anticoagulants, such as dabigatran, a direct inhibitor of thrombin or rivaroxaban and apixaban, direct inhibitors of activated factor X, have been compared to warfarin in randomized clinical phase three trials (RCTs) for thromboembolic prevention in patients with non valvular AF with the aim to demonstrate their non inferiority when compared to warfarin. The results of these trials have been recently published. In this article the authors review the results of efficacy and safety of these three more recently published large RCTs.Conclusions All RCTs, RE-LY for dabigatran, ROCKET-AF for rivaroxaban and ARISTOTLE for apixaban met the study end-points and demonstrated a good safety profile of each new oral anticoagulant, so promising a new era for thromboembolic prevention therapy in AF.

Published
2012
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15. Clinical characteristics and management of cancer-associated acute venous thromboembolism: findings from the MASTER Registry

Author

Davide Imberti, Giancarlo Agnelli, Walter Ageno, Marco Moia, Gualtiero Palareti, Riccardo Pistelli, Romina Rossi, and Melina Verso

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Background Clinical characteristics and management of acute deep vein thrombosis and pulmonary embolism (PE) have been reported to be different in patients with and without cancer. The aim of this paper was to provide information on clinical characteristics and management of acute venous thromboembolism in patients with cancer by means of a large prospective registry.Design and Methods MASTER is a multicenter registry of consecutively recruited patients with symptomatic, objectively confirmed, acute venous thromboembolism. Information about clinical characteristics and management was collected by an electronic data network at the time of the index event.Results A total of 2119 patients were enrolled, of whom 424 (20%) had cancer. The incidence of bilateral lower limb deep vein thrombosis was significantly higher in patients with cancer than in patients without cancer (8.5% versus 4.6%; p

Published
2008
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16. 36-month clinical outcomes of patients with venous thromboembolism

Author

Alexander G.G. Turpie, Alfredo E. Farjat, Sylvia Haas, Walter Ageno, Jeffrey I. Weitz, Samuel Z. Goldhaber, Shinya Goto, Pantep Angchaisuksiri, Gloria Kayani, Renato D. Lopes, Chern-En Chiang, Harry Gibbs, Eric Tse, Peter Verhamme, Hugo ten Cate, Juan Muntaner, Sebastian Schellong, Henri Bounameaux, Paolo Prandoni, Uma Maheshwari, Ajay K. Kakkar, Ab Loualidi, Abdurrahim Colak, Abraham Bezuidenhout, Abu Abdool-Carrim, Addala Azeddine, Adriaan Beyers, Adriaan Dees, Ahmed Mohamed, Ahmet Aksoy, Akihiko Abiko, Akinori Watanabe, Alan Krichell, Alberto Alfredo Fernandez, Alberto Tosetto, Alexey Khotuntsov, Alisha Oropallo, Alison Slocombe, Allan Kelly, Amanda Clark, Amr Gad, Amy Arouni, Andor Schmidt, Andrea Berni, Andres Javier Kleiban, Andrew Machowski, Andrey Kazakov, Angel Galvez, Ann Lockman, Anna Falanga, Anoop Chauhan, Antoni Riera-Mestre, Antonino Mazzone, Armando D'Angelo, Artur Herdy, Atsushi Kato, Ayman Abd Elhamid Ebrahim Mahmoud Salem, Azlan Husin, Barbara Erdelyi, Barry Jacobson, Beatrice Amann-Vesti, Bektas Battaloglu, Benedicte Wilson, Benilde Cosmi, Bergmann Jean Francois, Berremeli Toufek, Beverley Hunt, Bhavesh Natha, Bisher Mustafa, Bonnie Chi Shan Kho, Boulon Carine, Brian Zidel, Brisot Dominique, Brousse Christophe, Bruno Trimarco, Canhua Luo, Carlos Alberto Cuneo, Carlos Jerjes Sanchez Diaz, Carsten Schwencke, Cas Cader, Celal Yavuz, Cesar Javier Zaidman, Charles Lunn, Chau-Chung Wu, Cheng Hock Toh, Chevrier Elisa, Chien-Hsun Hsia, Chien-Lung Huang, Chi-Hang Kevin Kwok, Chih-Cheng Wu, Chi-Hung Huang, Chris Ward, Christian Opitz, Christina Jeanneret-Gris, Chung Yin Ha, Chun-Yao Huang, Claude Luyeye Bidi, Clifford Smith, Cornelia Brauer, Corrado Lodigiani, Couturaud Francis, Cynthia Wu, Daniel Staub, Daniel Theodoro, Daniela Poli, David - Riesco Acevedo, David Adler, David Jimenez, David Keeling, David Scott, Davide Imberti, Desmond Creagh, Desmurs-Clavel Helene, Dirk Hagemann, Dirk Le Roux, Dirk Skowasch, Dmitry Belenky, Dmitry Dorokhov, Dmitry Petrov, Dmitry Zateyshchikov, Domenico Prisco, Dorthe Møller, Dusan Kucera, Ehab M. Esheiba, Elizaveta Panchenko, Elkouri Dominique, Emre Dogan, Emre Kubat, Enrique Diaz Diaz, Eric Wai Choi Tse, Erik Yeo, Erman Hashas, Ernst Grochenig, Eros Tiraferri, Erwin Blessing, Escande Orthlieb Michèle, Esther Usandizaga, Ettore Porreca, Fabian Ferroni, Falvo Nicolas, Félix Ayala-Paredes, Firas Koura, Fitjerald Henry, Franco Cosmi, Frans Erdkamp, Gadel Kamalov, Garcia-Bragado Dalmau, Garrigues Damien, Garry Klein, Gaurand Shah, Geert Hollanders, Geno Merli, Georg Plassmann, George Platt, Germain Poirier, German Sokurenko, Ghassan Haddad, Gholam Ali, Giancarlo Agnelli, Gin Gin Gan, Grace Kaye-Eddie, Gregoire Le Gal, Gregory Allen, Guillermo Antonio Llamas Esperón, Guillot Jean-Paul, Hagen Gerofke, Hallah Elali, Hana Burianova, Hans-Juergen Ohler, Haofu Wang, Harald Darius, Harinder S. Gogia, Harry Striekwold, Hatice Hasanoglu, Hatice Turker, Hendrik Franow, Herbert De Raedt, Herman Schroe, Hesham Salah ElDin, Hesham Zidan, Hiroaki Nakamura, Ho Young Kim, Holger Lawall, Hong Zhu, Hongyan Tian, Ho-Young Yhim, Hun Gyu Hwang, Hyeok Shim, Igor Kim, Igor Libov, Igor Sonkin, Igor Suchkov, Ik-Chan Song, Ilker Kiris, Ilya Staroverov, Irene Looi, Isabel M. De La Azuela Tenorio, Ismail Savas, Ivan Gordeev, Ivo Podpera, Jae Hoon Lee, Jameela Sathar, James Welker, Jan Beyer-Westendorf, Jan Kvasnicka, Jan Vanwelden, JangYong Kim, Jaromira Svobodova, Jaspal Gujral, Javier Marino, Javier Tristan Galvar, Jeannine Kassis, Jen-Yuan Kuo, Jhih-Yuan Shih, JiHyun Kwon, Jin Hyun Joh, Jin Hyun Park, Jin Seok Kim, Jinghua Yang, Jiri Krupicka, Jiri Lastuvka, Jiri Pumprla, Jiri Vesely, Joan Carlos Souto, João Antônio Correa, Johan Duchateau, John Perry Fletcher, Jorge del Toro, Jorge Guillermo Chavez Paez, Jørn Nielsen, Jose Dalmo Araujo Filho, Jose Saraiva, Jose Antonio Diaz Peromingo, Jose Gomez Lara, Jose Luis Fedele, Jose Maria Surinach, Joseph Chacko, Juan Antonio Muntaner, Juan Carlos Álvarez Benitez, Juan Moreno Hoyos Abril, Julian Humphrey, Julio Bono, Junji Kanda, Juree Boondumrongsagoon, Kai Hang Yiu, Kanchana Chansung, Karin Boomars, Kate Burbury, Katsuhiro Kondo, Kemal Karaarslan, Kensuke Takeuchi, Knut Kroeger, Konstantin Zrazhevskiy, Koscál Svatopluk, Kou-Gi Shyu, Kristel Vandenbosch, Kuan-Cheng Chang, Kuan-Ming Chiu, Kubina Jean-Manuel, Kwan Jing Wern, Kwo-Chang Ueng, Lalita Norasetthada, Laure Binet, Lee Ping Chew, Lei Zhang, Leone Maria Cristina, Lidwine Tick, Lilia Beatriz Schiavi, Lily Lee Lee Wong, Lohana Borges, Louis Botha, Luc Capiau, Luc Timmermans, Luciano Eduardo López, Luigi Ria, Luis Manuel Hernandez Blasco, Luis Alberto Guzman, Luis Flota Cervera, Mahe Isabelle, Manuel Monreal Bosch, Manuel de los Rios Ibarra, Manuel Núñez Fernandez, Marc Carrier, Marcelo Raul Barrionuevo, Marco Antonio Alcocer Gamba, Marco Cattaneo, Marco Moia, Margaret Bowers, Mariam Chetanachan, Mario Alberto Berli, Mark Fixley, Markus Faghih, Markus Stuecker, Marlin Schul, Martin Banyai, Martin Koretzky, Martin Myriam, Mary Elizabeth Gaffney, Masao Hirano, Masashi Kanemoto, Mashio Nakamura, Mersel Tahar, Messas Emmanuel, Michael Kovacs, Michael Leahy, Michael Levy, Michael Munch, Michael Olsen, Michel De Pauw, Michel Gustin, Michiel Van Betsbrugge, Mikhail Boyarkin, Miroslav Homza, Modise Koto, Mohamed Abdool-Gaffar, Mohamed Ayman Fakhry Nagib, Mohamed El-Dessoki, Mohamed Khan, Monniaty Mohamed, Moo Hyun Kim, Moon-Hee Lee, Mosaad Soliman, Mostafa Shawky Ahmed, Mostafa Soliman Abd el Bary, Moustafa A. Moustafa, Muhammad Hameed, Muhip Kanko, Mujibur Majumder, Nadezhda Zubareva, Nicola Mumoli, Nik Azim Nik Abdullah, Nisa Makruasi, Nishen Paruk, Nonglak Kanitsap, Norberto Duda, Nordiana Nordin, Ole Nyvad, Olga Barbarash, Orcun Gurbuz, Oscar Gomez Vilamajo, Oscar Nandayapa Flores, Ozcan Gur, Oztekin Oto, Pablo Javier Marchena, Patrick Carroll, Pavel Lang, Peter MacCallum, Peter Baron von Bilderling, Peter Blombery, Petr Jansky, Peuch Bernadette, Philippe De Vleeschauwer, Philippe Hainaut, Piera Maria Ferrini, Piriyaporn Iamsai, Ponchaux Christian, Pongtep Viboonjuntra, Ponlapat Rojnuckarin, Prahlad Ho, Pramook Mutirangura, Rachel Wells, Rafael Martinez, Raimundo Tirado Miranda, Ralf Kroening, Rapule Ratsela, Raquel Lopez Reyes, Raul Franco Diaz de Leon, Raymond Siu Ming Wong, Raz Alikhan, Reinhold Jerwan-Keim, Remedios Otero, Renate Murena-Schmidt, Reto Canevascini, Richard Ferkl, Richard White, Rika Van Herreweghe, Rita Santoro, Robert Klamroth, Robert Mendes, Robert Prosecky, Roberto Cappelli, Rudolf Spacek, Rupesh Singh, Sam Griffin, Sang Hoon Na, Sanjeev Chunilal, Saskia Middeldorp, Satoshi Nakazawa, See Guan Toh, Seinturier Christophe, Selim Isbir, Selma Raymundo, Seng Kiat Ting, Serge Motte, Serir Ozkan Aktogu, Servaas Donders, Seung Ick Cha, Seung-Hyun Nam, Sevestre-Pietri Marie-Antoinette, Shaun Maasdorp, Shenghua Sun, Shenming Wang, Sherif Mohamed Essameldin, Sherif Mohamed Sholkamy, Shintaro Kuki, Shuichi Yoshida, Shunzo Matsuoka, Simon McRae, Simon Watt, Siriwimon Patanasing, Siwe-Nana Jean-Léopold, Somchai Wongkhantee, Soo-Mee Bang, Sophie Testa, Stanislav Zemek, Steffen Behrens, Stephan Dominique, Stuart Mellor, Suaran Singh Gurcharan Singh, Sudip Datta, Sunee Chayangsu, Susan Solymoss, Tamara Everington, Tarek Ahmed Adel Abdel-Azim, Tawatchai Suwanban, Taylan Adademir, Terence Hart, Terriat Béatrice, Thifhelimbilu Luvhengo, Thomas Horacek, Thomas Zeller, Tim Boussy, Tim Reynolds, Tina Biss, Ting-Hsing Chao, Tomas Smith Casabella, Tomoya Onodera, Tontanai Numbenjapon, Victor Gerdes, Vladimir Cech, Vladimir Krasavin, Vladimir Tolstikhin, W.A. Bax, Wagih Fawzy Abdel Malek, Wai Khoon Ho, Walter Pharr, Weihong Jiang, Wei-Hsiang Lin, Weihua Zhang, Wei-Kung Tseng, Wen-Ter Lai, Wilfried De Backer, Wilhelm Haverkamp, Winston Yoshida, Wolfgang Korte, Won Il Choi, Yang-Ki Kim, Yasuhiro Tanabe, Yasushi Ohnuma, Yeung-Chul Mun, Yohan Balthazar, Yong Park, Yoshisato Shibata, Yuriy Burov, Yuriy Subbotin, Zdenek Coufal, Zhenwen Yang, Zhicheng Jing, Zhongqi Yang, Pulmonary Medicine, Clinical Genetics, Internal Medicine, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, ARD - Amsterdam Reproduction and Development, ACS - Diabetes & metabolism, VU University medical center, Interne Geneeskunde, MUMC+: MA Alg Interne Geneeskunde (9), and RS: Carim - B04 Clinical thrombosis and Haemostasis

Subjects
History, Anticoagulation, Registry, Polymers and Plastics, SDG 3 - Good Health and Well-being, Deep vein thrombosis, Pulmonary embolism, Hematology, Business and International Management, Industrial and Manufacturing Engineering, Venous thromboembolism
Abstract

BACKGROUND: Venous thromboembolism (VTE), encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a leading cause of morbidity and mortality worldwide. METHODS: GARFIELD-VTE is a prospective, non-interventional observational study of real-world treatment practices. We aimed to capture the 36-month clinical outcomes of 10,679 patients with objectively confirmed VTE enrolled between May 2014 and January 2017 from 415 sites in 28 countries. FINDINGS: A total of 6582 (61.6 %) patients had DVT alone, 4097 (38.4 %) had PE ± DVT. At baseline, 98.1 % of patients received anticoagulation (AC) with or without other modalities of therapy. The proportion of patients on AC therapy decreased over time: 87.6 % at 3 months, 73.0 % at 6 months, 54.2 % at 12 months and 42.0 % at 36 months. At 12-months follow-up, the incidences (95 % confidence interval [CI]) of all-cause mortality, recurrent VTE and major bleeding were 6.5 (7.0-8.1), 5.4 (4.9-5.9) and 2.7 (2.4-3.0) per 100 person-years, respectively. At 36-months, these decreased to 4.4 (4.2-4.7), 3.5 (3.2-2.7) and 1.4 (1.3-1.6) per 100 person-years, respectively. Over 36-months, the rate of all-cause mortality and major bleeds were highest in patients treated with parenteral therapy (PAR) versus oral anti-coagulants (OAC) and no OAC, and the rate of recurrent VTE was highest in patients on no OAC versus those on PAR and OAC. The most frequent cause of death after 36-month follow-up was cancer (n = 565, 48.6 %), followed by cardiac (n = 94, 8.1 %), and VTE (n = 38, 3.2 %). Most recurrent VTE events were DVT alone (n = 564, 63.3 %), with the remainder PE, (n = 236, 27.3 %), or PE in combination with DVT (n = 63, 7.3 %). INTERPRETATION: GARFIELD-VTE provides a global perspective of anticoagulation patterns and highlights the accumulation of events within the first 12 months after diagnosis. These findings may help identify treatment gaps for subsequent interventions to improve patient outcomes in this patient population. ispartof: THROMBOSIS RESEARCH vol:222 pages:31-39 ispartof: location:United States status: published

Published
2023

17. Practical '1-2-3-4-Day' Rule for Starting Direct Oral Anticoagulants After Ischemic Stroke With Atrial Fibrillation: Combined Hospital-Based Cohort Study

