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2. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial
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Ray, K, Colhoun, H, Szarek, M, Baccara-Dinet, M, Bhatt, D, Bittner, V, Budaj, A, Diaz, R, Goodman, S, Hanotin, C, Harrington, R, Jukema, J, Loizeau, V, Lopes, R, Moryusef, A, Murin, J, Pordy, R, Ristic, A, Roe, M, Tunon, J, White, H, Zeiher, A, Schwartz, G, Steg, P, Tricoci, P, Mahaffey, K, Edelberg, J, Lecorps, G, Sasiela, W, Tamby, J, Aylward, P, Drexel, H, Sinnaeve, P, Dilic, M, Gotcheva, N, Prieto, J, Yong, H, Lopez-Jaramillo, P, Pecin, I, Reiner, Z, Ostadal, P, Viigimaa, M, Nieminen, M, Chumburidze, V, Marx, N, Danchin, N, Liberopoulos, E, Montenegro Valdovinos, P, Tse, H, Kiss, R, Xavier, D, Zahger, D, Valgimigli, M, Kimura, T, Kim, H, Kim, S, Erglis, A, Laucevicius, A, Kedev, S, Yusoff, K, Ramos Lopez, G, Alings, M, Halvorsen, S, Correa Flores, R, Morais, J, Dorobantu, M, Karpov, Y, Chua, T, Fras, Z, Dalby, A, de Silva, H, Hagstrom, E, Landmesser, U, Chiang, C, Sritara, P, Guneri, S, Parkhomenko, A, Moriarty, P, Vogel, R, Chaitman, B, Kelsey, S, Olsson, A, Rouleau, J, Simoons, 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S, Heidenreich, L, Offers, E, Gremmler, U, Killat, H, Rieker, W, Patsilinakos, S, Kartalis, A, Manolis, A, Sionis, D, Chachalis, G, Skoumas, I, Athyros, V, Vardas, P, Parthenakis, F, Alexopoulos, D, Hahalis, G, Lekakis, J, Hatzitolios, A, Fausto Ovando, S, Arango Benecke, J, Rodriguez De Leon, E, Yan, B, Siu, D, Turi, T, Merkely, B, Ungi, I, Lupkovics, G, Nagy, L, Katona, A, Edes, I, Muller, G, Horvath, I, Kapin, T, Szigeti, Z, Falukozy, J, Kumbla, M, Sandhu, M, Annam, S, Proddutur, N, Regella, R, Premchand, R, Mahajan, A, Pawar, S, Abhyanakar, A, Kerkar, P, Govinda, R, Oomman, A, Sinha, D, Patil, S, Kahali, D, Sawhney, J, Joshi, A, Chaudhary, S, Harkut, P, Guha, S, Porwal, S, Jujjuru, S, Pothineni, R, Monteiro, M, Khan, A, Iyengar, S, Grewal, J, Chopda, M, Fulwani, M, Patange, A, Sachin, P, Chopra, V, Goyal, N, Shinde, R, Manakshe, G, Patki, N, Sethi, S, Munusamy, V, Karna, S, Thanvi, S, Adhyapak, S, Patil, C, Pandurangi, U, Mathur, R, Gupta, J, Kalashetti, S, Bhagwat, A, Raghuraman, 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Y., Tang I-Shing J., Micko K., Nociar J., Pella D., Fulop P., Hranai M., Palka J., Mazur J., Majercak I., Dzupina A., Fazekas F., Gonsorcik J., Bugan V., Selecky J., Kamensky G., Strbova J., Smik R., Dukat A., Zuran I., Poklukar J., Cernic Suligoj N., Cevc M., Cyster H. P., Ranjith N., Corbett C., Bayat J., Makotoko E. M., du Toit Theron H., Kapp I. E., de V Basson M. M., Lottering H., Van Aswegen D., Van Zyl L. J., Sebastian P. J., Pillay T., Saaiman J. A., Commerford P. J., Cassimjee S., Riaz G., Ebrahim I. O., Sarvan M., Mynhardt J. H., Reuter H., Moodley R., Vida M., Cequier Fillat A. R., Bodi Peris V., Fuentes Jimenez F., Marin F., Cruz Fernandez J. M., Hidalgo Urbano R. J., Gil-Extremera B., Toledo P., Worner Diz F., Garcia-Dorado D., Iniguez A., Gonzalez-Juanatey J. R., Fernandez Portales J., Civeira Murillo F., Matas Pericas L., Zamorano J. L., De Mora Martin M., Bruguera Cortada J., Alonso Martin J. J., Serrano Antolin J. M., De Berrazueta Fernandez J. R., Vazquez de Prada J. A., Diaz Fernandez J. F., Garcia Lledo J. A., Cosin Sales J., Botas Rodriguez J., Gusi Tragant G., Benedicto A., Gonzalez-Juanatey C., Camprubi Potau M., Plaza Perez I., De La Tassa C. M., Loma-Osorio Rincon P., Balaguer Recena J., Escudier J. M., Payeras A. C., Alonso Orcajo N., Valdivielso P., Constantine G., Haniffa R., Tissera N., Amarasekera S., Ponnamperuma C., Fernando N., Fernando K., Jayawardena J., Wijeyasingam S., Ranasinghe G., Ekanayaka R., Mendis S., Senaratne V., Mayurathan G., Sirisena T., Rajapaksha A., Herath J. I., Amarasena N., Berglund S., Rasmanis G., Vedin O., Witt N., Mourtzinis G., Nicol P., Hansen O., Romeo S., Agergaard Jensen S., Torstensson I., Ahremark U., Sundelin T., Moccetti T., Muller C., Mach F., Binde R., Tsai W. -C., Ueng K. -C., Lai W. -T., Liu M. -E., Hwang J. -J., Yin W. -H., Hsieh I. -C., Hsieh M. -J., Lin W. H., Kuo J. -Y., Huang T. -Y., Fang C. -Y., Kaewsuwanna P., Soonfuang W., Jintapakorn W., Sukonthasarn A., Wongpraparut N., Sastravaha K., Sansanayudh N., Kehasukcharoen W., Piyayotai D., Chotnoparatpat P., Camsari A., Kultursay H., Mutlu B., Ersanli M., Demirtas M., Kirma C., Ural E., Koldas L., Karpenko O., Prokhorov A., Vakaluyk I., Myshanych H., Reshotko D., Batushkin V., Rudenko L., Kovalskyi I., Kushnir M., Tseluyko V., Mostovoy Y., Stanislavchuk M., Kyiak Y., Karpenko Y., Malynovsky Y., Klantsa A., Kutniy O., Amosova E., Tashchuk V., Leshchuk O., Rishko M., Kopytsya M., Yagensky A., Vatutin M., Bagriy A., Barna O. M., Ushakov O., Dzyak G., Goloborodko B., Rudenko A., Zheleznyy V., Trevelyan J., Zaman A., Lee K., Moriarty A., Aggarwal R. K., Clifford P., Wong Y. -K., Iqbal S. M., Subkovas E., Braganza D., Sarkar D., Storey R., Griffiths H., McClure S., Muthusamy R., Smith S., Kurian J., Levy T., Barr C., Kadr H., Gerber R., Simaitis A., Soran H., Mathur A., Brodison A., Ayaz M., Cheema M., Oliver R., Thackray S., Mudawi T., Rahman G., Sultan A., Sharman D., Sprigings D., Butler R., Wilkinson P., Lip G. Y., Halcox J., Gallagher S., Ossei-Gerning N., Vardi G., Baldari D., Brabham D., Treasure II C., Dahl C., Palmer B., Wiseman A., Puri S., Mohart A. E., Ince C., Flores E., Wright S., Cheng S. -C., Rosenberg M., Rogers W., Kosinski E., Forgosh L., Waltman J., Khan M., Shoukfeh M., Dagher G., Cambier P., Lieber I., Kumar P., East C., Krichmar P., Hasan M., White L., Knickelbine T., Haldis T., Gillespie E., Amidon T., Suh D., Arif I., Abdallah M., Akhter F., Carlson E., D'Urso M., El-Ahdab F., Nelson W., Moriarty K., Harris B., Cohen S., Carter L., Doty D., Sabatino K., Haddad T., Malik A., Rao S., Mulkay A., Jovin I., Klancke K., Malhotra V., Devarapalli S. K., Koren M., Chandna H., Dodds III G., Goraya T., Bengston J., Janik M., Moran J., Sumner A., Kobayashi J., Davis W., Yazdani S., Pasquini J., Thakkar M., Vedere A., Leimbach W., Rider J., Fenton S., Singh N., Shah A. V., Janosik D., Pepine C., Berman B., Gelormini J., Daniels C., Richard K., Keating F., Kondo N. I., Shetty S., Levite H., Waider W., Takata T., Abu-Fadel M., Shah V., Aggarwal R., Izzo M., Kumar A., Hattler B., Do R., Link C., Bortnick A., Kinzfogl III G., Ghitis A., Larry J., Teufel E., Kuhlman P., Mclaurin B., Zhang W., Thew S., Abbas J., White M., Islam O., Subherwal S., Ranadive N., Vakili B., Gring C., Henderson D., Schuchard T., Farhat N., Kline G., Mahal S., Whitaker J., Speirs S., Andersen R., Daboul N., Horwitz P., Zahr F., Ponce G., Jafar Z., Mcgarvey J., Panchal V., Voyce S., Blok T., Sheldon W., Azizad M. M., Schmalfuss C., Picone M., Pederson R., Herzog W., Friedman K., Lindsey J., Nowins R., Timothy E., Leonard P., Lepor N., El Shahawy M., Weintraub H., Irimpen A., Alonso A., May W., Christopher D., Galski T., Chu A., Mody F., Ramin E., Hodes Z., Rossi J., Rose G., Fairlamb J., Lambert C., Raisinghani A., Abbate A., Vetrovec G., King M., Carey C., Gerber J., Younis L., Park H. T., Vidovich M., Knutson T., Friedman D., Chaleff F., Loussararian A., Rozeman P., Kimmelstiel C., Kuvin J., Silver K., Foster M., Tonnessen G., Espinoza A., Amlani M., Wali A., Malozzi C., Jong G. T., Massey C., Wattanakit K., O'Donnell P. J., Singal D., Jaffrani N., Banuru S., Fisher D., Xenakis M., Perlmutter N., Bhagwat R., Strader J., Blonder R., Akyea-Djamson A., Labroo A., Marais H. J., Claxton E., Weiss R., Kathryn R., Berk M., Rossi P., Joshi P., Khera A., Khaira A. S., Kumkumian G., Lupovitch S., Purow J., Welka S., Hoffman D., Fischer S., Soroka E., Eagerton D., Pancholy S., Ray M., Erenrich N., Farrar M., Pollock S., French W. J., Diamantis S., Guy D., Gimple L., Neustel M., Schwartz S., Pereira E., Albert S., Spriggs D., Strain J., Mittal S., Vo A., Chane M., Hall J., Vijay N., Lotun K., Lester F. M., Nahhas A., Pope T., Nager P., Vohra R., Sharma M., Bashir R., Ahmed H., Berlowitz M., Fishberg R., Barrucco R., Yang E., Radin M., Sporn D., Stapleton D., Eisenberg S., Landzberg J., Mcgough M., Turk S., Schwartz M., Sundram P. S., Jain D., Zainea M., Bayron C., Karlsberg R., Dohad S., Lui H., Keen W., Westerhausen D., Khurana S., Agarwal H., Birchem J., Penny W., Chang M., Murphy S., Henry J., Schifferdecker B., Gilbert J. M., Chalavarya G., Eaton C., Schmedtje J. F., Christenson S., Dotani I., Denham D., Macdonell A., Gibson P., Rahman A., Al Joundi T., Assi N., Conrad G., Kotha P., Love M., Giesler G., Rubenstein H., Gamil D., Akright L., Krawczyk J., Cobler J., Wells T., Welker J., Foster R., Gilmore R., Anderson J., Jacoby D., Gardner G., Dandillaya R., Vora K., Kostis J., Hunter J., Laxson D., Ball E., Lopes R., Egydio F., Kawakami A., Oliveira J., Wozniak J., Matthews A., Ratky C., Valiris J., Berdan L., Hepditch A., Quintero K., Rorick T., Westbrook M., Pascual A., Rovito C., Bezault M., Drouet E., Simon T., Alsweiler C., Luyten A., Butters J., Griffith L., Shaw M., Grunberg L., Islam S., Bregeault M. -F., Bougon N., Faustino D., Fontecave S., Murphy J., Verrier M., Agnetti V., Andersen D., Badreddine E., Bekkouche M., Bouancheau C., Brigui I., Brocklehurst M., Cianciarulo J., Devaul D., Domokos S., Gache C., Gobillot C., Guillou S., Healy J., Heath M., Jaiwal G., Javierre C., Labeirie J., Monier M., Morales U., Mrabti A., Mthombeni B., Okan B., Smith L., Sheller J., Sopena S., Pellan V., Benbernou F., Bengrait N., Lamoureux M., Kralova K., Scemama M., Bejuit R., Coulange A., Berthou C., Repincay J., Lorenzato C., Etienne A., Gouet V., Normand M., Ourliac A., Rondel C., Adamo A., Beltran P., Barraud P., Dubois-Gache H., Halle B., Metwally L., Mourgues M., Sotty M., Vincendet M., Cotruta R., Chengyue Z., Fournie-Lloret D., Morrello C., Perthuis A., Picault P., Zobouyan I., Dempsey M. 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P., Hominal M. A., Montana O. R., Caccavo A., Gomez Vilamajo O. A., Lorenzatti A. J., Cartasegna L. R., Paterlini G. A., Mackinnon I. J., Caime G. D., Amuchastegui M., Salomone O., Codutti O. R., Jure H. O., Bono J. O., Hrabar A. D., Vallejos J. A., Ahuad Guerrero R. A., Novoa F., Patocchi C. A., Zaidman C. J., Giuliano M. E., Dran R. D., Vico M. L., Carnero G. S., Guzman P. N., Medrano Allende J. C., Garcia Brasca D. F., Bustamante Labarta M. H., Nani S., Blumberg E. D., Colombo H. R., Liberman A., Fuentealba V., Luciardi H. L., Waisman G. D., Berli M. A., Garcia Duran R. O., Cestari H. G., Luquez H. A., Giordano J. A., Saavedra S. S., Zapata G., Costamagna O., Llois S., Waites J. H., Collins N., Soward A., Hii C. L., Shaw J., Arstall M. A., Horowitz J., Ninio D., Rogers J. F., Colquhoun D., Oqueli Flores R. E., Roberts-Thomson P., Raffel O., Lehman S. J., Aroney C., Coverdale S. G., Garrahy P. J., Starmer G., Sader M., Carroll P. A., Dick R., Zweiker R., Hoppe U., Huber K., Berger R., Delle-Karth G., Frey B., Weidinger F., Faes D., Hermans K., Pirenne B., Leone A., Hoffer E., Vrolix M. C., De Wolf L., Wollaert B., Castadot M., Dujardin K., Beauloye C., Vervoort G., Striekwold H., Convens C., Roosen J., Barbato E., Claeys M., Cools F., Terzic I., Barakovic F., Midzic Z., Pojskic B., Fazlibegovic E., Kulic M., Durak-Nalbantic A., Vulic D., Muslibegovic A., Goronja B., Reis G., Sousa L., Nicolau J. C., Giorgeto F. E., Silva R. P., Nigro Maia L., Rech R., Rossi P. R., Cerqueira M. J. A., Duda N., Kalil R., Kormann A., Abrantes J. A. M., Pimentel Filho P., Soggia A. P., de Santos M. O., Neuenschwander F., Bodanese L. C., Michalaros Y. L., Eliaschewitz F. G., Vidotti M. H., Leaes P. E., Botelho R. V., Kaiser S., Manenti E. R. F., Precoma D. B., Moura Jorge J. C., de B Silva P. G., Silveira J. A., Saporito W., Marin-Neto J. A., Feitosa G. S., Ritt L. E. F., de Souza J. A., Costa F., Souza W. K., Reis H. J., Machado L., Ayoub J. C. A., Todorov G. V., Nikolov F. P., Velcheva E. S., Tzekova M. L., Benov H. O., Petranov S. L., Tumbev H. S., Shehova-Yankova N. S., Markov D. T., Raev D. H., Mollov M. N., Kichukov K. N., Ilieva-Pandeva K. A., Ivanova R., Gospodinov M., Mincheva