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1. Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial

Author

Abe, Mitsunori, Abhaichand, Rajpal K, Abhayaratna, Walter P, Abhyankar, Atul, Abidin, Imran B Zainal, Abou Assi, Hiba, Accini Mendoza, Jose L, Adas, Mine, Agaiby, John M, Agarwal, Devendra K, Agha, Maher, Ahmed, Azazuddin, Ahtiainen, Petteri, Aigner, Elmar, Ajay, Naik, Ali, Norsiah, Al-Karadsheh, Amer, Allison, Roy, Allison, Dale C, Alpenidze, Diana, Altuntas, Yuksel, Al-Zoebi, Ayham, Ambuj, Roy, Amerena, John, Anderson, Robert J, Ando, Toshiaki, Andrews, Robert, Antonova, Elizaveta, Appel, Karl-Friedrich, Arantes, Flávia B, Araz, Mustafa, Arbel, Yaron, Arenas León, José L, Argyrakopoulou, Georgia, Ariani, Mehrdad, Arias Mendoza, Maria A, Arif, Ahmed A, Arneja, Jaspal, Aroda, Vanita R, Aronne, Louis J, Arstall, Margaret, Asamoah, Njaimeh, Asanin, Milika, Audish, Hanid, Avram, Rodica, Badat, Aysha, Badiu, Corin V, Bakdash, Wa'el, Bakiner, Okan S, Bandezi, Vuyokazi N, Bang, Liew H, Bansal, Sandeep, Baranyai, Marietta, Barbarash, Olga, Barber, Mark, Barnum, Otis, Barone Rochette, Gilles, Bashkin, Amir, Baum, Seth, Bays, Harold E, Bazzoni Ruiz, Alberto E, Beckowski, Maciej, Beerachee, Yaswin, Bellary, Srikanth, Belousova, Lidia, Berk, Martin, Bernstein, Marc, Berra, Cesare, Beshay, Isaac, Bhagwat, Ajit, Bhan, Arti, Biggs, William C, Billings, Liana, Bitar, Fahed, Block, Bradley, Bo, Simona, Bogdanski, Pawel, Bolshakova, Olga O, Boshchenko, Alla A, Bosworth, Hayden, Botero Lopez, Rodrigo, Bôttcher, Morten, Bourgeois, Ronald, Brautigam, Donald, Breton, Cristian F, Broadley, Andrew, Brockmyre, Andrew P, Brodie, Steven K, Bucci, Marco, Budincevic, Hrvoje, Budoff, Matthew J, Buffman, Barry, Buljubasic, Nediljka, Buranapin, Supawan, Burgess, Lesley, Burguera, Bartolomé, Buriakovska, Olena, Buscemi, Silvio, Busch, Robert, Buse, John B, Buynak, Robert, Byrne, Maria, Caceaune, Elena, Cadena Bonfanti, Alberto J, Calinescu, Cornell V, Call, Robert S, Canecki Varzic, Silvija, Cannon, Kevin, Capehorn, Matt, Cariou, Bertrand, Carr, Jeffrey, Carrillo-Jimenez, Rodolfo, Casas, Marcelo, Castro, Almudena, Celik, Ahmet, Cercato, Cintia, Cermak, Ondrej, Cha, James Y, Chacon, Carolina, Chaicha-Brom, Tira, Chandra, Sandeep, Chettibi, Mohamed, Chevts, Julia, Christopher, Johann, Chrustowski, Witold, Cif, Adriana, Clark, Rebecca, Clark, Wayne, Clifford, Piers, Coetzee, Kathleen, Cogni, Giulia, Colao, Anna Maria, Colquhoun, David M, Concha, Mauricio, Condit, Jonathan, Constance, Christian, Constantin, Ciprian, Constantinescu, Silviana, Corbett, Clive, Cornett, George M, Correia, Marcelo, Cortinovis, Fiorenzo, Cosma, Dana, Creely, Steven, Cross, David, Curtis, Brian, Czochra, Wojciech, Daboul, Nizar Y, Dagdelen, Selcuk, D'agostino, Ronald, Dang, Cuong, Datta, Sudip, Davuluri, Ashwini K, Dawood, Saleem Y, De Jong, Douwe M, De La Cuesta, Carmen, De Los Rios Ibarra, Manuel O, De Pablo, Carmen, De Pauw, Michel, Dela Llana, Alexander, Delibasic, Maja, Delic-Brkljacic, Diana, Demicheli, Thibaud, Denger, Ralf J, Desai, Devang, Desai, Piyush, Desouza, Cyrus V, Dicker, Dror, Djenic, Nemanja, Dobson, Simon, Doi, Masayuki, Doran, Jesse A, Dorman, Reinhart, Dotta, Francesco, Dukes, Carl E, Duronto, Ernesto, Durst, Ronen, Dvoryashina, Irina V, Ebrahim, Iftikhar O, Eggebrecht, Holger, Egstrup, Kenneth, Ekinci, Elif I, Eliasson, Björn, Eliasson, Ken, Enache, Georgiana, Enculescu, Dan, English, Patrick, Ermakova, Polina, Ershova, Olga, Ezaki, Hirotaka, Ezhov, Marat, Farias, Eduardo, Farias, Javier M, Farsky, Pedro S, Ferreira, Daniel, Filteau, Pierre, Finneran, Matthew P, Folkens, Eric M, Fonseca, Alberto G, Fonseca, Luisa, Fordan, Steven, Fourie, Nyda, França, Sara, Franco, Denise R, Franek, Edward, Friedman, Keith, Frittitta, Lucia, Froer, Michael, Fuckar, Krunoslav, Fujii, Kenshi, Fujita, Ryoko, Fukushima, Yasushi, Fulat, Mohamed, Fulwani, Mahesh, Gajos, Grzegorz, Galyavich, Albert, Gambill, Michael L, Gandotra, Dheeraj, Winston, Gandy, Jr., Garcia Hernandez, Pedro A, García Reza, Raymundo, Garg, Naveen, Garg, Sandeep, Garvey, William T, Garza, Juan C, Gatta-Cherifi, Blandine, Gelev, Valeri, Geller, Steven A, Geohas, Jeffrey G, Georgiev, Borislav, Ghazi, Adline, Gilbert, Matthew P, Gilinskaya, Olga, Gislason, Gunnar, Gogas Yavuz, Dilek, González Albarrán, Olga, Gordeev, Ivan G, Gorton, Sidney C, Goudev, Assen, Gretland Valderhaug, Tone, Groenemeijer, Bjorn, Gul, Ibrahim, Gullestad, Lars, Gurieva, Irina, Guseva, Galina N, Hagenow, Andreas, Haluzik, Martin, Halvorsen, Sigrun, Hammoudi, Naima, Hanaoka, Keiichi, Hancu, Nicolae, Hanusch, Ursula, Harris, Kathleen, Harris, Barry, Hartleib, Michael, Hartman, Aaron N, Hata, Yoshiki, Heimer, Brian, Herman, Lee, Herzog, William, Hewitt, Eric, Heymer, Peter, Hiremath, Shirish, Hjelmesaeth, Joeran, Høgalmen, Rasmus Geir, Høivik, Hans Olav, Holmer, Helene, Horoshko, Olha, Houser, Patricia M, Hove, Jens D, Hsieh, I-Chang, Hulot, Jean-Sébastien, Hussein, Zanariah, Ilashchuk, Tetiana, Ilveskoski, Erkki, Ipatko, Irina, Iranmanesh, Ali, Isawa, Tsuyoshi, Issa, Moises, Iteld, Bruce, Iwasawa, Takamasa, Jabbar, Danish, Jackson, Richard A, Jackson-Voyzey, Ewart, Jacob, Stephan, Jaffrani, Naseem A, Jardula, Michael F, Jastreboff, Ania, Jensen, Svend E, Jerkins, Terri, Jimenez-Ramos, Silvia A, Jitendra Pal Singh, Sawhney, Johnson, Wallace, Joyce, John M, Jozefowska, Malgorzata, Jugnundan, Prakash, Jungmair, Wolfgang, Jurowiecki, Jaroslaw, Kadokami, Toshiaki, Kahali, Dhiman, Kahrmann, Gerd, Kaiser, Sergio E, Kalmucki, Piotr, Kanadasi, Mehmet, Kandath, David, Kania, Grzegorz, Kannan, J, Kapp, Cornelia, Karczmarczyk, Agnieszka, Kartalis, Athanasios, Kaser, Susanne, Kasim, Sazzli Shahlan, Kastelic, Richard, Kato, Toshiaki, Katova, Tzvetana, Kaul, Upendra, Kautzky-Willer, Alexandra, Kawanishi, Masahiro, Kayikcioglu, Meral, Kazakova, Elena E, Keeling, Philip, Kempe, Hans-Peter, Kereiakes, Dean J, Kerneis, Mathieu, Keski-Opas, Tiina, Khadra, Suhail, Khaisheva, Larisa, Kharakhulakh, Marina, Khlevchuk, Tatiana, Khoo, Jeffrey, Kiatchoosakun, Songsak, Kinoshita, Noriyuki, Kinoshita, Masaharu, Kitamura, Ryoji, Kiyosue, Arihiro, Klavina, Irina, Klein, Eric J, Klimsa, Zdenek, Klonoff, David, Klug, Eric, Kobalava, Zhanna, Kodera, Satoshi, Koga, Tokushi, Kokkinos, Alexander, Koleckar, Pavel, Könyves, László, Koren, Michael J, Kormann, Adrian P, Kostner, Karam, Kreutzmann, Kristin, Krishinan, Saravanan, Krishnasamy, Sathya S, Krivosheeva, Inga, Kruljac, Ivan, Kubicki, Ted, Kuchar, Ladislav, Kujawiak, Monika, Kunishige, Hideyuki, Kurtinecz, Melinda, Kurtz Lisboa, Hugo R, Kushnir, Mykola, Kyyak, Yulian, Lace, Arija, Lakka, Timo, Lalic, Nebojsa, Lalic, Katarina, Lambadiari, Vaia, Lanaras, Leonidas, Lang, Chim, Langlois, Marie-France, Lash, Joseph, Latkovskis, Gustavs, Lau, David, Lazcano Soto, José Roberto, Le Roux, Carel, Ledesma, Gilbert N, Lee, Li Yuan, Lee, Thung-Lip, Lee, Kelvin, Lehrke, Michael, Leite, Silmara O, Leksycka, Agata, Lenzmeier, Thomas, Leonetti, Frida, Leonidova, Viktoriia, Lepor, Norman, Leung, Melissa, Levchenko, Olena, Levins, Peter, Levy, Louis J, Lewis, Matthew, Liberopoulos, Evangelos, Liberty, Idit, Lindholm, Carl-Johan, Lingvay, Ildiko, Linhart, Ales, Liu, Ming-En, Liu, Jenny, Lofton, Holly, Logemann, Timothy, Lombaard, Johannes J, Lombard, Landman, Lorraine, Richard, Lovell, Charles F, Ludvik, Bernhard, Lukaszewicz, Monika, Lupkovics, Géza, Lupovitch, Steven, Lupu, Sirona, Lynch, Mary, Lysak, Zoreslava, Lysenko, Tatyana