Author

Shunsuke Kimura, Kazunori Toyoda, Sohei Yoshimura, Kazuo Minematsu, Masahiro Yasaka, Maurizio Paciaroni, David J. Werring, Hiroshi Yamagami, Takehiko Nagao, Shinichi Yoshimura, Alexandros Polymeris, Annaelle Zietz, Stefan T. Engelter, Bernd Kallmünzer, Manuel Cappellari, Tetsuya Chiba, Takeshi Yoshimoto, Masayuki Shiozawa, Takanari Kitazono, Masatoshi Koga, Kenichi Todo, Kazumi Kimura, Yoshiki Yagita, Eisuke Furui, Ryo Itabashi, Tadashi Terasaki, Yoshiaki Shiokawa, Teruyuki Hirano, Kenji Kamiyama, Jyoji Nakagawara, Shunya Takizawa, Kazunari Homma, Satoshi Okuda, Yasushi Okada, Keisuke Tokunaga, Tomoaki Kameda, Kazuomi Kario, Yoshinari Nagakane, Yasuhiro Hasegawa, Hisanao Akiyama, Satoshi Shibuya, Hiroshi Mochizuki, Yasuhiro Ito, Takahiro Nakashima, Hideki Matsuoka, Kazuhiro Takamatsu, Kazutoshi Nishiyama, Shoichiro Sato, Shoji Arihiro, Manabu Inoue, Masahito Takagi, Kanta Tanaka, Kazuyuki Nagatsuka, Takenori Yamaguchi, Yoichiro Hashimoto, Kiyohiro Houkin, Kazuo Kitagawa, Masayasu Matsumoto, Norio Tanahashi, Yasuo Terayama, Shinichiro Uchiyama, Etsuro Mori, Yutaka Furukawa, Takeshi Kimura, Yoshiaki Kumon, Ken Nagata, Shigeru Nogawa, Tomohiro Sakamoto, Toshinori Hirai, Kohsuke Kudo, Makoto Sasaki, Shotai Kobayashi, Toshimitsu Hamasaki, Michela Giustozzi, Monica Acciarresi, Giancarlo Agnelli, Valeria Caso, Fabio Bandini, Georgios Tsivgoulis, Shadi Yaghi, Karen L. Furie, Prasanna Tadi, Cecilia Becattini, Marialuisa Zedde, Azmil H Abdul-Rahim, Kennedy R Lees, Andrea Alberti, Michele Venti, Cataldo D’Amore, Maria Giulia Mosconi, Ludovica Anna Cimini, Paolo Bovi, Monica Carletti, Alberto Rigatelli, Jukka Putaala, Liisa Tomppo, Turgut Tatlisumak, Simona Marcheselli, Alessandro Pezzini, Loris Poli, Alessandro Padovani, Vieri Vannucchi, Sung-Il Sohn, Gianni Lorenzini, Rossana Tassi, Francesca Guideri, Maurizio Acampa, Giuseppe Martini, George Ntaios, George Athanasakis, Konstantinos Makaritsis, Efstathia Karagkiozi, Konstantinos Vadikolias, Chrissoula Liantinioti, Maria Chondrogianni, Nicola Mumoli, Franco Galati, Simona Sacco, Cindy Tiseo, Francesco Corea, Walter Ageno, Marta Bellesini, Giovanna Colombo, Giorgio Silvestrelli, Alfonso Ciccone, Alessia Lanari, Umberto Scoditti, Licia Denti, Michelangelo Mancuso, Miriam Maccarrone, Leonardo Ulivi, Giovanni Orlandi, Nicola Giannini, Tiziana Tassinari, Maria Luisa De Lodovici, Christina Rueckert, Antonio Baldi, Danilo Toni, Federica Letteri, Martina Giuntini, Enrico Maria Lotti, Yuriy Flomin, Alessio Pieroni, Odysseas Kargiotis, Theodore Karapanayiotides, Serena Monaco, Mario Maimone Baronello, Laszló Csiba, Lilla Szabó, Alberto Chiti, Elisa Giorli, Massimo Del Sette, Davide Imberti, Dorjan Zabzuni, Boris Doronin, Vera Volodina, Patrik Michel, Peter Vanacker, Kristian Barlinn, Lars-Peder Pallesen, Jessica Barlinn, Dirk Deleu, Gayane Melikyan, Faisal Ibrahim, Naveed Akhtar, Vanessa Gourbali, Luca Masotti, Adrian Parry-Jones, Chris Patterson, Christopher Price, Abduelbaset Elmarimi, Anthea Parry, Arumug Nallasivam, Azlisham Mohd Nor, Bernard Esis, David Bruce, Christine Roffe, Clare Holmes, David Cohen, David Hargroves, David Mangion, Dinesh Chadha, Djamil Vahidassr, Dulka Manawadu, Elio Giallombardo, Elizabeth Warburton, Enrico Flossman, Gunaratam Gunathilagan, Harald Proschel, Hedley Emsley, Ijaz Anwar, James Okwera, Janet Putterill, Janice O’Connell, John Bamford, John Corrigan, Jon Scott, Jonathan Birns, Karen Kee, Kari Saastamoinen, Kath Pasco, Krishna Dani, Lakshmanan Sekaran, Lillian Choy, Liz Iveson, Maam Mamun, Mahmud Sajid, Martin Cooper, Matthew Burn, Matthew Smith, Michael Power, Michelle Davis, Nigel Smyth, Roland Veltkamp, Pankaj Sharma, Paul Guyler, Paul O’Mahony, Peter Wilkinson, Prabel Datta, Prasanna Aghoram, Rachel Marsh, Robert Luder, Sanjeevikumar Meenakishundaram, Santhosh Subramonian, Simon Leach, Sissi Ispoglou, Sreeman Andole, Timothy England, Aravindakshan Manoj, Frances Harrington, Habib Rehman, Jane Sword, Julie Staals, Karim Mahawish, Kirsty Harkness, Louise Shaw, Michael McCormich, Nikola Sprigg, Syed Mansoor, Vinodh Krishnamurthy, Philippe A Lyrer, Leo H Bonati, David J Seiffge, Christopher Traenka, Nils Peters, Gian Marco De Marchis, Sebastian Thilemann, Nikolaos S Avramiotis, Henrik Gensicke, Lisa Hert, Benjamin Wagner, Fabian Schaub, Louisa Meya, Joachim Fladt, Tolga Dittrich, Urs Fisch, Bruno Bonetti, Giampaolo Tomelleri, Nicola Micheletti, Cecilia Zivelonghi, Andrea Emiliani, Kosmas Macha, Gabriela Siedler, Svenja Stoll, Ruihao Wang, Bastian Volbers, Stefan Schwab, David Haupenthal, and Luise Gaßmann

Subjects
Advanced and Specialized Nursing, acute ischemic stroke, Time Factors, Administration, Oral, Anticoagulants, Hemorrhage, cardioembolism, Hospitals, United States, Brain Ischemia, anticoagulation, atrial fibrillation, stroke prevention, Cohort Studies, Stroke, Treatment Outcome, Ischemic Attack, Transient, Atrial Fibrillation, Humans, Prospective Studies, Neurology (clinical), Cardiology and Cardiovascular Medicine, Ischemic Stroke
Abstract

Background: The “1-3-6-12-day rule” for starting direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation after acute ischemic stroke or transient ischemic attack recommends timings that may be later than used in clinical practice. We investigated more practical optimal timing of DOAC initiation according to stroke severity. Methods: The combined data of prospective registries in Japan, Stroke Acute Management with Urgent Risk-factor Assessment and Improvement-nonvalvular atrial fibrillation (September 2011 to March 2014) and RELAXED (February 2014 to April 2016) were used. Patients were divided into transient ischemic attack and 3 stroke subgroups by the National Institutes of Health Stroke Scale score: mild (0–7), moderate (8–15), and severe (≥16). The early treatment group was defined as patients starting DOACs earlier than the median initiation day in each subgroup. Outcomes included a composite of recurrent stroke or systemic embolism, ischemic stroke, and severe bleeding within 90 days. Six European prospective registries were used for validation. Results: In the 1797 derivation cohort patients, DOACs were started at median 2 days after transient ischemic attack and 3, 4, and 5 days after mild, moderate, and severe strokes, respectively. Stroke or systemic embolism was less common in Early Group (n=785)—initiating DOACS within 1, 2, 3, and 4 days, respectively—than Late Group (n=1012) (1.9% versus 3.9%; adjusted hazard ratio, 0.50 [95% CI, 0.27–0.89]), as was ischemic stroke (1.7% versus 3.2%, 0.54 [0.27–0.999]). Major bleeding was similarly common in the 2 groups (0.8% versus 1.0%). On validation, both ischemic stroke (2.4% versus 2.2%) and intracranial hemorrhage (0.2% versus 0.6%) were similarly common in Early (n=547) and Late (n=1483) Groups defined using derivation data. Conclusions: In Japanese and European populations, early DOAC initiation within 1, 2, 3, or 4 days according to stroke severity seemed to be feasible to decrease the risk of recurrent stroke or systemic embolism and no increase in major bleeding. These findings support ongoing randomized trials to better establish the optimal timing of DOAC initiation.

Published
2022

18. Timing of initiation of oral anticoagulants in patients with acute ischemic stroke and atrial fibrillation comparing posterior and anterior circulation strokes

Author

Michele Venti, Walter Ageno, Alfonso Ciccone, Luana Gentile, Vanessa Gourbali, Antonio Baldi, Elisa Grifoni, László Csiba, Cataldo D'Amore, Prasanna Tadi, Yuriy Flomin, Rossana Tassi, Sung Il Sohn, Bruno Bonetti, Patrik Michel, Erika Schirinzi, Alessandro Padovani, Cindy Tiseo, Maria Luisa De Lodovici, Odysseas Kargiotis, Konstantinos Vadikolias, Shadi Yaghi, Maurizio Paciaroni, Georgios Tsivgoulis, Enrico Maria Lotti, Manuel Cappellari, Lilla Szabó, Ashraf Eskandari, Federica Letteri, Leonardo Ulivi, Chrissoula Liantinioti, Valeria Caso, Lina Palaiodimou, Dirk Deleu, Jesse Dawson, Licia Denti, Konstantinos Makaritsis, Gianni Lorenzini, Marina Mannino, Monica Acciarresi, Miriam Maccarrone, Nicola Mumoli, Marta Bellesini, Simona Sacco, George Athanasakis, Umberto Scoditti, Maurizio Acampa, Giuseppe Martini, Brian Mac Grory, Alberto Rigatelli, Kristian Barlinn, Vieri Vannucchi, Serena Monaco, Efstathia Karagkiozi, Elisa Giorli, Francesca Guideri, Martina Giuntini, Dorjan Zabzuni, Davide Imberti, Giorgio Silvestrelli, Luca Masotti, Loris Poli, Karen L. Furie, Alessio Pieroni, Marialuisa Zedde, Franco Galati, Andrea Alberti, Giancarlo Agnelli, Jessica Barlinn, Turgut Tatlisumak, Maria Chiara Caselli, Boris Doronin, Liisa Tomppo, Kennedy R. Lees, Mario Maimone Baronello, Maria Giulia Mosconi, Jukka Putaala, Tiziana Tassinari, Azmil H. Abdul-Rahim, Peter Vanacker, Christina Rueckert, Valentina Bogini, Alessandro Pezzini, Francesco Corea, Giovanni Orlandi, Simona Marcheselli, Michela Giustozzi, Theodore Karapanayiotides, Michelangelo Mancuso, George Ntaios, Fabio Bandini, Vera Volodina, Nicola Giannini, Cesare Porta, Danilo Toni, Alberto Chiti, and Massimo Del Sette

Subjects
Severe bleeding, medicine.medical_specialty, Stroke recurrence, Infarction, stroke recurrence, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Original Research Articles, Internal medicine, Ischaemic stroke, Acute stroke, Medicine, atrial fibrillation, In patient, Acute ischemic stroke, business.industry, Atrial fibrillation, medicine.disease, Cardiology, Human medicine, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery
Abstract

Introduction The aim of this study in patients with acute posterior ischaemic stroke (PS) and atrial fibrillation (AF) was to evaluate (1) the risks of recurrent ischaemic event and severe bleeding and (2) these risks in relation with oral anticoagulant therapy (OAT) and its timing. Materials and Methods Patients with PS were prospectively included; the outcome events of these patients were compared with those of patients with anterior stroke (AS) which were taken from previous registries. The primary outcome was the composite of stroke recurrence, transient ischaemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding and major extracranial bleeding occurring within 90 days from acute stroke. Results A total of 2470 patients were available for the analysis: 473 (19.1%) with PS and 1997 (80.9%) with AS. Over 90 days, 213 (8.6%) primary outcome events were recorded: 175 (8.7%) in patients with AS and 38 (8.0%) in those with PS. In patients who initiated OAT within 2 days, the primary outcome occurred in 5 out of 95 patients (5.3%) with PS compared to 21 out of 373 patients (4.3%) with AS (OR 1.07; 95% CI 0.39–2.94). In patients who initiated OAT between days 3 and 7, the primary outcome occurred in 3 out of 103 patients (2.9%) with PS compared to 26 out of 490 patients (5.3%) with AS (OR 0.54; 95% CI 0.16–1.80). Discussion our findings suggest that, when deciding the time to initiate oral anticoagulation, the location of stroke, either anterior or posterior, does not predict the risk of outcome events. Conclusions Patients with PS or AS and AF appear to have similar risks of ischaemic or haemorrhagic events at 90 days with no difference concerning the timing of initiation of OAT.

Published
2020

19. Patients with isolated pulmonary embolism in comparison to those with deep venous thrombosis. Differences in characteristics and clinical evolution

Author

Gualtiero Palareti, Andrea Fontanella, Davide Imberti, Daniela Mastroiacovo, Nicola Mumoli, Vincenzo Giannicola Menditto, Vittorio Pengo, Francesco Dentali, Emilia Antonucci, Sophie Testa, Pietro Luigi Pujatti, and Daniela Poli

Subjects
Male, medicine.medical_specialty, Deep vein, Oral anticoagulation, Hormonal contraception, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Deep vein thrombosis, Internal medicine, Isolated pulmonary embolism, Venous thromboembolism, Aged, Female, Humans, Middle Aged, Prevalence, Pulmonary Embolism, Venous Thrombosis, Internal Medicine, medicine, In patient, cardiovascular diseases, 030212 general & internal medicine, business.industry, Cancer, medicine.disease, Thrombosis, Pulmonary embolism, Venous thrombosis, medicine.anatomical_structure, Heart failure, business
Abstract

Background Patients with acute pulmonary embolism (PE) often have leg deep vein thrombosis (DVT); sometimes, however, a DVT is not detected (isolated PE, I-PE). We aimed at assessing the proportion of patients with I-PE, and their characteristics and clinical evolution compared to those with DVT with/without PE (DVT/PE). Methods Among 3573 patients included in the START2-Register for a venous thromboembolic event, 2880 (80.6%) had DVT/PE, the remaining I-PE (19.4%). Results Patients with I-PE were older [(≥75 years, OR 1.4 (95%CI 1.13–1.69)], and more frequently females [OR 1.4 (1.19–1.67)]. Young females (aged ≤ 50 years) with an index event occurring during hormonal contraception (HC), were more prevalent in I-PE [OR 1.96 (1.26–3.03)]. At multivariate analysis, age > 75 years, female sex, heart failure, cancer and use of HC were risk factors significantly associated with I-PE, whereas thrombophilic alterations were associated with DVT/PE. During a follow-up of 4504 years (during anticoagulation), the rate of bleeding events was 1.1% patient/years and 1.0% patient/years in I-PE and DVT/PE, respectively. Venous thromboembolic events were equally prevalent in DVT/PE or I-PE (1.94% vs 0.86%, ns), whereas arterial complications were more prevalent in the latter group (1.01% vs 0.28%, p = 0.008). Conclusion I-PE and DVT/PE have important differences. Older age, female sex, heart failure and cancer, were risk factors for I-PE; thrombophilic alterations were associated with DVT/PE. HC use was more frequent in the I-PE group. The prevalence of arterial complications was higher in patients with I-PE. Further studies, specifically designed on this issue, are warranted.

Published
2019

20. Management and Outcomes of Isolated Distal Deep Vein Thromboses: A Questionable Trend toward Long-Lasting Anticoagulation Treatment. Results from the START-Register

Author

Cristina Legnani, Walter Ageno, Sophie Testa, Daniela Mastroiacovo, Francesco Dentali, Daniela Poli, Emilia Antonucci, Anna Falanga, Eugenio Bucherini, Benilde Cosmi, Fulvio Pomero, Davide Imberti, G. Palareti, Nicola Mumoli, and Andrea Fontanella

Subjects
Long lasting, medicine.medical_specialty, Renal function, 030204 cardiovascular system & hematology, Anticoagulation Treatment, 03 medical and health sciences, 0302 clinical medicine, oral anticoagulant, Medicine, Diseases of the circulatory (Cardiovascular) system, 030212 general & internal medicine, isolated distal deep vein thrombosis, bleeding, duration of treatment, business.industry, Warfarin, Surgery, Natural history, Increased risk, Deep vein thromboses, RC666-701, Original Article, Observational study, business, medicine.drug
Abstract

Background Isolated distal deep vein thromboses (IDDVT) are frequently diagnosed; however, their natural history and real risk of complications are still uncertain. Though treatment is still not well standardized, international guidelines recommend no more than 3 months of anticoagulation therapy. We investigated how Italian clinicians treat IDDVT patients in their real life in our country. Methods Baseline characteristics and clinical history of the patients enrolled in the prospective, observational, multicenter START-Register for a first IDDVT or proximal DVT (PDVT) were analyzed. Results Overall, 412 IDDVT patients were significantly younger, with better renal function, and more frequent major transient risk factors, when compared with 1,173 PDVT patients. The anticoagulation duration was >180 days in 52.7% of IDDVT patients (70.7% in PDVT). During treatment, bleeding occurred in 5.6 and 2.8% patient-years in IDDVT and PDVT, respectively (p = 0082). Bleeding was more frequent in IDDVT than PDVT patients treated with warfarin (6.8 vs. 3.2 patient-years, p = 0.0228, respectively). Thrombotic complications occurred in 1.1 and 2.4% patient-years in IDDVT and PDVT patients, respectively. Analyzing together the two groups, 66.1% of bleeds and 86.1% thrombotic complications occurred after 90 days anticoagulation treatment. Conclusion The large majority of IDDVT patients received anticoagulation for more than 3 months. Most bleeding and thrombotic complications occurred after the first 90 days of anticoagulation therapy. These results indicate that an extended anticoagulation beyond 90 days in IDDVT patients is associated with increased risk of complications. Whether an extended treatment may lower recurrences after anticoagulation withdrawal should be assessed by specifically designed studies.

Published
2021

21. Anticoagulation After Stroke in Patients With Atrial Fibrillation

Author

Francesca Guideri, Martina Giuntini, Luca Masotti, Sung Il Sohn, László Csiba, Marta Bellesini, Ludovica Anna Cimini, Lars-Peder Pallesen, Michele Venti, Walter Ageno, Efstathia Karagkiozi, Davide Imberti, Leonardo Ulivi, Alessandro Padovani, Giancarlo Agnelli, Giovanni Orlandi, Danilo Toni, Gianni Lorenzini, Alfonso Ciccone, Dirk Deleu, Licia Denti, Federica Letteri, Giorgio Bono, Karen L. Furie, Vieri Vannucchi, Miriam Maccarrone, Cecilia Becattini, Theodore Karapanayiotides, Domenico Consoli, Monica Carletti, Jukka Putaala, Cataldo D'Amore, Nicola Mumoli, Maria Chondrogianni, Alberto Chiti, Peter Vanacker, Marialuisa Zedde, Michelangelo Mancuso, Boris Doronin, Giorgio Silvestrelli, Vanessa Gourbali, Simona Sacco, Manuel Cappellari, Giuseppe Martini, Christina Rueckert, Faisal Ibrahim, George Ntaios, Serena Monaco, Franco Galati, Antonio Carolei, Alessio Pieroni, Dorjan Zabzuni, Simona Marcheselli, Naveed Akhtar, Prasanna Tadi, Loris Poli, Mario Maimone Baronello, Antonio Baldi, Fabio Bandini, Vera Volodina, George Athanasakis, Yuriy Flomin, Chrysoula Liantinioti, Nicola Giannini, Umberto Scoditti, Elisa Giorli, Gayane Melikyan, Alessandro Pezzini, Alessia Lanari, Andrea Alberti, Konstantinos Makaritsis, Cindy Tiseo, Francesco Corea, Rossana Tassi, Georgios Tsivgoulis, Maria Luisa De Lodovici, Enrico Maria Lotti, Odysseas Kargiotis, Jessica Barlinn, Massimo Del Sette, Konstantinos Vadikolias, Paolo Bovi, Kennedy R. Lees, Riccardo Altavilla, Turgut Tatlisumak, Liisa Tomppo, Maurizio Paciaroni, Lilla Szabó, Alberto Rigatelli, Kristian Barlinn, Monica Acciarresi, Patrik Michel, Tiziana Tassinari, Maurizio Acampa, Maria Giulia Mosconi, Shadi Yaghi, Jessica Fusaro, Valeria Caso, Sebastiano D'Anna, Azmil H. Abdul-Rahim, Gino Gialdini, HUS Neurocenter, Department of Neurosciences, and Neurologian yksikkö

Subjects
anticoagulants, medicine.medical_specialty, LEUKOARAIOSIS, ARTERIAL TERRITORIES, 030204 cardiovascular system & hematology, 3124 Neurology and psychiatry, 03 medical and health sciences, 0302 clinical medicine, atrial fibrillation, humans, incidence, secondary prevention, Internal medicine, medicine, In patient, ACUTE ISCHEMIC-STROKE, Stroke, METAANALYSIS, Cerebral Hemorrhage, RISK, Advanced and Specialized Nursing, Secondary prevention, OUTCOMES, Cardioembolic stroke, Heparin, business.industry, Incidence (epidemiology), Low-Molecular-Weight, 3112 Neurosciences, Atrial fibrillation, HUMAN BRAIN, medicine.disease, Anticoagulants, Atrial Fibrillation, Heparin, Low-Molecular-Weight, Humans, Secondary Prevention, 3. Good health, Heparin.low molecular weight, 3121 General medicine, internal medicine and other clinical medicine, Cardiology, Human medicine, HEMORRHAGIC TRANSFORMATION, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Background and Purpose— Bridging therapy with low-molecular-weight heparin reportedly leads to a worse outcome for acute cardioembolic stroke patients because of a higher incidence of intracerebral bleeding. However, this practice is common in clinical settings. This observational study aimed to compare (1) the clinical profiles of patients receiving and not receiving bridging therapy, (2) overall group outcomes, and (3) outcomes according to the type of anticoagulant prescribed. Methods— We analyzed data of patients from the prospective RAF and RAF-NOACs studies. The primary outcome was defined as the composite of ischemic stroke, transient ischemic attack, systemic embolism, symptomatic cerebral bleeding, and major extracerebral bleeding observed at 90 days after the acute stroke. Results— Of 1810 patients who initiated oral anticoagulant therapy, 371 (20%) underwent bridging therapy with full-dose low-molecular-weight heparin. Older age and the presence of leukoaraiosis were inversely correlated with the use of bridging therapy. Forty-two bridged patients (11.3%) reached the combined outcome versus 72 (5.0%) of the nonbridged patients ( P =0.0001). At multivariable analysis, bridging therapy was associated with the composite end point (odds ratio, 2.3; 95% CI, 1.4–3.7; P P =0.005) and hemorrhagic (odds ratio, 2.4; 95% CI, 1.2–4.9; P =0.01) end points separately. Conclusions— Our findings suggest that patients receiving low-molecular-weight heparin have a higher risk of early ischemic recurrence and hemorrhagic transformation compared with nonbridged patients.