V. M., Lazov P. V., Dimov B. I., Senaratne M., Stone J., Kornder J., Pearce S., Dion D., Savard D., Pesant Y., Pandey A., Robinson S., Gosselin G., Vizel S., Hoag G., Bourgeois R., Morisset A., Sabbah E., Sussex B., Kouz S., MacDonald P., Diaz A., Michaud N., Fell D., Leung R., Vuurmans T., Lai C., Nigro F., Davies R., Nogareda G., Vijayaraghavan R., Ducas J., Lepage S., Mehta S., Cha J., Dupuis R., Fong P., Lutchmedial S., Rodes-Cabau J., Fadlallah H., Cleveland D., Huynh T., Bata I., Hameed A., Pincetti C., Potthoff S., Prieto J. C., Acevedo M., Aguirre A., Vejar M., Yanez M., Araneda G., Fernandez M., Perez L., Varleta P., Florenzano F., Huidobro L., Raffo C. A., Olivares C., Nahuelpan L., Montecinos H., Chen J., Dong Y., Huang W., Wang J., Huang S. A., Yao Z., Li X., Cui L., Lin W., Sun Y., Li J., Zhang X., Zhu H., Chen D., Huang L., Dong S., Su G., Xu B., Su X., Cheng X., Lin J., Zong W., Li H., Feng Y., Xu D., Yang X., Ke Y., Lin X., Zhang Z., Zheng Z., Luo Z., Chen Y., Ding C., Zhong Y., Zheng Y., Peng D., Zhao S., Li Y., Liu X., Wei M., Liu S., Yu Y., Qu B., Jiang W., Zhou Y., Zhao X., Yuan Z., Guo Y., Xu X., Shi X., Ge J., Fu G., Bai F., Fang W., Shou X., Wang J. A., Xiang M., Lu Q., Zhang R., Zhu J., Xu Y., Fan Z., Li T., Wu C., Jaramillo N., Sanchez Vallejo G., Luna Botia D. C., Botero Lopez R., Molina De Salazar D. I., Cadena Bonfanti A. J., Cotes Aroca C., Diego Higuera J., Blanquicett M., Barrera Silva S. I., Garcia Lozada H. J., Coronel Arroyo J. A., Accini Mendoza J. L., Fernandez Ruiz R. L., Quintero Ossa A. M., Manzur Jatin F. G., Sotomayor Herazo A., Castellanos Parada J., Suarez Arambula R., Urina Triana M. A., Fernandez Trujillo A. M., Strozzi M., Car S., Jeric M., Milicic D., Bencic M. L., Pintaric H., Prvulovic D., Sikic J., Persic V., Mileta D., Stambuk K., Babic Z., Tomulic V., Lukenda J., Mejic-Krstulovic S., Starcevic B., Spinar J., Horak D., Velicka Z., Stasek J., Alan D., Machova V., Linhart A., Novotny V., Kaucak V., Rokyta R., Naplava R., Coufal Z., Adamkova V., Podpera I., Zizka J., Motovska Z., Marusincova I., Svab P., Heinc P., Kuchar J., Povolny P., Matuska J., Poulsen S. H., Raungaard B., Clemmensen P., Bang L. E., May O., Bottcher M., Hove J. D., Frost L., Gislason G., Larsen J., Betton Johansen P., Hald F., Johansen P., Jeppesen J., Nielsen T., Kristensen K. S., Walichiewicz P. M., Lomholdt J. D., Klausen I. C., Nielsen P. K., Davidsen F., Videbaek L., Soots M., Vahula V., Hedman A., Soopold U., Martsin K., Jurgenson T., Kristjan A., Helsinki J. K., Vikman S., Huikuri H., Airaksinen J., Coste P., Ferrari E., Morel O., Montalescot G., Machecourt J., Barone-Rochette G., Mansourati J., Cottin Y., Leclercq F., Belhassane A., Delarche N., Boccara F., Paganelli F., Clerc J., Schiele F., Aboyans V., Probst V., Berland J., Lefevre T., Citron B., Khintibidze I., Shaburishvili T., Pagava Z., Ghlonti R., Lominadze Z., Khabeishvili G., Hemetsberger R., Edward K., Rauch-Krohnert U., Stratmann M., Appel K. -F., Schmidt E., Omran H., Stellbrink C., Dorsel T., Lianopoulos E., Vohringer H. F., Marx R., Zirlik A., Schellenberg D., Heitzer T., Laufs U., Werner C., Gielen S., Nuding S., Winkelmann B., Behrens S., Sydow K., Karakas M., Simonis G., Muenzel T., Werner N., Leggewie S., Bocker D., Braun-Dullaeus R., Toursarkissian N., Jeserich M., Weissbrodt M., Schaeufele T., Weil J., Voller H., Waltenberger J., Natour M., Schmitt S., Muller-Wieland D., Steiner S., Heidenreich L., Offers E., Gremmler U., Killat H., Rieker W., Patsilinakos S., Kartalis A., Manolis A., Sionis D., Chachalis G., Skoumas I., Athyros V., Vardas P., Parthenakis F., Alexopoulos D., Hahalis G., Lekakis J., Hatzitolios A., Fausto Ovando S. R., Arango Benecke J. L., Rodriguez De Leon E. R., Yan B. P., Siu D. C., Turi T., Merkely B., Ungi I., Lupkovics G., Nagy L., Katona A., Edes I., Muller G., Horvath I., Kapin T., Szigeti Z., Falukozy J., Kumbla M., Sandhu M., Annam S., Proddutur N. R., Regella R., Premchand R. K., Mahajan A., Pawar S., Abhyanakar A. D., Kerkar P., Govinda R. A., Oomman A., Sinha D., Patil S. N., Kahali D., Sawhney J., Joshi A. B., Chaudhary S., Harkut P., Guha S., Porwal S., Jujjuru S., Pothineni R. B., Monteiro M. R., Khan A., Iyengar S. S., Grewal J. S., Chopda M., Fulwani M. C., Patange A., Sachin P., Chopra V. K., Goyal N. K., Shinde R., Manakshe G. V., Patki N., Sethi S., Munusamy V., Karna S., Thanvi S., Adhyapak S., Patil C., Pandurangi U., Mathur R., Gupta J., Kalashetti S., Bhagwat A., Raghuraman B., Yerra S. K., Bhansali P., Borse R., Rahul P., Das S., Kumar V., Abdullakutty J., Saathe S., Palimkar P., Sathe S., Atar S., Shechter M., Mosseri M., Arbel Y., Ehud C., Ofer H., Lotan C., Rosenschein U., Katz A., Henkin Y., Francis A., Klutstein M., Nikolsky E., Zukermann R., Turgeman Y., Halabi M., Marmor A., Kornowski R., Jonas M., Amir O., Hasin Y., Rozenman Y., Fuchs S., Zvi V., Hussein O., Gavish D., Vered Z., Caraco Y., Elias M., Tov N., Wolfovitz E., Lishner M., Elias N., Piovaccari G., De Pellegrin A., Garbelotto R., Guardigli G., Marco V., Licciardello G., Auguadro C., Scalise F., Cuccia C., Salvioni A., Musumeci G., Senni M., Calabro P., Novo S., Faggiano P., Metra M., De Cesare N. B., Berti S., Cavallini C., Puccioni E., Galvani M., Tespili M., Piatti P., Palvarini M., De Luca G., Violini R., De Leo A., Olivari Z., Perrone Filardi P., Ferratini M., Racca V., Dai K., Shimatani Y., Kamiya H., Ando K., Takeda Y., Morino Y., Hata Y., Kimura K., Kishi K., Michishita I., Uehara H., Higashikata T., Hirayama A., Hirooka K., Doi Y., Sakagami S., Taguchi S., Koike A., Fujinaga H., Koba S., Kozuma K., Kawasaki T., Ono Y., Shimizu M., Katsuda Y., Wada A., Shinke T., Ako J., Fujii K., Takahashi T., Sakamoto T., Nakao K., Furukawa Y., Sugino H., Tamura R., Mano T., Uematsu M., Utsu N., Ito K., Haraguchi T., Sato K., Ueda Y., Nishibe A., Fujimoto K., Masutani M., Yoon J. H., Kim H. -L., Park H. S., Chae I. -H., Kim M. H., Jeong M. H., Rha S., Kim C., Kim H. -S., Kim H. Y., Hong T., Tahk S. -J., Kim Y., Busmane A., Pontaga N., Strelnieks A., Mintale I., Sime I., Petrulioniene Z., Kavaliauskiene R., Jurgaitiene R., Sakalyte G., Slapikas R., Norkiene S., Misonis N., Kibarskis A., Kubilius R., Bojovski S., Lozance N., Kjovkaroski A., Doncovska S., Ong T. K., Kasim S., Maskon O., Kandasamy B., Liew H. B., Wan Mohamed W. M. I., Garcia Castillo A., Carrillo Calvillo J., Fajardo Campos P., Nunez Fragoso J. C., Bayram Llamas E. A., Alcocer Gamba M. A., Carranza Madrigal J., Gonzalez Salas L. G., Lopez Rosas E., Gonzalez Diaz B., Salcido Vazquez E., Nacoud Ackar A., Llamas Esperon G. A., Martinez Sanchez C. R., Guerrero De Leon M., Suarez Otero R., Fanghanel Salmon G., Perez Rios J. A., Garza Ruiz J. A., Breedveld R. W., Feenema-Aardema M., Borger-Van Der Burg A., Hoogslag P. A., Suryapranata H., Oomen A., Van Haelst P., Wiersma J. J., Basart D., Van Der Wal R. M., Zwart P., Monraats P., Van Kesteren H., Karalis I., Jukema J., Verdel G. J., Brueren B. R., Troquay R. P., Viergever E. P., Al-Windy N. Y., Bartels G. L., Cornel J. H., Hermans W. R., Herrman J. P., Bos R. J., Groutars R. G., Van Der Zwaan C. C., Kaplan R., Lionarons R., Ronner E., Groenemeijer B. E., Bronzwaer P. N., Liem A. A., Rensing B. J., Bokern M. J., Nijmeijer R., Hersbach F. M., Willems F. F., Gosselink A. T., Rasoul S., Elliott J., Wilkins G., Fisher R., Scott D., Hart H., Stewart R., Harding S., Ternouth I., Fisher N., Wilson S., Aitken D., Anscombe R., Davidson L., Tomala T., Nygard O., Sparby J. A., Andersen K., Gullestad L., Jortveit J., Munk P. S., Singsaas E. G., Hurtig U., Calderon Ticona J. R., Durand Velasquez J. R., Negron Miguel S. A., Sanabria Perez E. S., Carrion Chambilla J. M., Chavez Ayala C. A., Castillo Leon R. P., Vargas Gonzales R. J., Hernandez Zuniga J. D., Camacho Cosavalente L. A., Bravo Mannucci J. E., Heredia Landeo J., Llerena Navarro N. C., Roldan Concha Y. M., Rodriguez Chavez V. E., Anchante Hernandez H. A., Zea Nunez C. A., Mogrovejo Ramos W., Ferrolino A., Sy R. A. G., Tirador L., Sy R. G., Matiga G., Coching R. M., Bernan A., Rogelio G., Morales D. D., Tan E., Sulit D. J., Wlodarczak A., Jaworska K., Skonieczny G., Pawlowicz L., Wojewoda P., Busz-Papiez B., Bednarski J., Goch A., Staneta P., Dulak E., Saminski K., Krasowski W., Sudnik W., Zurakowski A., Skorski M., Miklaszewicz B., Kubica J., Andrzej Lipko J., Kostarska-Srokosz E., Piepiorka M., Drzewiecka A., Stasiewski A., Blicharski T., Bystryk L., Szpajer M., Korol M., Czerski T., Mirek-Bryniarska E., Gniot J., Lubinski A., Gorny J., Franek E., Raczak G., Szwed H., Monteiro P., Mesquita Bastos J., Pereira H. H., Martins D., Seixo F., Mendonca C., Botelho A., Caetano F., Minescu B., Istratoaie O., Tesloianu D. N., Cristian G., Dumitrescu S., Podoleanu C. G., Constantinescu M. C., Bengus C. M., Militaru C., Rosu D., Parepa I. R., Matei A. V., Alexandru T. M., Malis M., Coman I., Stanescu-Cioranu R., Dimulescu D., Shvarts Y., Orlikova O., Kobalava Z., Barbarash O. L., Markov V., Lyamina N., Gordienko A., Zrazhevsky K., Vishnevsky A. Y., Gurevich V., Stryuk R., Lomakin N. V., Bokarev I., Khlevchuk T., Shalaev S., Khaisheva L., Chizhov P., Viktorova I., Osokina N., Shchekotov V., Akatova E., Chumakova G., Libov I., Voevoda M. I., Tretyakova T. V., Baranov E., Shustov S., Yakushin S., Gordeev I., Khasanov N., Reshetko O., Sotnikova T., Molchanova O., Nikolaev K., Gapon L., Baranova E., Shogenov Z., Kosmachova E., Povzun A., Egorova L., Tyrenko V. V., Ivanov I. G., Ilya M., Kanorsky S., Simic D., Ivanovic N., Davidovic G., Tasic N., Asanin M. R., Stojic S., Apostolovic S. R., Ilic S., Putnikovic Tosic B., Stankovic A., Arandjelovic A., Radovanovic S., Todic B., Balinovac J., Dincic D. V., Seferovic P., Karadzic A., Dodic S., Dimkovic S., Jakimov T., Poh K. -K., Ong H. Y., Tang I-Shing J., Micko K., Nociar J., Pella D., Fulop P., Hranai M., Palka J., Mazur J., Majercak I., Dzupina A., Fazekas F., Gonsorcik J., Bugan V., Selecky J., Kamensky G., Strbova J., Smik R., Dukat A., Zuran I., Poklukar J., Cernic Suligoj N., Cevc M., Cyster H. P., Ranjith N., Corbett C., Bayat J., Makotoko E. M., du Toit Theron H., Kapp I. E., de V Basson M. M., Lottering H., Van Aswegen D., Van Zyl L. J., Sebastian P. J., Pillay T., Saaiman J. A., Commerford P. J., Cassimjee S., Riaz G., Ebrahim I. O., Sarvan M., Mynhardt J. H., Reuter H., Moodley R., Vida M., Cequier Fillat A. R., Bodi Peris V., Fuentes Jimenez F., Marin F., Cruz Fernandez J. M., Hidalgo Urbano R. J., Gil-Extremera B., Toledo P., Worner Diz F., Garcia-Dorado D., Iniguez A., Gonzalez-Juanatey J. R., Fernandez Portales J., Civeira Murillo F., Matas Pericas L., Zamorano J. L., De Mora Martin M., Bruguera Cortada J., Alonso Martin J. J., Serrano Antolin J. M., De Berrazueta Fernandez J. R., Vazquez de Prada J. A., Diaz Fernandez J. F., Garcia Lledo J. A., Cosin Sales J., Botas Rodriguez J., Gusi Tragant G., Benedicto A., Gonzalez-Juanatey C., Camprubi Potau M., Plaza Perez I., De La Tassa C. M., Loma-Osorio Rincon P., Balaguer Recena J., Escudier J. M., Payeras A. C., Alonso Orcajo N., Valdivielso P., Constantine G., Haniffa R., Tissera N., Amarasekera S., Ponnamperuma C., Fernando N., Fernando K., Jayawardena J., Wijeyasingam S., Ranasinghe G., Ekanayaka R., Mendis S., Senaratne V., Mayurathan G., Sirisena T., Rajapaksha A., Herath J. I., Amarasena N., Berglund S., Rasmanis G., Vedin O., Witt N., Mourtzinis G., Nicol P., Hansen O., Romeo S., Agergaard Jensen S., Torstensson I., Ahremark U., Sundelin T., Moccetti T., Muller C., Mach F., Binde R., Tsai W. -C., Ueng K. -C., Lai W. -T., Liu M. -E., Hwang J. -J., Yin W. -H., Hsieh I. -C., Hsieh M. -J., Lin W. H., Kuo J. -Y., Huang T. -Y., Fang C. -Y., Kaewsuwanna P., Soonfuang W., Jintapakorn W., Sukonthasarn A., Wongpraparut N., Sastravaha K., Sansanayudh N., Kehasukcharoen W., Piyayotai D., Chotnoparatpat P., Camsari A., Kultursay H., Mutlu B., Ersanli M., Demirtas M., Kirma C., Ural E., Koldas L., Karpenko O., Prokhorov A., Vakaluyk I., Myshanych H., Reshotko D., Batushkin V., Rudenko L., Kovalskyi I., Kushnir M., Tseluyko V., Mostovoy Y., Stanislavchuk M., Kyiak Y., Karpenko Y., Malynovsky