A, Maeda, Hajime, Maeda, Itaru, Mæng, Michael, Mahajan, Ajay U, Maher, Vincent, Maia, Lilia N, Makotoko, Ellen M, Malavazos, Alexis, Malecha, Jan, Malicherova, Emilia, Manita, Mamoru, Mannucci, Edoardo, Mareev, Viacheslav, Marin, Liliana, Markova, Tatiana, Marso, Steven P, Martens, F.M.A.C., Martinez, Cuper, Martinez Cano, Carlos A, Martins, Cristina, Masmiquel Comas, Luis, Matsumoto, Takashi, Mcdonald, Kenneth, Mcgowan, Barbara, Mcgrew, Frank, Mclean, Barry K, Mcpherson, David D, Merino Torres, Juan Francisco, Meyers, Peter, Meyhöfer, Sebastian, Mezquita Raya, Pedro, Milanova, Maria, Milicic, Davor, Miller, Gary, Mills, Richard E, Mîndrescu, Nicoleta M, Mingrone, Geltrude, Minkova, Dotska A, Mirani, Marco, Miras, Alexander, Mistodie, Cristina V, Mitomo, Satoru, Mittal, Sanjay, Miyake, Taiji, Miyamoto, Naomasa, Molony, David, Monteiro, Pedro, Mooe, Thomas, Moosa, Naeem, Morales Portillo, Cristobal, Morales Villegas, Enrique C, Morawski, Emily J, Morbey, Claire, Morin, Robert P, Morisaki, Kuniaki, Morosanu, Magdalena, Mosenzon, Ofri, Mostovoy, Yuriy, Munir, Iqbal, Muratori, Fabrizio, Murray, Ryan, Murthy, Avinash, Myint, Min, Myshanych, Galyna, Nafornita, Valerica, Nagano, Takuya, Nair, Sunil, Nakhle, Samer N, Natsuaki, Masahiro, Nayak, Bindu M, Nibouche, Djamel Eddine, Nicholls, Stephen, Nicolau, José C, Nicolescu, Georgiana, Nierop, Peter, Niskanen, Leo, Ntaios, George, Nygård, Ottar Kjell, Oaks, Joshua B, Obrezan, Andrey, O'donnell, Philip, Oguri, Mitsutoshi, Oguzhan, Abdurrahman, Oh, Fumiki, Ohsugi, Mitsuru, Okada, Yoshio, Okayama, Hideki, Onaca, Adriana, Onaka, Haruhiko, Oneil, Patrick, Ong, Tiong Kiam, Ong, Stephen, Ono, Yasuhiro, Opsahl, Paul J, Ostrowska, Lucyna, Oviedo, Alejandra, Ozdogan, Oner, Ozpelit, Ebru, Pagkalos, Emmanouil, Pagotto, Uberto, Páll, Dénes, Pandey, Amritanshu- Shekhar, Parkhomenko, Oleksandr, Parvathareddy, Krishna Malakondareddy, Patel, Minesh B, Patsilinakos, Sotirios, Paul, Neil, Pedersen, Sue, Pereira, Isabel, Pereira, Edward Scott, Perez Terns, Paula, Perez-Vargas, Elba A, Pergaeva, Yulia, Perkelvald, Alexander, Peskov, Andrey B, Peter, Jonathan, Peters, Karina, Petit, Catherine, Petrov, Ivo, Philis-Tsimikas, Athena, Pietilä, Mikko, Pinto, Fausto, Piros, Annamária, Piyayotai, Dilok, Platonov, Dmitriy, Poirier, Paul, Pop, Lavinia, Popa, Bogdan, Pop-Busui, Rodica, Poremba, John, Porto, Alejandro, Postadzhiyan, Arman, Pothineni, Ramesh B, Potu, Ranganatha P, Powell, Talessa, Prafulla, Kerkar G, Prager, Rudolf, Prakova-Teneva, Zhulieta R, Pratley, Richard E, Price, Hermione, Pulka, Grazyna, Pullman, John, Punt, Zelda E, Purighalla, Raman S, Purnell, Peter, Qureshi, Mansoor, Rabasa-Lhoret, Remi, Raikhel, Marina A, Rancane, Gita, Randeva, Harpal, Rasouli, Neda, Reurean Pintilei, Delia V, Reyes, Ciro R, Rezgale, Inga, Rice, Eva, Riley, Thaddeus H, Risser, Joseph A, Ristic, Arsen, Rivas Fernández, Margarita, Robbins, David, Robitaille, Yves, Rodbard, Helena W, Rodriguez Plazas, Jaime A, Römer, T.J., Rosen, Glenn, Rosman, Dr Azhari, Rossi, Paulo, Rudenko, Leonid, Ruffin, Omari, Ruhani, Anwar Irawan, Runev, Nikolay, Ruyatkin, Dmitriy, Ruzic, Alen, Ryabov, Vyacheslav V, Rydén, Lars, Saggar, Suraj, Sakamoto, Tomohiro, Salter, Tim, Samal, Aditya K, Samoilova, Yulia, Sanabria, Hugo D, Sancak, Seda, Sangrigoli, Renee, Sansanayudh, Nakarin, Santini, Ferruccio, Saraiva, José F, Sardinov, Ruslan, Sargeant, William, Sari, Ramazan, Sathananthan, Airani, Sathyapalan, Thozhukat, Sato, Atsushi, Sauter, Joachim, Sbraccia, Paolo, Schaap, J., Schaum, Thomas, Schiele, François, Scott, John, Segal Lieberman, Gabriella, Segner, Alexander, Senior, Roxy, Sergeeva-Kondrachenko, Marina Y, Serota, Harvey, Serusclat, Pierre, Sethi, Rishi, Shah, Manoj K, Shah, Neerav, Shalaev, Sergey, Sharma, Raj, Sharma, Sumeet, Shaydyuk, Oksana, Shea, Heidi C, Shechter, Michael, Shehadeh, Naim, Shirazi, Mitra, Shlesinger, Yshay, Shneker, Ayham, Shutemova, Elena, Siasos, Gerasimos, Siddiqui, Imran A, Sidey, Jennifer, Sigal, Felix, Sime, Iveta, Singh, Narendra, Siraj, Elias, Sivalingam, Kanagaratnam, Skoczylas, Grzegorz, Smith, Stephen K, Smolenskaya, Olga, Snyder, Brian, Sofer, Yael, Sofley, C.W., Solano, Royce, Sonmez, Yusuf A, Sorokin, Maxim, Soto González, Alfonso, Sotolongo, Carlos, Soufer, Joseph, Soyluk Selcukbiricik, Ozlem, Spaic, Tamara, Spriggs, Douglas, Sreenan, Seamus, Stahl, Hans-Detlev, Stamatelopoulos, Kimon, Stanislavchuk, Mykola, Stankovic, Goran, Stasek, Josef, Steg, Gabriel, Steindorf, Joerg, Stephan, Dominique, Stewart, John, Still, Christopher, St-Maurice, Francois, Stogowska-Nikiciuk, Barbara, Stoker, Jeff, Stokic, Edita, Strzelecka, Anna, Sturm, Kerstin, Sueyoshi, Atsushi, Sugiura, Toshiyuki, Sultan, Senan, Suplotova, Lyudmila A, Suwanagool, Arisara, Suwanwalaikorn, Sompongse, Sveklina, Tatiana, Swanson, Neil, Swart, Henk, Swenson, Bradley P, Szyprowska, Ewa, Tait, Graeme, Takács, Róbert, Takeuchi, Yuzo, Tamirisa, Aparna, Tanaka, Hideki, Tatovic, Danijela, Tellier, Guy, Teragawa, Hiroki, Teterovska, Dace, Thomas, Nihal, Thuan, Jean-Francois, Tinahones, Francisco, Tisheva-Gospodinova, Snezhanka, Toarba, Cristina, Todoriuk, Liudmyla, Tokmakova, Mariya, Tonstad, Serena, Toplak, Hermann, Tran, Henry, Tripathy, Devjit, Trusau, Aliaksandr, Tsabedze, Nqoba, Tsougos, Elias, Tsoukas, George M, Tuccinardi, Dario, Tuna, Mazhar M, Turatti, Luiz A, Tziomalos, Konstantinos, Udommongkol, Chesda, Ueda, Osamu, Ukkola, Olavi, Unubol, Mustafa, Urbach, Dorothea, Urina Triana, Miguel A, Usdan, Lisa, Vaidya, Bijay, Vale, Noah, Vallieres, Gerald, Van Beek, Andre P, Van De Borne, Philippe, Van Der Walt, Eugene, Van Der Zwaan, C., Van Nieuwenhuizen, Elane, Van Zyl, Louis, Vanduynhoven, Philippe, Varghese, Kiron, Vasileva, Svetla P, Vassilev, Dobrin, Vathesatogkit, Prin, Velychko, Valentyna, Vercammen, Chris, Verges, Bruno, Verma, Subodh, Verwerft, Jan, Vesela, Alica, Veselovskaya, Nadezhda G, Vettor, Roberto, Veze, Irina, Vijan, Vinod, Vijayaraghavan, Ram, Villarino, Adriana, Vincent, Royce, Vinogradova, Oksana, Vishlitzky, Victor, Vlad, Adrian, Vladu, Ionela Mihaela, Vo, Anthony, Von Engelhardt, Charlotte, Von Münchhausen, Candy, Vorobyeva, Olga, Vossenberg, T., Vrolix, Mathias, Vukicevic, Marjana, Vyshnyvetskyy, Ivan, Wadvalla, Shahid, Wagner, Jan, Wakeling, John, Wallace, James, Wan Mohamed, Wan Mohd Izani, Wander, Gurpreet S, Ward, Kathleen, Warren, Mark L, Watanabe, Atsuyuki, Weber, Bruce, Weintraub, Howard, Weisnagel, John, Welker, James, Wendisch, Ulrich, Wenocur, Howard S, Wierum, Craig, Wilding, John, William, Maged, Wilson, Pete, Wilson, Jonathan P, Wong, Yuk-Ki, Wongcharoen, Wanwarang, Wozniak, Iwona, Wu, Chau-Chung, Wyatt, Nell, Wynne, Alan, Yamaguchi, Hiroshi, Yamasaki, Masahiro, Yazici, Dilek, Yeh, Hung-I, Yotov, Yoto, Yuan, Qingyang, Zacher, Jeffrey, Zagrebelnaya, Olga, Zaidman, Cesar J, Zalevskaya, Alsu, Zarich, Stuart, Zatelli, Maria Chiara, Zeller, Helga, Zhdanova, Elena A, Zornitzki, Taiba, Zrazhevskiy, Konstantin, Zykov, Mikhail, Lincoff, A Michael, Ryan, Donna H, Colhoun, Helen M, Deanfield, John E, Emerson, Scott S, Kahn, Steven E, Kushner, Robert F, Plutzky, Jorge, Brown-Frandsen, Kirstine, Hovingh, G Kees, Hardt-Lindberg, Soren, Tornøe, Christoffer W, Deanfield, John, Scirica, Benjamin M, Ryan, Donna, Kosiborod, Mikhail N, Hardt-Lindberg, Søren, Frenkel, Ofir, Weeke, Peter E, Rasmussen, Søren, Lang, Chim C, and Urina-Triana, Miguel