Published
2019

22. Evaluation of unmet clinical needs in prophylaxis and treatment of venous thromboembolism in high-risk patient groups: cancer and critically ill

Author

Russell Hull, Benjamin Brenner, James D. Douketis, Ismail Elalamy, Davide Imberti, Zhenguo Zhai, Roopen Arya, and Jan Beyer-Westendorf

Subjects
medicine.medical_specialty, medicine.drug_class, Low molecular weight heparin, Risk management tools, Review, 030204 cardiovascular system & hematology, Vte prophylaxis, 03 medical and health sciences, 0302 clinical medicine, medicine, In patient, 030212 general & internal medicine, cardiovascular diseases, Low-molecular-weight heparin, Intensive care medicine, Critically ill, Cancer, High risk patients, business.industry, lcsh:RC633-647.5, Anticoagulants, Hematology, lcsh:Diseases of the blood and blood-forming organs, medicine.disease, business, Venous thromboembolism
Abstract

Background Clinical practice shows that venous thromboembolism (VTE) presents a substantial burden in medical patients, and awareness and advocacy for its primary and secondary prevention remains inadequate. Specific patient populations, such as those with cancer and the critically ill, show elevated risk for VTE, bleeding or both, and significant gaps in VTE prophylaxis and treatment exist in these groups. Objective To present current expert insights and evidence on the unmet needs in thromboprophylaxis, and on the treatment of VTE in two high-risk patient groups: patients with cancer and the critically ill. Methodology To identify specific unmet needs in the management of VTE, a methodology was designed and implemented that assessed gaps in prophylaxis and treatment of VTE through interviews with 44 experts in the field of thrombosis and haemostasis, and through a review of current guidelines and seminal studies to substantiate the insights provided by the experts. The research findings were then analysed, discussed and consolidated by a multidisciplinary group of experts. Results The gap analysis methodology identified shortcomings in the VTE risk assessment tools, patient stratification approaches for prophylaxis, and the suboptimal use of anticoagulants for primary prophylaxis and treatment. Conclusions Specifically, patients with cancer need better VTE risk assessment tools to tailor primary thromboprophylaxis to tumour types and disease stages, and the potential for drug–drug interactions needs to be considered. In critically ill patients, unfractionated heparin is not advised as a first-line treatment option, low-molecular weight heparins remain the first choice for prophylaxis in critically ill and cancer patients due to their safety and efficacy profile, and the strength of evidence is increasing for direct oral anticoagulants as a treatment option over low-molecular-weight heparins. Herein we present novel insights and consolidated evidence collected from experts, clinical practice guidelines and original studies on the unmet needs in thromboprophylaxis, and on the treatment of VTE in patients with cancer and the critically ill.

Published
2019

23. A survey on the views and attitudes of Italian physicians regarding the prophylaxis and treatment of venous thromboembolism

Author

Hernan Polo Friz, Walter Ageno, Claudio Cimminiello, Paolo Prandoni, Giovanni Di Minno, Giancarlo Agnelli, Davide Imberti, Francesco Scaglione, Ageno, W., Di Minno, G., Agnelli, G., Cimminiello, C., Imberti, D., Polo Friz, H., Prandoni, P., and Scaglione, F.

Subjects
medicine.medical_specialty, Time Factors, business.industry, Attitude of Health Personnel, MEDLINE, Contraindications, Drug, Anticoagulants, General Medicine, Venous Thromboembolism, Heparin, Low-Molecular-Weight, Health Care Surveys, Physicians, medicine, Humans, Enoxaparin, Mobility Limitation, Intensive care medicine, business, Venous thromboembolism
Published
2020

24. Safety of anticoagulation in patients treated with urgent reperfusion for ischemic stroke related to atrial fibrillation

Author

Antonio Baldi, Licia Denti, Kennedy R. Lees, Nicola Mumoli, Panagiotis Halvatsiotis, Massimo Del Sette, Alberto Chiti, Peter Vanacker, Marta Bellesini, Tiziana Tassinari, Paolo Bovi, Alessandro Padovani, Christina Rueckert, Jessica Barlinn, Dorjan Zabzuni, Cataldo D'Amore, Loris Poli, Maria Luisa De Lodovici, Federica Letteri, Odysseas Kargiotis, Manuel Cappellari, Prasanna Tadi, Turgut Tatlisumak, Cecilia Becattini, Ludovica Anna Cimini, Liisa Tomppo, Yuriy Flomin, Giancarlo Agnelli, Aikaterini Theodorou, Serena Monaco, Elena Ferrari, Rossana Tassi, Monica Acciarresi, Patrik Michel, Alessio Pieroni, Enrico Maria Lotti, Michele Venti, Walter Ageno, Sung Il Sohn, Leonardo Ulivi, Maurizio Paciaroni, Konstantinos Vadikolias, Jukka Putaala, Cindy Tiseo, Valeria Caso, Alessandro Pezzini, Giorgio Silvestrelli, Alfonso Ciccone, Francesco Corea, Lilla Szabó, Francesca Guideri, Martina Giuntini, Gianni Lorenzini, Efstathia Karagkiozi, Davide Imberti, Luca Masotti, Azmil H. Abdul-Rahim, Theodore Karapanayiotides, Alessia Lanari, Andrea Alberti, Simona Marcheselli, Vieri Vannucchi, Giuseppe Martini, Shadi Yaghi, Marialuisa Zedde, Michela Giustozzi, Karen L. Furie, Danilo Toni, Chrissoula Liantinioti, Dirk Deleu, Franco Galati, Elisa Giorli, Monica Carletti, Vanessa Gourbali, Michelangelo Mancuso, George Ntaios, George Athanasakis, Fabio Bandini, Vera Volodina, Nicola Giannini, Umberto Scoditti, Mario Maimone Baronello, Boris Doronin, Simona Sacco, Maria Giulia Mosconi, Georgios Tsivgoulis, László Csiba, Alberto Rigatelli, Kristian Barlinn, Konstantinos Makaritsis, Maurizio Acampa, and Giovanni Orlandi

Subjects
Male, anticoagulants, medicine.medical_specialty, medicine.medical_treatment, Hemorrhage, Brain Ischemia, Dabigatran, Brain ischemia, Internal medicine, 80 and over, medicine, Humans, atrial fibrillation, Prospective Studies, Prospective cohort study, Blood Coagulation, Stroke, Aged, thrombolytic therapy, Aged, 80 and over, Advanced and Specialized Nursing, Rivaroxaban, business.industry, Warfarin, Atrial fibrillation, Thrombolysis, Middle Aged, medicine.disease, secondary prevention, thrombectomy, Anticoagulants, Atrial Fibrillation, Female, Reperfusion, Thrombectomy, Thrombolytic Therapy, Treatment Outcome, Cardiology, Neurology (clinical), Human medicine, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract

Background and Purpose: The optimal timing for starting oral anticoagulant after an ischemic stroke related to atrial fibrillation remains a challenge, mainly in patients treated with systemic thrombolysis or mechanical thrombectomy. We aimed at assessing the incidence of early recurrence and major bleeding in patients with acute ischemic stroke and atrial fibrillation treated with thrombolytic therapy and/or thrombectomy, who then received oral anticoagulants for secondary prevention. Methods: We combined the dataset of the RAF and the RAF-NOACs (Early Recurrence and Major Bleeding in Patients With Acute Ischemic Stroke and Atrial Fibrillation Treated With Non–Vitamin K Oral Anticoagulants) studies, which were prospective observational studies carried out from January 2012 to March 2014 and April 2014 to June 2016, respectively. We included consecutive patients with acute ischemic stroke and atrial fibrillation treated with either vitamin K antagonists or nonvitamin K oral anticoagulants. Primary outcome was the composite of stroke, transient ischemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding, and major extracerebral bleeding within 90 days from the inclusion. Treated-patients were propensity matched to untreated-patients in a 1:1 ratio after stratification by baseline clinical features. Results: A total of 2159 patients were included, 564 (26%) patients received acute reperfusion therapies. After the index event, 505 (90%) patients treated with acute reperfusion therapies and 1287 of 1595 (81%) patients untreated started oral anticoagulation. Timing of starting oral anticoagulant was similar in reperfusion-treated and untreated patients (median 7.5 versus 7.0 days, respectively). At 90 days, the primary study outcome occurred in 37 (7%) patients treated with reperfusion and in 146 (9%) untreated patients (odds ratio, 0.74 [95% CI, 0.50–1.07]). After propensity score matching, risk of primary outcome was comparable between the 2 groups (odds ratio, 1.06 [95% CI, 0.53–2.02]). Conclusions: Acute reperfusion treatment did not influence the risk of early recurrence and major bleeding in patients with atrial fibrillation–related acute ischemic stroke, who started on oral anticoagulant.

Published
2020

25. Evaluation of unmet clinical needs in prophylaxis and treatment of venous thromboembolism in at-risk patient groups:Pregnancy, elderly and obese patients

Author

Roopen Arya, Zhenguo Zhai, Jan Beyer-Westendorf, Davide Imberti, James D. Douketis, Benjamin Brenner, Ismail Elalamy, Russell Hull, King's College Hospital (KCH), University Hospital Carl Gustav Carus [Dresden, Germany], Technische Universität Dresden = Dresden University of Technology (TU Dresden), 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), CHU Tenon [AP-HP], and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
medicine.medical_specialty, medicine.drug_class, MEDLINE, Low molecular weight heparin, Review, 030204 cardiovascular system & hematology, Pregnant, Obese, 03 medical and health sciences, 0302 clinical medicine, Elderly, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Pregnancy, medicine, 030212 general & internal medicine, Dosing, cardiovascular diseases, Obesity, Low-molecular-weight heparin, Intensive care medicine, Angiology, business.industry, lcsh:RC633-647.5, Anticoagulant, Anticoagulants, Hematology, lcsh:Diseases of the blood and blood-forming organs, medicine.disease, equipment and supplies, Thrombosis, 3. Good health, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Venous thromboembolism
Abstract

Background Venous thromboembolism (VTE) accounts for an estimated 900,000 cases per year in the US alone and constitutes a considerable burden on healthcare systems across the globe. Objective To understand why the burden is so high, qualitative and quantitative research was carried out to gain insights from experts, guidelines and published studies on the unmet clinical needs and therapeutic strategies in VTE prevention and treatment in three populations identified as being at increased risk of VTE and in whom VTE prevention and treatment were regarded as suboptimal: pregnant women, the elderly and obese patients. Methodology A gap analysis methodology was created to highlight unmet needs in VTE management and to discover the patient populations considered most at risk. A questionnaire was devised to guide qualitative interviews with 44 thrombosis and haemostasis experts, and a review of the literature on VTE in the specific patient groups from 2015 to 2017 was completed. This was followed by a Think Tank meeting where the results from the research were discussed. Results This review highlights the insights gained and examines in detail the unmet needs with regard to VTE risk-assessment tools, biomarkers, patient stratification methods, and anticoagulant and dosing regimens in pregnant women, the elderly and obese patients. Conclusions Specifically, in pregnant women at high risk of VTE, low-molecular-weight heparin (LMWH) is the therapy of choice, but it remains unclear how to use anticoagulants when VTE risk is intermediate. In elderly patients, evaluation of the benefit of VTE prophylaxis against the bleeding risk is particularly important, and a head-to-head comparison of efficacy and safety of LMWH versus direct oral anticoagulants is needed. Finally, in obese patients, lack of guidance on anticoagulant dose adjustment to body weight has emerged as a major obstacle in effective prophylaxis and treatment of VTE.

Published
2019

26. Multidisciplinary approach to the management of patients with pulmonary embolism and deep vein thrombosis: a consensus on diagnosis, traditional therapy and therapy with rivaroxaban

Author

Cecilia Becattini, Davide Imberti, Claudio Cuccia, Damiano Paretti, Enrico Bernardi, Francesco Dentali, and Giuseppe Camporese

Subjects
medicine.medical_specialty, Consensus, Deep vein, 030204 cardiovascular system & hematology, Fibrin Fibrinogen Degradation Products, Anticoagulation, 03 medical and health sciences, 0302 clinical medicine, Rivaroxaban, Health care, Internal Medicine, medicine, EINSTEIN DVT Study, EINSTEIN PE Study, Pulmonary embolism, Venous thromboembolism, Biomarkers, Disease Management, Factor Xa Inhibitors, Heparin, Low-Molecular-Weight, Humans, Interdisciplinary Communication, Italy, Patient Care Team, Pulmonary Embolism, Treatment Outcome, Ultrasonography, Venous Thrombosis, 030212 general & internal medicine, Intensive care medicine, Heparin, business.industry, Low-Molecular-Weight, Warfarin, medicine.disease, Thrombosis, medicine.anatomical_structure, Emergency Medicine, Concomitant, business, medicine.drug
Abstract

Despite the availability of updated guidelines for the diagnosis and treatment of venous thromboembolism (VTE), the management of this disorder in clinical practice is often not standardized, given the different degree of compliance with official recommendations by the various involved specialists. The aim of this consensus paper, as a result of a board of experts in thromboembolism, is to define strategies to improve the quality of patients' care and the efficiency of healthcare resources utilization, by means of: (a) analysis of the guidelines for diagnosis and treatment of VTE; (b) analysis of diagnostic and therapeutic algorithms currently used in clinical practice by different specialists; (c) agreement on a common algorithm for diagnosis and treatment of VTE in different clinical settings; (d) definition of the possible role of the new oral anticoagulant agents (NOAC), such as rivaroxaban, based on their potential benefits for both acute and chronic therapy. The so-called "single drug approach" (as opposed to the traditional heparin/VKA combination), which can be adopted with these drugs, makes anticoagulation more convenient for both patients and healthcare providers, without the need for a close monitoring of the hemocoagulative status, and with a concomitant reduction of length of hospitalization and treatment costs. Among NOACs, in this paper we focused on rivaroxaban only because it was the unique available NOAC in Italy for the treatment of VTE at the time the manuscript was written. Concerning rivaroxaban, the results of two phase III, randomized and controlled trials confirm the non-inferiority of this drug compared to standard therapy (enoxaparin/warfarin) for the treatment of patients with pulmonary embolism (EINSTEIN PE Study) or deep vein thrombosis (EINSTEIN DVT Study) in terms of both efficacy and safety, supporting its use as an effective therapeutic option for these disorders.

Published
2018

27. Antithrombotic therapy for venous thromboembolism in patients with cancer: expert guidance

Author

Marco Marietta, Walter Ageno, Davide Imberti, Hernan Polo Friz, Marcello Di Nisio, and Claudio Cimminiello

Subjects
anticoagulants, medicine.medical_specialty, Evidence-based practice, (MeSH): low-molecular-weight heparin, edoxaban, evidence-based practice, venous thromboembolism, Fibrinolytic Agents, Humans, Neoplasms, Venous Thromboembolism, Pharmacology, Pharmacology (medical), 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, Antithrombotic, medicine, In patient, cardiovascular diseases, 030212 general & internal medicine, Intensive care medicine, business.industry, Cancer, General Medicine, medicine.disease, Thrombosis, chemistry, business, Venous thromboembolism
Abstract

Introduction: Most of the current clinical guidelines recommend the use of Low-Molecular-Weight Heparins (LMWHs) for cancer-associated thrombosis (CAT). The Hokusai VTE-cancer trial reported the first results of a direct comparison between a direct oral anticoagulant (DOAC), edoxaban, and LMWH in this setting. Areas covered: This review aims to critically appraise the currently available evidence on the efficacy and safety of anticoagulant agents for the long-term treatment of CAT and to provide an expert opinion and guidance in this field. Expert opinion: Based on the available evidence, DOACs represent a valid alternative to LMWH for the treatment of CAT for the majority of patients with active cancer. Currently, most solid evidence comes from the Hokusai VTE-cancer study, which showed that edoxaban is non-inferior to the LMWH dalteparin, with a trend toward fewer recurrent venous thromboembolic events, but with more major bleeding events. Similar findings were reported with rivaroxaban, although the study was not sufficiently powered to allow definitive conclusions. The majority of bleeding events occurred in the upper gastrointestinal tract and in patients with gastrointestinal cancer. Thus, LMWH remains the preferred option for patients with gastrointestinal cancer. Additional studies aimed to confirm these findings with other DOACs are now warranted.

Published
2018

28. An association between residual vein thrombosis and subclinical atherosclerosis: Cross-sectional study

Author

Franco Noventa, Marta Milan, Nicola Mumoli, Paolo Prandoni, Eugenio Bucherini, Raffaella Benedetti, Giampiero Avruscio, V. Rossetto, Carlo Bova, Giuseppe Camporese, Nello Zanatta, Maurizio Ciammaichella, Adriana Visonà, Davide Imberti, and Veritas Investigators

Subjects
Male, medicine.medical_specialty, Cross-sectional study, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, D-dimer, medicine, Humans, cardiovascular diseases, Vein, Aged, Venous Thrombosis, business.industry, Ultrasound, Hematology, Atherosclerosis, medicine.disease, Thrombosis, Pulmonary embolism, Cross-Sectional Studies, medicine.anatomical_structure, Subclinical atherosclerosis, Cohort, Cardiology, Female, business, 030215 immunology
Abstract

The association between venous and arterial thrombotic disorders is still unclear. We assessed the association between residual vein thrombosis (RVT) and subclinical atherosclerosis in a cohort of patients with unprovoked (or associated with weak risk factors) proximal deep-vein thrombosis (DVT).In a multicenter cross-sectional study, consecutive patients over 40years free from atherosclerotic disorders received the ultrasound assessment of the leg vein system and that of carotid arteries approximately three months after an episode of proximal DVT. In each center the evaluation was done by two independent assessors. The presence of RVT was defined as the incompressibility of at least 4mm in either the popliteal or the common femoral vein, and that of subclinical atherosclerosis as the presence of increased (0.9mm) intima-media tickness (IMT) and/or carotid plaques.Out of 252 patients (mean age, 67; males, 53%; unprovoked, 77%), the presence of RVT was found in 139 (55.2%). An increased IMT was shown in 76 (54.7%) patients with and in 35 (31.0%) without RVT (p0.001). At least one carotid plaque was found in 80 (57.6%) patients with and in 36 (31.9%) without RVT (p0.001). After adjusting for the baseline characteristics, the odds ratio of subclinical atherosclerosis (increased IMT and/or carotid plaques) was 2.8 (95% CI, 1.6 to 4.7).The ultrasound detection of RVT after an episode of proximal DVT that is either unprovoked or triggered by weak risk factors is associated with a higher prevalence of subclinical atherosclerosis. These findings may have implications for patient prognosis.

