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1. Complete 2-Year Results Confirm Bayesian Analysis of the SURTAVI Trial

Author

Sorajja, Paul, Sun, Benjamin, Agarwal, Himanshu, Langdon, Thomas, den Heijer, Peter, Bentala, Mohamed, O’Hair, Daniel, Bajwa, Tanvir, Byrne, Timothy, Caskey, Michael, Paulus, Basil, Garrett, Edward, Jr., Stoler, Robert, Hebeler, Robert, Popma, Jeffrey J., Khabbaz, Kamal, Lim, David Scott, Bladergroen, Mark, Fail, Peter, Feinberg, Edgar, II, Rinaldi, Michael, Skipper, Eric, Chawla, Atul, Hockmuth, David, Makkar, Raj, Cheng, Wen, Kodali, Susheel, George, Isaac, Aji, Janah, Bowen, Frank, Schreiber, Theodore, Henry, Scott, Hengstenberg, Christian, Bleiziffer, Sabine, Harrison, J. Kevin, Hughes, Chad, Joye, James, Gaudiani, Vincent, Babaliaros, Vasilis, Thourani, Vinod, van Mieghem, Nicolas, Kappetein, A. Pieter, Dauerman, Harold, Schmoker, Joseph, Skelding, Kimberly, Casale, Alfred, Kovac, Jan, Spyt, Tomasz, Seshiah, Puvi, Smith, J. Michael, McKay, Raymond, Hagberg, Robert, Matthews, Ray, Starnes, Vaughn, O’Neill, William, Paone, Gaetano, Hernandez García, Jose Maria, Such, Miguel, Morís de la Tassa, Cesar, Llosa Cortina, Juan Carlos, Windecker, Stephan, Carrel, Thierry, Whisenant, Brian, Doty, John, Resar, Jon, Conte, John, Aharonian, Vicken, Pfeffer, Thomas, Rück, Andreas, Corbascio, Matthias, Blackman, Daniel, Kaul, Pankaj, Kliger, Chad, Brinster, Derek, Teefy, Patrick, Kiaii, Bob, Leya, Ferdinand, Bakhos, Mamdouh, Sandhu, Gurpreet, Pochettino, Alberto, Piazza, Nicolo, de Varennes, Benoit, van Boven, Ad, Boonstra, Piet, Waksman, Ron, Bafi, Ammar, Asgar, Anita, Cartier, Raymond, Kipperman, Robert, Brown, John, Lin, Lang, Rovin, Joshua, Sharma, Samin, Adams, David, Katz, Stanley, Hartman, Alan, Al-Jilaihawi, Hasanian, Williams, Mathew, Crestanello, Juan, Lilly, Scott, Ghani, Mohammad, Bodenhamer, Robert Mark, Rajagopal, Vivek, Kauten, James, Mumtaz, Mumbashir, Bachinsky, Williams, Nickenig, Georg, Welz, Armin, Søndergaard, Lars, Olsen, Peter Skov, Yakubov, Steven, Watson, Daniel, Chhatriwalla, Adnan, Allen, Keith, Teirstein, Paul, Tyner, Jeffrey, Mahoney, Paul, Newton, Joseph, Merhi, William, Keiser, John, Yeung, Alan, Miller, Craig, ten Berg, Jurriën, Heijmen, Robin, Petrossian, George, Robinson, Newell, Brecker, Stephen, Jahangiri, Marjan, Davis, Thomas, Batra, Sanjay, Hermiller, James, Heimansohn, David, Radhakrishnan, Sam, Fremes, Stephen, Maini, Brijeshwar, Bethea, Brian, Brown, David, Ryan, William, Reardon, Michael, Kleiman, Neal, Spies, Christian, Lau, Jeffrey, Herrmann, Howard, Bavaria, Joseph, Horlick, Eric, Feindel, Chris, Neumann, Franz-Josef, Beyersdorf, Friedhelm, Binder, Roland, Maisano, Francesco, Costa, Marco, Markowitz, Alan, Tadros, Peter, Zorn, George, III, de Marchena, Eduardo, Salerno, Tomas, Chetcuti, Stanley, Deeb, G. Michael, Labinz, Marino, Ruel, Marc, Sup Lee, Joon, Gleason, Thomas, Ling, Frederick, Knight, Peter, Robbins, Mark, Ball, Stephen, Giacomini, John, Burdon, Thomas, Applegate, Robert, Kon, Neal, Schwartz, Richard, Schubach, Scott, Forrest, John, Mangi, Abeel, Van Mieghem, Nicolas M., Yakubov, Steven J., Serruys, Patrick W., Mumtaz, Mubashir, Gada, Hemal, Kleiman, Neal S., Oh, Jae K., Kappetein, Arie Pieter, Chang, Yanping, Mugglin, Andrew S., and Reardon, Michael J.