Published
2024
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2. Cardiopoietic cell therapy for advanced ischemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

Author

Bartunek, Jozef, Terzic, Andre, Davison, Beth A, Filippatos, Gerasimos S, Radovanovic, Slavica, Beleslin, Branko, Merkely, Bela, Musialek, Piotr, Wojakowski, Wojciech, Andreka, Peter, Horvath, Ivan G, Katz, Amos, Dolatabadi, Dariouch, El Nakadi, Badih, Arandjelovic, Aleksandra, Edes, Istvan, Seferovic, Petar M, Obradovic, Slobodan, Vanderheyden, Marc, Jagic, Nikola, Petrov, Ivo, Atar, Shaul, Halabi, Majdi, Gelev, Valeri L, Shochat, Michael K, Kasprzak, Jaroslaw D, Sanz-Ruiz, Ricardo, Heyndrickx, Guy R, Nyolczas, Noémi, Legrand, Victor, Guédès, Antoine, Heyse, Alex, Moccetti, Tiziano, Fernandez-Aviles, Francisco, Jimenez-Quevedo, Pilar, Bayes-Genis, Antoni, Hernandez-Garcia, Jose Maria, Ribichini, Flavio, Gruchala, Marcin, Waldman, Scott A, Teerlink, John R, Gersh, Bernard J, Povsic, Thomas J, Henry, Timothy D, Metra, Marco, Hajjar, Roger J, Tendera, Michal, Behfar, Atta, Alexandre, Bertrand, Seron, Aymeric, Stough, Wendy Gattis, Sherman, Warren, Cotter, Gad, and Wijns, William

Subjects
Heart Disease, Clinical Research, Clinical Trials and Supportive Activities, Cardiovascular, Stem Cell Research, Adult, Aged, Double-Blind Method, Female, Heart Failure, Humans, Male, Mesenchymal Stem Cell Transplantation, Middle Aged, Myocardial Ischemia, Prospective Studies, Treatment Outcome, Young Adult, Regenerative medicine, Cardiopoiesis, Cardiovascular disease, Stem cell, Target population, Disease severity, Marker, Precision medicine, CHART Program, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology
Abstract

AimsCardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort.Methods and resultsThis multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370 mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death.ConclusionThe primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted.