Y., Klantsa A., Kutniy O., Amosova E., Tashchuk V., Leshchuk O., Rishko M., Kopytsya M., Yagensky A., Vatutin M., Bagriy A., Barna O. M., Ushakov O., Dzyak G., Goloborodko B., Rudenko A., Zheleznyy V., Trevelyan J., Zaman A., Lee K., Moriarty A., Aggarwal R. K., Clifford P., Wong Y. -K., Iqbal S. M., Subkovas E., Braganza D., Sarkar D., Storey R., Griffiths H., McClure S., Muthusamy R., Smith S., Kurian J., Levy T., Barr C., Kadr H., Gerber R., Simaitis A., Soran H., Mathur A., Brodison A., Ayaz M., Cheema M., Oliver R., Thackray S., Mudawi T., Rahman G., Sultan A., Sharman D., Sprigings D., Butler R., Wilkinson P., Lip G. Y., Halcox J., Gallagher S., Ossei-Gerning N., Vardi G., Baldari D., Brabham D., Treasure II C., Dahl C., Palmer B., Wiseman A., Puri S., Mohart A. E., Ince C., Flores E., Wright S., Cheng S. -C., Rosenberg M., Rogers W., Kosinski E., Forgosh L., Waltman J., Khan M., Shoukfeh M., Dagher G., Cambier P., Lieber I., Kumar P., East C., Krichmar P., Hasan M., White L., Knickelbine T., Haldis T., Gillespie E., Amidon T., Suh D., Arif I., Abdallah M., Akhter F., Carlson E., D'Urso M., El-Ahdab F., Nelson W., Moriarty K., Harris B., Cohen S., Carter L., Doty D., Sabatino K., Haddad T., Malik A., Rao S., Mulkay A., Jovin I., Klancke K., Malhotra V., Devarapalli S. K., Koren M., Chandna H., Dodds III G., Goraya T., Bengston J., Janik M., Moran J., Sumner A., Kobayashi J., Davis W., Yazdani S., Pasquini J., Thakkar M., Vedere A., Leimbach W., Rider J., Fenton S., Singh N., Shah A. V., Janosik D., Pepine C., Berman B., Gelormini J., Daniels C., Richard K., Keating F., Kondo N. I., Shetty S., Levite H., Waider W., Takata T., Abu-Fadel M., Shah V., Aggarwal R., Izzo M., Kumar A., Hattler B., Do R., Link C., Bortnick A., Kinzfogl III G., Ghitis A., Larry J., Teufel E., Kuhlman P., Mclaurin B., Zhang W., Thew S., Abbas J., White M., Islam O., Subherwal S., Ranadive N., Vakili B., Gring C., Henderson D., Schuchard T., Farhat N., Kline G., Mahal S., Whitaker J., Speirs S., Andersen R., Daboul N., Horwitz P., Zahr F., Ponce G., Jafar Z., Mcgarvey J., Panchal V., Voyce S., Blok T., Sheldon W., Azizad M. M., Schmalfuss C., Picone M., Pederson R., Herzog W., Friedman K., Lindsey J., Nowins R., Timothy E., Leonard P., Lepor N., El Shahawy M., Weintraub H., Irimpen A., Alonso A., May W., Christopher D., Galski T., Chu A., Mody F., Ramin E., Hodes Z., Rossi J., Rose G., Fairlamb J., Lambert C., Raisinghani A., Abbate A., Vetrovec G., King M., Carey C., Gerber J., Younis L., Park H. T., Vidovich M., Knutson T., Friedman D., Chaleff F., Loussararian A., Rozeman P., Kimmelstiel C., Kuvin J., Silver K., Foster M., Tonnessen G., Espinoza A., Amlani M., Wali A., Malozzi C., Jong G. T., Massey C., Wattanakit K., O'Donnell P. J., Singal D., Jaffrani N., Banuru S., Fisher D., Xenakis M., Perlmutter N., Bhagwat R., Strader J., Blonder R., Akyea-Djamson A., Labroo A., Marais H. J., Claxton E., Weiss R., Kathryn R., Berk M., Rossi P., Joshi P., Khera A., Khaira A. S., Kumkumian G., Lupovitch S., Purow J., Welka S., Hoffman D., Fischer S., Soroka E., Eagerton D., Pancholy S., Ray M., Erenrich N., Farrar M., Pollock S., French W. J., Diamantis S., Guy D., Gimple L., Neustel M., Schwartz S., Pereira E., Albert S., Spriggs D., Strain J., Mittal S., Vo A., Chane M., Hall J., Vijay N., Lotun K., Lester F. M., Nahhas A., Pope T., Nager P., Vohra R., Sharma M., Bashir R., Ahmed H., Berlowitz M., Fishberg R., Barrucco R., Yang E., Radin M., Sporn D., Stapleton D., Eisenberg S., Landzberg J., Mcgough M., Turk S., Schwartz M., Sundram P. S., Jain D., Zainea M., Bayron C., Karlsberg R., Dohad S., Lui H., Keen W., Westerhausen D., Khurana S., Agarwal H., Birchem J., Penny W., Chang M., Murphy S., Henry J., Schifferdecker B., Gilbert J. M., Chalavarya G., Eaton C., Schmedtje J. F., Christenson S., Dotani I., Denham D., Macdonell A., Gibson P., Rahman A., Al Joundi T., Assi N., Conrad G., Kotha P., Love M., Giesler G., Rubenstein H., Gamil D., Akright L., Krawczyk J., Cobler J., Wells T., Welker J., Foster R., Gilmore R., Anderson J., Jacoby D., Gardner G., Dandillaya R., Vora K., Kostis J., Hunter J., Laxson D., Ball E., Lopes R., Egydio F., Kawakami A., Oliveira J., Wozniak J., Matthews A., Ratky C., Valiris J., Berdan L., Hepditch A., Quintero K., Rorick T., Westbrook M., Pascual A., Rovito C., Bezault M., Drouet E., Simon T., Alsweiler C., Luyten A., Butters J., Griffith L., Shaw M., Grunberg L., Islam S., Bregeault M. -F., Bougon N., Faustino D., Fontecave S., Murphy J., Verrier M., Agnetti V., Andersen D., Badreddine E., Bekkouche M., Bouancheau C., Brigui I., Brocklehurst M., Cianciarulo J., Devaul D., Domokos S., Gache C., Gobillot C., Guillou S., Healy J., Heath M., Jaiwal G., Javierre C., Labeirie J., Monier M., Morales U., Mrabti A., Mthombeni B., Okan B., Smith L., Sheller J., Sopena S., Pellan V., Benbernou F., Bengrait N., Lamoureux M., Kralova K., Scemama M., Bejuit R., Coulange A., Berthou C., Repincay J., Lorenzato C., Etienne A., Gouet V., Normand M., Ourliac A., Rondel C., Adamo A., Beltran P., Barraud P., Dubois-Gache H., Halle B., Metwally L., Mourgues M., Sotty M., Vincendet M., Cotruta R., Chengyue Z., Fournie-Lloret D., Morrello C., Perthuis A., Picault P., Zobouyan I., Dempsey M. A., and McClanahan M. A.
- Abstract
Background: After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1·4–1·8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes. Methods: ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1–12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1:1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0·65–1·30 mmol/L. In this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)—defined on the basis of patient history, review of medical records, or baseline HbA1c or fasting serum glucose—and risk of new-onset diabetes among those without diabetes at baseline. The primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring
- Published
- 2019
3. Tracking the migration of cardially delivered therapeutic stem cells in vivo: state of the art
- Author
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Nyolczas, N, Charwat, S, Posa, A, Hemetsberger, R, Pavo, N, Hemetsberger, H, Pavo, IJ, Glogar, D, Maurer, G, and Gyöngyösi, M
- Published
- 2009
- Full Text
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4. Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery
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MM, Schmalfuss, C, Picone, M, Herzog, W, Lindsey, J, Nowins, R, Lepor, N, El Shahawy, M, Weintraub, H, Irimpen, A, May, W, Galski, T, Chu, A, Mody, F, Hodes, Z, Fairlamb, J, Lambert, C, Raisinghani, A, Abbate, A, King, M, Carey, C, Gerber, J, Younis, L, Park, H, Vidovich, M, Knutson, T, Friedman, D, Chaleff, F, Loussararian, A, Kimmelstiel, C, Silver, K, Foster, M, Tonnessen, G, Amlani, M, Wali, A, Malozzi, C, Wattanakit, K, O'Donnell, PJ, Singal, D, Jaffrani, N, Banuru, S, Fisher, D, Xenakis, M, Perlmutter, N, Bhagwat, R, Strader, J, Akyea-Djamson, A, Labroo, A, Marais, HJ, Claxton, E, Berk, M, Rossi, P, Joshi, P, Khaira, AS, Kumkumian, G, Lupovitch, S, Purow, J, Welka, S, Hoffman, D, Fischer, S, Soroka, E, Eagerton, D, Pancholy, S, Ray, M, Farrar, M, Pollock, S, French, WJ, Diamantis, S, Gimple, L, Schwartz, S, Pereira, E, Spriggs, D, Strain, J, Vo, A, Chane, M, Hall, J, Vijay, N, Lotun, K, Lester, FM, Nahhas, A, Pope, T, Nager, P, Vohra, R, Bashir, R, Ahmed, H, Berlowitz, M, Fishberg, R, Barrucco, R, Yang, E, Radin, M, Sporn, D, Eisenberg, S, Landzberg, J, Mcgough, M, Turk, S, Schwartz, M, Sundram, PS, Jain, D, Zainea, M, Bayron, C, Karlsberg, R, Lui, H, Keen, W, Westerhausen, D, Khurana, S, Agarwal, H, Birchem, J, Penny, W, Chang, M, Gilbert, JM, Chalavarya, G, Eaton, C, Schmedtje, JF, Christenson, S, Denham, D, Macdonell, A, Gibson, P, Rahman, A, Al Joundi, T, Conrad, G, Kotha, P, Love, M, Giesler, G, Rubenstein, H, Akright, L, Schifferdecker, B, Krawczyk, J, Wells, T, Welker, J, Foster, R, Gilmore, R, Anderson, J, Jacoby, D, Gardner, G, Dandillaya, R, Vora, K, Kostis, J, Hunter, J, Laxson, D, Ball, E, İÜC, and Ege Üniversitesi
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Male ,medicine.medical_specialty ,Acute coronary syndrome ,alirocumab ,030204 cardiovascular system & hematology ,Antibodies, Monoclonal, Humanized ,lipids ,PCSK9 ,03 medical and health sciences ,0302 clinical medicine ,Postoperative Complications ,Double-Blind Method ,coronary artery bypass graft ,Internal medicine ,medicine ,Humans ,Cardiac and Cardiovascular Systems ,030212 general & internal medicine ,Myocardial infarction ,cardiovascular diseases ,Acute Coronary Syndrome ,Coronary Artery Bypass ,Alirocumab ,Aged ,Kardiologi ,business.industry ,Unstable angina ,Hazard ratio ,cholesterol ,Middle Aged ,medicine.disease ,surgical procedures, operative ,Bypass surgery ,Cardiovascular Diseases ,Cardiology ,Drug Therapy, Combination ,Female ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,Cardiology and Cardiovascular Medicine ,business ,Mace - Abstract
Sherwood, Matthew/0000-0002-4305-5883; Taskinen, Marja-Riitta/0000-0002-6229-3588; Leonardi, Sergio/0000-0002-4800-6132; Raffel, Owen C/0000-0001-5470-7050; Muenzel, Thomas/0000-0001-5503-4150; Ersanli, Murat/0000-0003-1847-3087; Gislason, Gunnar H/0000-0002-0548-402X; bastos, jose/0000-0002-9526-3123; Abbate, Antonio/0000-0002-1930-785X; Chumakova, Galina A/0000-0002-2810-6531; Nikolaev, Konstantin/0000-0003-4601-6203; Tse, Hung Fat/0000-0002-9578-7808; Keskin, Kudret/0000-0002-9049-1530; Reshetko, Olga/0000-0003-3107-7636; Podoleanu, Cristian/0000-0001-9987-2519; Aylward, Philip/0000-0002-5358-8552; LETIERCE, Alexia/0000-0001-6679-5772, WOS: 000483334800002, PubMed: 31466614, BACKGROUND Patients with acute coronary syndrome (ACS) and history of coronary artery bypass grafting (CABG) are at high risk for recurrent cardiovascular events and death. OBJECTIVES This study sought to determine the clinical benefit of adding alirocumab to statins in ACS patients with prior CABG in a pre-specified analysis of ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab). METHODS Patients (n = 18,924) 1 to 12 months post-ACS with elevated atherogenic lipoprotein levels despite high-intensity statin therapy were randomized to alirocumab or placebo subcutaneously every 2 weeks. Median follow-up was 2.8 years. the primary composite endpoint of major adverse cardiovascular events (MACE) comprised coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint. Patients were categorized by CABG status: no CABG (n = 16,896); index CABG after qualifying ACS, but before randomization (n = 1,025); or CABG before the qualifying ACS (n = 1,003). RESULTS in each CABG category, hazard ratios (95% confidence intervals) for MACE (no CABG 0.86 [0.78 to 0.95], index CABG 0.85 [0.54 to 1.35], prior CABG 0.77 [0.61 to 0.98]) and death (0.88 [ 0.75 to 1.03], 0.85 [0.46 to 1.59], 0.67 [0.44 to 1.01], respectively) were consistent with the overall trial results (0.85 [ 0.78 to 0.93] and 0.85 [0.73 to 0.98], respectively). Absolute risk reductions (95% confidence intervals) differed across CABG categories for MACE (no CABG 1.3% [0.5% to 2.2%], index CABG 0.9% [-2.3% to 4.0%], prior CABG 6.4% [0.9% to 12.0%]) and for death (0.4% [-0.1% to 1.0%], 0.5% [-1.9% to 2.9%], and 3.6% [0.0% to 7.2%]). CONCLUSIONS Among patients with recent ACS and elevated atherogenic lipoproteins despite intensive statin therapy, alirocumab was associated with large absolute reductions in MACE and death in those with CABG preceding the ACS event. (ODYSSEY OUTCOMES: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402) (C) 2019 by the American College of Cardiology Foundation., Fondation Assistance Publique-Hopitaux de Paris, Paris, France, The authors thank the patients, study coordinators, and investigators who participated in this trial. Sophie Rushton-Smith, PhD (MedLink Healthcare Communications, London) provided editorial assistance in the preparation of the manuscript (limited to editing for style, referencing, and figure and table editing) and was funded by Fondation Assistance Publique-Hopitaux de Paris, Paris, France.