Published
2020
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2. Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry)

Author

Hernández-Enriquez, Marco, Andrea, Rut, Brugaletta, Salvatore, Jiménez-Quevedo, Pilar, Hernández-García, José María, Trillo, Ramiro, Larman, Mariano, Fernández-Avilés, Francisco, Vázquez-González, Nicolás, Iñiguez, Andrés, Zueco, Javier, Ruiz-Salmerón, Rafael, del Valle, Raquel, Molina, Eduardo, García del Blanco, Bruno, Berenguer, Alberto, Valdés, Mariano, Moreno, Raúl, Urbano-Carrillo, Cristóbal, Hernández-Antolín, Rosana, Gimeno, Federico, Cequier, Ángel, Cruz, Ignacio, López-Mínguez, José Ramón, Aramendi, José Ignacio, Sánchez, Ángel, Goicolea, Javier, Albarrán, Agustín, Díaz, José Francisco, Navarro, Felipe, Moreu, José, Morist, Andrés, Fernández-Nofrerías, Eduard, Fernández-Vázquez, Felipe, Ten, Francisco, Mainar, Vicente, Mari, Belén, Saenz, Alberto, Alfonso, Fernando, Diarte, José Antonio, Sancho, Manuel, Lezáun, Román, Arzamendi, Dabit, and Sabaté, Manel

Published
2016
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3. Effect of Pre-Hospital Ticagrelor During the First 24 h After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction: The ATLANTIC-H24 Analysis