Published
2017

3. Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial

Author

Deanfield, John, Verma, Subodh, Scirica, Benjamin M, Kahn, Steven E, Emerson, Scott S, Ryan, Donna, Lingvay, Ildiko, Colhoun, Helen M, Plutzky, Jorge, Kosiborod, Mikhail N, Hovingh, G Kees, Hardt-Lindberg, Søren, Frenkel, Ofir, Weeke, Peter E, Rasmussen, Søren, Goudev, Assen, Lang, Chim C, Urina-Triana, Miguel, Pietilä, Mikko, Lincoff, A Michael, Abe, Mitsunori, Abhaichand, Rajpal K, Abhayaratna, Walter P, Abhyankar, Atul, Abidin, Imran B Zainal, Abou Assi, Hiba, Accini Mendoza, Jose L, Adas, Mine, Agaiby, John M, Agarwal, Devendra K, Agha, Maher, Ahmed, Azazuddin, Ahtiainen, Petteri, Aigner, Elmar, Ajay, Naik, Ali, Norsiah, Al-Karadsheh, Amer, Allison, Roy, Allison, Dale C, Alpenidze, Diana, Altuntas, Yuksel, Al-Zoebi, Ayham, Ambuj, Roy, Amerena, John, Anderson, Robert J, Ando, Toshiaki, Andrews, Robert, Antonova, Elizaveta, Appel, Karl-Friedrich, Arantes, Flávia B, Araz, Mustafa, Arbel, Yaron, Arenas León, José L, Argyrakopoulou, Georgia, Ariani, Mehrdad, Arias Mendoza, Maria A, Arif, Ahmed A, Arneja, Jaspal, Aroda, Vanita R, Aronne, Louis J, Arstall, Margaret, Asamoah, Njaimeh, Asanin, Milika, Audish, Hanid, Avram, Rodica, Badat, Aysha, Badiu, Corin V, Bakdash, Wa'el, Bakiner, Okan S, Bandezi, Vuyokazi N, Bang, Liew H, Bansal, Sandeep, Baranyai, Marietta, Barbarash, Olga, Barber, Mark, Barnum, Otis, Barone Rochette, Gilles, Bashkin, Amir, Baum, Seth, Bays, Harold E, Bazzoni Ruiz, Alberto E, Beckowski, Maciej, Beerachee, Yaswin, Bellary, Srikanth, Belousova, Lidia, Berk, Martin, Bernstein, Marc, Berra, Cesare, Beshay, Isaac, Bhagwat, Ajit, Bhan, Arti, Biggs, William C, Billings, Liana, Bitar, Fahed, Block, Bradley, Bo, Simona, Bogdanski, Pawel, Bolshakova, Olga O, Boshchenko, Alla A, Bosworth, Hayden, Botero Lopez, Rodrigo, Bôttcher, Morten, Bourgeois, Ronald, Brautigam, Donald, Breton, Cristian F, Broadley, Andrew, Brockmyre, Andrew P, Brodie, Steven K, Bucci, Marco, Budincevic, Hrvoje, Budoff, Matthew J, Buffman, Barry, Buljubasic, Nediljka, Buranapin, Supawan, Burgess, Lesley, Burguera, Bartolomé, Buriakovska, Olena, Buscemi, Silvio, Busch, Robert, Buse, John B, Buynak, Robert, Byrne, Maria, Caceaune, Elena, Cadena Bonfanti, Alberto J, Calinescu, Cornell V, Call, Robert S, Canecki Varzic, Silvija, Cannon, Kevin, Capehorn, Matt, Cariou, Bertrand, Carr, Jeffrey, Carrillo-Jimenez, Rodolfo, Casas, Marcelo, Castro, Almudena, Celik, Ahmet, Cercato, Cintia, Cermak, Ondrej, Cha, James Y, Chacon, Carolina, Chaicha-Brom, Tira, Chandra, Sandeep, Chettibi, Mohamed, Chevts, Julia, Christopher, Johann, Chrustowski, Witold, Cif, Adriana, Clark, Rebecca, Clark, Wayne, Clifford, Piers, Coetzee, Kathleen, Cogni, Giulia, Colao, Anna Maria, Colquhoun, David M, Concha, Mauricio, Condit, Jonathan, Constance, Christian, Constantin, Ciprian, Constantinescu, Silviana, Corbett, Clive, Cornett, George M, Correia, Marcelo, Cortinovis, Fiorenzo, Cosma, Dana, Creely, Steven, Cross, David, Curtis, Brian, Czochra, Wojciech, Daboul, Nizar Y, Dagdelen, Selcuk, D'agostino, Ronald, Dang, Cuong, Datta, Sudip, Davuluri, Ashwini K, Dawood, Saleem Y, De Jong, Douwe M, De La Cuesta, Carmen, De Los Rios Ibarra, Manuel O, De Pablo, Carmen, De Pauw, Michel, Dela Llana, Alexander, Delibasic, Maja, Delic-Brkljacic, Diana, Demicheli, Thibaud, Denger, Ralf J, Desai, Devang, Desai, Piyush, Desouza, Cyrus V, Dicker, Dror, Djenic, Nemanja, Dobson, Simon, Doi, Masayuki, Doran, Jesse A, Dorman, Reinhart, Dotta, Francesco, Dukes, Carl E, Duronto, Ernesto, Durst, Ronen, Dvoryashina, Irina V, Ebrahim, Iftikhar O, Eggebrecht, Holger, Egstrup, Kenneth, Ekinci, Elif I, Eliasson, Björn, Eliasson, Ken, Enache, Georgiana, Enculescu, Dan, English, Patrick, Ermakova, Polina, Ershova, Olga, Ezaki, Hirotaka, Ezhov, Marat, Farias, Eduardo, Farias, Javier M, Farsky, Pedro S, Ferreira, Daniel, Filteau, Pierre, Finneran, Matthew P, Folkens, Eric M, Fonseca, Alberto G, Fonseca, Luisa, Fordan, Steven, Fourie, Nyda, França, Sara, Franco, Denise R, Franek, Edward, Friedman, Keith, Frittitta, Lucia, Froer, Michael, Fuckar, Krunoslav, Fujii, Kenshi, Fujita, Ryoko, Fukushima, Yasushi, Fulat, Mohamed, Fulwani, Mahesh, Gajos, Grzegorz, Galyavich, Albert, Gambill, Michael L, Gandotra, Dheeraj, Winston, Gandy, Garcia Hernandez, Pedro A, García Reza, Raymundo, Garg, Naveen, Garg, Sandeep, Garvey, William T, Garza, Juan C, Gatta-Cherifi, Blandine, Gelev, Valeri, Geller, Steven A, Geohas, Jeffrey G, Georgiev, Borislav, Ghazi, Adline, Gilbert, Matthew P, Gilinskaya, Olga, Gislason, Gunnar, Gogas Yavuz, Dilek, González Albarrán, Olga, Gordeev, Ivan G, Gorton, Sidney C, Goudev, Assen, Gretland Valderhaug, Tone, Groenemeijer, Bjorn, Gul, Ibrahim, Gullestad, Lars, Gurieva, Irina, Guseva, Galina N, Hagenow, Andreas, Haluzik, Martin, Halvorsen, Sigrun, Hammoudi, Naima, Hanaoka, Keiichi, Hancu, Nicolae, Hanusch, Ursula, Harris, Kathleen, Harris, Barry, Hartleib, Michael, Hartman, Aaron N, Hata, Yoshiki, Heimer, Brian, Herman, Lee, Herzog, William, Hewitt, Eric, Heymer, Peter, Hiremath, Shirish, Hjelmesaeth, Joeran, Høgalmen, Rasmus Geir, Høivik, Hans Olav, Holmer, Helene, Horoshko, Olha, Houser, Patricia M, Hove, Jens D, Hsieh, I-Chang, Hulot, Jean-Sébastien, Hussein, Zanariah, Ilashchuk, Tetiana, Ilveskoski, Erkki, Ipatko, Irina, Iranmanesh, Ali, Isawa, Tsuyoshi, Issa, Moises, Iteld, Bruce, Iwasawa, Takamasa, Jabbar, Danish, Jackson, Richard A, Jackson-Voyzey, Ewart, Jacob, Stephan, Jaffrani, Naseem A, Jardula, Michael F, Jastreboff, Ania, Jensen, Svend E, Jerkins, Terri, Jimenez-Ramos, Silvia A, Jitendra Pal Singh, Sawhney, Johnson, Wallace, Joyce, John M, Jozefowska, Malgorzata, Jugnundan, Prakash, Jungmair, Wolfgang, Jurowiecki, Jaroslaw, Kadokami, Toshiaki, Kahali, Dhiman, Kahrmann, Gerd, Kaiser, Sergio E, Kalmucki, Piotr, Kanadasi, Mehmet, Kandath, David, Kania, Grzegorz, Kannan, J, Kapp, Cornelia, Karczmarczyk, Agnieszka, Kartalis, Athanasios, Kaser, Susanne, Kasim, Sazzli Shahlan, Kastelic, Richard, Kato, Toshiaki, Katova, Tzvetana, Kaul, Upendra, Kautzky-Willer, Alexandra, Kawanishi, Masahiro, Kayikcioglu, Meral, Kazakova, Elena E, Keeling, Philip, Kempe, Hans-Peter, Kereiakes, Dean J, Kerneis, Mathieu, Keski-Opas, Tiina, Khadra, Suhail, Khaisheva, Larisa, Kharakhulakh, Marina, Khlevchuk, Tatiana, Khoo, Jeffrey, Kiatchoosakun, Songsak, Kinoshita, Noriyuki, Kinoshita, Masaharu, Kitamura, Ryoji, Kiyosue, Arihiro, Klavina, Irina, Klein, Eric J, Klimsa, Zdenek, Klonoff, David, Klug, Eric, Kobalava, Zhanna, Kodera, Satoshi, Koga, Tokushi, Kokkinos, Alexander, Koleckar, Pavel, Könyves, László, Koren, Michael J, Kormann, Adrian P, Kostner, Karam, Kreutzmann, Kristin, Krishinan, Saravanan, Krishnasamy, Sathya S, Krivosheeva, Inga, Kruljac, Ivan, Kubicki, Ted, Kuchar, Ladislav, Kujawiak, Monika, Kunishige, Hideyuki, Kurtinecz, Melinda, Kurtz Lisboa, Hugo R, Kushnir, Mykola, Kyyak, Yulian, Lace, Arija, Lakka, Timo, Lalic, Nebojsa, Lalic, Katarina, Lambadiari, Vaia, Lanaras, Leonidas, Lang, Chim, Langlois, Marie-France, Lash, Joseph, Latkovskis, Gustavs, Lau, David, Lazcano