Published
2017

29. Real-Life Management of Venous Thromboembolism With Rivaroxaban: Results From EXperience VTE, an Italian Epidemiological Survey

Author

Giovanni Barillari and Davide Imberti

Subjects
Adult, endocrine system, medicine.medical_specialty, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Rivaroxaban, Randomized controlled trial, Risk Factors, law, Surveys and Questionnaires, Epidemiology, medicine, Humans, International Normalized Ratio, cardiovascular diseases, 030212 general & internal medicine, Intensive care medicine, Life management, Aged, Drug Substitution, business.industry, Anticoagulants, Disease Management, Venous Thromboembolism, Original Articles, Hematology, General Medicine, Middle Aged, equipment and supplies, medicine.disease, Pulmonary embolism, Italy, Pulmonary Embolism, business, Venous thromboembolism, medicine.drug
Abstract

Two large randomized controlled trials examined the efficacy and safety of rivaroxaban for the treatment of venous thromboembolism (VTE). The aim of this epidemiological study was to analyze a cohort of Italian patients affected by VTE who were treated with rivaroxaban in clinical practice. The data were collected by physicians using an online electronic questionnaire. The study was performed during a 6-month period from January to June 2014. We analyzed the clinical characteristics, risk factors for VTE, comorbidities, diagnostic techniques, and treatments in the whole population and in the subgroups with deep vein thrombosis (DVT) only, pulmonary embolism (PE) only, and DVT+PE. Overall, 75.9% of patients were affected by DVT; 20% of patients had DVT and PE; and 4.8% of patients had only PE. Approximately 90% of patients were symptomatic upon diagnosis, and 46.3% of patients required hospitalization. More than half of the patients switched to rivaroxaban after receiving another anticoagulant therapy. The main reasons for changing treatment included difficulties in managing vitamin K antagonists, patient choice, and prothrombin time-international normalized ratio (PT-INR) instability. The switch to rivaroxaban occurred after a mean of 1.8 PT-INR measurements. Clinical characteristic were overall similar to those of patients enrolled in prior clinical trials evaluating the safety and efficacy of rivaroxaban.

Published
2017

30. Recanalization rate in patients with proximal vein thrombosis treated with the direct oral anticoagulants

Author

Giampiero Avruscio, Nello Zanatta, Franco Noventa, Roberto Cappelli, Lucia Sarolo, Adriana Visonà, Davide Imberti, Walter Ageno, S. Cuppini, Marcello Di Nisio, Eugenio Bucherini, Nicola Mumoli, Paolo Prandoni, Giacomo Turatti, Livio Simioni, Giuseppe Camporese, Maurizio Ciammaichella, and Roberto Parisi

Subjects
Oral, Adult, Male, medicine.medical_specialty, Vitamin K, Anticoagulation, Deep venous thrombosis, Direct oral anticoagulants, Residual thrombosis, Venous thromboembolism, Vitamin K antagonists, Hematology, Administration, Oral, 030204 cardiovascular system & hematology, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, 80 and over, Humans, Medicine, In patient, 030212 general & internal medicine, Aged, Aged, 80 and over, Venous Thrombosis, business.industry, Ultrasound, Anticoagulants, Odds ratio, Middle Aged, Prognosis, medicine.disease, Surgery, Vein thrombosis, Venous thrombosis, Female, Italy, Administration, Cohort, business, Cohort study
Abstract

Background The recanalization rate in patients with deep venous thrombosis (DVT) of the legs treated with the direct oral anticoagulants (DOAC) is unknown. Methods In an Italian cohort, we investigated the rate of residual vein thrombosis (RVT) after three and/or six months in 352 patients with proximal DVT who had been treated with the DOACs as a stand-alone therapy or lead-in parenteral anticoagulants, and compared it to that recorded in a historical cohort of 1094 patients in which vitamin K antagonists (VKAs) had been employed. In both cohorts, RVT was defined as the ultrasound persistence of thrombotic material resulting in a diameter of at least 4 mm of incompressibility of the proximal veins. Results RVT was detected in 143 patients treated with DOACs (41.2%) after three months and in 58 patients (21.1%) after six months; the corresponding figure in patients treated with conventional anticoagulation was 52.3% and 54.5%, respectively. After adjusting for the baseline characteristics, the odds ratio of RVT in patients treated with the DOACs as compared with those treated with conventional anticoagulation was 0.63 (95% CI, 0.48–0.81) after three months, and 0.17 (95% CI; 0.11–0.26) after six months. Conclusions In patients with proximal DVT treated with the DOACs, the persistence of ultrasound detectable RVT is likely to occur less frequently than in patients treated with conventional anticoagulation. These results may have implications for the prognosis of patients with DVT.

Published
2017

31. The Changing Landscape for Stroke Prevention in AF

Author

Mercedes Samson, Siegfried Frickel, Hirosi Meno, Niels Gadsbøll, Sébastien Prévôt, Sorin Alexandru Antonescu, Xiaodong Li, Tetsuya Haruna, Zicheng Li, Catarina Fonseca, Ralf Zahn, Shahid Aziz, Takashi Tsutsui, Galal Kerfes, Elisabeth Louise Zeuthen, Lluís Mont, Angelika Tamm, Bogdan Minescu, Eric Lo, Gerardo Ansalone, Malcolm Foster, Tristan Mirault, Nabil Andrawis, Apostolos Katsivas, Imad Kreidieh, Juliano Novaes Cardoso, Margaret Ikpoh, Dimitar Raev, Said Chaaban, Dan Tesloianu, Philippe Loiselet, Joachim Gmehling, Joseph Hakas, Steven Forman, Ernst Günter Vester, Bettina Schmitz, Hassan El-Sayed, Hiroshi Tsutsui, Salvatore Pirelli, Jens Taggeselle, Arnljot Tveit, David Smith, Manuel De Los Rios Ibarra, Rafael Salguero, Jindrich Spinar, Vanja Bašić Kes, Jose Walter Cabrera Honorio, Adrien Salem, Gavino Casu, Jean Michel Quedillac, Ana Fruntelata, Peter Siostrzonek, Dmitry Napalkov, Luthando Adams, Valeria Calvi, Jeff S. Healey, Magnus Forsgren, Larisa Kalinina, Ratika Parkash, P. F.M.M. Bergen van, Carmen Manuela Muresan, H. Gorka, Andreas Mügge, Gustavo Maid, Serge Yvorra, Alexander Paraschos, Bernhard Witzenbichler, Viktor Peršić, Jeong Su Kim, Dong Jin Oh, Yutaka Furukawa, Steve Compton, Ravikiran Korabathina, Tammam Al-Joundi, Muzahir H. Tayebjee, Robert Betzu, David J. Cislowski, Alon Steinberg, Carisi Anne Polanczyk, Sanjiv Petkar, Andy Lam, Mingsheng Wang, Galina Ivanchura, Ruediger Seebass, Thomas Guarnieri, Seth H. Baker, Paula Carvalho, Brian First, Konstantinos Makaritsis, Alex C. Spyropoulos, Mohiburrahman Sirajuddin, Richard Bala, David Goldscher, G. Larsen Kneller, Ki Seok Kim, Sherman Tang, Venkat Iyer, Payman Sattar, Yamile Porro, Gregory Y.H. Lip, Christa Raters, Olivier Gartenlaub, Elizaveta Panchenko, Niccolo' Marcionni, Ole Nyvad, Sibel Zehra Aydin, Kenji Kawajiri, Dipankar Dutta, Gabriel Contreras Buenostro, Shaival Kapadia, Harry J.G.M. Crijns, Miroslav Rubacek, Myriam Brunehaut, Igor Diemberger, Kyle Rickner, Katsumi Tanaka, Moon Hyoung Lee, Pamela Nerheim, Jose Carlos Moura Jorge, Michael Gumbley, Katie Randall, Francesco Melandri, Sunil Chand, Harukazu Iseki, Thalie Traissac, Ningfu Wang, Ghiath Mikdadi, Peter D. Schellinger, Andrew M. Rubin, Conrad Genz, Karl Heinz Seidl, Maurice Pye, Giorgio Annoni, Adalberto Menezes Lorga Filho, William H. Pentz, Lisa Schmitz, Gary Miller, Didier Smadja, Elena Khludeeva, David Hargroves, Hans-Christoph Diener, Tiziano Moccetti, Azlisham Mohd Nor, Kai Koenig, F. A. Rooyer, Kiyoo Mori, Carlos Gonzalez Juanatey, Jan Beyer-Westendorf, Charles Landau, Steven B Eisenberg, Hugh F. McIntyre, Emilio Gonzalez Cocina, Erik May, Gyo-Seung Hwang, Alberto Giniger, Karl-Heinz Kuck, Yan Carlos Duarte Vera, Vladimir Gorbunov, Priya Nair, Shih Ann Chen, Beat J. Meyer, Donghui Zhang, Feng Wang, Richard J.H. Smith, Michele Massimo Gulizia, Darko Pocanic, Abul Azim, Jose Maria Lobos, Patrick Leprince, Peter Vanacker, Marica Bracic Kalan, James Crenshaw, Ewa Nowalany-Kozielska, Ayham Al-Zoebi, Eiji Hishida, Louis Essandoh, Younghoon Kim, Yanmin Yang, Dhiraj Gupta, Fausto J. Pinto, Arnold Pinter, Stanley Koch, Luis Felipe Pezo, Dzifa Wosornu Abban, Martin S. Green, Chrystalenia Kafkala, Zhitao Liu, Jose Luis Llisterri, Su Mei Angela Koh, Lin Chih-Chan, Ruth Davies, Ursula Rauch-Kroehnert, Julio Tallet, Juan Benezet-Mazuecos, Andreas Kastrup, Rohit Malhotra, Serge Timsit, Thierry Frappé, Kostas Oikonomou, Ameer Kabour, Kishor Vora, Douglas Roberts, Carlos Scherr, Pedro Dionísio, Nicoleta Violeta Miu, Eve Gillespie, Petr Povolny, F.R. Grondin, Philippe Lyrer, Raymond Fisher, Philip O'Donnell, Nima Amjadi, Juan Vazquez, Lynn Corbett, Patrick Peters, Jing Zhou, Thomas Kümler, Danny H.K. Wong, Evaldas Giedrimas, William McGarity, Frank L. Silver, Emmanuel Touzé, Ana Leitão, Suk keun Hong, Marwan Salfity, Constantin Militaru, S T Matskeplishvili, Johannes A. Kragten, Sam Henein, Anthony D'Souza, B. J. Krenning, Francesco Chiarella, Rene Casanova, Stephan Willems, Yong Keun Cho, Tae Joon Cha, Stewart Pollock, Rajendra Moodley, Rosa Ysabel Cotrina Pereyra, Volker Laske, Zhanquan Li, Kenneth B. Harris, Johnny Dy, Gabriele Guardigli, Hisham Kashou, Norberto Matadamas Hernandez, Zdravka Poljaković, E. Decoulx, Paul Wakefield, Sung Ho Her, Fatma Qaddoura, Giuseppe Boriani, Younus Ismail, Franz Goss, Shigeru Fujii, J. R. Groot de, Ming Shien Wen, Rui Candeias, Thomas Rebane, Juan Carlos Arias, Robert Jobe, Nicolas Ley, Taishi Sasaoka, Luigi Ria, Jonathan Banayan, Paul McLaughlin, Sergei Zenin, Luis E. Martinez, Thuraia Nageh, Fabrizio Ammirati, M. E.W. Hemels, Yutaka Shimizu, Elina Trendafilova, Maxime Fayard, Randeep Suneja, Attilia Maria Pizzini, Mark B. Abelson, Rabih R. Azar, Jian Zhou, Valerie Bockisch, Martin Koschutnik, James Hitchcock, Vlad Ciobotaru, Didier Irles, Patrik Michel, Witold Streb, John F. Corrigan, Ajit Singh Khaira, Marco Antônio Mota Gomes, Richard Tytus, Christian Hall, Antonius Ziekenhuis, Catherine Mallecourt, David J. Williams, Doo Il Kim, Brian Gordon, Salvatore Novo, Soufian Al Mahameed, Anil Shah, N. Joseph Deumite, Brent T. McLaurin, Ruth H. Strasser, Somnath Kumar, Genshan Ma, Aurel Cracan, Rajiv Mallik, Anthony Vlastaris, Francesco Perticone, Julio Alberto Aguilar Linares, Angel Moya, William Ashcraft, Steven Lupovitch, Renate Weinrich, Ralph F. Bosch, Gerald Ukrainski, Jon Arne Sparby, Norbert Schön, Pierre Jean Scala, Steven E. Hearne, Mark Roman, Ramin Farsad, Werner Rieker, Guillaume Cayla, Ramon Freixa, Hidemitsu Nakagawa, Kunihiro Nishida, Thomas J. Mulhearn, Tak W. Kwan, Jeffrey Shanes, Tiziana Tassinari, Ka Sing Lawrence Wong, Kneale Metcalf, Dominique Lejay, Daniel Savard, Pierre Chevallereau, Gilles O'Hara, Milan Mikus, Hiroshi Fukunaga, Olga Korennova, Xavier Ducrocq, Edvard Berngard, Mario Bo, Hoi Fan Chow, E. Ronner, Yuriy Grinshstein, Amparo Mena, Sidiqullah Rahimi, Axel Brandes, Shigenobu Bando, Freddy Del-Carpio Munoz, Jonathan L. Halperin, Ronald D. Jenkins, Carlos Rodríguez Pascual, Alain Lacroix, Sergio Agosti, Franklin Handel, Aylmer Tang, Nan Jiang, Diana A. Gorog, Dimitrios Stakos, Gerald Greer, Dudley Goulden, Martin Grond, Oran Corey, Stellan Bandh, Efrain Gonzalez, Alexander Klein, Jacques Scemama, Amelie Elsaesser, Nathan Foster, Francesco Fedele, Dinesh Mistry, Alberto Caccavo, Bjørn Bratland, Jean Marc Davy, D. J. Boswijk, Abdullah Al Ali, Muhammad Khalid, Terry McCormack, Clare Seamark, Enrico Passamonti, Zoran Olivari, Simon W Dubrey, Wlodzimierz Musial, Antonio Martín Santana, Jianqiu Liang, Manuel de Mora, Dmitry Dupljakov, Nicholas Jones, Mohamed Alshehri, Paul Charbel, John Bullinga, Petr Polasek, Hossein Almassi, Reza Mehzad, Gamal Hussein, Marcus Wiemer, Ali Sharareh, Alexandra Finsen, David Huckins, Denis Angoulvant, Matthias Leschke, Craig Vogel, Stefan Schuster, Juan E. Mesa, Yong Seog Oh, Axel De La Briolle, Jacek Kowalczyk, Louise Shaw, Eduardo de Teresa, Stefan Naydenov, Hubert Vial, Ian I Joffe, Christoph Kleinschnitz, Takeshi Yamashita, A. Salvioni, Aman M. Shah, Michael Renzi, Claude Brunschwig, Ioannis Styliadis, Ravi Bhagwat, Julian Coronel, Asok Venkataraman, Zayd Eldadah, Dinesh Singal, Byung Chun Jung, Michael Lillestol, Mirza S. Baig, Jose Polo, Ira Dauber, Olga Barbarash, Kristina Zint, Pavel Galin, P. J. A. M. Brouwers, Ki Byeong Nam, Andrey Ezhov, Kevin F. Browne, Iveta Sime, Tetsuo Sakai, Jean Louis Georges, Manish Jain, Alexey Nizov, Jean Dillinger, Arif Elvan, John Barton, Rainer Zimmermann, Junji Kanda, Clare Holmes, Werner Jung, Aurélien Miralles, Tatiana Novikova, Steven Georgeson, Yorihiko Higashino, Akira Yamada, David Sprigings, Haroon Rashid, J. W.M. Eck van, Bernard Erickson, Barry Seidman, Koji Kajiwara, Kannappan Krishnaswamy, Daniel Ferreira, Sébastien Armero, Brian Wong, Dong Gu Shin, Ludovic Chartier, Priit Kampus, Francisco Marín, Rickey Manning, Martin Köhrmann, Edward J. Kosinski, Bengt Johansson, Y. S. Tuininga, Simon Cattan, Sergio Dubner, Imran Dotani, Wenchi Kevin Tsai, Gregorio Sanchez, Edwin Blumberg, Charles Crump, Frank Jäger, Christoforos Olympios, Matthew Hoghton, Xinwen Zhao, Derek Muse, Alexandre Guignier, Toby Black, Yuichiro Takagi, Phil Keeling, Richard A. Bernstein, Omar Elhag, Jean Ernst Poulard, Fernando Gabriel Manzur Jattin, James Hampsey, Shahid Mahmood, Steffen Behrens, Tianlun Yang, Elena Dotcheva, Krishnan Challappa, Nam Ho Kim, Claudio Cavallini, Eric Espaliat, Martin James, June Soo Kim, Marc Roelke, Harold Thomas, Charles A. Shoultz, Rami El Mahmoud, José Francisco Kerr Saraiva, Jürgen vom Dahl, Xuebo Liu, Dong Ju Choi, Sergio Mondillo, Ian Parker, Kazuya Yamamoto, Rafael Martin Suarez, Karla M. Kurrelmeyer, Akber Mohammed, Nikitas Moschos, Benoit Coutu, Georgios Hananis, Hamed M. Zuhairy, Giovanni Baula, Suchdeep Bains, Menno V. Huisman, Heng Jiang, Jaroslaw Sek, Yoto Yotov, Malik Ali, Dalmo Antonio Ribeiro Moreira, Torben Larsen, Raed Osman, Marie Paule Houppe Nousse, Shulin Wu, Arturo Raisaro, Efrain Alonso Gomez Lopez, Violeta Cindea Nica, Eduardo Julián José Roberto Chuquiure Valenzuela, Wladmir Faustino Saporito, Changsheng Ma, Francesco Romeo, Jorge Martínez, M. Shakil Aslam, Kenneth J. Rothman, Kamal Al Ghalayini, Magdy Mikhail, Charles Augenbraun, Andreas Wilke, Peter Goethals, John D. McClure, Humberto Rodriguez Reyes, Peter Schoeniger, Nabil Jarmukli, Elizabeth S. Kaufman, Nathalie Duvilla, Jens Wicke, Kausik Chatterjee, Philippe Audouin, Dragan Kovacic, Xingwei Zhang, Brad Frandsen, Alberto Conti, Francisco Aguilar, Sasalu Deepak, Geir Heggelund, David S. Rosenbaum, Sergey P. Golitsyn, Alessandro Capucci, Rodolfo Sotolongo, Begoña Sevilla, François Poulain, Thomas Ronzière, Naseem Jaffrani, Dominik Michalski, Jose Lopez-Sendon, Silvia Di Legge, Bernard Jouve, Chang Sheng Ma, Robert Parris, Sumeet K. Mainigi, Jing Yao, Lars Udo Krause, Ulrich Tebbe, Quansan Zhang, Mathieu Amelot, Peter Crean, Benzy J. Padanilam, Nicolas Breton, Fernando Tomas Lanas Zanetti, Subhash Banerjee, Andrew I. Cohen, Michel Galinier, Jacek Miarka, Gerian Grönefeld, Vicente Bertomeu, Mariusz Gierba, Danny, Anna Ferrier, Luciano Marcelo Backes, Lianqun Cui, Eun-Seok Shin, Andreas Meinel, Jay Koons, Jen Yuan Kuo, Brett Graham, Antonio Garcia Quintana, Michael Hill, Sylvain Destrac, Janko Szavits-Nossan, Shanglang Cai, Joaquín Osca, Luis Aguinaga, Hemal M. Nayak, Chander Arora, Shinji Tayama, Diana Delić Brkljačić, Tiemin Jiang, Miguel Agustin Reyes Rocha, Ronan Collins, Davide Imberti, Kwang Soo Cha, Matthias Gabelmann, Alfredo Astesiano, Christian Weimar, William Eaves, Tatiana Ionova, Khalid Almuti, Thierry Schaupp, Bernhard Paul Lodde, Darlene Elias, Yuichiro Nakamura, Raed Al-Dallow, Eric Parrens, Weihua Li, Alan Bell, Noah Israel, Nadezda Rozkova, Nediljko Pivac, Nooshin Bazargani, Armando Pineda-Velez, Hyung Wook Park, Amin Karim, Clemens Steinwender, Davor Milicic, Gonzalo Barón, Robert Topkis, Mehrdad Ariani, Craig S. Barr, Paulo Bettencourt, Roberto Zanini, Andrew Moriarty, Pascal Goube, Fausto Rigo, Irene Madariaga, Atsushi Sueyoshi, Małgorzata Lelonek, Kevin R. Wheelan, Richard Huntley, Donald Brautigam, Jacek Gniot, Ido Lori, Dragos Vinereanu, Daniel Lee, Kouki Watanabe, Michael Vargas, Natalya Koziolova, James S. Zebrack, Basel Hanbali, Cesare Greco, José Luis Zamorano, Rajesh Patel, Fernando Carvalho Neuenschwander, Sergio Luiz Zimmermann, Shuiping Zhao, Pedro Adragão, Karl Heinz Schmitz, Abdelfatah Alasfar, Olga Ferreira de Souza, David N. Pham, Mark Dayer, Thomas Davee, Yoshiki Hata, Mika Skeppholm, Martin O'Donnell, David Molony, Joe Hargrove, Hani Sabbour, Pascal Defaye, Jochen Bott, Dora Ines Molina de Salazar, Anthony Clay, Giancarlo Landini, Michael McGuire, Dae Kyeong Kim, A. Shekhar Pandey, Bouziane Benhalima, Serge Cohen, Aamir Cheema, Matthias Claus, Marcus L. Williams, Qiangsun Zheng, Karim Bakhtiar, Hailong Lin, Sergio Berti, David Hartley, Libor Nechvatal, Rami Mihail Chreih, Domingo Pozzer, James Capo, John Floyd, Bhola Rama, Harald Darius, Ioannis Mantas, Pareed Aliyar, Carlos Barrera, Galina Ketova, Mark Chang, Alan J. Bank, José Ferreira Santos, Samir Turk, Lakshmanan Sekaran, Adam Ellery, Aurélie Buhl, Naomasa Miyamoto, Kuo Ho Yeh, Nicolas Mousallem, Hassan Soda, Dimitrios J. Richter, Zhaohui Wu, Tim Edwards, Kai Sukles, Koji Maeno, Huanyi Zhang, Paolo Verdecchia, Alexandros Gkotsis, Joe Pouzar, Philippe Berdagué, Edoardo Gronda, Olesya Rubanenko, Cristian Podoleanu, Mariano Ruiz Borret, Guillermo Llamas Esperon, Iveta Mintale, Hideki Shimomura, Dadong Zhang, Angelo Amato Vicenzo de Paola, Kenneth Butcher, Pascal Tessier, Minang Turakhia, Peter Svensson, Shabbir Reza, Herbert Pardell, Wilfried Lang, Holger Poppert, Alan Ackermann, Olivier Citerne, Emil Hayek, Yang Zheng, Jin bae Kim, Lorenzo Fácila, Tetsuo Hisadome, Li Sun, Panagiotis Vardas, Angel Grande, Piers Clifford, C. Zwaan van der, Nicki Law, Ilsbe Salecker, Steven Isserman, Shozo Tanaka, Dorothee B. Bartels, Yann Hemery, Susanna Cary, Mehiar El-Hamdani, Indira Natarajan, Miney Paquette, C. Wilson Sofley, Charles C. Gornick, Fu-Tien Chiang, Ellen Bøhmer, Hiroki Yamanoue, Toru Nakayama, Chakri Yarlagadda, Ciro Indolfi, Narendra Singh, Juan Carlos Nunez Fragoso, Eisho Kyo, Laurent Deluche, Andreas Götte, Stephen Phlaum, Jong Sung Park, Paresh Mehta, Terrence C. Hack, Fred Cucher, Olivier Dibon, Chia Theng Daniel Oh, Shannon Twiddy, Sean Connors, Edo Bottacchi, Beata Wożakowska-Kapłon, Ronald B. Goldberg, Jordi Bruguera, James J. Kmetzo, Jeanne Wei, John Kazmierski, Pilar Mazón, M Frais, Kazuya Kawai, Dimitrios Alexopoulos, Abayomi Osunkoya, Wanda Sudnik, Ramon Horacio Limon Rodriguez, William J. French, Ira Lieber, Rajesh Aggarwal, Stuart W. Zarich, John A. Puleo, David Cudmore, Jost Henner Wirtz, Ute Altmann, Kyung Tae Jung, Jennifer Litchfield, Jei Keon Chae, Rainer Dziewas, James Neiman, Karin Rybak, Galina Chumakova, Riccardo Pini, Richard Oliver, Benoit Lequeux, Athanasios J. Manolis, Luisa Fonseca, César A. Jardim, Katsuhiro Matsuda, Paul Hermany, Ming Luo, Ronnie Garcia, Oscar Pereira Dutra, John Culp, Amrit Pal Singh Takhar, Victor Howard, Oyidie Igbokidi, Kuo Yang Wang, Britta Goldmann, Thomas Walter, Mohamed K. Al-Obaidi, Antonio Pose, Christine Teutsch, Arthur J. Labovitz, Thomas Folk, Nell Wyatt, A. Huizenga, Benhur Henz, Konstantin Protasov, Petra Maskova, Ioannis Goudevenos, Kier Huehnergarth, Elena Kinova, Georgios Stergiou, Guohai Su, Hüseyin Ince, Chi Hung Huang, Winfried Haerer, Saad Al Ismail, Michael Gabris, Brian Carlson, Feng Liu, Yansheng Li, Luis Gustavo Gomes Ferreira, Radosław Lenarczyk, Ruben Omar Iza Villanueva, Nandkishore Ranadive, Yong Xu, Oscar Saenz Morales, Wayne Turner, Aleksey Khripun, Paul G. Grena, Yusuke Fujino, Abraham Salacata, Aleksandar Knezevic, Fouad Elghelbazouri, Hamid Bayeh, Mikhail Torosoff, Martin Cooper, Alenka Mavri, Marina Freydlin, Vassilios Vassilikos, Naresh Ranjith, Laurent Prunier, E. Hoffer, George Mitchell, Javier León Jiménez, S.S. Kabbani, Waldemar Krysiak, Emmanuel Nsah, John Ip, Charles B. Eaton, Jérome Thevenin, Dimitrios Chrysos, Asaad Bakbak, L. Steven Zukerman, Maria Grazia Bongiorni, Matthias von Mering, Lisa Alderson, Jean Joseph Muller, Yann Jamon, Roger Moore, Harinath Chandrashekar, Athanasios Pras, Venkatesh Nadar, B. J. Berg van den, Tomas Ripoll, Eric Van De Graaff, Patrick Dary, Peter L. Schwimmbeck, James Poock, Robert Schnitzler, Rohit Arora, Vuong DuThinh, Uwe Gremmler, Nuno Raposo, Chirag Sandesara, Ping Yen Bryan Yan, Junya Shite, Andrea Berz, Isabel Egocheaga, Karine Lavandier, Jose M. Teixeira, Ewart Jackson-Voyzey, Mayar Jundi, Ignacio Iglesias, Stephen Bloom, Hans Rickli, Rudolph Evonich, Giulio Molon, Vinay Shah, Salvador Bruno Valdovinos Chavez, Walter Ageno, Mauro Esteves Hernandes, Ali Ghanbasha, Stefan Regner, Luc De Wolf, Abdel El Hallak, Mohammad Shoukfeh, Francesco Musumeci, Pablo Andres Sepulveda Varela, Gershan Davis, Xianyan Jiang, Matthew Ebinger, Xiangdong Xu, Andreas Winkler, T. A. Simmers, Olivier Dascotte, Dominique Magnin, Karen Mahood, Carolina Guevara Caiedo, Zulu Wang, Hung-Fat Tse, John Camm, Didier Cadinot, Javier Aguila Marin, Juan Jose Olalla, Tamara Everington, Sherryn Roth, Feliz Alvaro Medina Palomino, Gregg Coodley, Wenhui Liu, G. Y. H. Lip, Ricky Ganim, Paul Ainsworth, Luiz Eduardo Fonteles Ritt, Yalin Liu, Sung Won Jang, Percy Berrospi, Dhananjai Menzies, Julien Pineau, Robert J. Jeanfreau, Hervé Buathier, John D. Osborne, Ted S. N. Lo, Li Fern Hsu, Xi Su, Beate Wild, Alvaro Rabelo Alves, Tomas Cieza-Lara, Neeraj Prasad, Yoshinori Seko, Jaydutt Patel, Malte Kuniss, Guy Chouinard, Jacek Morka, Frank Rubalcava, Fran Adams, Ignacio Rodriguez Briones, Vivek Sharma, Xinhua Wang, Amir Malik, Walid Amara, Adnan El Jabali, José Arturo Maldonado Villalon, Frederic Georger, Hong Ma, Steffen Schnupp, Nolan Mayer, Adam Sokal, Nasser Abdul, Gérald Phan Cao Phai, Jorge Hugo Blanco Ibaceta, Ramakrishnan Iyer, Yves Cottin, Barry Troyan, Achim Küppers, Anastas Stoikov, Jasjit Walia, Bruce Iteld, Abdul Alawwa, Christos Milonas, Frank Mibach, Mahfouz El Shahawy, H.William Stites, Neerav Shah, Clifford Ehrlich, Zia Ahmad, Furio Colivicchi, and Laszlo Karolyi