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- 2019
5. Effect of Alirocumab on Mortality After Acute Coronary Syndromes An Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial
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Baranova, E, Shogenov, Z, Kosmachova, E, Povzun, A, Egorova, L, Tyrenko, VV, Ivanov, IG, Kanorsky, S, Simic, D, Ivanovic, N, Davidovic, G, Tasic, N, Asanin, MR, Stojic, S, Apostolovic, SR, Ilic, S, Putnikovic, B, Stankovic, A, Arandjelovic, A, Radovanovic, S, Balinovac, J, Dincic, DV, Seferovic, P, Dodic, S, Dimkovic, S, Poh, K-K, Ong, HY, Micko, K, Nociar, J, Pella, D, Fulop, P, Hranai, M, Palka, J, Mazur, J, Majercak, I, Dzupina, A, Fazekas, F, Gonsorcik, J, Bugan, V, Selecky, J, Kamensky, G, Strbova, J, Smik, R, Dukat, A, Olexa, P, Zuran, I, Poklukar, J, Suligoj, NC, Cevc, M, Cyster, HP, Ranjith, N, Corbett, C, Bayat, J, Makotoko, EM, Kapp, IE, Basson, MMDV, Lottering, H, Van Zyl, LJ, Sebastian, PJ, Pillay, T, Saaiman, JA, Commerford, PJ, Cassimjee, S, Ebrahim, IO, Sarvan, M, Mynhardt, JH, Reuter, H, Moodley, R, Vida, M, Cequier Fillat, AR, Peris, VB, Jimenez, FF, Marin, F, Cruz Fernandez, JM, Gil-Extremera, B, Diz, FW, Garcia-Dorado, D, Iniguez, A, Tunon Fernandez, J, Gonzalez-Juanatey, JR, Fernandez Portales, J, Civeira Murillo, F, Matas Pericas, L, Luis Zamorano, J, De Mora Martin, M, Bruguera Cortada, J, Alonso Martin, JJ, De Berrazueta Fernandez, JR, Diaz Fernandez, JF, Garcia Lledo, JA, Cosin Sales, J, Botas Rodriguez, J, Gusi Tragant, G, Benedicto, A, Gonzalez-Juanatey, C, Camprubi Potau, M, Plaza Perez, I, Moris De La Tassa, C, Loma-Osorio Rincon, P, Balaguer Recena, J, Escudier, JM, Coca Payeras, A, Alonso Orcajo, N, Valdivielso, P, Constantine, G, Haniffa, R, Tissera, N, Amarasekera, S, Fernando, N, Jayawardena, J, Santharaj, W, Ekanayaka, R, Mendis, S, Senaratne, V, Mayurathan, G, Sirisena, T, Rajapaksha, A, Herath, JI, Amarasena, N, Berglund, S, Rasmanis, G, Witt, N, Mourtzinis, G, Nicol, P, Hansen, O, Romeo, S, Jensen, SA, Torstensson, I, Ahremark, U, Sundelin, T, Moccetti, T, Mach, F, Binder, R, Tsai, W-C, Ueng, K-C, Lai, W-T, Liu, M-E, Hwang, J-J, Yin, W-H, Hsieh, I-C, Lin, WH, Kuo, J-Y, Huang, T-Y, Fang, C-Y, Kaewsuwanna, P, Soonfuang, W, Jintapakorn, W, Sukonthasarn, A, Wongpraparut, N, Sastravaha, K, Sansanayudh, N, Kehasukcharoen, W, Piyayotai, D, Chotnoparatpat, P, Camsari, A, Kultursay, H, Mutlu, B, Ersanli, M, Demirtas, M, Kirma, C, Ural, E, Koldas, L, Karpenko, O, Prokhorov, A, Vakaluyk, I, Myshanych, H, Reshotko, D, Batushkin, V, Rudenko, L, Kovalskyi, I, Kushnir, M, Tseluyko, V, Mostovoy, Y, Stanislavchuk, M, Kyiak, Y, Karpenko, Y, Malynovsky, Y, Klantsa, A, Kutniy, O, Amosova, E, Tashchuk, V, Leshchuk, O, Rishko, M, Kopytsya, M, Yagensky, A, Vatutin, M, Bagriy, A, Barna, OM, Ushakov, O, Dzyak, G, Goloborodko, B, Rudenko, A, Zheleznyy, V, Trevelyan, J, Zaman, A, Lee, K, Moriarty, A, Aggarwal, RK, Clifford, P, Wong, Y-K, Iqbal, SMR, Subkovas, E, Braganza, D, Sarkar, D, Storey, R, Griffiths, H, Mcclure, S, Muthusamy, R, Kurian, J, Levy, T, Barr, C, Kadr, H, Gerber, R, Simaitis, A, Soran, H, Mathur, A, Brodison, A, Oliver, R, Mudawi, T, Reynolds, T, Sharman, D, Butler, R, Wilkinson, P, Lip, GYH, Halcox, J, Vardi, G, Baldari, D, Brabham, D, Treasure, C, Dahl, C, Palmer, B, Wiseman, A, Puri, S, Mohart, AE, Ince, C, Flores, E, Wright, S, Cheng, S-C, Rosenberg, M, Rogers, W, Kosinski, E, Forgosh, L, Waltman, J, Khan, M, Shoukfeh, M, Dagher, G, Lieber, I, Kumar, P, East, C, Krichmar, P, White, L, Knickelbine, T, Haldis, T, Gillespie, E, Suh, D, Arif, I, Akhter, F, Carlson, E, D'Urso, M, El-Ahdab, F, Nelson, W, Harris, B, Cohen, S, Carter, L, Sabatino, K, Haddad, T, Malik, A, Rao, S, Mulkay, A, Jovin, I, Klancke, K, Malhotra, V, Devarapalli, SK, Koren, M, Chandna, H, Dodds, G, Janik, M, Moran, J, Sumner, A, Kobayashi, J, Davis, W, Yazdani, S, Pasquini, J, Thakkar, M, Vedere, A, Leimbach, W, Rider, J, Singh, N, Shah, AV, Janosik, D, Pepine, C, Berman, B, Gelormini, J, Daniels, C, Keating, F, Kondo, NI, Shetty, S, Waider, W, Takata, T, Abu-Fadel, M, Shah, V, Aggarwal, R, Izzo, M, Kumar, A, Hattler, B, Link, C, Bortnick, A, Kinzfogl, G, Ghitis, A, Larry, J, Teufel, E, Kuhlman, P, Mclaurin, B, Zhang, W, Thew, S, Abbas, J, White, M, Ranadive, N, Gring, C, Henderson, D, Schuchard, T, Farhat, N, Kline, G, Mahal, S, Whitaker, J, Speirs, S, Andersen, R, Daboul, N, Horwitz, P, Ponce, G, Jafar, Z, Mcgarvey, J, Panchal, V, Voyce, S, Blok, T, Sheldon, W, Azizad, MM, Schmalfuss, C, Picone, M, Herzog, W, Lindsey, J, Nowins, R, Lepor, N, El Shahawy, M, Weintraub, H, Irimpen, A, May, W, Galski, T, Chu, A, Mody, F, Hodes, Z, Rose, G, Fairlamb, J, Lambert, C, Raisinghani, A, Abbate, A, King, M, Carey, C, Gerber, J, Younis, L, Park, HT, Vidovich, M, Knutson, T, Friedman, D, Chaleff, F, Loussararian, A, Rozeman, P, Kimmelstiel, C, Silver, K, Foster, M, Tonnessen, G, Amlani, M, Wali, A, Malozzi, C, Wattanakit, K, O'Donnell, PJ, Singal, D, Jaffrani, N, Banuru, S, Fisher, D, Xenakis, M, Perlmutter, N, Bhagwat, R, Strader, J, Akyea-Djamson, A, Labroo, A, Marais, HJ, Claxton, E, Berk, M, Rossi, P, Joshi, P, Khaira, AS, Kumkumian, G, Lupovitch, S, Purow, J, Welka, S, Hoffman, D, Fischer, S, Soroka, E, Eagerton, D, Pancholy, S, Ray, M, Farrar, M, Pollock, S, French, WJ, Diamantis, S, Gimple, L, Neustel, M, Schwartz, S, Pereira, E, Spriggs, D, Strain, J, Vo, A, Chane, M, Hall, J, Vijay, N, Lotun, K, Lester, FM, Nahhas, A, Pope, T, Nager, P, Vohra, R, Bashir, R, Ahmed, H, Berlowitz, M, Fishberg, R, Barrucco, R, Yang, E, Radin, M, Sporn, D, Eisenberg, S, Landzberg, J, Mcgough, M, Turk, S, Schwartz, M, Sundram, PS, Jain, D, Zainea, M, Bayron, C, Karlsberg, R, Lui, H, Keen, W, Westerhausen, D, Khurana, S, Agarwal, H, Birchem, J, Penny, W, Chang, M, Murphy, S, Schifferdecker, B, Gilbert, JM, Chalavarya, G, Eaton, C, Schmedtje, JF, Christenson, S, Denham, D, Macdonell, A, Gibson, P, Rahman, A, Al Joundi, T, Conrad, G, Kotha, P, Love, M, Giesler, G, Rubenstein, H, Akright, L, Krawczyk, J, Wells, T, Welker, J, Foster, R, Gilmore, R, Anderson, J, Jacoby, D, Gardner, G, Dandillaya, R, Vora, K, Kostis, J, Hunter, J, Laxson, D, Ball, E, Camp, A, Lopes, R, Egydio, F, Kawakami, A, Oliveira, J, Wozniak, J, Matthews, A, Ratky, C, Valiris, J, Berdan, L, Hepditch, A, Quintero, K, Rorick, T, Westbrook, M, Pascual, A, Rovito, C, Bezault, M, Drouet, E, Simon, T, Alsweiler, C, Luyten, A, Aylward, P, Butters, J, Griffith, L, Shaw, M, Grunberg, L, Islam, S, Bougon, N, Faustino, D, Fontecave, S, Murphy, J, Verrier, M, Agnetti, V, Andersen, D, Badreddine, E, Bekkouche, M, Bouancheau, C, Brigui, I, Brocklehurst, M, Cianciarulo, J, Devaul, D, Domokos, S, Gache, C, Gobillot, C, Guillou, S, Healy, J, Heath, M, Jaiwal, G, Javierre, C, Labeirie, J, Monier, M, Morales, U, Mrabti, A, Mthombeni, B, Okan, B, Smith, L, Sheller, J, Sopena, S, Pellan, V, Benbernou, F, Bengrait, N, Lamoureux, M, Kralova, K, Scemama, M, Bejuit, R, Coulange, A, Berthou, C, Repincay, J, Lorenzato, C, Etienne, A, Gouet, V, Loizeau, V, Normand, M, Ourliac, A, Rondel, C, Adamo, A, Beltran, P, Barraud, P, Dubois-Gache, H, Halle, B, Metwally, L, Mourgues, M, Sotty, M, Vincendet, M, Cotruta, R, Zhu, C, Fournie-Lloret, D, Morrello, C, Perthuis, A, Picault, P, Zobouyan, I, ODYSSEY OUTCOMES Comm, İÜC, Ege Üniversitesi, Rushton-Smith, Sophie, and ODYSSEY OUTCOMES Committees and Investigators
- Subjects
Male ,Cardiac & Cardiovascular Systems ,MONOCLONAL-ANTIBODY ,alirocumab ,Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage ,law.invention ,PCSK9 ,chemistry.chemical_compound ,Randomized controlled trial ,law ,Cardiac and Cardiovascular Systems ,1102 Cardiorespiratory Medicine and Haematology ,Hypercholesterolemia/blood ,Kardiologi ,Hazard ratio ,Middle Aged ,Treatment Outcome ,SAFETY ,Cardiology ,Female ,Drug Therapy, Combination ,Cholesterol, LDL/antagonists & inhibitors ,Cardiology and Cardiovascular Medicine ,Life Sciences & Biomedicine ,REDUCING LIPIDS ,Akutes Koronarsyndrom ,acute coronary syndrome ,cholesterol ,mortality ,PCSK9 protein ,Antibodies, Monoclonal, Humanized/administration & dosage ,medicine.medical_specialty ,Acute coronary syndrome ,Injections, Subcutaneous ,Hypercholesterolemia ,Placebo ,Antibodies, Monoclonal, Humanized ,1117 Public Health and Health Services ,Sterblichkeit ,Double-Blind Method ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,ddc:610 ,Alirocumab ,Aged ,Science & Technology ,Cholesterol ,business.industry ,EVOLOCUMAB ,1103 Clinical Sciences ,Cholesterol, LDL ,medicine.disease ,EFFICACY ,Increased risk ,chemistry ,Peripheral Vascular Disease ,Cardiovascular System & Hematology ,Cardiovascular System & Cardiology ,Acute Coronary Syndrome/blood ,Cholesterin ,Human medicine ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,business ,Follow-Up Studies - Abstract
bastos, jose/0000-0002-9526-3123; Manakshe, Gajendra/0000-0002-4983-4271; Tse, Hung Fat/0000-0002-9578-7808; Gislason, Gunnar H/0000-0002-0548-402X; Taskinen, Marja-Riitta/0000-0002-6229-3588; Racca, Vittorio/0000-0002-4465-3789; Keskin, Kudret/0000-0002-9049-1530; Sherwood, Matthew/0000-0002-4305-5883; Sandhu, Manjinder/0000-0003-2538-2079; Nikolaev, Konstantin/0000-0003-4601-6203; Ersanli, Murat/0000-0003-1847-3087; Raffel, Owen C/0000-0001-5470-7050; Abbate, Antonio/0000-0002-1930-785X; Muenzel, Thomas/0000-0001-5503-4150; Leonardi, Sergio/0000-0002-4800-6132; Chumakova, Galina A/0000-0002-2810-6531; Podoleanu, Cristian/0000-0001-9987-2519; Pereira, Helder/0000-0001-8656-4883; Reshetko, Olga/0000-0003-3107-7636, WOS: 000476768100007, PubMed: 31117810, Background: Previous trials of PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitors demonstrated reductions in major adverse cardiovascular events, but not death. We assessed the effects of alirocumab on death after index acute coronary syndrome. Methods: ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) was a double-blind, randomized comparison of alirocumab or placebo in 18 924 patients who had an ACS 1 to 12 months previously and elevated atherogenic lipoproteins despite intensive statin therapy. Alirocumab dose was blindly titrated to target achieved low-density lipoprotein cholesterol (LDL-C) between 25 and 50 mg/dL. We examined the effects of treatment on all-cause death and its components, cardiovascular and noncardiovascular death, with log-rank testing. Joint semiparametric models tested associations between nonfatal cardiovascular events and cardiovascular or noncardiovascular death. Results: Median follow-up was 2.8 years. Death occurred in 334 (3.5%) and 392 (4.1%) patients, respectively, in the alirocumab and placebo groups (hazard ratio [HR], 0.85; 95% CI, 0.73 to 0.98; P=0.03, nominal P value). This resulted from nonsignificantly fewer cardiovascular (240 [2.5%] vs 271 [2.9%]; HR, 0.88; 95% CI, 0.74 to 1.05; P=0.15) and noncardiovascular (94 [1.0%] vs 121 [1.3%]; HR, 0.77; 95% CI, 0.59 to 1.01; P=0.06) deaths with alirocumab. in a prespecified analysis of 8242 patients eligible for >= 3 years follow-up, alirocumab reduced death (HR, 0.78; 95% CI, 0.65 to 0.94; P=0.01). Patients with nonfatal cardiovascular events were at increased risk for cardiovascular and noncardiovascular deaths (P= 100 mg/dL (2.59 mmol/L) had a greater absolute risk of death and a larger mortality benefit from alirocumab (HR, 0.71; 95% CI, 0.56 to 0.90; P-interaction=0.007). in the alirocumab group, all-cause death declined with achieved LDL-C at 4 months of treatment, to a level of approximately 30 mg/dL (adjusted P=0.017 for linear trend). Conclusions: Alirocumab added to intensive statin therapy has the potential to reduce death after acute coronary syndrome, particularly if treatment is maintained for >= 3 years, if baseline LDL-C is >= 100 mg/dL, or if achieved LDL-C is low., Sanofi; Regeneron Pharmaceuticals, Inc., The trial was funded by Sanofi and Regeneron Pharmaceuticals, Inc.