Soto, José Roberto, Le Roux, Carel, Ledesma, Gilbert N, Lee, Li Yuan, Lee, Thung-Lip, Lee, Kelvin, Lehrke, Michael, Leite, Silmara O, Leksycka, Agata, Lenzmeier, Thomas, Leonetti, Frida, Leonidova, Viktoriia, Lepor, Norman, Leung, Melissa, Levchenko, Olena, Levins, Peter, Levy, Louis J, Lewis, Matthew, Liberopoulos, Evangelos, Liberty, Idit, Lindholm, Carl-Johan, Lingvay, Ildiko, Linhart, Ales, Liu, Ming-En, Liu, Jenny, Lofton, Holly, Logemann, Timothy, Lombaard, Johannes J, Lombard, Landman, Lorraine, Richard, Lovell, Charles F, Ludvik, Bernhard, Lukaszewicz, Monika, Lupkovics, Géza, Lupovitch, Steven, Lupu, Sirona, Lynch, Mary, Lysak, Zoreslava, Lysenko, Tatyana A, Maeda, Hajime, Maeda, Itaru, Mæng, Michael, Mahajan, Ajay U, Maher, Vincent, Maia, Lilia N, Makotoko, Ellen M, Malavazos, Alexis, Malecha, Jan, Malicherova, Emilia, Manita, Mamoru, Mannucci, Edoardo, Mareev, Viacheslav, Marin, Liliana, Markova, Tatiana, Marso, Steven P, Martens, F.M.A.C., Martinez, Cuper, Martinez Cano, Carlos A, Martins, Cristina, Masmiquel Comas, Luis, Matsumoto, Takashi, Mcdonald, Kenneth, Mcgowan, Barbara, Mcgrew, Frank, Mclean, Barry K, Mcpherson, David D, Merino Torres, Juan Francisco, Meyers, Peter, Meyhöfer, Sebastian, Mezquita Raya, Pedro, Milanova, Maria, Milicic, Davor, Miller, Gary, Mills, Richard E, Mîndrescu, Nicoleta M, Mingrone, Geltrude, Minkova, Dotska A, Mirani, Marco, Miras, Alexander, Mistodie, Cristina V, Mitomo, Satoru, Mittal, Sanjay, Miyake, Taiji, Miyamoto, Naomasa, Molony, David, Monteiro, Pedro, Mooe, Thomas, Moosa, Naeem, Morales Portillo, Cristobal, Morales Villegas, Enrique C, Morawski, Emily J, Morbey, Claire, Morin, Robert P, Morisaki, Kuniaki, Morosanu, Magdalena, Mosenzon, Ofri, Mostovoy, Yuriy, Munir, Iqbal, Muratori, Fabrizio, Murray, Ryan, Murthy, Avinash, Myint, Min, Myshanych, Galyna, Nafornita, Valerica, Nagano, Takuya, Nair, Sunil, Nakhle, Samer N, Natsuaki, Masahiro, Nayak, Bindu M, Nibouche, Djamel Eddine, Nicholls, Stephen, Nicolau, José C, Nicolescu, Georgiana, Nierop, Peter, Niskanen, Leo, Ntaios, George, Nygård, Ottar Kjell, Oaks, Joshua B, Obrezan, Andrey, O'donnell, Philip, Oguri, Mitsutoshi, Oguzhan, Abdurrahman, Oh, Fumiki, Ohsugi, Mitsuru, Okada, Yoshio, Okayama, Hideki, Onaca, Adriana, Onaka, Haruhiko, Oneil, Patrick, Ong, Tiong Kiam, Ong, Stephen, Ono, Yasuhiro, Opsahl, Paul J, Ostrowska, Lucyna, Oviedo, Alejandra, Ozdogan, Oner, Ozpelit, Ebru, Pagkalos, Emmanouil, Pagotto, Uberto, Páll, Dénes, Pandey, Amritanshu- Shekhar, Parkhomenko, Oleksandr, Parvathareddy, Krishna Malakondareddy, Patel, Minesh B, Patsilinakos, Sotirios, Paul, Neil, Pedersen, Sue, Pereira, Isabel, Pereira, Edward Scott, Perez Terns, Paula, Perez-Vargas, Elba A, Pergaeva, Yulia, Perkelvald, Alexander, Peskov, Andrey B, Peter, Jonathan, Peters, Karina, Petit, Catherine, Petrov, Ivo, Philis-Tsimikas, Athena, Pietilä, Mikko, Pinto, Fausto, Piros, Annamária, Piyayotai, Dilok, Platonov, Dmitriy, Poirier, Paul, Pop, Lavinia, Popa, Bogdan, Pop-Busui, Rodica, Poremba, John, Porto, Alejandro, Postadzhiyan, Arman, Pothineni, Ramesh B, Potu, Ranganatha P, Powell, Talessa, Prafulla, Kerkar G, Prager, Rudolf, Prakova-Teneva, Zhulieta R, Pratley, Richard E, Price, Hermione, Pulka, Grazyna, Pullman, John, Punt, Zelda E, Purighalla, Raman S, Purnell, Peter, Qureshi, Mansoor, Rabasa-Lhoret, Remi, Raikhel, Marina A, Rancane, Gita, Randeva, Harpal, Rasouli, Neda, Reurean Pintilei, Delia V, Reyes, Ciro R, Rezgale, Inga, Rice, Eva, Riley, Thaddeus H, Risser, Joseph A, Ristic, Arsen, Rivas Fernández, Margarita, Robbins, David, Robitaille, Yves, Rodbard, Helena W, Rodriguez Plazas, Jaime A, Römer, T.J., Rosen, Glenn, Rosman, Dr Azhari, Rossi, Paulo, Rudenko, Leonid, Ruffin, Omari, Ruhani, Anwar Irawan, Runev, Nikolay, Ruyatkin, Dmitriy, Ruzic, Alen, Ryabov, Vyacheslav V, Rydén, Lars, Saggar, Suraj, Sakamoto, Tomohiro, Salter, Tim, Samal, Aditya K, Samoilova, Yulia, Sanabria, Hugo D, Sancak, Seda, Sangrigoli, Renee, Sansanayudh, Nakarin, Santini, Ferruccio, Saraiva, José F, Sardinov, Ruslan, Sargeant, William, Sari, Ramazan, Sathananthan, Airani, Sathyapalan, Thozhukat, Sato, Atsushi, Sauter, Joachim, Sbraccia, Paolo, Schaap, J., Schaum, Thomas, Schiele, François, Scott, John, Segal Lieberman, Gabriella, Segner, Alexander, Senior, Roxy, Sergeeva-Kondrachenko, Marina Y, Serota, Harvey, Serusclat, Pierre, Sethi, Rishi, Shah, Manoj K, Shah, Neerav, Shalaev, Sergey, Sharma, Raj, Sharma, Sumeet, Shaydyuk, Oksana, Shea, Heidi C, Shechter, Michael, Shehadeh, Naim, Shirazi, Mitra, Shlesinger, Yshay, Shneker, Ayham, Shutemova, Elena, Siasos, Gerasimos, Siddiqui, Imran A, Sidey, Jennifer, Sigal, Felix, Sime, Iveta, Singh, Narendra, Siraj, Elias, Sivalingam, Kanagaratnam, Skoczylas, Grzegorz, Smith, Stephen K, Smolenskaya, Olga, Snyder, Brian, Sofer, Yael, Sofley, C.W., Solano, Royce, Sonmez, Yusuf A, Sorokin, Maxim, Soto González, Alfonso, Sotolongo, Carlos, Soufer, Joseph, Soyluk 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Tsoukas, George M, Tuccinardi, Dario, Tuna, Mazhar M, Turatti, Luiz A, Tziomalos, Konstantinos, Udommongkol, Chesda, Ueda, Osamu, Ukkola, Olavi, Unubol, Mustafa, Urbach, Dorothea, Urina Triana, Miguel A, Usdan, Lisa, Vaidya, Bijay, Vale, Noah, Vallieres, Gerald, Van Beek, Andre P, Van De Borne, Philippe, Van Der Walt, Eugene, Van Der Zwaan, C., Van Nieuwenhuizen, Elane, Van Zyl, Louis, Vanduynhoven, Philippe, Varghese, Kiron, Vasileva, Svetla P, Vassilev, Dobrin, Vathesatogkit, Prin, Velychko, Valentyna, Vercammen, Chris, Verges, Bruno, Verma, Subodh, Verwerft, Jan, Vesela, Alica, Veselovskaya, Nadezhda G, Vettor, Roberto, Veze, Irina, Vijan, Vinod, Vijayaraghavan, Ram, Villarino, Adriana, Vincent, Royce, Vinogradova, Oksana, Vishlitzky, Victor, Vlad, Adrian, Vladu, Ionela Mihaela, Vo, Anthony, Von Engelhardt, Charlotte, Von Münchhausen, Candy, Vorobyeva, Olga, Vossenberg, T., Vrolix, Mathias, Vukicevic, Marjana, Vyshnyvetskyy, Ivan, Wadvalla, Shahid, Wagner, Jan, Wakeling, John, Wallace, James, Wan Mohamed, Wan Mohd Izani, Wander, Gurpreet S, Ward, Kathleen, Warren, Mark L, Watanabe, Atsuyuki, Weber, Bruce, Weintraub, Howard, Weisnagel, John, Welker, James, Wendisch, Ulrich, Wenocur, Howard S, Wierum, Craig, Wilding, John, William, Maged, Wilson, Pete, Wilson, Jonathan P, Wong, Yuk-Ki, Wongcharoen, Wanwarang, Wozniak, Iwona, Wu, Chau-Chung, Wyatt, Nell, Wynne, Alan, Yamaguchi, Hiroshi, Yamasaki, Masahiro, Yazici, Dilek, Yeh, Hung-I, Yotov, Yoto, Yuan, Qingyang, Zacher, Jeffrey, Zagrebelnaya, Olga, Zaidman, Cesar J, Zalevskaya, Alsu, Zarich, Stuart, Zatelli, Maria Chiara, Zeller, Helga, Zhdanova, Elena A, Zornitzki, Taiba, Zrazhevskiy, Konstantin, Zykov, Mikhail, Lincoff, A Michael, Ryan, Donna H, Colhoun, Helen M, Deanfield, John E, Emerson, Scott S, Kahn, Steven E, Kushner, Robert F, Plutzky, Jorge, Brown-Frandsen, Kirstine, Hovingh, G Kees, Hardt-Lindberg, Soren, and Tornøe, Christoffer W