Subjects
medicine.medical_specialty, business.industry, Atrial fibrillation, 030204 cardiovascular system & hematology, medicine.disease, Dabigatran, 03 medical and health sciences, 0302 clinical medicine, Stroke prevention, Antithrombotic, Emergency medicine, medicine, In patient, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, Intensive care medicine, Prospective cohort study, business, Stroke, Fibrinolytic agent, medicine.drug
Abstract

Background: GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic t...

Published
2017

32. Prevalence of Pulmonary Embolism among Patients Hospitalized for Syncope

Author

Adriana Visonà, Martin H. Prins, Paolo Prandoni, Nicola Mumoli, Maurizio Ciammaichella, Carlo Bova, Sofia Barbar, Eugenio Bucherini, Stefano Campostrini, Marica Perlati, Anthonie W. A. Lensing, Davide Imberti, RS: CAPHRI - R5 - Optimising Patient Care, Epidemiologie, and MUMC+: KIO Kemta (9)

Subjects
Male, medicine.medical_specialty, Pediatrics, Cross-sectional study, Respiratory physiology, 030204 cardiovascular system & hematology, Syncope, Computed tomographic, 03 medical and health sciences, Geriatric cardiology, 0302 clinical medicine, Internal medicine, 80 and over, Prevalence, Pulmonary angiography, Humans, Medicine, 030212 general & internal medicine, Settore SECS-S/05 - Statistica Sociale, Aged, First episode, biology, business.industry, Medicine (all), Aged, 80 and over, Cross-Sectional Studies, Female, Hospitalization, Italy, Middle Aged, Pulmonary Embolism, Syncope (genus), General Medicine, medicine.disease, biology.organism_classification, humanities, Pulmonary embolism, Cardiology, business
Abstract

BACKGROUND The prevalence of pulmonary embolism among patients hospitalized for syncope is not well documented, and current guidelines pay little attention to a diagnostic workup for pulmonary embolism in these patients. METHODS We performed a systematic workup for pulmonary embolism in patients admitted to 11 hospitals in Italy for a first episode of syncope, regardless of whether there were alternative explanations for the syncope. The diagnosis of pulmonary embolism was ruled out in patients who had a low pretest clinical probability, which was defined according to the Wells score, in combination with a negative D-dimer assay. In all other patients, computed tomographic pulmonary angiography or ventilation-perfusion lung scanning was performed. RESULTS A total of 560 patients (mean age, 76 years) were included in the study. A diagnosis of pulmonary embolism was ruled out in 330 of the 560 patients (58.9%) on the basis of the combination of a low pretest clinical probability of pulmonary embolism and negative D- dimer assay. Among the remaining 230 patients, pulmonary embolism was identified in 97 (42.2%). In the entire cohort, the prevalence of pulmonary embolism was 17.3% (95% confidence interval, 14.2 to 20.5). Evidence of an embolus in a main pulmonary or lobar artery or evidence of perfusion defects larger than 25% of the total area of both lungs was found in 61 patients. Pulmonary embolism was identified in 45 of the 355 patients (12.7%) who had an alternative explanation for syncope and in 52 of the 205 patients (25.4%) who did not. CONCLUSIONS Pulmonary embolism was identified in nearly one of every six patients hospitalized for a first episode of syncope.

Published
2016

33. Ischemic Stroke despite Oral Anticoagulant Therapy in Patients with Atrial Fibrillation

Author

David, Seiffge, Gian Marco De Marchis, Masatoshi, Koga, Maurizio, Paciaroni, Duncan, Wilson, Manuel, Cappellari, Kosmas, Macha, Georgios, Tsivgoulis, Gareth, Ambler, Shoji, Arihiro, Leo, H Bonati, Bruno, Bonetti, Bernd, Kallmünzer, Keith, W Muir, Paolo, Bovi, Henrik, Gensicke, Manabu, Inoue, Stefan, Schwab, Shadi, Yaghi, Martin, M Brown, Philippe, Lyrer, Masahito, Takagi, Monica, Acciarrese, Hans Rolf Jager, Alexandros, A Polymeris, Kazunori, Toyoda, Michele, Venti, Christopher, Traenka, Hiroshi, Yamagami, Andrea, Alberti, Sohei, Yoshimura, Valeria, Caso, Stefan, T Engelter, David, J Werring, Kenichi, Todo, Kazumi, Kimura, Kensaku, Shibazaki, Yoshiki, Yagita, Eisuke, Furui, Ryo, Itabashi, Tadashi, Terasaki, Yoshiaki, Shiokawa, Teruyuki, Hirano, Rieko, Suzuki, Kenji, Kamiyama, Jyoji, Nakagawara, Shunya, Takizawa, Kazunari, Homma, Satoshi, Okuda, Yasushi, Okada, Koichiro, Maeda, Tomoaki, Kameda, Kazuomi, Kario, Yoshinari, Nagakane, Yasuhiro, Hasegawa, Hisanao, Akiyama, Satoshi, Shibuya, Hiroshi, Mochizuki, Yasuhiro, Ito, Takahiro, Nakashima, Hideki, Matsuoka, Kazuhiro, Takamatsu, Kazutoshi, Nishiyama, Kanta, Tanaka, Kaoru, Endo, Tetsuya, Miyagi, Masato, Osaki, Junpei, Kobayashi, Takuya, Okata, Eijiro, Tanaka, Yuki, Sakamoto, Keisuke, Tokunaga, Hotake, Takizawa, Junji, Takasugi, Soichiro, Matsubara, Kyoko, Higashida, Takayuki, Matsuki, Naoto, Kinoshita, Masayuki, Shiozawa, Toshihiro, Ide, Takeshi, Yoshimoto, Daisuke, Ando, Kyohei, Fujita, Masaya, Kumamoto, Teppei, Kamimura, Muneaki, Kikuno, Tadataka, Mizoguchi, Takeo, Sato, Karen, L Furie, Prasanna, Tadi, Cecilia, Becattini, Nicola, Falocci, Marialuisa, Zedde, Azmil, H Abdul-Rahim, Kennedy, R Lees, Cataldo, D’Amore, Maria, G Mosconi, Ludovica, A Cimini, Monica, Carletti, Alberto, Rigatelli, Jukka, Putaala, Liisa, Tomppo, Turgut, Tatlisumak, Fabio, Bandini, Simona, Marcheselli, Alessandro, Pezzini, Loris, Poli, Alessandro, Padovani, Luca, Masotti, Vieri, Vannucchi, Sung-Il, Sohn, Gianni, Lorenzini, Rossana, Tassi, Francesca, Guideri, Maurizio, Acampa, Giuseppe, Martini, George, Ntaios, Efstathia, Karagkiozi, George, Athanasakis, Kostantinos, Makaritsis, Kostantinos, Vadikolias, Chrysoula, Liantinioti, Maria, Chondrogianni, Nicola, Mumoli, Domenico, Consoli, Franco, Galati, Simona, Sacco, Antonio, Carolei, Cindy, Tiseo, Francesco, Corea, Walter, Ageno, Marta, Bellesini, Giorgio, Silvestrelli, Alfonso, Ciccone, Umberto, Scoditti, Licia, Denti, Mancuso, Michelangelo, Miriam, Maccarrone, Orlandi, Giovanni, Nicola, Giannini, Gino, Gialdini, Tiziana, Tassinari, Maria Luisa De Lodovici, Giorgio, Bono, Christina, Rueckert, Antonio, Baldi, Danilo, Toni, Federica, Letteri, Martina, Giuntini, Enrico, M Lotti, Yuriy, Flomin, Alessio, Pieroni, Odysseas, Kargiotis, Theodore, Karapanayiotides, Serena, Monaco, Laszló, Csiba, Lilla, Szabó, Alberto, Chiti, Elisa, Giorli, Massimo Del Sette, Davide, Imberti, Dorjan, Zabzuni, Boris, Doronin, Vera, Volodina, Patrik, Michel, Peter, Vanacker, Kristian, Barlinn, Lars, P Pallesen, Ulf, Bodechtel, Leonardo, Ulivi, Dirk, Deleu, Gayane, Melikyan, Jessica, Bourlinn, Naveed, Akhar, Falsal, Ibrahin, Gourbali, Vanessa, Hawone, Baronello, Lisa, Hert, Nils, Peters, Marina, Maurer, and Martina, Wiegert

Subjects
0301 basic medicine, medicine.medical_specialty, Vascular disease, business.industry, Hazard ratio, Ischemia, 610 Medicine & health, Atrial fibrillation, medicine.disease, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Neurology, Interquartile range, Internal medicine, Heart failure, medicine, Neurology (clinical), Prospective cohort study, business, Stroke, 030217 neurology & neurosurgery, Research Articles, Research Article
Abstract

Objective:\ud It is not known whether patients with atrial fibrillation (AF) with ischemic stroke despite oral anticoagulant therapy are at increased risk for further recurrent strokes or how ongoing secondary prevention should be managed.\ud \ud Methods:\ud We conducted an individual patient data pooled analysis of 7 prospective cohort studies that recruited patients with AF and recent cerebral ischemia. We compared patients taking oral anticoagulants (vitamin K antagonists [VKA] or direct oral anticoagulants [DOAC]) prior to index event (OACprior ) with those without prior oral anticoagulation (OACnaive ). We further compared those who changed the type (ie, from VKA or DOAC, vice versa, or DOAC to DOAC) of anticoagulation (OACchanged ) with those who continued the same anticoagulation as secondary prevention (OACunchanged ). Time to recurrent acute ischemic stroke (AIS) was analyzed using multivariate competing risk Fine-Gray models to calculate hazard ratios (HRs) and 95% confidence intervals (CIs).\ud \ud Results:\ud We included 5,413 patients (median age = 78 years [interquartile range (IQR) = 71-84 years]; 5,136 [96.7%] had ischemic stroke as the index event, median National Institutes of Health Stroke Scale on admission = 6 [IQR = 2-12]). The median CHA2 DS2 -Vasc score (congestive heart failure, hypertension, age≥ 75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65-74 years, sex category) was 5 (IQR = 4-6) and was similar for OACprior (n = 1,195) and OACnaive (n = 4,119, p = 0.103). During 6,128 patient-years of follow-up, 289 patients had AIS (4.7% per year, 95% CI = 4.2-5.3%). OACprior was associated with an increased risk of AIS (HR = 1.6, 95% CI = 1.2-2.3, p = 0.005). OACchanged (n = 307) was not associated with decreased risk of AIS (HR = 1.2, 95% CI = 0.7-2.1, p = 0.415) compared with OACunchanged (n = 585).\ud \ud Interpretation:\ud Patients with AF who have an ischemic stroke despite previous oral anticoagulation are at a higher risk for recurrent ischemic stroke despite a CHA2 DS2 -Vasc score similar to those without prior oral anticoagulation. Better prevention strategies are needed for this high-risk patient group.