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- 2019
6. Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial
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DiCenso, D, Gotcheva, N, Sourdille, T, White, HD, Schwartz, GG, Steg, PG, Bhatt, DL, Bittner, VA, Diaz, R, Harrington, RA, Jukema, JW, Szarek, M, Zeiher, AM, Tricoci, P, Mahaffey, KW, Edelberg, JM, Hanotin, C, Lecorps, G, Moryusef, A, Pordy, R, Sasiela, WJ, Drexel, H, Sinnaeve, P, Dilic, M, Gotcheva, NN, Goodman, SG, Prieto, JC, Yong, H, Lopez-Jaramillo, P, Pecin, I, Reiner, Z, Poulsen, SH, Viigimaa, M, Nieminen, MS, Danchin, N, Chumburidze, V, Tse, HF, Xavier, D, Zahger, D, Valgimigli, M, Kim, HS, Erglis, A, Laucevicius, A, Lopez, R, Lopez, GAR, Alings, M, Chua, T, Murin, J, Fras, Z, Dalby, AJ, Tunon, J, De Silva, HA, Chiang, CE, Sritara, P, Guneri, S, Parkhomenko, A, Ray, KK, Moriarty, PM, Roe, MT, Chaitman, B, Kelsey, SF, Olsson, AG, Rouleau, JL, Simoons, ML, Alexander, K, Meloni, C, Rosenson, R, Sijbrands, EJG, Alexander, JH, Armaganijan, L, Bagai, A, Bahit, MC, Brennan, JM, Clifton, S, DeVore, AD, Deloatch, S, Dickey, S, Dombrowski, K, Ducrocq, G, Eapen, Z, Endsley, P, Eppinger, A, Harrison, RW, Hess, CN, Hlatky, MA, Jordan, JD, Knowles, JW, Kolls, BJ, Kong, DF, Leonardi, S, Lillis, L, Maron, DJ, Marcus, J, Mathews, R, Mehta, RH, Mentz, RJ, Moreira, HG, Patel, CB, Pereira, SB, Perkins, L, Povsic, TJ, Puymirat, E, Jones, WS, Shah, BR, Sherwood, MW, Stringfellow, K, Sujjavanich, D, Toma, M, Van Diepen, SFP, Wilson, MD, Yan, ATK, Lopes, RD, Trotter, C, Schiavi, LB, Garrido, M, Alvarisqueta, AF, Sassone, SA, Bordonava, AP, De Lima, AEA, Schmidberg, JM, Duronto, EA, Caruso, OC, Novaretto, LP, Hominal, MA, Montana, OR, Caccavo, A, Vilamajo, OAG, Lorenzatti, AJ, Cartasegna, LR, Paterlini, GA, Mackinnon, IJ, Caime, GD, Amuchastegui, M, Salomone, R, Codutti, OR, Jure, HO, Bono, JOE, Hrabar, AD, Vallejos, JA, Guerrero, RAA, Novoa, F, Patocchi, CA, Zaidman, CJ, Giuliano, ME, Dran, RD, Vico, ML, Carnero, GS, Guzman, PN, Allende, JCM, Brasca, DFG, Labarta, MHB, Nani, S, Blumberg, EDS, Colombo, HR, Liberman, A, Luciardi, HL, Waisman, GD, Berli, MA, Duran, ROG, Cestari, HG, 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MH, Leaes, PE, Botelho, RV, Kaiser, S, Manenti, ERFF, Precoma, DB, Jorge, JCM, Silva, PGMD, Silveira, JA, Saporito, W, Marin, JA, Feitosa, GS, Ritt, LEF, de Souza, JA, Costa, F, Souza, WKSB, Reis, HJL, Machado, L, Ayoub, JCA, Todorov, GV, Nikolov, FP, Velcheva, ES, Tzekova, ML, Benov, HO, Petranov, SL, Tumbev, HS, Shehova-Yankova, NS, Markov, DT, Raev, DH, Mollov, MN, Kichukov, KN, Ilieva-Pandeva, KA, Ivanova, R, Mincheva, VM, Lazov, PV, Dimov, BI, Senaratne, M, Stone, J, Kornder, J, Pearce, S, Dion, D, Savard, D, Pesant, Y, Pandey, A, Robinson, S, Gosselin, G, Vizel, S, Hoag, G, Bourgeois, R, Morisset, A, Sabbah, E, Sussex, B, Kouz, S, MacDonald, P, Diaz, A, Michaud, N, Fell, D, Leung, R, Vuurmans, T, Lai, C, Nigro, F, Davies, R, Nogareda, G, Vijayaraghavan, R, Ducas, J, Lepage, S, Mehta, S, Cha, J, Dupuis, R, Fong, P, Rodes-Cabau, J, Fadlallah, H, Cleveland, D, Huynh, T, Bata, I, Hameed, A, Pincetti, C, Potthoff, S, Acevedo, M, Aguirre, A, Vejar, M, Yanez, M, Araneda, G, Fernandez, 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Dimkovic, S, Poh, KK, Ong, HY, Micko, K, Nociar, J, Pella, D, Fulop, P, Hranai, M, Palka, J, Mazur, J, Majercak, I, Dzupina, A, Fazekas, F, Gonsorcik, J, Bugan, V, Selecky, J, Kamensky, G, Strbova, J, Smik, R, Dukat, A, Olexa, P, Zuran, I, Poklukar, J, Suligoj, NC, Cevc, M, Cyster, HP, Ranjith, N, Corbett, C, Bayat, J, Makotoko, EM, Kapp, IE, Basson, MMD, Lottering, H, Van Zyl, LJ, Sebastian, PJ, Pillay, T, Saaiman, JA, Commerford, PJ, Cassimjee, S, Ebrahim, IO, Sarvan, M, Mynhardt, JH, Reuter, H, Moodley, R, Vida, M, Fillat, ARC, Peris, VB, Jimenez, FF, Marin, F, Fernandez, JMC, Gil-Extremera, B, Diz, FW, Garcia-Dorado, D, Iniguez, A, Fernandez, JT, Gonzalez-Juanatey, JR, Portales, JF, Murillo, FC, Pericas, LM, Zamorano, JL, Martin, MD, Cortada, JB, Martin, JJA, Fernandez, JRD, Fernandez, JFD, Lledo, JAG, Sales, JC, Rodriguez, JB, Tragant, GG, Benedicto, A, Gonzalez-Juanatey, C, Potau, MC, Perez, IP, De La Tassa, CM, Rincon, PLO, Recena, JB, Escudier, JM, Payeras, AC, Orcajo, NA, Valdivielso, P, Constantine, G, Haniffa, R, Tissera, N, Amarasekera, S, Fernando, N, Jayawardena, J, Santharaj, W, Ekanayaka, R, Mendis, S, Senaratne, V, Mayurathan, G, Sirisena, T, Rajapaksha, A, Herath, JI, Amarasena, N, Berglund, S, Rasmanis, G, Witt, N, Mourtzinis, G, Nicol, P, Hansen, O, Romeo, S, Jensen, SA, Torstensson, I, Ahremark, U, Sundelin, T, Moccetti, T, Muller, C, Mach, F, Binder, R, Tsai, WC, Ueng, KC, Lai, WT, Liu, ME, Hwang, JJ, Yin, WH, Hsieh, IC, Kuo, JY, Huang, TY, Fang, CY, Kaewsuwanna, P, Soonfuang, W, Jintapakorn, W, Sukonthasarn, A, Wongpraparut, N, Sastravaha, K, Sansanayudh, N, Kehasukcharoen, W, Piyayotai, D, Chotnoparatpat, P, Camsari, A, Kultursay, H, Mutlu, B, Ersanli, M, Demirtas, M, Kirma, C, Ural, E, Koldas, L, Karpenko, O, Prokhorov, A, Vakaluyk, I, Myshanych, H, Reshotko, D, Batushkin, V, Rudenko, L, Kovalskyi, I, Kushnir, M, Tseluyko, V, Mostovoy, Y, Stanislavchuk, M, Kyiak, Y, Karpenko, Y, Malynovsky, Y, Klantsa, A, Kutniy, O, Amosova, E, Tashchuk, V, Leshchuk, O, Rishko, M, Kopytsya, M, Yagensky, A, Vatutin, M, Bagriy, A, Barna, OM, Ushakov, O, Dzyak, G, Goloborodko, B, Rudenko, A, Zheleznyy, V, Trevelyan, J, Zaman, A, Lee, K, Moriarty, A, Aggarwal, RK, Clifford, P, Wong, YK, Iqbal, SM, Subkovas, E, Braganza, D, Sarkar, D, Storey, R, Griffiths, H, Mcclure, S, Muthusamy, R, Kurian, J, Levy, T, Barr, C, Kadr, H, Gerber, R, Simaitis, A, Soran, H, Mathur, A, Brodison, A, Oliver, R, Mudawi, T, Reynolds, T, Sharman, D, Butler, R, Wilkinson, P, Lip, GYH, Halcox, J, Vardi, G, Baldari, D, Brabham, D, Treasure, C, Dahl, C, Palmer, B, Wiseman, A, Puri, S, Mohart, AE, Ince, C, Flores, E, Wright, S, Cheng, SC, Rosenberg, M, Rogers, W, Kosinski, E, Forgosh, L, Waltman, J, Khan, M, Shoukfeh, M, Dagher, G, Lieber, I, Kumar, P, East, C, Krichmar, P, White, L, Knickelbine, T, Haldis, T, Gillespie, E, Suh, D, Arif, I, Akhter, F, Carlson, E, D'Urso, M, El-Ahdab, F, Nelson, W, Harris, B, Cohen, S, Carter, L, Sabatino, K, Haddad, T, Malik, A, Rao, S, Mulkay, A, Jovin, I, Klancke, K, Malhotra, V, Devarapalli, SK, Koren, M, Chandna, H, Dodds, G, Janik, M, Moran, J, Sumner, A, Kobayashi, J, Davis, W, Yazdani, S, Pasquini, J, Thakkar, M, Vedere, A, Leimbach, W, Rider, J, Singh, N, Shah, AV, Janosik, D, Pepine, C, Berman, B, Gelormini, J, Daniels, C, Keating, F, Kondo, NI, Shetty, S, Waider, W, Takata, T, Abu-Fadel, M, Shah, V, Aggarwal, R, Izzo, M, Kumar, A, Hattler, B, Link, C, Bortnick, A, Kinzfogl, G, Ghitis, A, Larry, J, Teufel, E, Kuhlman, P, Mclaurin, B, Zhang, WW, Thew, S, Abbas, J, White, M, Ranadive, N, Gring, C, Henderson, D, Schuchard, T, Farhat, N, Kline, G, Mahal, S, Whitaker, J, Speirs, S, Andersen, R, Daboul, N, Horwitz, P, Ponce, G, Jafar, Z, Mcgarvey, J, Panchal, V, Voyce, S, Blok, T, Sheldon, W, Azizad, MM, Schmalfuss, C, Picone, M, Herzog, W, Lindsey, J, Nowins, R, Lepor, N, El Shahawy, M, Weintraub, H, Irimpen, A, May, W, Galski, T, Chu, A, Mody, F, Hodes, Z, Rose, G, Fairlamb, J, Lambert, C, Raisinghani, A, Abbate, A, King, M, Carey, C, Gerber, J, Younis, L, Park, H, Vidovich, M, Knutson, T, Friedman, D, Chaleff, F, Loussararian, A, Rozeman, P, Kimmelstiel, C, Silver, K, Foster, M, Tonnessen, G, Amlani, M, Wali, A, Malozzi, C, Wattanakit, K, O'Donnell, PJ, Singal, D, Jaffrani, N, Banuru, S, Fisher, D, Xenakis, M, Perlmutter, N, Bhagwat, R, Strader, J, Akyea-Djamson, A, Labroo, A, Marais, HJ, Claxton, E, Berk, M, Rossi, P, Joshi, P, Khaira, AS, Kumkumian, G, Lupovitch, S, Purow, J, Welka, S, Hoffman, D, Fischer, S, Soroka, E, Eagerton, D, Pancholy, S, Ray, M, Farrar, M, Pollock, S, French, WJ, Diamantis, S, Gimple, L, Neustel, M, Schwartz, S, Pereira, E, Spriggs, D, Strain, J, Vo, A, Chane, M, Hall, J, Vijay, N, Lotun, K, Lester, FM, Nahhas, A, Pope, T, Nager, P, Vohra, R, Bashir, R, Ahmed, H, Berlowitz, M, Fishberg, R, Barrucco, R, Yang, E, Radin, M, Sporn, D, Eisenberg, S, Landzberg, J, Mcgough, M, Turk, S, Schwartz, M, Sundram, PS, Jain, D, Zainea, M, Bayron, C, Karlsberg, R, Lui, H, Keen, W, Westerhausen, D, Khurana, S, Agarwal, H, Birchem, J, Penny, W, Chang, M, Murphy, S, Schifferdecker, B, Gilbert, JM, Chalavarya, G, Eaton, C, Schmedtje, JF, Christenson, S, Denham, D, Macdonell, A, Gibson, P, Rahman, A, Al Joundi, T, Conrad, G, Kotha, P, Love, M, Giesler, G, Rubenstein, H, Akright, L, Krawczyk, J, Wells, T, Welker, J, Foster, R, Gilmore, R, Anderson, J, Jacoby, D, Gardner, G, Dandillaya, R, Vora, K, Kostis, J, Hunter, J, Laxson, D, Ball, E, Camp, A, Lopes, R, Egydio, F, Kawakami, A, Oliveira, J, Wozniak, J, Matthews, A, Ratky, C, Valiris, J, Berdan, L, Hepditch, A, Quintero, K, Rorick, T, Westbrook, M, Pascual, A, Rovito, C, Bezault, M, Drouet, E, Simon, T, Alsweiler, C, Luyten, A, Aylward, P, Butters, J, Griffith, L, Shaw, M, Hagstrom, E, Grunberg, L, Islam, S, Bregeault, MF, Bougon, N, Faustino, D, Fontecave, S, Murphy, J, Tamby, JF, Verrier, M, Agnetti, V, Andersen, D, Badreddine, E, Bekkouche, M, Bouancheau, C, Brigui, I, Brocklehurst, M, Cianciarulo, J, Devaul, D, Domokos, S, Gache, C, Gobillot, C, Guillou, S, Healy, J, Heath, M, Jaiwal, G, Javierre, C, Labeirie, J, Monier, M, Morales, U, Mrabti, A, Mthombeni, B, Okan, B, Smith, L, Sheller, J, Sopena, S, Pellan, V, Benbernou, F, Bengrait, N, Lamoureux, M, Kralova, K, Scemama, M, Bejuit, R, Coulange, A, Berthou, C, Repincay, J, Lorenzato, C, Etienne, A, Gouet, V, Loizeau, V, Normand, M, Ourliac, A, Rondel, C, Adamo, A, Beltran, P, Barraud, P, Dubois-Gache, H, Halle, B, Metwally, L, Mourgues, M, Sotty, M, Vincendet, M, Cotruta, R, Zhu, CY, Fournie-Lloret, D, Morrello, C, Perthuis, A, Picault, P, Zobouyan, I, ODYSSEY OUTCOMES Comm Inve, Ege Üniversitesi, Cardiology, and Internal Medicine
- Subjects
medicine.medical_specialty ,Acute coronary syndrome ,Time Factors ,acute coronary syndrome ,alirocumab ,global burden of disease ,hospitalization ,myocardial infarction ,PCSK9 ,030204 cardiovascular system & hematology ,Antibodies, Monoclonal, Humanized ,Placebo ,Patient Readmission ,Risk Assessment ,03 medical and health sciences ,Patient Admission ,0302 clinical medicine ,Risk Factors ,Internal medicine ,medicine ,Humans ,Angina, Unstable ,Hospital Mortality ,030212 general & internal medicine ,Myocardial infarction ,03.02. Klinikai orvostan ,Dyslipidemias ,Alirocumab ,Out of hospital ,business.industry ,Anticholesteremic Agents ,Cholesterol, HDL ,Cholesterol hdl ,Cholesterol, LDL ,medicine.disease ,Treatment Outcome ,Drug Therapy, Combination ,Human medicine ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,Cardiology and Cardiovascular Medicine ,business ,Cardiovascular outcomes ,Biomarkers - Abstract