Abstract

Semaglutide, a GLP-1 receptor agonist, reduces the risk of major adverse cardiovascular events (MACE) in people with overweight or obesity, but the effects of this drug on outcomes in patients with atherosclerotic cardiovascular disease and heart failure are unknown. We report a prespecified analysis of the effect of once-weekly subcutaneous semaglutide 2·4 mg on ischaemic and heart failure cardiovascular outcomes. We aimed to investigate if semaglutide was beneficial in patients with atherosclerotic cardiovascular disease with a history of heart failure compared with placebo; if there was a difference in outcome in patients designated as having heart failure with preserved ejection fraction compared with heart failure with reduced ejection fraction; and if the efficacy and safety of semaglutide in patients with heart failure was related to baseline characteristics or subtype of heart failure.

Published
2024
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8. Arrhythmias in COVID-19

Author

Traykov, Vassil and Gelev, Valeri

Subjects
SARS-CoV-2, coronavirus, COVID-19, polymorphic ventricular tachycardia, atrial fi brillation, supraventricular tachycardia, torsades-de-pointes, RC666-701, cardiovascular system, Medicine, Diseases of the circulatory (Cardiovascular) system, cardiovascular diseases, atrial fi brilla
Abstract

Coronavirus pandemic has led to the accumulation of substantial evidence about the arrhythmogenic potential of COVID-19. Arrhythmias in COVID-19 develop more frequently in severely and critically ill patients. Hypoxia, direct or indirect myocardial injury as well as the role of immune response to the virus are among the possible mechanisms of arrhythmia. Although management of these arrhythmias during the pandemic does not differ signifi cantly from the currently accepted standard of care, the potential for drug interactions and the impact of some antiviral medications on the QTc interval should be taken into consideration. The current review aims to summarize the available evidence and provide practical guidance on the management of arrhythmia patients with COVID-19.

Published
2021

9. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial

Author

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

Published
2022
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11. Percutaneous coronary interventions of unprotected left main stenosis

Author

Zheleva-Kyuchukova, Ivayla and Gelev, Valeri

Subjects
left main, percutaneous coronary interventions, coronary artery disease
Abstract

Significant stenosis of the trunk of the left coronary artery (LCA) or left main (LM) stenosis is a serious injury that puts a large myocardial area at risk, being found in 4-9% of patients referred for selective coronary angiography. Revascularization in patients with severe left main stenosis significantly improves their prognosis, with bypass surgery being the standard of care. Percutaneous coronary intervention (PCI) has proven to be an effective and safe alternative, especially in patients with less complex lesions or unsuitable for surgery. The aim of this article is to review the topic and to analyze the frequency of adverse cardiovascular events in a two-year follow-up of patients with PCI of unprotected LM stenosis from real practice. Material and methods: Since March 2013, all patients with an interventional procedure for LM stenosis in the Cardiology Clinic of Acibadem City Clinic Tokuda Hospital are included in a register. For the period from 06.2013 to 06.2018, 209 PCIs of LM lesions were performed, and in the present study a series of 136 consecutive patients with PCIs of unprotected LM stenosis were analyzed. The mean Syntax Score (SS) of the study group was 26.3 ± 10.09 (11-58.5) with a median of 24.00. The mean Euro Score is 2.61 ± 4.19 (0.50-34.42) with a median of 1.22. Maximum revascularization was achieved in all subjects, and patients with STEMI and/or cardiogenic shock, previous LM PCI and protected LM PCI were excluded from the analysis. Patients were followed for 2 years for the combined indicator of adverse cardiovascular events, which included death from any cause (so-called overall mortality), cardiac mortality, stroke and revascularization. Results: 22 adverse events were registered (16.2%). The overall mortality was 9.6%, cardiac death – 8.8%, stroke – 0.7% and restenosis and revascularization – 8.1%. Conclusion: PCI of LM stenosis in patients from real clinical practice and achieving maximum revascularization is a procedure with minimal risks and favorable follow-up results, and the operator‘s experience and the capabilities of the respective medical institution to conduct such complex interventions are important.

Published
2021

13. Ретрограден достъп при реканилизация на хронични оклузии на коронарни артерии

Author

Gelev, Valeri, Проф. д-р Милена Станева Станева, дм, and Prof. Milena Staneva Staneva, MD, PhD

Abstract

Хроничните коронарни оклузии (ХКО) са едно от най-големите предизвикателства в инвазивната кардиология, с честотата от около 15 до 30% при пациенти с исхимична болест на сърцето (ИБС). Успешната реканализация на води до значима редукция на ангиозната симптоматика, подобряване на качеството на живот, a вероятно и прогнозата на пациентите. Въвеждането на ретроградния достъп за реканализация на хронични коронарни оклузии доведе до значително по-ефективното им успешно третиране и се превърна във важен инструмент за успешно третиране на много комплексни оклузии. Настоящата рабта разглежда значението на ретороградния достъп за успешна реканализация на ХКО след рутинното му въвеждане в практиката. За целта са анализирани пациенти, при които е използван антеграден и ретрограден достъп за реканализация на ХКО – група А(N = 375) и група , при които реканализацията е проведена само с традиционния антеграден достъп преди навлизането на ретороградния достъп – група B(N = 212). Описани са, комплексността на оклузиите, процедурните характеристики, процедурия успех и усложненията. Установи се, че в групата с изпозване на ретрограден достъп, е постигнат значително по-висок процедурен успех при пациенти със значително по-комплексни ХКО, въпреки по-високия рисков профил, както и по-напредналата форма на ИБС. Налице са данни, че ретроградния достъп е високо ефективен за третирането на комплексни ХКО. Не се установи значима ралзика в усложненията между двете групи., Chronic coronary occlusions (CТО) are one of the biggest challenges in invasive cardiology. The incidence of CTO is 15 to 30% in patients with coronary heart disease (CHD). Successful recanalization is associated with significant reduction of symptoms and improvement of patients' quality of life and probably improving prognosis. The invention of the retrograde approach for recanalization of CTOs has led to their significantly more effective successful treatment and has become an important tool for the successful treatment of complex CTOs. This work discusses the importance of the retrograde access for successful recanalization of CTO after its routine implementation. Analyzed are patients with antegrade and retrograde access for recanalization of CTO - group A (N = 375) and a group in which the recanalization was done with the traditional antegrade access before the entry of the retrograde access - group B (N = 212). The complexity of the occlusions, the procedural characteristics, the procedural success and complications are described. It was found that in the group using retrograde access, significantly higher procedural success was achieved in patients with significantly more complex CTO, despite the higher risk profile, as well as the more advanced form of (CHD). There is evidence that retrograde access is highly effective for the treatment of complex CTO. No significant difference was found in the complications between the two groups.

Published
2021

15. Antiplatelet therapy after PCI in patients with high risk of bleeding

Author

Zheleva-Kyuchukova, Ivayla and Gelev, Valeri

Subjects
surgical procedures, operative, percutaneous coronary interventions (PCI), dual antiplatelet therapy (DAPT), acetylsalicylic acid (ASA), high bleeding risk (HBR), cardiovascular diseases
Abstract

The progress of percutaneous coronary interventions (PCI) over the last few decades facilitated treatment of increasingly complex patient populations. The introduction of drug-eluting stents (DESs) led to need of stronger and prolonged inhibition of platelets which in turn increased the incidence of bleeding complications. The identification and management of patients at high bleeding risk (HBR) during and after percutaneous coronary interventions (PCI) is still problematic in everyday clinical practice.