Published
2019

34. Anticoagulation therapy patterns for acute treatment of venous thromboembolism in GARFIELD-VTE patients

Author

Sylvia Haas, Walter Ageno, Jeffrey I. Weitz, Samuel Z. Goldhaber, Alexander G.G. Turpie, Shinya Goto, Pantep Angchaisuksiri, Joern Dalsgaard Nielsen, Gloria Kayani, Audrey Zaghdoun, Alfredo E. Farjat, Sebastian Schellong, Henri Bounameaux, Lorenzo G. Mantovani, Paolo Prandoni, Ajay K. Kakkar, Ab Loualidi, Abdurrahim Colak, Abraham Bezuidenhout, Abu Abdool‐Carrim, Addala Azeddine, Adriaan Beyers, Adriaan Dees, Ahmed Mohamed, Ahmet Aksoy, Akihiko Abiko, Akinori Watanabe, Alan Krichell, Alberto Alfredo Fernandez, Alberto Tosetto, Alexey Khotuntsov, Alisha Oropallo, Alison Slocombe, Allan Kelly, Amanda Clark, Amr Gad, Amy Arouni, Andor Schmidt, Andrea Berni, Andres Javier Kleiban, Andrew Machowski, Andrey Kazakov, Angel Galvez, Ann Lockman, Anna Falanga, Anoop Chauhan, Antoni Riera‐Mestre, Antonino Mazzone, Armando D'Angelo, Artur Herdy, Atsushi Kato, Ayman Abd Elhamid Ebrahim, Mahmoud Salem, Azlan Husin, Barbara Erdelyi, Barry Jacobson, Beatrice Amann‐Vesti, Bektas Battaloglu, Benedicte Wilson, Benilde Cosmi, Bergmann Jean Francois, Berremeli Toufek, Beverley Hunt, Bhavesh Natha, Bisher Mustafa, Bonnie Chi Shan Kho, Boulon Carine, Brian Zidel, Brisot Dominique, Brousse Christophe, Bruno Trimarco, Canhua Luo, Carlos Alberto Cuneo, Carlos Jerjes Sanchez Diaz, Carsten Schwencke, Cas Cader, Celal Yavuz, Cesar Javier Zaidman, Charles Lunn, Chau‐Chung Wu, Cheng Hock Toh, Chern‐En Chiang, Chevrier Elisa, Chien‐Hsun Hsia, Chien‐Lung Huang, Chi‐Hang Kevin Kwok, Chih‐Cheng Wu, Chi‐Hung Huang, Chris Ward, Christian Opitz, Christina Jeanneret‐Gris, Chung Yin Ha, Chun‐Yao Huang, Claude Luyeye Bidi, Clifford Smith, Cornelia Brauer, Corrado Lodigiani, Couturaud Francis, Cynthia Wu, Daniel Staub, Daniel Theodoro, Daniela Poli, Riesco Acevedo, David Adler, David Jimenez, David Keeling, David Scott, Davide Imberti, Desmond Creagh, Desmurs‐Clavel Helene, Dirk Hagemann, Dirk Le Roux, Dirk Skowasch, Dmitry Belenky, Dmitry Dorokhov, Dmitry Petrov, Dmitry Zateyshchikov, Domenico Prisco, Dorthe Møller, Dusan Kucera, Ehab M. Esheiba, Elizaveta Panchenko, Elkouri Dominique, Emre Dogan, Emre Kubat, Enrique Diaz Diaz, Eric Wai Choi Tse, Erik Yeo, Erman Hashas, Ernst Grochenig, Eros Tiraferri, Erwin Blessing, Escande Orthlieb Michèle, Esther Usandizaga, Ettore Porreca, Fabian Ferroni, Falvo Nicolas, Félix Ayala‐Paredes, Firas Koura, Fitjerald Henry, Franco Cosmi, Frans Erdkamp, Gadel Kamalov, Garcia‐Bragado Dalmau, Garrigues Damien, Garry Klein, Gaurand Shah, Geert Hollanders, Geno Merli, Georg Plassmann, George Platt, Germain Poirier, German Sokurenko, Ghassan Haddad, Gholam Ali, Giancarlo Agnelli, Gin Gin Gan, Grace Kaye‐Eddie, Gregoire Le Gal, Gregory Allen, Guillermo Antonio Llamas Esperón, Guillot Jean‐Paul, Hagen Gerofke, Hallah Elali, Hana Burianova, Hans‐Juergen Ohler, Haofu Wang, Harald Darius, Harinder S. Gogia, Harry Striekwold, Harry Gibbs, Hatice Hasanoglu, Hatice Turker, Hendrik Franow, Herbert De Raedt, Herman Schroe, Hesham Salah ElDin, Hesham Zidan, Hiroaki Nakamura, Ho Young Kim, Holger Lawall, Hong Zhu, Hongyan Tian, Ho‐Young Yhim, Hugo ten Cate, Hun Gyu Hwang, Hyeok Shim, Igor Kim, Igor Libov, Igor Sonkin, Igor Suchkov, Ik‐Chan Song, Ilker Kiris, Ilya Staroverov, Irene Looi, Isabel M De La Azuela Tenorio, Ismail Savas, Ivan Gordeev, Ivo Podpera, Jae Hoon Lee, Jameela Sathar, James Welker, Jan Beyer‐Westendorf, Jan Kvasnicka, Jan Vanwelden, JangYong Kim, Jaromira Svobodova, Jaspal Gujral, Javier Marino, Javier Tristan Galvar, Jeannine Kassis, Jen‐Yuan Kuo, Jhih‐Yuan Shih, JiHyun Kwon, Jin Hyun Joh, Jin Hyun Park, Jin Seok Kim, Jinghua Yang, Jiri Krupicka, Jiri Lastuvka, Jiri Pumprla, Jiri Vesely, Joan Carlos Souto, João Antônio Correa, Johan Duchateau, John Perry Fletcher, Jorge del Toro, Jorge Guillermo Chavez Paez, Jose Dalmo Araujo Filho, Jose Saraiva, Jose Antonio Diaz Peromingo, Jose Gomez Lara, Jose Luis Fedele, Jose Maria Surinach, Joseph Chacko, Juan Antonio Muntaner, Juan Carlos Álvarez Benitez, Juan Moreno Hoyos Abril, Julian Humphrey, Julio Bono, Junji Kanda, Juree Boondumrongsagoon, Kai Hang Yiu, Kanchana Chansung, Karin Boomars, Kate Burbury, Katsuhiro Kondo, Kemal Karaarslan, Kensuke Takeuchi, Knut Kroeger, Konstantin Zrazhevskiy, Koscál Svatopluk, Kou‐Gi Shyu, Kristel Vandenbosch, Kuan‐Cheng Chang, Kuan‐Ming Chiu, Kubina Jean‐Manuel, Kwan Jing Wern, Kwo‐Chang Ueng, Lalita Norasetthada, Laure Binet, Lee Ping Chew, Lei Zhang, Leone Maria Cristina, Lidwine Tick, Lilia Beatriz Schiavi, Lily Lee Lee Wong, Lohana Borges, Louis Botha, Luc Capiau, Luc Timmermans, Luciano Eduardo López, Luigi Ria, Luis Manuel Hernandez Blasco, Luis Alberto Guzman, Luis Flota Cervera, Mahe Isabelle, Manuel Monreal Bosch, Manuel de los Rios Ibarra, Manuel Núñez Fernandez, Marc Carrier, Marcelo Raul Barrionuevo, Marco Antonio Alcocer Gamba, Marco Cattaneo, Marco Moia, Margaret Bowers, Mariam Chetanachan, Mario Alberto Berli, Mark Fixley, Markus Faghih, Markus Stuecker, Marlin Schul, Martin Banyai, Martin Koretzky, Martin Myriam, Mary Elizabeth Gaffney, Masao Hirano, Masashi Kanemoto, Mashio Nakamura, Mersel Tahar, Messas Emmanuel, Michael Kovacs, Michael Leahy, Michael Levy, Michael Munch, Michael Olsen, Michel De Pauw, Michel Gustin, Michiel Van Betsbrugge, Mikhail Boyarkin, Miroslav Homza, Modise Koto, Mohamed Abdool‐Gaffar, Mohamed Ayman Fakhry Nagib, Mohamed El‐Dessoki, Mohamed Khan, Monniaty Mohamed, Moo Hyun Kim, Moon‐Hee Lee, Mosaad Soliman, Mostafa Shawky Ahmed, Mostafa Soliman Abd el Bary, Moustafa A. Moustafa, Muhammad Hameed, Muhip Kanko, Mujibur Majumder, Nadezhda Zubareva, Nicola Mumoli, Nik Azim Nik Abdullah, Nisa Makruasi, Nishen Paruk, Nonglak Kanitsap, Norberto Duda, Nordiana Nordin, Ole Nyvad, Olga Barbarash, Orcun Gurbuz, Oscar Gomez Vilamajo, Oscar Nandayapa Flores, Ozcan Gur, Oztekin Oto, Pablo Javier Marchena, Patrick Carroll, Pavel Lang, Peter MacCallum, Peter Baron von Bilderling, Peter Blombery, Peter Verhamme, Petr Jansky, Peuch Bernadette, Philippe De Vleeschauwer, Philippe Hainaut, Piera Maria Ferrini, Piriyaporn Iamsai, Ponchaux Christian, Pongtep Viboonjuntra, Ponlapat Rojnuckarin, Prahlad Ho, Pramook Mutirangura, Rachel Wells, Rafael Martinez, Raimundo Tirado Miranda, Ralf Kroening, Rapule Ratsela, Raquel Lopez Reyes, Raul Franco Diaz de Leon, Raymond Siu Ming Wong, Raz Alikhan, Reinhold Jerwan‐Keim, Remedios Otero, Renate Murena‐Schmidt, Reto Canevascini, Richard Ferkl, Richard White, Rika Van Herreweghe, Rita Santoro, Robert Klamroth, Robert Mendes, Robert Prosecky, Roberto Cappelli, Rudolf Spacek, Rupesh Singh, Sam Griffin, Sang Hoon Na, Sanjeev Chunilal, Saskia Middeldorp, Satoshi Nakazawa, See Guan Toh, Seinturier Christophe, Selim Isbir, Selma Raymundo, Seng Kiat Ting, Serge Motte, Serir Ozkan Aktogu, Servaas Donders, Seung Ick Cha, Seung‐Hyun Nam, Sevestre‐Pietri Marie‐Antoinette, Shaun Maasdorp, Shenghua Sun, Shenming Wang, Sherif Mohamed Essameldin, Sherif Mohamed Sholkamy, Shintaro Kuki, Shuichi Yoshida, Shunzo Matsuoka, Simon McRae, Simon Watt, Siriwimon Patanasing, Siwe‐Nana Jean‐Léopold, Somchai Wongkhantee, Soo‐Mee Bang, Sophie Testa, Stanislav Zemek, Steffen Behrens, Stephan Dominique, Stuart Mellor, Suaran Singh Gurcharan Singh, Sudip Datta, Sunee Chayangsu, Susan Solymoss, Tamara Everington, Tarek Ahmed Adel Abdel‐Azim, Tawatchai Suwanban, Taylan Adademir, Terence Hart, Terriat Béatrice, Thifhelimbilu Luvhengo, Thomas Horacek, Thomas Zeller, Tim Boussy, Tim Reynolds, Tina Biss, Ting‐Hsing Chao, Tomas Smith Casabella, Tomoya Onodera, Tontanai Numbenjapon, Victor Gerdes, Vladimir Cech, Vladimir Krasavin, Vladimir Tolstikhin, W.A. Bax, Wagih Fawzy Abdel Malek, Wai Khoon Ho, Walter Pharr, Weihong Jiang, Wei‐Hsiang Lin, Weihua Zhang, Wei‐Kung Tseng, Wen‐Ter Lai, Wilfried De Backer, Wilhelm Haverkamp, Winston Yoshida, Wolfgang Korte, Won II Choi, Yang‐Ki Kim, Yasuhiro Tanabe, Yasushi Ohnuma, Yeung‐Chul Mun, Yohan Balthazar, Yong Park, Yoshisato Shibata, Yuriy Burov, Yuriy Subbotin, Zdenek Coufal, Zhenwen Yang, Zhicheng Jing, Zhongqi Yang, Haas, S, Ageno, W, Weitz, J, Goldhaber, S, Turpie, A, Goto, S, Angchaisuksiri, P, Dalsgaard Nielsen, J, Kayani, G, Zaghdoun, A, Farjat, A, Schellong, S, Bounameaux, H, Mantovani, L, Prandoni, P, and Kakkar, A

Subjects
Male, pulmonary embolism, Time Factors, Deep vein, direct oral anticoagulant, Practice Patterns, 030204 cardiovascular system & hematology, heparin, Direct oral anticoagulants, 0302 clinical medicine, Pregnancy, Deep vein thrombosis, 80 and over, Registries, Practice Patterns, Physicians', ddc:616, Aged, 80 and over, Venous Thrombosis, Anticoagulant, Hematology, Heparin, Middle Aged, Thrombosis, Pulmonary embolism, medicine.anatomical_structure, Treatment Outcome, Practice Guidelines as Topic, Female, Guideline Adherence, medicine.drug, medicine.medical_specialty, medicine.drug_class, venous thromboembolism, direct oral anticoagulants, deep vein thrombosis, Aged, Anticoagulants, Blood Coagulation, Drug Utilization, Healthcare Disparities, Humans, Pulmonary Embolism, Venous Thromboembolism, 03 medical and health sciences, Thromboembolism, Internal medicine, medicine, In patient, cardiovascular diseases, Rivaroxaban, Physicians', business.industry, deep vein thrombosi, deep vein thrombosis, direct oral anticoagulants, heparin, pulmonary embolism, venous thromboembolism, equipment and supplies, Venous, medicine.disease, business, Venous thromboembolism
Abstract

Background Parenteral anticoagulants and vitamin K antagonists (VKAs) have constituted the cornerstone of venous thromboembolism (VTE) treatment. Meanwhile, direct oral anticoagulants (DOACs) provide physicians with an alternative. The Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE observes real-world treatment practices. Objectives Describe initial anticoagulation (AC) treatment patterns in VTE patients who received parenteral AC, VKAs, and/or DOACs within ±30 days of diagnosis. Methods VTE patients were categorized into parenteral AC only, parenteral AC with transition to VKA, VKA only, parenteral AC with transition to DOAC, and DOAC only. Results A total of 9647 patients were initiated on AC treatment alone. 4781 (49.6%) patients received DOACs ± parenteral ACs; 3187 (33.0%), VKA ± parenteral ACs; and 1679 (17.4%) parenteral ACs alone. Rivaroxaban was the most frequently used DOAC (79.4%). DOACs were more frequently used in North America/Australia (58.1%), Europe (52.2%), and Asia (47.6%) than in Latin America (29.7%) and the Middle East/South Africa (32.5%). In patients with suspected VTE, most received parenteral AC monotherapy (67.7%). Patients with deep vein thrombosis were more likely to receive DOACs alone than those with pulmonary embolism with or without deep vein thrombosis (36.2% vs 25.9%). Active cancer patients received parenteral AC alone (58.9%), with 25.5% receiving DOAC ± parenteral AC and 12.8% parenteral AC and VKA. A total of 46.5% of pregnant patients received parenteral AC monotherapy, 34.0% were treated with VKA ± parenteral AC, and 19.5% received a DOAC (± parenteral AC). Conclusion AC treatment patterns vary by patient population, geographic region and site of VTE. Guidelines for AC therapy are not always adhered to.

Published
2019

35. Treatment of venous thromboembolism with tinzaparin in oncological patients

Author

Davide Imberti, Marcello Di Nisio, Lorenzo G. Mantovani, Walter Ageno, Roberto Labianca, Sandro Barni, Anna Falanga, Ageno, W, Barni, S, Di Nisio, M, Falanga, A, Imberti, D, Labianca, R, and Mantovani, L

Subjects
medicine.medical_specialty, Anticoagulants, Heparin, Low-Molecular-Weight, Humans, Neoplasms, Tinzaparin, Venous Thromboembolism, 03 medical and health sciences, 0302 clinical medicine, Cancer associated thrombosis, Internal medicine, medicine, In patient, Secondary prevention, business.industry, Heparin, Gold standard, Low-Molecular-Weight, Cancer, General Medicine, medicine.disease, Thrombosis, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, business, Venous thromboembolism, medicine.drug
Abstract

Venous thromboembolism (VTE) is a major cause of morbidity and mortality in patients with cancer. For over a decade, the gold standard of treatment and secondary prevention of cancer-associated thrombosis (CAT) has been represented by low-molecular-weight heparins (LMWHs), which are currently recommended as the first-line treatment for CAT. Among the LMWHs that were more extensively tested in patients with CAT, tinzaparin is a LMWH produced by the enzymatic degradation of porcine-derived unfractionated heparin. The efficacy of tinzaparin in this setting is supported by well-grounded evidence. However, there is a need to discuss the positioning of tinzaparin in the continuously evolving treatment scenario of VTE therapy in cancer patients. In this paper, which was developed by a group of clinicians with wide experience in the treatment of VTE in cancer patients, we discuss the current therapeutic options and the role of tinzaparin for the treatment of CAT.