Author

Bougherbal, Rachid, Bouafia, Mohamed Tahar, Chettibi, Mohamed, Nibouche, Djamaleddine, Moklati, Abdelkader, Benalia, Ahmed, Kaid, Omar, Krim, Messaad, Hammett, Christopher, Garrahy, Paul, Jayasinghe, Rohan, Rashford, Stephen, Huber, Kurt, Neunteufl, Thomas, Brussee, Helmut, Alber, Hannes, Weidinger, Franz, Brunner, Michael, Sipoetz, Johann, Prause, Gerhard, Baubin, Michael, Sebald, Dieter, Cantor, Warren, Vijayaraghavan, Ram, Bata, Iqbal, Lavoie, Andrea, Lassen, Jens Flensted, Ravkilde, Jan, Jensen, Lisette Okkels, Christensen, Alf Møl, Toftegaard, Marianne, Köhler, Dennis, Montalescot, Gilles, Ducrocq, Gregory, Danchin, Nicolas, Henry, Patrick, Livarek, Bernard, Berthier, Romain, Hovasse, Thomas, Garot, Philippe, Payot, Laurent, Benamer, Hakim, Esteve, Jean Baptiste, Elhadad, Simon, Teiger, Emmanuel, Bonnet, Jean Louis, Paganelli, Franck, Cottin, Yves, Schiele, François, Thuaire, Christophe, Cayla, Guillaume, Coste, Pierre, Ohlmann, Patrick, Cudraz, Eric Bonnefoy, Lantelme, Pierre, Perret, Thibault, Tron, Christophe, De Labriolle, Axel, Aptecar, Edouardo, Beliard, Olivier, Varenne, Olivier, El Mahmoud, Rami, Filippi-Codaccioni, Emmanuelle, Angoulvant, Denis, Peycher, Patrick, Poitrineau, Olivier, Tabone, Xavier, Ecollan, Patrick, Broche, Claire, Lambert, Yves, Briole, Nicolas, Beruben, Arielle, Porcher, Nicolas, Auffray, Jean-Pierre, Freysz, Marc, Depardieu, Franck, Poubel, David, De La Cousaye, Jean-Emmanuel, Bartier, Jean-Claude, Jardel, Benoît, Boulanger, Bertrand, Labourel, Hervé, Soulat, Louis-Christophe, Lapostolle, Frédéric, Julie, Véronique, Thicoipe, Michel, Capel, Olivier, Stibbe, Olivier, Carli, Pierre, Tazarourte, Karim, Alcouffe, Fabrice, Aboucaya, David, Aubert, Gaële, Kierzek, Gérald, Cahun-Giraud, Séverine, Zeymer, Uwe, Hamm, Christian, Dengler, Thomas, Prondzinsky, Roland, Biever, Paul Marc, Schäfer, Andreas, Seyfarth, Melchior, Lemke, Bernd, Werner, Gerald, Nef, Holger, Steiger, Holger, Leschke, Matthias, Münzel, Thomas, Dell Orto, Marco Campo, Loges, Christian, Schinke, Monika, Koberne, Frank, Reiffen, Hans Peter, Tiroch, Klaus, Wierich, Dirk, Kneussel, Michael, Little, Simon, Sauer, Hartmut, Laufenberg-Feldmann, Rita, Merkely, Béla, Ungi, Imre, Horváth, Iván, Édes, István, Mártai, István, Bolognese, Leonardo, Berti, Sergio, Chiarella, Francesco, Calabria, Paolo, Fineschi, Massimo, Galvani, Marcello, Valgimigli, Marco, Moretti, Luciano, Tespili, Maurizio, Mandó, Massimo, Bermano, Francesco, Biagioni, Robusto, Fabbri, Andrea, Ricciardelli, Adelina, Petroni, Maria Romana, Vatteroni, Umberto Roberto, Palumbo, Francesco, Willems, Frank F., Al Mafragi, Amar, Heestermans, Ton A.A.C.M., Van Eck, Martijn J., Heutz, Wim M.J.M., Meppelder, H.H., Jong, Anika Roukema-de, Van de Pas, Harm, Fillat, Ángel Cequier, Tenas, Manel Sabaté, Ferrer, Josepa Mauri, Peñaranda, Antoni Serra, Ferrer, Joan Ángel, Del Blanco, Bruno García, Guardiola, Faustino Miranda, Ruiz Nodar, Juan Miguel, Romo, Andrés Íñiguez, González, Nicolás Vázquez, Nouche, Ramiro Trillo, De La Llera, Luis Díaz, Hernández García, José María, Rivero-Crespo, Fernando, Hernández, Felipe Hernández, Zamorano Gómez, José Luis, Fárega, Xavier Jiménez, Fernández, Gilberto Alonso, Toboso, José Luis, Carrasco, Mercedes, Barreiro, Victoria, Iglesias Vázquez, José Antonio, Montero, María del Mar Ruiz, Ortiz, Fernando Rosell, Escudero, Guillermo Garcia, Ingelmo, Vicente Sánchez-Brunete, García, Antonio Lara, Janzon, Magnus, Oldgren, Jonas, Calais, Fredrik, Kastberg, Robert, Bergsten, Per-Adolf, Blomberg, Hans, Thörn, Kristian, Skoog, Gunnar, Storey, Robert F., Zaman, Azfar, Gerber, Robert, Ryding, Alisdair, Spence, Mark, Swanson, Neil, Been, Martin, Grosser, Konrad, Schofield, Peter, Mackin, David, Fell, Paul, Quinn, Tom, Foster, Teresa, McManus, David, Carson, Andy, van ’t Hof, Arnoud W., Cantor, Warren J., Cequier, Angel, Collet, Jean-Philippe, Goodman, Shaun G., Hammett, Christopher J., Licour, Muriel, Salhi, Néjoua, Silvain, Johanne, ten Berg, Jurriën M., Tsatsaris, Anne, Vicaut, Eric, and Hamm, Christian W.