Published
2020

19. Multicentric survey of patient doses in fluoroscopy guided diagnostic and interventional cardiac procedures: comparison with Diagnostic Reference Levels and follow-up levels for patients at risk for radiation induced skin effects

Author

Zagorska, Anna, primary, Ivanova, Desislava, additional, Kostova-Lefterova, Dessislava, additional, Simeonov, Filip, additional, Gelev, Valeri, additional, Bogov, Ivaylo, additional, Mateev, Hristo, additional, Alexandrov, Alexandar, additional, Jeleva, Ivayla, additional, Stoyanov, Nikolay, additional, Romanova, Katerina, additional, Dyakov, Ilia, additional, Krastev, Valentin, additional, Vasilev, Dobrin, additional, and Ivanov, Vladimir, additional

Published
2020
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20. LONG-TERM SAFETY OF TICAGRELOR MONOTHERAPY IN PATIENTS UNDERGOING PCI FOR STABLE CORONARY ARTERY DISEASE IN THE GLOBAL LEADERS STUDY: IMPACT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Author

Tomaniak, Mariusz, primary, Chichareon, Ply, additional, Takahashi, Kuniaki, additional, Kogame, Norihiro, additional, Modolo, Rodrigo, additional, Chang, Chun Chin, additional, Katagiri, Yuki, additional, Cano, Ernest Spitzer, additional, Neumann, Franz-Joseph, additional, Plante, Sylvain, additional, Antolin, Rosana Hernandez, additional, Gelev, Valeri, additional, Brunel, Philippe, additional, Beygui, Farzin, additional, Filipiak, Krzysztof, additional, van Geuns, Robert, additional, Hamm, Christian, additional, Storey, Robert, additional, Soliman, Osama, additional, Onuma, Yoshinobu, additional, Vranckx, Pascal, additional, Windecker, Stephan, additional, Valgimigli, Marco, additional, and Serruys, Patrick, additional

Published
2019
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22. Effect of Apabetalone on Cardiovascular Events in Diabetes, CKD, and Recent Acute Coronary Syndrome

Author

Kalantar-Zadeh, Kamyar, Schwartz, Gregory G., Nicholls, Stephen J., Buhr, Kevin A., Ginsberg, Henry N., Johansson, Jan O., Kulikowski, Ewelina, Lebioda, Kenneth, Toth, Peter P., Wong, Norman, Sweeney, Michael, Ray, Kausik K., Ray, Kausik K., Schwartz, Gregory G., Nicholls, Stephen J., Kalantar-Zadeh, Kaymar, Toth, Peter, Ginsberg, Henry, Sweeney, Michael, Wong, Norman, Johansson, Jan, Lorenzatti, Alberto, Vico, Marisa, Milanova, Maria, Milicevic, Goran, Popovic, Zeljko, Ebelt, Henning, Kiss, Róbert Gábor, Lewis, Basil, Llamas, Edmundo Bayram, Banach, Maciej, Tereschenko, Sergey, Pavlovic, Milan, Pella, Daniel, Chiang, Chern-En, Lonn, Eva, Watkins, Paul, Waters, David, Szarek, Michael, Currier, Judith, Leiter, Lawrence Alan, McMurray, John, Petrie, Mark, Jhund, Pardeep, Walters, Matthew, Connolly, Eugene, Lang, Ninian, Schiavi, Lilia, Vico, Marisa, Maffei, Laura, Bordonava, Anselmo, Prado, Aldo, Vallejos, Julio, Farias, Javier, Nardone, Lucrecia, Resk, Jorge, Caruso, Orlando, Lorenzatti, Alberto, Maldonado, Natacha, Padilla, Lucio, Hominal, Miguel, Luquez, Hugo, Sposetti, Georgina, Caccavo, Alberto, Glenny, Jorge, Mansilla, Virginia, Alvarez, Maria, Parody, Maria, Sarjanovich, Rodolfo, Klyver, Maria, Valdez, Maria Eugenia, Colombo, Hugo, Baccaro, Claudia, Visco, Virginia, Bono, Julio, Cuneo, Carlos, Pácora, Fredy Ferré, Guzman, Pablo, Piskorz, Daniel, Vogel, Daniel, Grigorov, Mladen, Gatzov, Plamen, Stoyanov, Miroslav, Apostolova, Emilya, Milanova, Maria, Petrov, Ivo, Angelov, Atanas, Lazov, Petar, Grigorova, Valentina, Yanev, Todor, Vuchkova, Emilena, Vassilev, Dobrin, Tisheva, Snezhanka, Gelev, Valeri, Canecki-Varzic, Silvia, Popovic, Zeljko, Tusek, Srecko, Šunić, Ema Drvodelić, Milicevic, Goran, Jandric-Balen, Marica, Marinic, Nikolina, Moser, Natasa, Ebelt, Henning, Natour, Mohammed, Schwimmbeck, Peter, Appel, Karl-Friedrich, Kleinertz, Klaus, Merkely, Béla, Papp, András, Kiss, Robert, Kovács, Zsolt, Vértes, András, Sárszegi, Zsolt, Kis, Ernö, Benedek, Amália, Takács, János, Papp, Aniko, Matoltsy, Andras, Andrassy, Peter, Ungi, Imre, Shechter, Michael, Atar, Shaul, Shotan, Avraham, Vazan, Alicia, Alcalai, Ronny, Lotan, Chaim, Lewis, Basil, Hayek, Tony, Moriel, Mady, Katz, Amos, Liberty, Idit, Harman-Boehm, Ilana, Schiff, Elad, Kracoff, Oscar, Rozenman, Yoseph, Mosseri, Morris, Slezak, Ladislav, Sabbah, Muhammad, Zeltser, David, Adawi, Khaled, Omary, Muhamed, Ness, Rosane Abramof, Adawi, Faiad, Ruiz, Jose Garza, Carrillo, Jorge, Nevarez Ruiz, Luis Alejandro, Hernandez, Pedro Garcia, Arechavaleta-Granell, Maria, los Rios Ibarra, Manuel De, Velasco-Sanchez, Raul, Molina, Hugo Laviada, Morales, Lucas Solis, Gonzalez, Efrain Montano, Esperón, Guillermo Llamas, Bayram Llamas, Edmundo Alfredo, Rocha, Cynthia Mustieles, Suarez-Otero, Rodrigo, Real, Manuel Aguilera, Cruz, Eliud Montes, Lopez, Humberto Alvarez, Vaca, Susano Lara, Fanghanel-Salmon, Guillermo, Herrera, Carlos Hernandez, Saldaña, Joel Rodriguez, Garcia, Elier Pedroza, Velázquez, Maricela Vidrio, Briones, Ignacio Rodriguez, Hamer, Bas, Slagboom, Ton, Zurakowski, Aleksander, Debinski, Marcin, Kobielusz-Gembala, Iwona, Bartkowiak, Radoslaw, Rajzer, Marek, Witkowski, Adam, Kowalisko, Alicja, Piepiorka, Marek, Stania, Karol, Domzal, Michal, Korecki, Janusz, Korzeniak, Romuald, Mazurkiewicz, Lukasz, Mirek-Bryniarska, Ewa, Banach, Maciej, Madziarska, Katarzyna, Mlodziankowski, Adam, Rewerska, Barbara, Gaciong, Zbigniew, Mazurkiewicz, Maciej, Maksimov, Ivan, Shvarts, Yuri, Khaisheva, Larisa, Samitin, Vasily, Boldueva, Svetlana, Zykov, Mikhail, Barbarash, Olga, Kostenko, Victor, Kulibaba, Elena, Smolenskaya, Olga, Tarasov, Nikolay, Shogenov, Zaur, Strongin, Leonid, Kuzin, Anatoly, Makukhin, Valeriy, Nikolaev, Konstantin, Tereschenko, Sergey, Vezikova, Natalya, Miloradovic, Vladimir, Pavlovic, Milan, Ilic, Marina Deljanin, Simic, Dragan, Pudar-Brankovic, Georgina, Jozic, Tanja, Dodic, Slobodan, Ristic, Arsen, Hinic, Sasa, Mitov, Vladimir, Stokuca-Korac, Natasa, Stokic, Edita, Celic, Vera, Despotovic, Nebojsa, Dincic, Dragan, Tosic, Biljana Putnikovic, Selakovic, Aleksandar, Pella, Daniel, Banik, Milan, Fedacko, Jan, Micko, Karol, Duris, Tibor, Kokles, Martin, Lachova, Beata, Dzupina, Andrej, Mazur, Juraj, Buganova, Ingrid, Behuncik, Milan, Vadinova, Silvia, Yeh, Hung-I, Chiang, Chern-En, Lee, Cheng-Hen, Hsieh, I-Chang, Jiunn-Lee, Lin, Lin, We-Hsiang, Wu, Yen-Wen, Hsia, Chien Hsun, and Lo, Ping Han

Published
2021
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23. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial

Author

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

Published
2018
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28. Initiating sacubitril/valsartan (LCZ696) in heart failure: results of TITRATION, a double‐blind, randomized comparison of two uptitration regimens

Author

Senni, Michele, primary, McMurray, John J.V., additional, Wachter, Rolf, additional, McIntyre, Hugh F., additional, Reyes, Antonio, additional, Majercak, Ivan, additional, Andreka, Peter, additional, Shehova‐Yankova, Nina, additional, Anand, Inder, additional, Yilmaz, Mehmet B., additional, Gogia, Harinder, additional, Martinez‐Selles, Manuel, additional, Fischer, Steffen, additional, Zilahi, Zsolt, additional, Cosmi, Franco, additional, Gelev, Valeri, additional, Galve, Enrique, additional, Gómez‐Doblas, Juanjo J., additional, Nociar, Jan, additional, Radomska, Maria, additional, Sokolova, Beata, additional, Volterrani, Maurizio, additional, Sarkar, Arnab, additional, Reimund, Bernard, additional, Chen, Fabian, additional, and Charney, Alan, additional

Published
2016
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30. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vsaspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial

Author

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

Abstract

We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens.