Published
2019

36. Early recurrence in paroxysmal versus sustained atrial fibrillation in patients with acute ischaemic stroke

Author

Karen L. Furie, Franco Galati, Antonio Carolei, Simona Sacco, Naveed Akhtar, Andrea Alberti, Vanessa Gourbali, Elisa Giorli, Federica Letteri, Filippo Angelini, Georgios Tsivgoulis, Simona Marcheselli, L.-P. Pallesen, Nicola Falocci, Serena Monaco, Giovanni Orlandi, Maria Luisa De Lodovici, Maria Giulia Mosconi, Michele Venti, Walter Ageno, Mario Maimone Baronello, László Csiba, Alfonso Ciccone, Odysseas Kargiotis, Kostantinos Vadikolias, Massimo Del Sette, Chrysoula Liantinioti, Maurizio Paciaroni, Valeria Caso, Cecilia Becattini, Danilo Toni, Peter Vanacker, Alessandro Padovani, Azmil H. Abdul-Rahim, Gino Gialdini, Christina Rueckert, Patrik Michel Pd-Mer, Giorgio Silvestrelli, Marialuisa Zedde, Cataldo D'Amore, Sung Il Sohn, Monica Acciarresi, Monica Carletti, George Ntaios, Kennedy R. Lees, Maria Chondrogianni, Gayane Melikyan, Domenico Consoli, Faisal Ibrahim, Francesca Guideri, Martina Giuntini, Alessandro Pezzini, Fabio Bandini, Vera Volodina, Alberto Rigatelli, Kristian Barlinn, Luca Masotti, Licia Denti, Boris Doronin, Tiziana Tassinari, Cindy Tiseo, Dorjan Zabzuni, Alberto Chiti, Francesco Corea, Nicola Giannini, Loris Poli, Nicola Mumoli, Jessica Kepplinger, Maurizio Acampa, Riccardo Altavilla, George Athanasakis, Theodore Karapanayiotides, Antonio Baldi, Prasanna Tadi, Umberto Scoditti, Turgut Tatlisumak, Yuriy Flomin, Rossana Tassi, Michelangelo Mancuso, Liisa Tomppo, Vieri Vannucchi, Efstathia Karagkiozi, Davide Imberti, Enrico Maria Lotti, Alessio Pieroni, Lilla Szabó, Dirk Deleu, Giancarlo Agnelli, Giorgio Bono, Miriam Maccarrone, Jukka Putaala, Giuseppe Martini, Marta Bellesini, Shadi Yaghi, Ludovica Anna Cimini, Gianni Lorenzini, K. Makaritsis, Paolo Bovi, Manuel Cappellari, HUS Neurocenter, Department of Neurosciences, Neurologian yksikkö, and University of Helsinki

Subjects
medicine.medical_specialty, ANTICOAGULATED PATIENTS, anticoagulation, atrial fibrillation, paroxysmal atrial fibrillation, Stroke, stroke recurrence, sustained atrial fibrillation, Early Recurrence, Paroxysmal atrial fibrillation, Stroke recurrence, macromolecular substances, 030204 cardiovascular system & hematology, 3124 Neurology and psychiatry, EVENTS, 03 medical and health sciences, PERSISTENT, 0302 clinical medicine, Original Research Articles, Internal medicine, Ischaemic stroke, medicine, ORAL ANTICOAGULATION, In patient, cardiovascular diseases, Prospective cohort study, OUTCOMES, business.industry, DEATH, 3112 Neurosciences, Atrial fibrillation, medicine.disease, PATTERN, Cardiology, cardiovascular system, Human medicine, Neurology (clinical), HIGHER RISK, Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery
Abstract

Background The relationship between different patterns of atrial fibrillation and early recurrence after an acute ischaemic stroke is unclear. Purpose In a prospective cohort study, we evaluated the rates of early ischaemic recurrence after an acute ischaemic stroke in patients with paroxysmal atrial fibrillation or sustained atrial fibrillation which included persistent and permanent atrial fibrillation. Methods In patients with acute ischaemic stroke, atrial fibrillation was categorised as paroxysmal atrial fibrillation or sustained atrial fibrillation. Ischaemic recurrences were the composite of ischaemic stroke, transient ischaemic attack and symptomatic systemic embolism occurring within 90 days from acute index stroke. Results A total of 2150 patients (1155 females, 53.7%) were enrolled: 930 (43.3%) had paroxysmal atrial fibrillation and 1220 (56.7%) sustained atrial fibrillation. During the 90-day follow-up, 111 ischaemic recurrences were observed in 107 patients: 31 in patients with paroxysmal atrial fibrillation (3.3%) and 76 with sustained atrial fibrillation (6.2%) (hazard ratio (HR) 1.86 (95% CI 1.24–2.81)). Patients with sustained atrial fibrillation were on average older, more likely to have diabetes mellitus, hypertension, history of stroke/ transient ischaemic attack, congestive heart failure, atrial enlargement, high baseline NIHSS-score and implanted pacemaker. After adjustment by Cox proportional hazard model, sustained atrial fibrillation was not associated with early ischaemic recurrences (adjusted HR 1.23 (95% CI 0.74–2.04)). Conclusions After acute ischaemic stroke, patients with sustained atrial fibrillation had a higher rate of early ischaemic recurrence than patients with paroxysmal atrial fibrillation. After adjustment for relevant risk factors, sustained atrial fibrillation was not associated with a significantly higher risk of recurrence, thus suggesting that the risk profile associated with atrial fibrillation, rather than its pattern, is determinant for recurrence.

Published
2019

37. Anticoagulation After Stroke in Patients With Atrial Fibrillation

Author

Riccardo, Altavilla, Valeria, Caso, Fabio, Bandini, Giancarlo, Agnelli, Georgios, Tsivgoulis, Shadi, Yaghi, Karen L, Furie, Prasanna, Tadi, Cecilia, Becattini, Marialuisa, Zedde, Azmil H, Abdul-Rahim, Kennedy R, Lees, Andrea, Alberti, Michele, Venti, Monica, Acciarresi, Cataldo, D'Amore, Maria Giulia, Mosconi, Ludovica, Anna Cimini, Jessica, Fusaro, Paolo, Bovi, Monica, Carletti, Alberto, Rigatelli, Manuel, Cappellari, Jukka, Putaala, Liisa, Tomppo, Turgut, Tatlisumak, Simona, Marcheselli, Alessandro, Pezzini, Loris, Poli, Alessandro, Padovani, Luca, Masotti, Vieri, Vannucchi, Sung-Il, Sohn, Gianni, Lorenzini, Rossana, Tassi, Francesca, Guideri, Maurizio, Acampa, Giuseppe, Martini, George, Ntaios, George, Athanasakis, Konstantinos, Makaritsis, Efstathia, Karagkiozi, Konstantinos, Vadikolias, Chrysoula, Liantinioti, Maria, Chondrogianni, Nicola, Mumoli, Domenico, Consoli, Franco, Galati, Simona, Sacco, Antonio, Carolei, Cindy, Tiseo, Francesco, Corea, Walter, Ageno, Marta, Bellesini, Giorgio, Silvestrelli, Alfonso, Ciccone, Alessia, Lanari, Umberto, Scoditti, Licia, Denti, Michelangelo, Mancuso, Miriam, Maccarrone, Leonardo, Ulivi, Giovanni, Orlandi, Nicola, Giannini, Gino, Gialdini, Tiziana, Tassinari, Maria Luisa, De Lodovici, Giorgio, Bono, Christina, Rueckert, Antonio, Baldi, Sebastiano, D'Anna, Danilo, Toni, Federica, Letteri, Martina, Giuntini, Enrico, Maria Lotti, Yuriy, Flomin, Alessio, Pieroni, Odysseas, Kargiotis, Theodore, Karapanayiotides, Serena, Monaco, Mario, Maimone Baronello, Laszló, Csiba, Lilla, Szabó, Alberto, Chiti, Elisa, Giorli, Massimo, Del Sette, Davide, Imberti, Dorjan, Zabzuni, Boris, Doronin, Vera, Volodina, Patrik, Michel, Peter, Vanacker, Kristian, Barlinn, Lars-Peder, Pallesen, Jessica, Barlinn, Dirk, Deleu, Gayane, Melikyan, Faisal, Ibrahim, Naveed, Akhtar, Vanessa, Gourbali, and Maurizio, Paciaroni

Subjects
Stroke, anticoagulants, atrial fibrillation, humans, incidence, secondary prevention, Heparin, Low-Molecular-Weight, Cerebral Hemorrhage
Abstract

Background and Purpose- Bridging therapy with low-molecular-weight heparin reportedly leads to a worse outcome for acute cardioembolic stroke patients because of a higher incidence of intracerebral bleeding. However, this practice is common in clinical settings. This observational study aimed to compare (1) the clinical profiles of patients receiving and not receiving bridging therapy, (2) overall group outcomes, and (3) outcomes according to the type of anticoagulant prescribed. Methods- We analyzed data of patients from the prospective RAF and RAF-NOACs studies. The primary outcome was defined as the composite of ischemic stroke, transient ischemic attack, systemic embolism, symptomatic cerebral bleeding, and major extracerebral bleeding observed at 90 days after the acute stroke. Results- Of 1810 patients who initiated oral anticoagulant therapy, 371 (20%) underwent bridging therapy with full-dose low-molecular-weight heparin. Older age and the presence of leukoaraiosis were inversely correlated with the use of bridging therapy. Forty-two bridged patients (11.3%) reached the combined outcome versus 72 (5.0%) of the nonbridged patients (P=0.0001). At multivariable analysis, bridging therapy was associated with the composite end point (odds ratio, 2.3; 95% CI, 1.4-3.7; P0.0001), as well as ischemic (odds ratio, 2.2; 95% CI, 1.3-3.9; P=0.005) and hemorrhagic (odds ratio, 2.4; 95% CI, 1.2-4.9; P=0.01) end points separately. Conclusions- Our findings suggest that patients receiving low-molecular-weight heparin have a higher risk of early ischemic recurrence and hemorrhagic transformation compared with nonbridged patients.

Published
2019

38. Direct oral anticoagulants for extended treatment of venous thromboembolism: insights from the EINSTEIN CHOICE study

Author

Davide, Imberti, Fulvio, Pomero, and Daniela, Mastroiacovo

Subjects
Vitamin K, Aspirin, Pyridones, Administration, Oral, Anticoagulants, Hemorrhage, Venous Thromboembolism, Review, Middle Aged, equipment and supplies, Dabigatran, Treatment Outcome, Rivaroxaban, Recurrence, Risk Factors, Humans, Pyrazoles, cardiovascular diseases, Aged, Glycosaminoglycans
Abstract

The risk of recurrence of venous thromboembolism (VTE) persists after interruption of the initial anticoagulation therapy. New evidence shows that direct oral anticoagulants are effective for extended treatment of VTE and may reduce the risk of all-cause mortality. The optimal duration of anticoagulation after VTE is, however, controversial and complicated by the need for individualised assessment and balance between thrombosis and bleeding risks. Three direct oral anticoagulants (rivaroxaban, apixaban and dabigatran) have been studied for extended treatment of VTE. Dabigatran was shown to be safer than vitamin K antagonists and similarly effective for the prevention of recurrent VTE. Dabigatran, apixaban and rivaroxaban resulted in significant decreases in the rate of recurrent symptomatic VTE when compared to placebo, without a statistically significant difference in the risk of major bleeding. The latest guidelines of the American College of Chest Physicians suggest the use of low-dose aspirin to prevent VTE recurrence in patients who want to stop anticoagulation. In the randomised, double-blind, phase 3 EINSTEIN CHOICE trial, once-daily rivaroxaban at doses of 20 mg or 10 mg and 100 mg of aspirin were compared in VTE patients for whom there was clinical equipoise for extended anticoagulation. Either a treatment dose (20 mg) or a prophylactic dose (10 mg) of rivaroxaban significantly reduced the risk of VTE recurrence without a significant increase in bleeding risk compared with aspirin. The EINSTEIN CHOICE trial included patients with provoked or unprovoked VTE. Patients with VTE provoked by minor persistent or minor transient risk factors enrolled in this trial had not-negligible VTE recurrence rates. These new findings on extended therapy suggest the possibility of anticoagulation regimens at intensities tailored to the patients’ risk profiles and VTE characteristics, with a shift of the risk-benefit balance in favour of extended treatment.

Published
2018

39. Safety ad efficacy of direct oral anticoagulants for extended treatment of venous thromboembolism

Author

Raffaella Benedetti, Davide Imberti, Fulvio Pomero, and Luigi Fenoglio

Subjects
Time Factors, Vitamin K, Pyridones, Administration, Oral, 030204 cardiovascular system & hematology, Placebo, law.invention, Dabigatran, 03 medical and health sciences, 0302 clinical medicine, Rivaroxaban, Randomized controlled trial, law, Internal Medicine, medicine, Humans, cardiovascular diseases, 030212 general & internal medicine, Aspirin, business.industry, Warfarin, Anticoagulants, Venous Thromboembolism, equipment and supplies, medicine.disease, Pulmonary embolism, Italy, Anesthesia, Emergency Medicine, Pyrazoles, Apixaban, business, medicine.drug
Abstract

Currently available anticoagulants have limitations for long-term treatment of venous thromboembolism (VTE). We have evaluated the efficacy and safety of direct oral anticoagulants (DOACs) for extended treatment of VTE. Four randomized controlled trials (RCTs) comparing DOACs (apixaban, rivaroxaban, and dabigatran) with placebo or warfarin for extended treatment of VTE were published. Primary efficacy outcome was recurrent VTE or VTE-related death, and primary safety outcome was major bleeding. DOACs significantly lower the risk of recurrent VTE or VTE-related death compared to placebo/warfarin, as well as all-cause mortality. Risk of major bleeding is not different with DOACs compared to placebo/warfarin. However, DOACs are associated with a significantly higher rate of the composite of major and clinically relevant bleeding compared to placebo. In conclusion, DOACs are effective and safe for the extended treatment of VTE, and may reduce the risk of all-cause mortality.

Published
2016

40. Management Strategies for Vitamin K Antagonists Reversal in Patients With Major Bleeding

Author

Davide Imberti, Enrico Bernardi, and Annamaria Ferrari

Subjects
medicine.medical_specialty, Vitamin K, business.industry, Hemorrhage, Hematology, General Medicine, 030204 cardiovascular system & hematology, Vitamin k, medicine.disease, Telephone survey, 03 medical and health sciences, 0302 clinical medicine, Italy, Surveys and Questionnaires, Emergency medicine, medicine, Humans, In patient, 030212 general & internal medicine, Medical emergency, Emergency Service, Hospital, business, Major bleeding
Abstract

Objective: Emergency physicians frequently deal with patients on vitamin K antagonists (VKAs) suffering major bleeding events, and rapid reversal of anticoagulation in this setting is of paramount importance. In Italy, given the absence of specific national guidelines, local policies are likely to differ, possibly impacting on clinical outcomes. We decided to perform a telephone survey among Italian emergency physicians to evaluate management strategies for VKAs reversal in patients with major bleeding. Methods: We conducted a computer-assisted, 10-minute telephone survey of 15 questions, focusing on the local prevalence, assessment, and management strategies of major and intracranial hemorrhage (ICH) occurring in patients on VKAs. We planned to interview a sample of 320 Italian emergency physicians. Institutions from all geographic areas of Italy were to participate in the survey. Results: Of the 320 physicians contacted, 150 (47%) completed the survey, 95% being employed in public hospitals. Focusing on ICH, only 29% of the responders stated they would reverse anticoagulation irrespective of the international normalized ratio value, and only 27% would use prothrombin-complex concentrate as first-line agent. In patients needing urgent neurosurgical operation, less than 50% would administer prothrombin-complex concentrate before surgery. Conclusion: The average knowledge of management strategies for reversal of anticoagulation displayed by Italian emergency physicians appears to be unsatisfactory. The need for an extensive educational program and for the implementation of specific guidelines, possibly endorsed by Scientific Societies, cannot be underemphasized.

Published
2016

41. Is it reasonable to use a lower DOACs dose in some patients with VTE? Yes

Author

Davide Imberti and Daniela Mastroiacovo

Subjects
medicine.medical_specialty, Pyridines, Pyridones, Administration, Oral, 030204 cardiovascular system & hematology, Dabigatran, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Rivaroxaban, Edoxaban, Internal Medicine, medicine, Humans, cardiovascular diseases, 030212 general & internal medicine, Intensive care medicine, Evidence-Based Medicine, Dose-Response Relationship, Drug, business.industry, Warfarin, Anticoagulants, Venous Thromboembolism, Reduced dose, Thiazoles, Regimen, chemistry, Emergency Medicine, Pyrazoles, Apixaban, business, Venous thromboembolism, medicine.drug
Abstract

In the Hokusai-VTE trial, 733 patients were treated with the reduced dose edoxaban regimen, which maintained efficacy and safety compared with the 60 mg dose, and was safer than warfarin. The prophylactic doses of apixaban and rivaroxaban reduced the risk of recurrent venous thromboembolism (VTE) in the extended treatment trials. Dabigatran 110 mg was approved by the European Medicine Agency for VTE treatment. Further data from registries and real-world studies will help to clarify whether patients, with other specific characteristics, can benefit from the reduced dose of direct oral anticoagulants.

Published
2017

42. Periprocedural management of rivaroxaban-treated patients

Author

Claudio Cimminiello, Davide Imberti, Filippo Ottani, Andrea Fanelli, Christian Compagnone, Armando Tripodi, and Andrea Luigi Ambrosoli

Subjects
Risk, medicine.medical_specialty, medicine.drug_mechanism_of_action, Morpholines, Factor Xa Inhibitor, Administration, Oral, Hemorrhage, Thiophenes, Postoperative Complications, Rivaroxaban, Thromboembolism, medicine, Humans, Pharmacology (medical), Perioperative Period, Intensive care medicine, Pharmacology, business.industry, Atrial fibrillation, General Medicine, Perioperative, medicine.disease, Thrombosis, Surgery, Surgical Procedures, Operative, Stroke prevention, Orthopedic surgery, business, Venous thromboembolism, Factor Xa Inhibitors, medicine.drug
Abstract

The increasing and widespread use of direct oral anticoagulants (DOACs) demands guidelines and experts' consensus for their rational and safe use, especially in certain situations for which there is no evidence-based consensus, such as the periprocedural setting. Rivaroxaban is an oral factor Xa inhibitor approved for stroke prevention in atrial fibrillation (AF) and for treatment and prevention of venous thromboembolism (VTE) in major orthopedic surgery. This article is addressed to all the clinicians involved in the periprocedural approach of patients treated with rivaroxaban, with the aim to give practical recommendations to improve patients' management during and after surgery.This article is based on a consensus of specialists involved in anticoagulant treatment and in periprocedural setting, including experts in thrombosis, cardiologists, internists, clinical pathologists and anesthesiologists. The authors performed a review of the literature and expressed statements based on the results of the review as well as on personal experience.Rivaroxaban is a safe and effective drug that simplifies management of anticoagulation also in patients undergoing invasive procedures. However, periprocedural management could be challenging and physicians must carefully balance the risk of bleeding and the risk of thrombosis.