Sherwood, Matthew/0000-0002-4305-5883; Abbate, Antonio/0000-0002-1930-785X; Moris, Cesar/0000-0002-2871-190X; Ersanli, Murat/0000-0003-1847-3087; Taskinen, Marja-Riitta/0000-0002-6229-3588; bastos, jose/0000-0002-9526-3123; Reshetko, Olga/0000-0003-3107-7636; Nikolaev, Konstantin/0000-0003-4601-6203; Leonardi, Sergio/0000-0002-4800-6132; Raffel, Owen C/0000-0001-5470-7050; Racca, Vittorio/0000-0002-4465-3789; Podoleanu, Cristian/0000-0001-9987-2519; Gislason, Gunnar H/0000-0002-0548-402X; Muenzel, Thomas/0000-0001-5503-4150; Tse, Hung Fat/0000-0002-9578-7808; Chumakova, Galina A/0000-0002-2810-6531, WOS: 000502609000004, PubMed: 31707826, Background: in ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), alirocumab was compared with placebo, added to high-intensity or maximum tolerated statin treatment after acute coronary syndrome in 18924 patients. Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths. the present analysis determined whether alirocumab reduced total (first and subsequent) hospitalizations and death and increased days alive and out of hospital (DAOH) and percent DAOH in ODYSSEY OUTCOMES. Methods and Results: in prespecified analyses, hazard functions for total hospitalizations and death were jointly estimated by a semiparametric model, while in post hoc analyses, DAOH and percent DAOH were compared between treatment groups with Poisson regression and one-inflated beta regression, respectively. With 16629 total hospitalizations and 726 deaths, 331 fewer hospitalizations, and 58 fewer deaths were observed with alirocumab compared with placebo, translating to 15.6 total hospitalizations or deaths avoided with alirocumab per 1000 patient-years of assigned treatment. Alirocumab reduced total hospitalizations (hazard ratio, 0.96 [95% CI, 0.92-1.00]; P=0.04) and increased DAOH relative to placebo (rate ratio, 1.003 [95% CI, 1.000-1.007]; P=0.05), primarily through a reduction in days dead (rate ratio, 0.847 [95% CI, 0.728-0.986]; P=0.03). Patients randomized to alirocumab were also more likely to survive to the end of the study without hospitalization (odds ratio, 1.06 [95% CI, 1.00-1.13]; P=0.03). Conclusions: Alirocumab reduced total hospitalizations with corresponding small increases in DAOH and percent DAOH. These outcomes provide alternative patient-centered metrics to capture the totality of alirocumab clinical efficacy after acute coronary syndrome. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01663402., Fondation Assistance Publique-Hopitaux de Paris, Paris, France, We thank the patients, study coordinators, and investigators who participated in this trial. Sophie Rushton-Smith, PhD (MedLink Healthcare Communications, London) provided editorial assistance in the preparation of the article (limited to editing for style, referencing, and figure and table editing) and was funded by Fondation Assistance Publique-Hopitaux de Paris, Paris, France.
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- 2019
7. P110Effect of MMP-2 on compromised homing of intracoronary delivery of mesenchymal stem cell in a porcine reperfused myocardial infarction: comparison with intramyocardial cell delivery
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Gugerell, A, primary, Zlabinger, K, additional, Lukovic, D, additional, Winkler, J, additional, Hemetsberger, R, additional, Mandic, L J, additional, Traxler, D, additional, Spannbauer, A, additional, Pavo, N, additional, and Gyongyosi, M, additional
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- 2018
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8. Imaging the Migration of Therapeutically Delivered Cardiac Stem Cells (vol 3, pg 772, 2010)
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Gyongyosi, M, Hemetsberger, R, Wolbank, S, Kaun, C, Posa, A, Marian, T, Balkay, L, Emri, M, Galuska, L, Mikecz, P, Petrasi, Z, Charwat, S, Hemetsberger, H, Blanco, J, and Maurer, G
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- 2011
9. Percutaneous coil embolization of a perforated side branch of the right coronary artery causing a pericardial tamponade 3 weeks after abdominal surgery
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Hemetsberger, R., primary, Schulze-Waltrup, N., additional, Nitschke, T., additional, and Heuer, H., additional
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- 2013
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10. Association between the efficacy of dual antiplatelet therapy and the development of in-stent neointimal hyperplasia in porcine coronary arteries.
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Hemetsberger R, Farhan S, Strehblow C, Sperker W, Pavo I, Petrasi Z, Hemetsberger H, Posa A, Huber K, Glogar D, Gyöngyösi M, Hemetsberger, Rayyan, Farhan, Serdar, Strehblow, Christoph, Sperker, Wolfgang, Pavo, Imre, Petrasi, Zsolt, Hemetsberger, Hani, Posa, Aniko, and Huber, Kurt
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- 2008
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11. Attainment of local drug delivery with paclitaxel-eluting balloon in porcine coronary arteries.
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Posa A, Hemetsberger R, Petnehazy O, Petrasi Z, Testor M, Glogar D, and Gyöngyösi M
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- 2008
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12. Ischemic Preconditioning Leads to Reduction of Circulating Mesenchymal Stem Cells in a Porcine Ischaemia/Reperfusion Model
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Hemetsberger, H., Sabine Steiner, Farhan, S., Kvakan, H., Hemetsberger, R., Pavo, N., Kopp, C., Garamvoelgyi, R., Petrasi, Z., Petnehazy, O., Manczur, F., Huber, K., Wojta, J., Glogar, D., and Gyongyosi, M.
13. Valvuloplasty with a paclitaxel-eluting balloon prevents restenosis in an experimental animal model of aortic stenosis
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Spargias, K., Gyöngyösi, M., Hemetsberger, R., Posa, A., Pavo, N., Pavo, I. J., Huber, K., Petrasi, Z., Ors Petnehazy, Strandmann, R. P., Park, J., Glogar, D., Maurer, G., and Rajamannan, N. M.
14. Ischemic preconditioning leads to reduction of circulating mesenchymal stem cells in a porcine ischaemia/reperfusion model,Ischämisches preconditioning führt zu einer reduktion zirkulierender mesenchymaler stammzellen im ischämie/reperfusionsmodell bei schweinen
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Hemetsberger, H., Sabine Steiner, Farhan, S., Kvakan, H., Hemetsberger, R., Pavo, N., Kopp, C., Garamvölgyi, R., Petrási, Z., Petneházy, Ö, Manczur, F., Huber, K., Wojta, J., Glogar, D., and Gyöngyösi, M.
15. Real-time gating of IVUS sequences based on motion blur analysis: method and quantitative validation
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Gatta, C., Balocco, S., Ciompi, F., Hemetsberger, R., Rodriguez Leor, O., and Petia Radeva
16. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial
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Kausik K Ray, Helen M Colhoun, Michael Szarek, Marie Baccara-Dinet, Deepak L Bhatt, Vera A Bittner, Andrzej J Budaj, Rafael Diaz, Shaun G Goodman, Corinne Hanotin, Robert A Harrington, J Wouter Jukema, Virginie Loizeau, Renato D Lopes, Angèle Moryusef, Jan Murin, Robert Pordy, Arsen D Ristic, Matthew T Roe, José Tuñón, Harvey D White, Andreas M Zeiher, Gregory G Schwartz, Philippe Gabriel Steg, Gregory G. Schwartz, Ph. Gabriel Steg, Deepak L. Bhatt, Vera A. Bittner, Shaun G. Goodman, Robert A. Harrington, J. Wouter Jukema, Harvey D. White, Andreas M. Zeiher, Pierluigi Tricoci, Matthew T. Roe, Kenneth W. Mahaffey, Jay M. Edelberg, Guillaume Lecorps, William J. Sasiela, Jean-François Tamby, Philip E. Aylward, Heinz Drexel, Peter Sinnaeve, Mirza Dilic, Renato D. Lopes, Nina N. Gotcheva, Juan-Carlos Prieto, Huo Yong, Patricio López-Jaramillo, Ivan Pećin, Zeljko Reiner, Petr Ostadal, Margus Viigimaa, Markku S. Nieminen, Vakhtang Chumburidze, Nikolaus Marx, Nicolas Danchin, Evangelos Liberopoulos, Pablo Carlos Montenegro Valdovinos, Hung-Fat Tse, Robert Gabor Kiss, Denis Xavier, Doron Zahger, Marco Valgimigli, Takeshi Kimura, Hyo Soo Kim, Sang-Hyun Kim, Andrejs Erglis, Aleksandras Laucevicius, Sasko Kedev, Khalid Yusoff, Gabriel Arturo Ramos López, Marco Alings, Sigrun Halvorsen, Roger M. Correa Flores, Andrzej Budaj, Joao Morais, Maria Dorobantu, Yuri Karpov, Arsen D. Ristic, Terrance Chua, Zlatko Fras, Anthony J. Dalby, H. Asita de Silva, Emil Hagström, Ulf Landmesser, Chern-En Chiang, Piyamitr Sritara, Sema Guneri, Alexander Parkhomenko, Kausik K. Ray, Patrick M. Moriarty, Robert Vogel, Bernard Chaitman, Sheryl F. Kelsey, Anders G. Olsson, Jean-Lucien Rouleau, Maarten L. Simoons, Karen Alexander, Chiara Meloni, Robert Rosenson, Eric J.G. Sijbrands, John H. Alexander, Luciana Armaganijan, Akshay Bagai, Maria Cecilia Bahit, J. Matthew Brennan, Shaun Clifton, Adam D. DeVore, Shalonda Deloatch, Sheila Dickey, Keith Dombrowski, Grégory Ducrocq, Zubin Eapen, Patricia Endsley, Arleen Eppinger, Robert W. Harrison, Connie Ng Hess, Mark A. Hlatky, Joseph Dedrick Jordan, Joshua W. Knowles, Bradley J. Kolls, David F. Kong, Sergio Leonardi, Linda Lillis, David J. Maron, Jill Marcus, Robin Mathews, Rajendra H. Mehta, Robert J. Mentz, Humberto Graner Moreira, Chetan B. Patel, Sabrina Bernardez-Pereira, Lynn Perkins, Thomas J. Povsic, Etienne Puymirat, William Schuyler Jones, Bimal R. Shah, Matthew W. Sherwood, Kenya Stringfellow, Darin Sujjavanich, Mustafa Toma, Charlene Trotter, Sean Van Diepen, Matthew D. Wilson, Andrew T. Yan, Lilia B. Schiavi, Marcelo Garrido, Andrés F. Alvarisqueta, Sonia A. Sassone, Anselmo P. Bordonava, Alberto E. Alves De Lima, Jorge M. Schmidberg, Ernesto A. Duronto, Orlando C. Caruso, Leonardo P. Novaretto, Miguel Angel Hominal, Oscar R. Montaña, Alberto Caccavo, Oscar A. Gomez Vilamajo, Alberto J. Lorenzatti, Luis R. Cartasegna, Gustavo A. Paterlini, Ignacio J. Mackinnon, Guillermo D. Caime, Marcos Amuchastegui, Oscar Salomone, Oscar R. Codutti, Horacio O. Jure, Julio OE Bono, Adrian D. Hrabar, Julio A. Vallejos, Rodolfo A. Ahuad Guerrero, Federico Novoa, Cristian A. Patocchi, Cesar J. Zaidman, Maria E. Giuliano, Ricardo D. Dran, Marisa L. Vico, Gabriela S. Carnero, Pablo N. Guzman, Juan C. Medrano Allende, Daniela F. 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Quintero Ossa, Fernando G Manzur Jatin, Aristides Sotomayor Herazo, Jeffrey Castellanos Parada, Rafael Suarez Arambula, Miguel A Urina Triana, Angela M Fernandez Trujillo, Maja Strozzi, Siniša Car, Melita Jerić, Davor Miličić, Martina Lovrić Benčić, Hrvoje Pintarić, Đeiti Prvulović, Jozica Šikić, Viktor Peršić, Dean Mileta, Kresimir Štambuk, Zdravko Babić, Vjekoslav Tomulic, Josip Lukenda, Stanka Mejic-Krstulovic, Boris Starcevic, Jindrich Spinar, David Horak, Zdenek Velicka, Josef Stasek, David Alan, Vilma Machova, Ales Linhart, Vojtech Novotny, Vladimir Kaucak, Richard Rokyta, Robert Naplava, Zdenek Coufal, Vera Adamkova, Ivo Podpera, Jiri Zizka, Zuzana Motovska, Ivana Marusincova, Premysl Svab, Petr Heinc, Jiri Kuchar, Petr Povolny, Jiri Matuska, Steen H Poulsen, Bent Raungaard, Peter Clemmensen, Lia E Bang, Ole May, Morten Bøttcher, Jens D Hove, Lars Frost, Gunnar Gislason, John Larsen, Peter Betton Johansen, Flemming Hald, Peter Johansen, Jørgen Jeppesen, Tonny Nielsen, Kjeld S Kristensen, Piotr Maria Walichiewicz, Jens D Lomholdt, Ib C Klausen, Peter Kaiser Nielsen, Flemming Davidsen, Lars Videbaek, Mai Soots, Veiko Vahula, Anu Hedman, Üllar Soopõld, Kaja Märtsin, Tiina Jurgenson, Arved Kristjan, Juhani K Helsinki, Saila Vikman, Heikki Huikuri, Juhani Airaksinen, Pierre Coste, Emile Ferrari, Olivier Morel, Gilles Montalescot, Jacques Machecourt, Gilles Barone-Rochette, Jacques Mansourati, Yves Cottin, Florence Leclercq, Abdelkader Belhassane, Nicolas Delarche, Franck Boccara, Franck Paganelli, Jérôme Clerc, Francois Schiele, Victor Aboyans, Vincent Probst, Jacques Berland, Thierry Lefèvre, Bernard Citron, Irakli Khintibidze, Tamaz Shaburishvili, Zurab Pagava, Ramaz Ghlonti, Zaza Lominadze, George Khabeishvili, Rayyan Hemetsberger, Kemala Edward, Ursula Rauch-Kröhnert, Matthias Stratmann, Karl-Friedrich Appel, Ekkehard Schmidt, Heyder Omran, Christoph Stellbrink, Thomas Dorsel, Emmanouil Lianopoulos, Hans Friedrich Vöhringer, Roger Marx, Andreas Zirlik, Detlev Schellenberg, Thomas Heitzer, Ulrich Laufs, Christian Werner, Stephan Gielen, Sebastian Nuding, Bernhard Winkelmann, Steffen Behrens, Karsten Sydow, Mahir Karakas, Gregor Simonis, Thomas Muenzel, Nikos Werner, Stefan Leggewie, Dirk Böcker, Rüdiger Braun-Dullaeus, Nicole Toursarkissian, Michael Jeserich, Matthias Weißbrodt, Tim Schaeufele, Joachim Weil, Heinz Völler, Johannes Waltenberger, Mohammed Natour, Susanne Schmitt, Dirk Müller-Wieland, Stephan Steiner, Lothar Heidenreich, Elmar