Published
2016
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4. 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, Wijns, W. i. l. l. i. a. m. Collaborators Clinical investigators, Dens, sites Belgium: Ziekenhuis Oost Limburg: J., Dupont, M., Mullens, W., Janssens, M., Dolatabadi, Hoˆpital Civil de Charleroi: D., De Bruyne, Y., Lalmand, J., Dubois, P., El Nakadi, B., Aminian, A., De Vuyst, E., Gurnet, P., Gujic, M., Blankoff, I., Guedes, CHU Mont Godinne UCL: A., Gabriel, L., Seldrum, S., Doyen, C., Andre´, M., Heyse, AZ Glorieux: A., Van Durme, F., Verschuere, J., Legrand, Domaine Universitaire du Sart Tilman: V., Gach, O., D’Orio, V., Davin, L., Lancellotti, P., Baudoux, E., Ancion, A., Dulgheru, R., Vanderheyden, OLV Ziekenhuis Aalst – Cardiologie: M., Bartunek, J., Wijns, W., Verstreken, S., Penicka, . M., Gelev, P. Meeus Bulgaria: Tokuda Hospital Sofia: V., Zheleva Kichukova, I., Parapunova, R., Melamed, R., Sardovski, S., Radev, O., Yordanov, A., Radinov, A., Nenov, D., Amine, I., Petrov, City Hospital Clinic Cardiology Center: I., Kichukov, K., Nikitasov, L., Stankov, Z., Stoyanov, H., Tasheva Dimitrova, I., Angelova, M., Dimitrov, E., Minchev, M., Garvanski, I., Botev, C., Polomski, P., Alexandrovska University Hospital, Vassilev, Sofia: D., Karamfiloff, K., Tarnovska Kadreva, R., Vladimirova, L., Dimitrov, G., Hadzhiev, E., Tzvetkova, G., Andreka, . M. Atanasova Hungary: Gottsegen Gyo¨ rgy Orszagos Kardiologiai Inte´zet: P., Fontos, G., Fabian, J., Csepregi, A., Uzonyi, G., Gelei, A., Edes, Debreceni Egyetem Orvos e´s Ege´szse´gtudomanyi Centrum Altalanos Orvostudomanyi Kar Kardiologia Inte´zet: I., Balogh, L., Vajda, G., Darago, A., Gergely, S., Fulop, T., Jenei, C., Horvath, Pe´csi Tudomanyegyetem Klinikai Ko¨zpont Szıvgyogyaszati Klinika: I., Magyari, B., Nagy, A., Cziraki, A., Faludi, R., Kittka, B., Alizadeh, H., Merkely, Semmelweis Egyetem Varosmajori Szıv e´s Ergyogyaszati Klinika: B., Geller, L., Farkas, P., Szombath, G., Foldes, G., Skopal, J., Kovacs, A., Kosztin, A., Gara, E., Sydo, N., Nyolczas, MH Ege´szse´gu¨gyi Ko¨zpont Kardiologiai Osztaly: N., Kerecsen, G., Korda, A., Kiss, . M., Borsanyi, T., Polgar, B., Muk, B., Sharif, Z. Bari Ireland: HRB Clinical Research Facility: F., Atar, Y. M. Smyth Israel:Western Galilee Hospital: S., Shturman, A., Akria, L., Kilimnik, M., Brezins, M., Halabi, Ziv Medical Center: M., Dally, N., Goldberg, A., Aehab, K., Rosenfeld, I., Levinas, T., Saleem, D., Katz, Barzilai Medical Center: A., Plaev, T., Drogenikov, T., Nemetz, A., Barshay, Y., Jafari, J., Orlov, I., Nazareth Hospital EMMS: M. Omory, N. Kogan Nielsen, Shochat, Hillel Yaffe Medical Center: M., Shotan, A., Frimerman, A., Meisel, S., Asif, A., Sofer, O., Blondheim, D. S., Vazan, A., Metra, L. Arobov Italy: A. O. Spedali Civili di Brescia: M., Bonadei, I., Inama, L., Chiari, E., Lombardi, C., Magatelli, M., Russo, D., Lazzarini, V., Carubelli, V., Vassanelli, AOUI Verona – Borgo Trento Hospital: C., Ribichini, Flavio Luciano, Bergamini, C., Krampera, Mauro, Cicoria, M. A., Zanolla, L., Dalla Mura, D., Gambaro, A., Rossi, A., Pesarini Poland: Jagiellonian University Department of Cardiac, G., Musialek, Vascular Diseases at John Paul II Hospital in Krakow: P., Mazurek, A., Drabik, L., Ka˛dzielski, A., Walter, Z., Dzieciuch Rojek, M., Rubis, P., Plazak, . W., Tekieli, L., Podolec, J., Orczyk, W., Sutor, U., Zmudka, K., Olszowska, M., Podolec, P., Gruchala, Uniwersyteckie Centrum Kliniczne: M., Ciecwierz, D., Mielczarek, M., Burakowski, S., Chmielecki, M., Zielinska, M., Frankiewicz, A., Wdowczyk, J., Stopczynska, I., Bellwon, J., Mosakowska, K., Nadolna, R., Wroblewska, J., Rozmyslowska, M., Rynkiewicz, M., Marciniak, I., Raczak, G., Tarnawska, M., Taszner, M., Kasprzak, Bieganski Hospital: J., Plewka, M., Fiutowska, D., Rechcinski, T., Lipiec, P., Sobczak, M., Weijner Mik, P., Wraga, M., Krecki, R., Markiewicz, M., Haval Qawoq, D., Wojakowski, Gornosla˛skie Centrum Medyczne Sla˛skie j. Akademii Medycznej: W., Ciosek, J., Dworowy, S., Gaszewska Zurek, E., Ochala, A., Cybulski, W., Jadczyk, T., Wanha, W., Parma, Z., Kozlowski, M., Dzierzak, M., Markiewicz Serbia: Clinical Hospital Center Zvezdara, M., Arandjelovic, Cardiology Clinic: A., Sekularac, N., Boljevic, D., Bogdanovic, A., Zivkovic, S., Cvetinovic, N., Loncar, G., Clinical Centre of Serbia, Beleslin, Cardiology Clinic: B., Nedeljkovic, M., Trifunovic, D., Giga, V., Banovic, M., Nedeljkovic, I., Stepanovic, J., Vukcevic, V., Djordjevic Dikic, A., Dobric, M., Obrenovic Kircanski, B., Seferovic, Cardiology Clinic: P., Orlic, D., Tesic, M., Petrovic, O., Milinkovic, I., Simeunovic, D., Jagic, Clinical Center of Kragujevac: N., Tasic, M., Nikolic, D., Miloradovic, V., Djurdjevic, P., Sreckovic, M., Zornic, N., Clinical Hospital Center Bezanijska Kosa, Radovanovic, Cardiology Department: S., Saric, J., Hinic, S., Djokovic, A., Ðordevic, S., Bisenic, V., Markovic, O., Stamenkovic, S., Malenkovic, V., Tresnjak, J., Misic, G., Cotra, D., Tomovic, L., Vuckovic, V., Clinic of Emergency Internal Medicine, Obradovic, Military Medical Academy: S., Jovic, Z., Vukotic, S., Markovic, D., Djenic, N., Ristic Andjelkov, A., Bayes Genis, D. Ljubinka Spain: Hospital Universitario Germans Trias I. Pujol: A., Rodriguez Leor, O., Labata, C., Vallejo, N., Ferrer, E., Batlle, M., Fernandez Aviles, Hospital General Universitario Gregorio Mara~non: F., Sanz Ruiz, R., Casado, A., Loughlin, G., Zatarain, E., Anguita, J., Ferna ndez Santos, M. E., Pascual, C., Bermejo, J., Hernandez Garcia, Hospital Clinico Universitario Virgen de la Victoria: J. M., Jimenez Navarro, M., Dominguez, A., Carrasco, F., Mu~noz, A., Garcia Pinilla, J. M., Ruiz, J., Queipo de Llano, M. P., Hernandez, A., Fernandez, A., Jimenez Quevedo, Hospital Clinico San Carlos: P., Guerra, R., Biagioni, C., Gonzalez, R. A., Gomez deDiego, J. J., Mansson Broberg, L. Perez de Isla Sweden: Karolinska University Hospital: A., Sylve´n, C., Leblanc, K., Winter, R., Blomberg, P., Gunyeli, E., Ruck, A., Silva, C., Fo¨rstedt Switzerland: CardioCentro Ticino, J., Moccetti, Switzerland: T., Rossi, M., Pasotti, E., Petrova, I., Crljenica, C., Monti, C., Murzilli, R., Su¨rder, D., Moccetti, M., Turchetto, L., Locicero, V., Chiumiento, L., Maspoli, S., Mombelli, M., Anesini, A., Biggiogero, M., Ponti, G., Camporini, C., Polledri, S., Hill, G. Dolci United Kingdom: Kings College Hospital: J., Plymen, C., Amin Youssef, G., Mcdonagh, T., Drasar, E., Mijovic, A., Jouhra, F., Mcloman, D., Dworakowski, R., Webb, I., Byrne, J., and Potter, V.