Published
2015

43. [The EINSTEIN CHOICE study]

Author

Giancarlo, Agnelli, Cecilia, Becattini, Michela, Giustozzi, Davide, Imberti, Raffaella, Benedetti, and Manuela, Fontana

Subjects
Aspirin, Double-Blind Method, Fibrinolytic Agents, Rivaroxaban, Humans, Venous Thromboembolism, Factor Xa Inhibitors
Published
2017

44. The introduction of biosimilars of low molecular weight heparins in Europe: a critical review and reappraisal endorsed by the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV)

Author

Hernan Polo Friz, Claudio Cimminiello, Marco Marietta, and Davide Imberti

Subjects
medicine.medical_specialty, Evidence-based practice, medicine.drug_class, Alternative medicine, Low molecular weight heparin, Review, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Biosimilar pharmaceuticals, medicine, Intensive care medicine, Vascular Medicine, Angiology, lcsh:RC633-647.5, business.industry, Therapeutic equivalency, Biosimilar, lcsh:Diseases of the blood and blood-forming organs, Hematology, Guideline, Venous Thromboembolism, Clinical trial, 030220 oncology & carcinogenesis, business
Abstract

Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane® and Inhixa®, biosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin. The authorization path is considerably different from the guidelines published by the EMA in 2009, as well as from the recommendations from the International Society on Thrombosis and Haemostasis published in 2013. Indeed, both of them recommended that LMWHs biosimilars therapeutic equivalence should be demonstrated in at least one adequately designed clinical trial. Shortly after enoxaparin biosimilars approval, EMA published a revised version of its guideline, no longer requiring the execution of a clinical study in patients at risk of venous thromboembolism. Also the assessment of safety shows some relevant flaws, as it relies only on a 20 healthy volunteers study, clearly underpowered to draw any conclusions about the safety profile of the drug. In our opinion, the approach taken by EMA for approval of enoxaparin biosimilars raises serious concerns about their actual, clinical “similarity”. On these grounds, with the endorsement of the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV), we elaborated the present document aimed at reviewing and reappraising some critical points regarding the introduction of biosimilars of LMWH in Europe. Moreover, we would strongly advise the Italian National Health Authorities not to entrust safety assessment to the post-marketing surveillance only, but to promote well designed and powered studies aimed at establish the actual efficacy and safety of LMWH biosimilars.

Published
2017

45. Prestroke CHA2DS2-VASc Score and Severity of Acute Stroke in Patients with Atrial Fibrillation: Findings from RAF Study

Author

Umberto Scoditti, Suzette Remillard, Maria Giulia Mosconi, Serena Monaco, Giancarlo Agnelli, Maurizio Paciaroni, Dorjan Zabzuni, Boris Doronin, Giorgio Bono, Simona Sacco, Ulf Bodechtel, Simona Marcheselli, Maria Luisa De Lodovici, Kennedy R. Lees, Alessio Pieroni, Lilla Szabó, Gianni Lorenzini, Cecilia Becattini, Nicola Falocci, Tiziana Tassinari, Jukka Putaala, Peter Vanacker, László Csiba, Giovanni Orlandi, Maria Cordier, Giuseppe Martini, Danilo Toni, Domenico Consoli, Christina Rueckert, Davide Imberti, Chrissoula Liantinioti, Monica Acciarresi, Paolo Costa, Sung Il Sohn, Monica Carletti, Dirk Deleu, Johannes Gerber, Francesca Guideri, Paolo Bovi, Rossana Tassi, Luca Masotti, Alberto Chiti, Licia Denti, Valeria Caso, Georgios Tsivgoulis, Antonio Baldi, Naveed Akhtar, Massimo Del Sette, Alberto Rigatelli, Kristian Barlinn, Cindy Tiseo, Franco Galati, Antonio Carolei, Andrea Morotti, Alessandro Pezzini, Francesco Corea, Patrik Michel, Vera Volodina, Cataldo D'Amore, Lars-Peder Pallesen, Andrea Alberti, Faisal Ibrahim, Mario Maimone Baronello, Jessica Kepplinger, Sebastiano D'Anna, Azmil H. Abdul-Rahim, Michele Venti, Walter Ageno, Gino Gialdini, Kostantinos Vadikolias, Gayane Melikyan, Turgut Tatlisumak, Alessandro Padovani, Neurologian yksikkö, Department of Neurosciences, Clinicum, University of Helsinki, and HUS Neurocenter

Subjects
Male, atrial fibrillation, CHA, 2, DS, VASc score, Ischemic stroke, outcome, scores, severity, Aged, Aged, 80 and over, Area Under Curve, Asia, Atrial Fibrillation, Chi-Square Distribution, Disability Evaluation, Europe, Female, Humans, Linear Models, Logistic Models, Magnetic Resonance Imaging, Multivariate Analysis, Odds Ratio, Predictive Value of Tests, Prognosis, Prospective Studies, ROC Curve, Risk Assessment, Risk Factors, Severity of Illness Index, Stroke, Time Factors, Tomography, X-Ray Computed, Decision Support Techniques, CHA2DS2-VASc score, Surgery, Rehabilitation, Neurology (clinical), Cardiology and Cardiovascular Medicine, ARTERIAL TERRITORIES, 030204 cardiovascular system & hematology, Logistic regression, CHADS(2), 3124 Neurology and psychiatry, 0302 clinical medicine, Modified Rankin Scale, 80 and over, Medicine, Elméleti orvostudományok, ACUTE ISCHEMIC-STROKE, Prospective cohort study, Tomography, OUTCOMES, Area under the curve, Atrial fibrillation, Orvostudományok, HUMAN BRAIN, X-Ray Computed, CHA(2)DS(2)-VASc score, Cardiology, medicine.medical_specialty, education, macromolecular substances, 03 medical and health sciences, Internal medicine, cardiovascular diseases, ischemic stroke, surgery, rehabilitation, neurology (clinical), cardiology and cardiovascular medicine, Receiver operating characteristic, business.industry, 3112 Neurosciences, medicine.disease, 3121 General medicine, internal medicine and other clinical medicine, CHA2DS2–VASc score, Physical therapy, Human medicine, business, 030217 neurology & neurosurgery
Abstract

Background and Purpose: The aim of this study was to investigate for a possible association between both prestroke CHA(2)DS(2)-VASc score and the severity of stroke at presentation, as well as disability and mortality at 90 days, in patients with acute stroke and atrial fibrillation (AF). Methods: This prospective study enrolled consecutive patients with acute ischemic stroke, AF, and assessment of prestroke CHA2DS2-VASc score. Severity of stroke was assessed on admission using the National Institutes of Health Stroke Scale (NIHSS) score (severe stroke: NIHSS >= 10). Disability and mortality at 90 days were assessed by the modified Rankin Scale (mRS = 3). Multiple logistic regression was used to correlate prestroke CHA(2)DS(2)-VASc and severity of stroke, as well as disability and mortality at 90 days. Results: Of the 1020 patients included in the analysis, 606 patients had an admission NIHSS score lower and 414 patients higher than 10. At 90 days, 510 patients had mRS >= 3. A linear correlation was found between the prestroke CHA(2)DS(2)-VASc score and severity of stroke (P = .001). On multivariate analysis, CHA(2)DS(2)-VASc score correlated with severity of stroke (P = .041) and adverse functional outcome (mRS = 3) (P = .001). A logistic regression with the receiver operating characteristic graph procedure (C-statistics) evidenced an area under the curve of .60 (P = .0001) for severe stroke. Furthermore, a correlation was found between prestroke CHA(2)DS(2)-VASc score and lesion size. Conclusions: In patients with AF, in addition to the risk of stroke, a high CHA(2)DS(2)-VASc score was independently associated with both stroke severity at onset and disability and mortality at 90 days.

Published
2017

46. Apixaban Versus Enoxaparin in Elective Major Orthopedic Surgery

Author

Pietro Maniscalco, Davide Imberti, Marco Caforio, Raffaella Benedetti, and Giuseppe Porcellini

Subjects
Oral, medicine.medical_specialty, Pyridones, Arthroplasty, Replacement, Hip, medicine.medical_treatment, venous thromboembolism, Replacement, apixaban, review, Administration, Oral, Knee replacement, major orthopedic surgery, Arthroplasty, Guidelines recommendations, knee replacement, Hip replacement, medicine, Humans, hip replacement, In patient, phase 3 clinical trials, Enoxaparin, Factor Xa Inhibitors, Pyrazoles, Venous Thromboembolism, Hematology, Medicine (all), Hip, business.industry, General Medicine, Surgery, Administration, Orthopedic surgery, Apixaban, business, Venous thromboembolism, medicine.drug
Abstract

Despite current guidelines recommendations about anticoagulant prophylaxis, many studies have shown an high venous thromboembolism (VTE) incidence in patients undergoing total hip and knee arthroplasty. A number of anticoagulants are currently available, but they have some limitations that affect their applicability and consequently their effectiveness. Several new oral anticoagulants (NOACs) have been developed in an attempt to overcome these limitations. Apixaban is a NOAC that selectively inhibits the coagulation factor Xa; it is approved for the prevention of VTE after total hip replacement and total knee replacement surgery. This review examines the results of main trials designed to test efficacy and safety of apixaban in major elective orthopedic surgery.

Published
2014

47. Prediction of Early Recurrent Thromboembolic Event and Major Bleeding in Patients With Acute Stroke and Atrial Fibrillation by a Risk Stratification Schema: The ALESSA Score Study

Author

Francesca Guideri, Martina Giuntini, Luca Masotti, Alessandro Padovani, Danilo Toni, Maria Chondrogianni, Monica Carletti, Cecilia Becattini, Dorjan Zabzuni, Loris Poli, Theodore Karapanayiotides, Monica Acciarresi, Antonio Procopio, Giuseppe Martini, Giovanni Orlandi, Maurizio Acampa, Nicola Falocci, Vieri Vannucchi, Valeria Caso, Cindy Tiseo, Enrico Maria Lotti, László Csiba, Giancarlo Agnelli, Michelangelo Mancuso, Giorgio Bono, Lilla Szabó, Antonio Baldi, Serena Monaco, Jukka Putaala, Faisal Ibrahim, Dirk Deleu, Prasanna Tadi, Yuriy Flomin, Miriam Maccarrone, Georgios Tsivgoulis, Kennedy R. Lees, George Ntaios, Massimo Del Sette, Alberto Rigatelli, Kristian Barlinn, Naveed Akhtar, Jessica Kepplinger, Simona Sacco, Fabio Bandini, Vera Volodina, Lars-Peder Pallesen, Rossana Tassi, Odysseas Kargiotis, Peter Vanacker, Tiziana Tassinari, Nicola Giannini, Christina Rueckert, Ulf Bodechtel, Elisa Giorli, Simona Marcheselli, Efstathia Karagkiozi, Davide Imberti, Michele Venti, Walter Ageno, Chrysoula Liantinioti, Kostantinos Vadikolias, Alfonso Ciccone, Federica Letteri, Domenico Consoli, Andrea Alberti, Turgut Tatlisumak, Marialuisa Zedde, Vanessa Gourbali, Alberto Chiti, Manuel Cappellari, Cataldo D'Amore, Alessandro Pezzini, Francesco Corea, Maurizio Paciaroni, Liisa Tomppo, Giorgio Silvestrelli, Gayane Melikyan, Gianni Lorenzini, K. Makaritsis, Paolo Bovi, Marta Bellesini, Patrik Michel, Ludovica Anna Cimini, Alessio Pieroni, Shadi Yaghi, Sebastiano D'Anna, Azmil H. Abdul-Rahim, Gino Gialdini, Licia Denti, Nicola Mumoli, Mario Maimone Baronello, Maria Luisa De Lodovici, Sung Il Sohn, Johannes Gerber, Giovanna Colombo, Boris Doronin, Karen L. Furie, Franco Galati, Antonio Carolei, Maria Giulia Mosconi, George Athanasakis, and Umberto Scoditti

Subjects
Male, medicine.medical_specialty, atrial fibrillation, myocardial infarction, risk stratification, stroke, Hemorrhage, 030204 cardiovascular system & hematology, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Recurrence, Internal medicine, Thromboembolism, Atrial Fibrillation, 80 and over, Medicine, Humans, Myocardial infarction, Aged, Aged, 80 and over, Anticoagulants, Female, Ischemic Attack, Transient, Prospective Studies, Stroke, Warfarin, Prospective cohort study, Advanced and Specialized Nursing, business.industry, Ischemic Attack, Transient, Neurology (clinical), Cardiology and Cardiovascular Medicine, atrial fibrillation, myocardial infarction, risk stratification, stroke, Atrial fibrillation, medicine.disease, Cardiology, Observational study, Human medicine, business, Risk assessment, Complication, 030217 neurology & neurosurgery, medicine.drug
Abstract

Background and Purposes— This study was designed to derive and validate a score to predict early ischemic events and major bleedings after an acute ischemic stroke in patients with atrial fibrillation. Methods— The derivation cohort consisted of 854 patients with acute ischemic stroke and atrial fibrillation included in prospective series between January 2012 and March 2014. Older age (hazard ratio 1.06 for each additional year; 95% confidence interval, 1.00–1.11) and severe atrial enlargement (hazard ratio, 2.05; 95% confidence interval, 1.08–2.87) were predictors for ischemic outcome events (stroke, transient ischemic attack, and systemic embolism) at 90 days from acute stroke. Small lesions (≤1.5 cm) were inversely correlated with both major bleeding (hazard ratio, 0.39; P =0.03) and ischemic outcome events (hazard ratio, 0.55; 95% confidence interval, 0.30–1.00). We assigned to age ≥80 years 2 points and between 70 and 79 years 1 point; ischemic index lesion >1.5 cm, 1 point; severe atrial enlargement, 1 point (ALESSA score). A logistic regression with the receiver-operating characteristic graph procedure (C statistic) showed an area under the curve of 0.697 (0.632–0.763; P =0.0001) for ischemic outcome events and 0.585 (0.493–0.678; P =0.10) for major bleedings. Results— The validation cohort consisted of 994 patients included in prospective series between April 2014 and June 2016. Logistic regression with the receiver-operating characteristic graph procedure showed an area under the curve of 0.646 (0.529–0.763; P =0.009) for ischemic outcome events and 0.407 (0.275–0.540; P =0.14) for hemorrhagic outcome events. Conclusions— In acute stroke patients with atrial fibrillation, high ALESSA scores were associated with a high risk of ischemic events but not of major bleedings.

Published
2016

48. Consenso intersocietario sulla profilassi antitrombotica in chirurgia protesica dell’anca e del ginocchio e nelle fratture del collo femorale: aggiornamento 2013

Author

G. Della Rocca, Domenico Prisco, Gualtiero Palareti, Filippo Randelli, Davide Imberti, P. Grossi, F. Biggi, and Raffaele Landolfi

Subjects
Rivaroxaban, medicine.medical_specialty, business.industry, medicine.medical_treatment, General surgery, Knee replacement, Traumatology, Surgery, Dabigatran, medicine.anatomical_structure, Intensive care, Orthopedic surgery, Medicine, Apixaban, business, medicine.drug, Femoral neck
Abstract

Anticoagulant prophylaxis for preventing VTE is a world wide established procedure in hip and knee replacement surgery, as well as in the treatment of femoral neck fractures. Different guidelines are available in literature with quite different recommendations. None of them is a multidisciplinary effort as the one presented. In 2010 the Italian Society on Haemostasis and Thrombosis (SISET), the Italian Society of Orthopaedics and Traumatology (SIOT), the Association of Orthopaedics and Traumatologists of Italian Hospitals (OTODI), together with the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI), have set down practical suggestions for VTE prophylaxis in hip and knee surgery as well as in femoral neck fracture treatment. This Intersociety Consensus Statement aimed at simplifying the grading system reported in the literature, and its goal was to favour its clinical application. Special focuses addressed fragile patients and those patients at high risk of bleeding or receiving chronic antiplatelet and vitamin K antagonists treatment, and a special chapter was dedicated to regional anaesthesia and VTE prophylaxis. The registration of three novel oral anticoagulants (dabigatran, rivaroxaban and apixaban) for VTE prophylaxis in major orthopedic surgery and the ongoing introduction of these drugs for the prevention of embolism in atrial fibrillation make it necessary an update of the Intersociety Consensus Statement.

Published
2013

49. Prevention of VTE in orthopedic surgery patients

Author

Diana Giannarelli, Davide Imberti, Lorenzo Terranova, Paolo Grossi, Rossella Letizia Mancusi, Emilio Mazza, Federico Spandonaro, and Il presente report HTA è stato supportato da Bayer S.p.A.

Subjects
medicine.medical_specialty, medicine.drug_class, Deep vein, medicine.medical_treatment, Population, new oral anticoagulants, Low molecular weight heparin, hta, deep vein thrombosis, Hip replacement, medicine, education, education.field_of_study, lcsh:R5-920, business.industry, low molecular weight heparin, medicine.disease, Arthroplasty, Surgery, Pulmonary embolism, medicine.anatomical_structure, New oral anticoagulants, Deep vein thrombosis, HTA, Low Molecular Weight Heparin, Orthopedic surgery, Emergency medicine, business, Orthopedic Procedures, lcsh:Medicine (General), Venous thromboembolism
Abstract

Venous thromboembolism (VTE) is defined as the obstruction, partial or complete, of one or more veins of deep circulation. It is a condition that can lead to a deterioration in his state of health until death, manifesting as deep vein thrombosis (DVT) or pulmonary embolism (PE). The major orthopedic surgery and the surgical oncology are frequently associated with thromboembolic complications, because of conditions that are often critical in these patients. It is estimated that in Italy DVT has an incidence that varies between 50 and 150 new cases per 100,000 population, while the prevalence would be between 2.5 and 5%. In the absence of thromboprophylaxis, the orthopedic surgery lead to a high increased risk of VTE. In elective hip replacement, in the absence of prophylaxis, the incidence of DVT and of fatal PE is about 50% and 2% respectively. In elective knee arthroplasty the risk of venous thromboembolic complications is even higher. It is estimated that 56.2% of the costs of prophylaxis with Low Molecular Weight Heparin (LMWH) in patients undergoing major orthopedic surgery are attributable to the cost of drugs (about € 200), followed (with 44.8%) by the cost of administration (approximately € 159). The average total cost/day was estimated at € 8 per patient. In Italy, it has been estimated an annual cost for new cases between 215 and 260 million €. The clinical advantages of the New Oral Anticoagulants (NOA) appear to be substantially clear, the major concern with regard to their reimbursement is therefore linked to the financial impact, due to the higher cost per day of the NOA compared with LMWH. To this end, it was built a model of budget impact, in the perspective of the Italian NHS, from the data related to cases of major surgical orthopedic procedures and a meta-analysis on the pivotal RCT, which aims to measure the differential effects in terms of prevention of VTE. The results show that the financial impact of the NOA in the prophylaxis of major orthopedic surgery is not particularly relevant. In fact, the major pharmaceutical costs that, at national level, amount to € 10.8 mil. (€ 15.2 mil. in the case of prolonged prophylaxis in knee operations) would be more than offset by savings in terms of fewer treatments of VTE, which is based on the assumption of more than 4,000 cases, up to about 6,600 in hypothesis best efficacy.

Published
2013

50. Inferior vena cava filters: use or abuse?

Author

Davide Imberti and Daniela Mastroiacovo

Subjects
Venous Thrombosis, medicine.medical_specialty, Vena Cava Filters, business.industry, Vena Cava, Inferior, 030204 cardiovascular system & hematology, Inferior vena cava, 03 medical and health sciences, 0302 clinical medicine, Text mining, medicine.vein, Emergency Medicine, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Radiology, Pulmonary Embolism, business
Published
2017

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