Offers, Uwe Gremmler, Holger Killat, Werner Rieker, Sotiris Patsilinakos, Athanasios Kartalis, Athanassios Manolis, Dimitrios Sionis, Geargios Chachalis, Ioannis Skoumas, Vasilios Athyros, Panagiotis Vardas, Frangkiskos Parthenakis, Dimitrios Alexopoulos, Georgios Hahalis, John Lekakis, Apostolos Hatzitolios, Sergio R Fausto Ovando, Juan L Arango Benecke, Edgar R Rodriguez De Leon, Bryan PY Yan, David CW Siu, Tibor Turi, Bela Merkely, Imre Ungi, Geza Lupkovics, Lajos Nagy, András Katona, István Édes, Gábor Müller, Iván Horvath, Tibor Kapin, Zsolt Szigeti, József Faluközy, Mukund Kumbla, Manjinder Sandhu, Sharath Annam, Naveen Reddy Proddutur, Reddy Regella, Rajendra K Premchand, Ajaykumar Mahajan, Sudhir Pawar, Atul D Abhyanakar, Prafulla Kerkar, Ravishankar A Govinda, Abraham Oomman, Dhurjati Sinha, Sachin N Patil, Dhiman Kahali, Jitendra Sawhney, Abhijeet B Joshi, Sanjeev Chaudhary, Pankaj Harkut, Santanu Guha, Sanjay Porwal, Srimannarayana Jujjuru, Ramesh B Pothineni, Minguel R Monteiro, Aziz Khan, Shamanna S Iyengar, Jasprakash Singh Grewal, Manoj Chopda, Mahesh C Fulwani, Aparna Patange, Patil Sachin, Vijay K Chopra, Naresh K Goyal, Rituparna Shinde, Gajendra V Manakshe, Nitin Patki, Sumeet Sethi, Vengatesh Munusamy, Sunil Karna, Sunil Thanvi, Srilakshmi Adhyapak, Chandrakant Patil, Ulhas Pandurangi, Rishabh Mathur, Jugal Gupta, Suhas Kalashetti, Ajit Bhagwat, Bagirath Raghuraman, Shiv Kumar Yerra, Prasant Bhansali, Rohidas Borse, Patil Rahul, Srihari Das, Vinay Kumar, Jabir Abdullakutty, Shireesh Saathe, Priya Palimkar, Shireesh Sathe, Shaul Atar, Michael Shechter, Morris Mosseri, Yaron Arbel, Chorin Ehud, Havakuk Ofer, Chaim Lotan, Uri Rosenschein, Amos Katz, Yaakov Henkin, Adi Francis, Marc Klutstein, Eugenia Nikolsky, Robert Zukermann, Yoav Turgeman, Majdi Halabi, Alon Marmor, Ran Kornowski, Michael Jonas, Offer Amir, Yonathan Hasin, Yoseph Rozenman, Shmuel Fuchs, Vered Zvi, Osamah Hussein, Dov Gavish, Zvi Vered, Yoseph Caraco, Mazen Elias, Naveh Tov, Efrat Wolfovitz, Michael Lishner, Nizar Elias, Giancarlo Piovaccari, Annamaria De Pellegrin, Raffaella Garbelotto, Gabriele Guardigli, Valgimigli Marco, Giovanni Licciardello, Carla Auguadro, Filippo Scalise, Claudio Cuccia, Alessandro Salvioni, Giuseppe Musumeci, Michelle Senni, Paolo Calabrò, Salvatore Novo, Pompilio Faggiano, Marco Metra, Nicoletta B De Cesare, Sergio Berti, Claudio Cavallini, Enrico Puccioni, Marcello Galvani, Maurizio Tespili, Piermarco Piatti, Michela Palvarini, Giuseppe De Luca, Roberto Violini, Alessandro De Leo, Zoran Olivari, Pasquale Perrone Filardi, Maurizio Ferratini, Vittorio Racca, Kazuoki Dai, Yuji Shimatani, Haruo Kamiya, Kenji Ando, Yoshihiro Takeda, Yoshihiro Morino, Yoshiki Hata, Kazuo Kimura, Koichi Kishi, Ichiro Michishita, Hiroki Uehara, Toshinori Higashikata, Atsushi Hirayama, Keiji Hirooka, Yasuji Doi, Satoru Sakagami, Shuichi Taguchi, Akihiro Koike, Hiroyuki Fujinaga, Shinji Koba, Ken Kozuma, Tomohiro Kawasaki, Yujiro Ono, Masatoshi Shimizu, Yousuke Katsuda, Atsuyuki Wada, Toshiro Shinke, Junya Ako, Kenshi Fujii, Toshiyuki Takahashi, Tomohiro Sakamoto, Koichi Nakao, Yutaka Furukawa, Hiroshi Sugino, Ritsu Tamura, Toshiaki Mano, Masaaki Uematsu, Noriaki Utsu, Kashima Ito, Takuya Haraguchi, Katsuhiko Sato, Yasunori Ueda, Akira Nishibe, Kazuteru Fujimoto, Motomaru Masutani, Jung Han Yoon, Hack-Lyoung Kim, Hun Sik Park, In-Ho Chae, Moo Hyun Kim, Myung Ho Jeong, Seungwoon Rha, Chongjin Kim, Hyo-Soo Kim, Hae Young Kim, Taekjong Hong, Seung-Jea Tahk, Youngkwon Kim, Arija Busmane, Natalija Pontaga, Aldis Strelnieks, Iveta Mintale, Iveta Sime, Zaneta Petrulioniene, Roma Kavaliauskiene, Ruta Jurgaitiene, Gintare Sakalyte, Rimvydas Slapikas, Sigute Norkiene, Nerijus Misonis, Aleksandras Kibarskis, Raimondas Kubilius, Stojko Bojovski, Nensi Lozance, Aleksandar Kjovkaroski, Snezana Doncovska, Tiong Kiam Ong, Sazzli Kasim, Oteh Maskon, Balachandran Kandasamy, Houng B Liew, Wan Mohd Izani Wan Mohamed, Armando García Castillo, Jorge Carrillo Calvillo, Pedro Fajardo Campos, Juan Carlos Núñez Fragoso, Edmundo Alfredo Bayram Llamas, Marco Antonio Alcocer Gamba, Jaime Carranza Madrigal, Luis Gerardo González Salas, Enrique López Rosas, Belinda González Díaz, Eduardo Salcido Vázquez, Alfredo Nacoud Ackar, Guillermo Antonio Llamas Esperón, Carlos Rodolfo Martínez Sánchez, María Guerrero De Leon, Rodrigo Suarez Otero, Guillermo Fanghänel Salmón, Jesús Antonio Pérez Ríos, José Angel Garza Ruíz, Robert W Breedveld, Margriet 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Istratoaie, O, Tesloianu, D, Cristian, G, Dumitrescu, S, Podoleanu, C, Constantinescu, M, Bengus, C, Militaru, C, Rosu, D, Parepa, I, Matei, A, Alexandru, T, Malis, M, Coman, I, Stanescu-Cioranu, R, Dimulescu, D, Shvarts, Y, Orlikova, O, Kobalava, Z, Barbarash, O, Markov, V, Lyamina, N, Gordienko, A, Zrazhevsky, K, Vishnevsky, A, Gurevich, V, Stryuk, R, Lomakin, N, Bokarev, I, Khlevchuk, T, Shalaev, S, Khaisheva, L, Chizhov, P, Viktorova, I, Osokina, N, Shchekotov, V, Akatova, E, Chumakova, G, Libov, I, Voevoda, M, Tretyakova, T, Baranov, E, Shustov, S, Yakushin, S, Gordeev, I, Khasanov, N, Reshetko, O, Sotnikova, T, Molchanova, O, Nikolaev, K, Gapon, L, Baranova, E, Shogenov, Z, Kosmachova, E, Povzun, A, Egorova, L, Tyrenko, V, Ivanov, I, Ilya, M, Kanorsky, S, Simic, D, Ivanovic, N, Davidovic, G, Tasic, N, Asanin, M, Stojic, S, Apostolovic, S, Ilic, S, Putnikovic Tosic, B, Stankovic, A, Arandjelovic, A, Radovanovic, S, Todic, B, Balinovac, J, Dincic, D, Seferovic, P, Karadzic, A, 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Fernandez, J, Garcia Lledo, J, Cosin Sales, J, Botas Rodriguez, J, Gusi Tragant, G, Benedicto, A, Gonzalez-Juanatey, C, Camprubi Potau, M, Plaza Perez, I, De La Tassa, C, Loma-Osorio Rincon, P, Balaguer Recena, J, Escudier, J, Payeras, A, Alonso Orcajo, N, Valdivielso, P, Constantine, G, Haniffa, R, Tissera, N, Amarasekera, S, Ponnamperuma, C, Fernando, N, Fernando, K, Jayawardena, J, Wijeyasingam, S, Ranasinghe, G, Ekanayaka, R, Mendis, S, Senaratne, V, Mayurathan, G, Sirisena, T, Rajapaksha, A, Herath, J, Amarasena, N, Berglund, S, Rasmanis, G, Vedin, O, Witt, N, Mourtzinis, G, Nicol, P, Hansen, O, Romeo, S, Agergaard Jensen, S, Torstensson, I, Ahremark, U, Sundelin, T, Moccetti, T, Muller, C, Mach, F, Binde, R, Tsai, W, Ueng, K, Lai, W, Liu, M, Hwang, J, Yin, W, Hsieh, I, Hsieh, M, Kuo, J, Huang, T, Fang, C, Kaewsuwanna, P, Soonfuang, W, Jintapakorn, W, Sukonthasarn, A, Wongpraparut, N, Sastravaha, K, Sansanayudh, N, Kehasukcharoen, W, Piyayotai, D, Chotnoparatpat, P, Camsari, A, Kultursay, H, Mutlu, B, Ersanli, M, Demirtas, M, Kirma, C, Ural, E, Koldas, L, Karpenko, O, Prokhorov, A, Vakaluyk, I, Myshanych, H, Reshotko, D, Batushkin, V, Rudenko, L, Kovalskyi, I, Kushnir, M, Tseluyko, V, Mostovoy, Y, Stanislavchuk, M, Kyiak, Y, Karpenko, Y, Malynovsky, Y, Klantsa, A, Kutniy, O, Amosova, E, Tashchuk, V, Leshchuk, O, Rishko, M, Kopytsya, M, Yagensky, A, Vatutin, M, Bagriy, A, Barna, O, Ushakov, O, Dzyak, G, Goloborodko, B, Rudenko, A, Zheleznyy, V, Trevelyan, J, Zaman, A, Lee, K, Moriarty, A, Aggarwal, R, Clifford, P, Wong, Y, Iqbal, S, Subkovas, E, Braganza, D, Sarkar, D, Storey, R, Griffiths, H, Mcclure, S, Muthusamy, R, Smith, S, Kurian, J, Levy, T, Barr, C, Kadr, H, Gerber, R, Simaitis, A, Soran, H, Mathur, A, Brodison, A, Ayaz, M, Cheema, M, Oliver, R, Thackray, S, Mudawi, T, Rahman, G, Sultan, A, Sharman, D, Sprigings, D, Butler, R, Wilkinson, P, Lip, G, Halcox, J, Gallagher, S, Ossei-Gerning, N, Vardi, G, Baldari, D, Brabham, D, Treasure II, C, Dahl, C, Palmer, B, Wiseman, A, Puri, S, Mohart, A, Ince, C, Flores, E, Wright, S, Cheng, S, Rosenberg, M, Rogers, W, Kosinski, E, Forgosh, L, Waltman, J, Khan, M, Shoukfeh, M, Dagher, G, Cambier, P, Lieber, I, Kumar, P, East, C, Krichmar, P, Hasan, M, White, L, Knickelbine, T, Haldis, T, Gillespie, E, Amidon, T, Suh, D, Arif, I, Abdallah, M, Akhter, F, Carlson, E, D'Urso, M, El-Ahdab, F, Nelson, W, Moriarty, K, Harris, B, Cohen, S, Carter, L, Doty, D, Sabatino, K, Haddad, T, Malik, A, Rao, S, Mulkay, A, Jovin, I, Klancke, K, Malhotra, V, Devarapalli, S, Koren, M, Chandna, H, Dodds III, G, Goraya, T, Bengston, J, Janik, M, Moran, J, Sumner, A, Kobayashi, J, Davis, W, Yazdani, S, Pasquini, J, Thakkar, M, Vedere, A, Leimbach, W, Rider, J, Fenton, S, Singh, N, Shah, A, Janosik, D, Pepine, C, Berman, B, Gelormini, J, Daniels, C, Richard, K, Keating, F, Kondo, N, Shetty, S, Levite, H, Waider, W, Takata, T, Abu-Fadel, M, Shah, V, Izzo, M, Kumar, A, Hattler, B, Do, R, Link, C, Bortnick, A, Kinzfogl III, G, Ghitis, A, Larry, J, Teufel, E, Kuhlman, P, Mclaurin, B, Zhang, W, Thew, S, Abbas, J, White, M, Islam, O, Subherwal, S, Ranadive, N, Vakili, B, Gring, C, Henderson, D, Schuchard, T, Farhat, N, Kline, G, Mahal, S, Whitaker, J, Speirs, S, Andersen, R, Daboul, N, Horwitz, P, Zahr, F, Ponce, G, Jafar, Z, Mcgarvey, J, Panchal, V, Voyce, S, Blok, T, Sheldon, W, Azizad, M, Schmalfuss, C, Picone, M, Pederson, R, Herzog, W, Friedman, K, Lindsey, J, Nowins, R, Timothy, E, Leonard, P, Lepor, N, El Shahawy, M, Weintraub, H, Irimpen, A, Alonso, A, May, W, Christopher, D, Galski, T, Chu, A, Mody, F, Ramin, E, Hodes, Z, Rossi, J, Rose, G, Fairlamb, J, Lambert, C, Raisinghani, A, Abbate, A, Vetrovec, G, King, M, Carey, C, Gerber, J, Younis, L, Vidovich, M, Knutson, T, Friedman, D, Chaleff, F, Loussararian, A, Rozeman, P, Kimmelstiel, C, Kuvin, J, Silver, K, Foster, M, Tonnessen, G, Espinoza, A, Amlani, M, Wali, A, Malozzi, C, Jong, G, Massey, C, Wattanakit, K, O'Donnell, P, Singal, D, Jaffrani, N, Banuru, S, Fisher, D, Xenakis, M, Perlmutter, N, Bhagwat, R, Strader, J, Blonder, R, Akyea-Djamson, A, Labroo, A, Marais, H, Claxton, E, Weiss, R, Kathryn, R, Berk, M, Joshi, P, Khera, A, Khaira, A, Kumkumian, G, Lupovitch, S, Purow, J, Welka, S, Hoffman, D, Fischer, S, Soroka, E, Eagerton, D, Pancholy, S, Ray, M, Erenrich, N, Farrar, M, Pollock, S, French, W, Diamantis, S, Guy, D, Gimple, L, Neustel, M, Schwartz, S, Pereira, E, Albert, S, Spriggs, D, Strain, J, Mittal, S, Vo, A, Chane, M, Hall, J, Vijay, N, Lotun, K, Lester, F, Nahhas, A, Pope, T, Nager, P, Vohra, R, Sharma, M, Bashir, R, Ahmed, H, Berlowitz, M, Fishberg, R, Barrucco, R, Yang, E, Radin, M, Sporn, D, Stapleton, D, Eisenberg, S, Landzberg, J, Mcgough, M, Turk, S, Schwartz, M, Sundram, P, Jain, D, Zainea, M, Bayron, C, Karlsberg, R, Dohad, S, Lui, H, Keen, W, Westerhausen, D, Khurana, S, Agarwal, H, Birchem, J, Penny, W, Chang, M, Murphy, S, Henry, J, Schifferdecker, B, Gilbert, J, Chalavarya, G, Eaton, C, Schmedtje, J, Christenson, S, Dotani, I, Denham, D, Macdonell, A, Gibson, P, Rahman, A, Al Joundi, T, Assi, N, Conrad, G, Kotha, P, Love, M, Giesler, G, Rubenstein, H, Gamil, D, Akright, L, Krawczyk, J, Cobler, J, Wells, T, Welker, J, Foster, R, Gilmore, R, Anderson, J, Jacoby, D, Gardner, G, Dandillaya, R, Vora, K, Kostis, J, Hunter, J, Laxson, D, Ball, E, Egydio, F, Kawakami, A, Oliveira, J, Wozniak, J, Matthews, A, Ratky, C, Valiris, J, Berdan, L, Hepditch, A, Quintero, K, Rorick, T, Westbrook, M, Pascual, A, Rovito, C, Bezault, M, Drouet, E, Simon, T, Alsweiler, C, Luyten, A, Butters, J, Griffith, L, Shaw, M, Grunberg, L, Islam, S, Bregeault, M, Bougon, N, Faustino, D, Fontecave, S, Murphy, J, Verrier, M, Agnetti, V, Andersen, D, Badreddine, E, Bekkouche, M, Bouancheau, C, Brigui, I, Brocklehurst, M, Cianciarulo, J, Devaul, D, Domokos, S, Gache, C, Gobillot, C, Guillou, S, Healy, J, Heath, M, Jaiwal, G, Javierre, C, Labeirie, J, Monier, M, Morales, U, Mrabti, A, Mthombeni, B, Okan, B, Smith, L, Sheller, J, Sopena, S, Pellan, V, Benbernou, F, Bengrait, N, Lamoureux, M, Kralova, K, Scemama, M, Bejuit, R, Coulange, A, Berthou, C, Repincay, J, Lorenzato, C, Etienne, A, Gouet, V, Normand, M, Ourliac, A, Rondel, C, Adamo, A, Beltran, P, Barraud, P, Dubois-Gache, H, Halle, B, Metwally, L, Mourgues, M, Sotty, M, Vincendet, M, Cotruta, R, Chengyue, Z, Fournie-Lloret, D, Morrello, C, Perthuis, A, Picault, P, Zobouyan, I, Dempsey, M, Mcclanahan, M, ODYSSEY OUTCOMES Comm Investigato, and Ege Üniversitesi