Subjects
0301 basic medicine, Male, Cardiopoiesis, Cardiovascular disease, Disease severity, Marker, Precision medicine, Regenerative medicine, Stem cell, Target population, Adult, Aged, Double-Blind Method, Female, Heart Failure, Humans, Mesenchymal Stem Cell Transplantation, Middle Aged, Myocardial Ischemia, Prospective Studies, Treatment Outcome, Young Adult, Cardiology and Cardiovascular Medicine, Cell- and Tissue-Based Therapy, mesenchymal stem-cells, 030204 cardiovascular system & hematology, Cardiorespiratory Medicine and Haematology, outcomes, Fast-Track Clinical Research, Sudden cardiac death, 0302 clinical medicine, Ischemia, cardiovascular disease, Clinical endpoint, target population, CHART Program, Ejection fraction, bone-marrow, Heart Failure/Cardiomyopathy, 3. Good health, Cohort, Cardiology, Fast Track, disease severity, delivery, medicine.medical_specialty, precision medicine, Clinical Sciences, regenerative medicine, 03 medical and health sciences, cardiopoiesis, Internal medicine, medicine, Adverse effect, marker, disease, business.industry, medicine.disease, mortality, Confidence interval, Clinical trial, stem cell, Editor's Choice, 030104 developmental biology, predictors, Cardiovascular System & Hematology, Heart failure, business
Abstract