Published
2018
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31. Initiating sacubitril/valsartan (LCZ696) in heart failure: results of TITRATION, a double-blind, randomized comparison of two uptitration regimens

Author

Beata Sokolova, Alan Charney, Michele Senni, Jan Nociar, Hugh F. McIntyre, Fabian Chen, Bernard Reimund, Harinder Gogia, John J.V. McMurray, Manuel Martínez-Sellés, Rolf Wachter, Franco Cosmi, Peter Andreka, Antonio Reyes, Valeri Gelev, Ivan Majercak, Nina Shehova-Yankova, Mehmet Yilmaz, Zsolt Zilahi, Maurizio Volterrani, Arnab Sarkar, Enrique Galve, Steffen Fischer, Inder S. Anand, Maria Radomska, Juanjo J. Gómez-Doblas, [Senni, Michele] Azienda Osped Papa Giovanni XXIII, Heart Failure & Heart Transplant Unit, Cardiol, Piazza OMS, I-24127 Bergamo, Italy -- [McMurray, John J. V.] Univ Glasgow, British Heart Fdn Cardiovasc Res Ctr, Glasgow, Lanark, Scotland -- [Wachter, Rolf] Univ Med Goettingen, Clin Cardiol & Pneumol, Gottingen, Germany -- [McIntyre, Hugh F.] Brighton & Sussex Med Sch, Med, Brighton, E Sussex, England -- [Reyes, Antonio] Univ Hosp Virgen de Valme, Med Interna, Seville, Spain -- [Andreka, Peter] Gottsegen Gyorgy, Orszagos Kardiol Int, Felnott Kardiol Osztaly, Budapest, Hungary -- [Shehova-Yankova, Nina] MHAT Bratan Shukerov, Dept Cardiol, Smoljan, Bulgaria -- [Anand, Inder] Vet Med Ctr Minneapolis, Minneapolis, MN USA -- [Yilmaz, Mehmet B.] Cumhuriyet Univ, Fac Med, Cardiol, Sivas, Turkey -- [Gogia, Harinder] Cardiol Consultants Orange Cty, Anaheim, CA USA -- [Martinez-Selles, Manuel] Hosp Gregorio Maranon, Serv Cardiol, Madrid, Spain -- [Martinez-Selles, Manuel] Univ Europea, Madrid, Spain -- [Martinez-Selles, Manuel] Univ Complutense, Madrid, Spain -- [Zilahi, Zsolt] Kardiol Szakrendeles, Nyiregyhaza, Hungary -- [Cosmi, Franco] UO Cardiol, PO Osped Valdichiana S Margherita, Cortona, Italy -- [Gelev, Valeri] MHAT Tokuda Hosp Sofia, Clin Cardiol & Angio, Sofia, Bulgaria -- [Galve, Enrique] Hosp Valle De Hebron, Cardiol, Barcelona, Spain -- [Gomez-Doblas, Juanjo J.] Hosp Virgen de la Victoria, Cardiol, Campus Univ Teatinos, Malaga, Spain -- [Nociar, Jan] Kardio 1 Sro, Lucenec, Slovakia -- [Radomska, Maria] Letesia Sro, Trebisov, Slovakia -- [Sokolova, Beata] Galenum Sro, Ambulancia & Odbore Vutorne Lekarstvo, Bratislava, Slovakia -- [Volterrani, Maurizio] IRCCS San Raffaele Pisana, Rome, Italy -- [Sarkar, Arnab] Novartis HC Ltd, Hyderabad, Andhra Pradesh, India -- [Reimund, Bernard] Novartis Pharma AG, Basel, Switzerland -- [Chen, Fabian -- Charney, Alan] Novartis Pharmaceut, E Hanover, NJ USA, Senni, Michele -- 0000-0001-5502-7882, volterrani, maurizio -- 0000-0002-2624-9213, YILMAZ, Mehmet Birhan -- 0000-0002-8169-8628, YILMAZ, MEHMET BIRHAN -- 0000-0002-8169-8628, Wachter, Rolf -- 0000-0003-2231-2200, Anand, Inder -- 0000-0003-1308-4963, mcmurray, john -- 0000-0002-6317-3975, Gomez Doblas, Juan Jose -- 0000-0002-9020-639X, Senni, M, Mcmurray, J, Wachter, R, Mcintyre, H, Reyes, A, Majercak, I, Andreka, P, Shehova-Yankova, N, Anand, I, Mehmet, B, Gogia, H, Martinez-Selles, M, Fischer, S, Zilahi, Z, Cosmi, F, Gelev, V, Galve, E, Gómez-Doblas, J, Nociar, J, Radomska, M, Sokolova, B, Volterrani, M, Sarkar, A, Reimund, B, Chen, F, and Charney, A

Subjects
Male, medicine.medical_specialty, Randomization, ARNI, Enfermedad cardiovascular, Urology, Tetrazoles, Heart failure, 030204 cardiovascular system & hematology, Sacubitril, 03 medical and health sciences, Medical Treatment, Angiotensin Receptor Antagonists, 0302 clinical medicine, Double-Blind Method, Internal medicine, medicine, LCZ696, Humans, 030212 general & internal medicine, Renal Insufficiency, Aged, Heart Failure, Ejection fraction, business.industry, Aminobutyrates, Biphenyl Compounds, Insuficiencia cardíaca, Middle Aged, Tolerability, Regimen, Drug Combinations, Blood pressure, Endocrinology, Treatment Outcome, Valsartan, Corazón - Enfermedades, Hyperkalemia, Female, Neprilysin, Hypotension, Cardiology and Cardiovascular Medicine, business, Sacubitril, Valsartan, medicine.drug, Research Article
Abstract

WOS: 000383604800016, PubMed ID: 27170530, AimsTo assess the tolerability of initiating/uptitrating sacubitril/valsartan (LCZ696) from 50 to 200 mg twice daily (target dose) over 3 and 6 weeks in heart failure (HF) patients (ejection fraction 35%). Methods and resultsA 5-day open-label run-in (sacubitril/valsartan 50 mg twice daily) preceded an 11-week, double-blind, randomization period [100 mg twice daily for 2 weeks followed by 200 mg twice daily (condensed' regimen) vs. 50 mg twice daily for 2 weeks, 100 mg twice daily for 3 weeks, followed by 200 mg twice daily (conservative' regimen)]. Patients were stratified by pre-study dose of angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker (ACEI/ARB; low-dose stratum included ACEI/ARB-naive patients). Of 540 patients entering run-in, 498 (92%) were randomized and 429 (86.1% of randomized) completed the study. Pre-defined tolerability criteria were hypotension, renal dysfunction and hyperkalaemia; and adjudicated angioedema, which occurred in (condensed' vs. conservative') 9.7% vs. 8.4% (P = 0.570), 7.3% vs. 7.6% (P = 0.990), 7.7% vs. 4.4% (P = 0.114), and 0.0% vs. 0.8% of patients, respectively. Corresponding proportions for pre-defined systolic blood pressure 5.5 mmol/L, and serum creatinine >3.0 mg/dL were 8.9% vs. 5.2% (P = 0.102), 7.3% vs. 4.0% (P = 0.097), and 0.4% vs. 0%, respectively. In total, 378 (76%) patients achieved and maintained sacubitril/valsartan 200 mg twice daily without dose interruption/down-titration over 12 weeks (77.8% vs. 84.3% for condensed' vs. conservative'; P = 0.078). Rates by ACEI/ARB pre-study dose stratification were 82.6% vs. 83.8% (P = 0.783) for high-dose/condensed' vs. high-dose/conservative' and 84.9% vs. 73.6% (P = 0.030) for low-dose/conservative' vs. low-dose/condensed'. ConclusionsInitiation/uptitration of sacubitril/valsartan from 50 to 200 mg twice daily over 3 or 6 weeks had a tolerability profile in line with other HF treatments. More gradual initiation/uptitration maximized attainment of target dose in the low-dose ACEI/ARB group., World Health Organization [001]

Published
2016

32. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial.

Author

Tomaniak M, Chichareon P, Takahashi K, Kogame N, Modolo R, Chang CC, Spitzer E, Neumann FJ, Plante S, Hernández Antolin R, Jambrik Z, Gelev V, Brunel P, Konteva M, Beygui F, Morelle JF, Filipiak KJ, van Geuns RJ, Soliman O, Tijssen J, Rademaker-Havinga T, Storey RF, Hamm C, Steg PG, Windecker S, Onuma Y, Valgimigli M, and Serruys PW

Subjects
Aged, Coronary Artery Disease diagnosis, Coronary Artery Disease mortality, Drug Administration Schedule, Dual Anti-Platelet Therapy, Dyspnea chemically induced, Dyspnea diagnosis, Dyspnea mortality, Female, Humans, Incidence, Male, Middle Aged, Platelet Aggregation Inhibitors adverse effects, Prospective Studies, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive mortality, Risk Assessment, Risk Factors, Ticagrelor adverse effects, Time Factors, Treatment Outcome, Coronary Artery Disease therapy, Dyspnea epidemiology, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Platelet Aggregation Inhibitors administration & dosage, Pulmonary Disease, Chronic Obstructive epidemiology, Ticagrelor administration & dosage
Abstract

Aims: To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence., Methods and Results: This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21-3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm., Conclusion: In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected., Clinical Trial Registration Unique Identifier: NCT01813435., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Published
2020
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