Altres ajuts: This work was supported by Celyad, SA (Mont-Saint-Guibert, Belgium). Celyad has received research grants from the Walloon Region (Belgium, DG06 funding). Cardiopoietic 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. This 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. The 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

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

Author

Bartunek J, Terzic A, Davison BA, Filippatos GS, Radovanovic S, Beleslin B, Merkely B, Musialek P, Wojakowski W, Andreka P, Horvath IG, Katz A, Dolatabadi D, El Nakadi B, Arandjelovic A, Edes I, Seferovic PM, Obradovic S, Vanderheyden M, Jagic N, Petrov I, Atar S, Halabi M, Gelev VL, Shochat MK, Kasprzak JD, Sanz-Ruiz R, Heyndrickx GR, Nyolczas N, Legrand V, Guédès A, Heyse A, Moccetti T, Fernandez-Aviles F, Jimenez-Quevedo P, Bayes-Genis A, Hernandez-Garcia JM, Ribichini F, Gruchala M, Waldman SA, Teerlink JR, Gersh BJ, Povsic TJ, Henry TD, Metra M, Hajjar RJ, Tendera M, Behfar A, Alexandre B, Seron A, Stough WG, Sherman W, Cotter G, and Wijns W

Subjects
Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Prospective Studies, Treatment Outcome, Young Adult, Heart Failure therapy, Mesenchymal Stem Cell Transplantation methods, Myocardial Ischemia therapy
Abstract

Aims: Cardiopoietic 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 Results: This 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., Conclusion: The 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., (© The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Published
2017
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12. Causes of death in early MI survivors with persistent infarct artery occlusion: results from the Occluded Artery Trial (OAT).

Author

Lang IM, Forman SA, Maggioni AP, Ruzyllo W, Renkin J, Vozzi C, Steg PG, Hernandez-Garcia JM, Zmudka K, Jimenez-Navarro M, Sopko G, Lamas GA, and Hochman JS

Subjects
Adult, Aged, Aged, 80 and over, Angioplasty, Balloon, Coronary adverse effects, Cause of Death, Chi-Square Distribution, Coronary Angiography, Coronary Occlusion complications, Coronary Occlusion diagnostic imaging, Female, Heart Failure etiology, Heart Failure mortality, Heart Rupture, Post-Infarction etiology, Heart Rupture, Post-Infarction mortality, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction diagnostic imaging, Myocardial Infarction etiology, Proportional Hazards Models, Recurrence, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Angioplasty, Balloon, Coronary mortality, Coronary Occlusion mortality, Coronary Occlusion therapy, Myocardial Infarction mortality, Myocardial Infarction therapy, Survivors
Abstract

Aims: OAT randomised patients with an occluded infarct artery three to 28 days after myocardial infarction (MI). The study demonstrated that PCI did not reduce the occurrence of the primary composite endpoint of death, re-MI, and New York Heart Association class IV heart failure in comparison with patients assigned to optimal medical therapy alone (MED). In view of prior literature in similar cohorts showing fewer sudden cardiac deaths and less left ventricular (LV) remodelling, but excess re-MI with PCI, causes of death were analysed in more detail., Methods and Results: Stepwise Cox regression was used to examine baseline variables associated with causes of death. The immediate and primary cause of death did not differ between 1,101 PCI and 1,100 MED patients. One-year cardiovascular death rates were 3.8% for the PCI group, and 3.7% for the MED group, and 0.9% per year for the next four years in both groups. Five of six cases of cardiac rupture occurred in patients undergoing PCI., Conclusions: In stable post-MI patients with occlusion of the infarct-related artery, PCI did not change the rate or cause of death. The observation that the majority of cardiac ruptures occurred in patients undergoing PCI deserves further investigation.

Published
2009
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