- Subjects
Male ,BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences ,STATIN THERAPY ,blood-glucose ,Endocrinology, Diabetes and Metabolism ,GUIDELINES ,PCSK9 ,0302 clinical medicine ,Endocrinology ,GENETIC-VARIANTS ,Cardiovascular Disease ,Diabetes Complication ,Aged Antibodies, Monoclonal, Humanized / therapeutic use* Cardiovascular Diseases / blood Cardiovascular Diseases / prevention & control* Diabetes Complications / blood Diabetes Complications / prevention & control* Female Humans Male Middle Aged Substances ,Clinical endpoint ,Medicine ,guidelines ,030212 general & internal medicine ,Prediabetes ,Myocardial infarction ,myocardial-infarction ,genetic-variants ,statin therapy ,risk ,pcsk9 ,association ,liraglutide ,evolocumab ,RISK ,BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti ,BLOOD-GLUCOSE ,ASSOCIATION ,Middle Aged ,Cardiovascular Diseases ,Female ,Life Sciences & Biomedicine ,Human ,medicine.medical_specialty ,Acute coronary syndrome ,PCSK9 inhibitor ,acute coronary syndrome ,lipoprotein(a) ,low-density lipoprotein cholesterol ,030209 endocrinology & metabolism ,Antibodies, Monoclonal, Humanized ,Diabetes Complications ,Endocrinology & Metabolism ,03 medical and health sciences ,Diabetes mellitus ,Internal medicine ,Internal Medicine ,Humans ,Aged ,Alirocumab ,diabetes, PCSK9, hyperlipidemia ,Science & Technology ,ODYSSEY OUTCOMES Committees and Investigators ,business.industry ,Unstable angina ,EVOLOCUMAB ,medicine.disease ,MYOCARDIAL-INFARCTION ,LIRAGLUTIDE ,Human medicine ,business - Abstract
Doi, Yasuji/0000-0002-8368-0827; galvani, marcello/0000-0001-5897-667X; Gislason, Gunnar H/0000-0002-0548-402X; Taskinen, Marja-Riitta/0000-0002-6229-3588; Sherwood, Matthew/0000-0002-4305-5883; Malynovsky, Yaroslav V/0000-0002-9118-1104; Viktorova, vic-inna@mail.ru I.A./0000-0001-8728-2722; bastos, jose/0000-0002-9526-3123; Yang, Eric H/0000-0003-4889-7454; Rudenko, Anatoliy Viktorovich/0000-0003-1099-1613; Novotny, Vojtech/0000-0003-3521-9945; Nikolaev, Konstantin/0000-0003-4601-6203; Reshetko, Olga/0000-0003-3107-7636; Leonardi, Sergio/0000-0002-4800-6132; Muenzel, Thomas/0000-0001-5503-4150; Ushakov, Alexei V/0000-0002-7020-4442; Tse, Hung Fat/0000-0002-9578-7808; Podoleanu, Cristian/0000-0001-9987-2519; Raffel, Owen C/0000-0001-5470-7050; Khasanov, Niiaz/0000-0002-7760-0763; Chumakova, Galina A/0000-0002-2810-6531; Ersanli, Murat/0000-0003-1847-3087; cornel, jan hein/0000-0002-1006-2112; Abbate, Antonio/0000-0002-1930-785X; Racca, Vittorio/0000-0002-4465-3789; Urina-Triana, Miguel A/0000-0001-6003-4622; Rasputina, Lesia/0000-0003-1230-4039; Racca, Vittorio/0000-0002-4465-3789; Reis, Gilmar/0000-0002-4847-1034; Sandhu, Manjinder/0000-0003-2538-2079; Keskin, Kudret/0000-0002-9049-1530; PAREPA, IRINEL/0000-0002-7571-9015; Manakshe, Gajendra/0000-0002-4983-4271; Nicolau, Jose C/0000-0002-9680-3689; Strelnieks, Aldis/0000-0003-3493-2562; Budaj, Andrzej/0000-0002-6395-2098; Marin, Francisco/0000-0001-7246-7708; Wongpraparut, Nattawut/0000-0002-1541-3313; Yuan, Zuyi/0000-0002-4141-0298; Jeong, Myung Ho/0000-0003-2424-810X; Mostovoy, Yuriy/0000-0002-7041-1230; Pepine, Carl/0000-0002-6011-681X; Lopez-Jaramillo, Patricio/0000-0002-9122-8742; Garcia-Lledo, Alberto/0000-0002-8986-2584; Tesloianu, Nicolae-Dan/0000-0002-1007-3022; Kosmacheva, Elena/0000-0001-8600-0199; Kunz Sebba Barroso Souza, Weimar/0000-0002-1265-1930; Katz, Amos/0000-0003-0422-934X; Tunon, Jose/0000-0002-1373-0999; Acevedo, Monica/0000-0002-7989-6633; Hove, Jens/0000-0002-5600-5623; Yakushin, Sergey/0000-0001-7202-742X; Gonzalez Juanatey, Jose Ramon/0000-0001-9681-3388; Lyamina, Nadezhda/0000-0001-6939-3234; Aylward, Philip/0000-0002-5358-8552; Apostolovic, Svetlana/0000-0001-9015-297X; Airaksinen, Juhani/0000-0002-0193-568X; Nahhas, Prof. Dr. Ahmed/0000-0002-2887-8187; Barbarash, Olga/0000-0002-4642-3610, WOS: 000475553300016, PubMed: 31272931, Background After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1.4-1.8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes. Methods ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1-12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1: 1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0.65-1.30 mmol/L. in this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)-defined on the basis of patient history, review of medical records, or baseline HbA(1c) or fasting serum glucose-and risk of new-onset diabetes among those without diabetes at baseline. the primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission. ODYSSEY OUTCOMES is registered with ClinicalTrials. gov, number NCT01663402. Findings At study baseline, 5444 patients (28.8%) had diabetes, 8246 (43.6%) had prediabetes, and 5234 (27.7%) had normoglycaemia. There were no significant differences across glycaemic categories in median LDL cholesterol at baseline (2.20-2.28 mmol/L), after 4 months' treatment with alirocumab (0.80 mmol/L), or after 4 months' treatment with placebo (2.25-2.28 mmol/L). in the placebo group, the incidence of the primary endpoint over a median of 2.8 years was greater in patients with diabetes (16.4%) than in those with prediabetes (9.2%) or normoglycaemia (8.5%); hazard ratio (HR) for diabetes versus normoglycaemia 2.09 (95% CI 1.78-2.46, p, Sanofi; Regeneron Pharmaceuticals, Sanofi and Regeneron Pharmaceuticals.
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- 2019
17. Bone mineral density and TAVR outcome: A comparative analysis between patients with enhanced and non-enhanced TAVR CT scans.
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Demirel C, Hamzaraj K, Seeber A, Hemetsberger R, Koschatko S, Jantsch C, Halavina K, Dona C, Koschutnik M, Mascherbauer K, Heitzinger G, Dannenberg V, Nitsche C, Andreas M, Hengstenberg C, Bartko PE, and Kammerlander A
- Abstract
Background: Preprocedural evaluation, including frailty estimation, is crucial in managing patients undergoing Transcatheter Aortic Valve Replacement (TAVR). This involves mandatory computed tomography (CT) scans for assessing body composition parameters. The impact of low bone mineral density (BMD) on TAVR outcomes remains unclear, especially when measured using both non-enhanced and contrast-enhanced CT scans., Objectives: The purpose of this study was to evaluate the influence of low bone mineral density (BMD) on survival following TAVR and to assess the feasibility of BMD measurement conducted with non-enhanced and enhanced TAVR CT scans., Methods: A cohort of consecutive TAVR-scheduled patients (n = 725, November 2015 to March 2022) with available enhanced and non-enhanced CT scans were included. BMD was quantified on a single axial image at the thoracic vertebrae level in both unenhanced and enhanced CT scans, and low BMD was defined as <200 HU. Cox regression was performed for cofounders, which are mainly associated with osteoporosis., Results: A total of 725 patients were included in the study, with 54.1 % being male and a mean age of 80.7 ± 7.3 years. Out of these, 175 patients died during a median follow-up period of 837 days. Lower BMD in patients assessed using non-enhanced CT scans was significantly associated with reduced survival, even after adjusting for predictors of osteoporosis (p = 0.046). However, this association was not observed in patients who underwent contrast-enhanced CT scans (p = 0.830)., Conclusion: Opportunistic BMD measurements on non-enhanced TAVR-CT scans are feasible and a predictor for poor adverse after TAVR, providing valuable insights for comprehensive frailty assessments. This underscores the significance of incorporating non-enhanced BMD assessments into the preprocedural evaluations of TAVR patients. However, this association was not observed in contrast-enhanced CT scans., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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18. The Impact of Body Mass Index on the Mortality of Myocardial Infarction Patients With Nonobstructive Coronary Arteries.
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Dong C, Kacmaz M, Schlettert C, Abumayyaleh M, Akin I, Hemetsberger R, Mügge A, Aweimer A, Hamdani N, and El-Battrawy I
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- Humans, Male, Female, Middle Aged, Risk Factors, Retrospective Studies, Prognosis, Follow-Up Studies, Aged, Time Factors, Risk Assessment methods, Coronary Artery Disease mortality, Coronary Artery Disease complications, Survival Rate trends, Coronary Vessels diagnostic imaging, Coronary Angiography, MINOCA complications, MINOCA mortality, Body Mass Index, Hospital Mortality, Myocardial Infarction mortality, Myocardial Infarction complications
- Abstract
Objectives: Myocardial infarction without significant stenosis or occlusion of the coronary arteries carries a high risk of recurrent major adverse cardiovascular events and poor prognosis. This study aimed to investigate the association between body mass index and outcomes in patients with a suspected myocardial infarction with nonobstructive coronary artery disease (MINOCA)., Methods: Patients were recruited at Bergmannsheil University Hospital from January 2010 to April 2021. The primary outcomes were in-hospital and long-term mortality. Secondary outcomes consisted of adverse events during hospitalization and during follow-up., Results: A total of 373 patients were included in the study, with a mean follow-up time of 6.2 years. The patients were divided into different BMI groups: < 25 kg/m² (n = 121), 25-30 kg/m² (n = 140), and > 30 kg/m² (n = 112). In-hospital mortality was 1.7% versus 2.1% versus 4.5% (p = 0.368). However, long-term mortality tended to be higher in the < 25 kg/m² group compared to the 25-30 and > 30 kg/m² groups (log-rank p = 0.067). Subgroup analysis using Kaplan-Meier analysis showed a higher rate of cardiac cause of death in the < 25 kg/m² group compared to the 25-30 and > 30 kg/m² groups: 5.7% versus 1.1% versus 0.0% (log-rank p = 0.042). No significant differences were observed in other adverse events between the different BMI groups during hospitalization and long-term follow-up., Conclusions: Patients with a BMI < 25 kg/m² who experience a suspected myocardial infarction without significant coronary artery disease may have higher all-cause mortality and cardiovascular cause of death. However, further data are needed to confirm these findings., (© 2024 The Author(s). Clinical Cardiology published by Wiley Periodicals, LLC.)
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- 2024
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19. Calcified coronary lesions: Imaging, prognosis, preparation and treatment state of the art review.
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Power DA, Hemetsberger R, Farhan S, Abdel-Wahab M, Yasumura K, Kini A, and Sharma SK
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- Humans, Treatment Outcome, Predictive Value of Tests, Coronary Vessels diagnostic imaging, Coronary Vessels pathology, Coronary Angiography, Ultrasonography, Interventional, Percutaneous Coronary Intervention instrumentation, Vascular Calcification diagnostic imaging, Vascular Calcification therapy, Coronary Stenosis diagnostic imaging, Coronary Stenosis therapy, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Coronary Artery Disease diagnosis, Atherectomy, Coronary
- Abstract
Calcific coronary artery stenosis is a complex disease associated with adverse outcomes and suboptimal percutaneous treatment. Calcium plaque modification has emerged as a key strategy to tackle the issues that accompany calcific stenosis - namely reduced device deliverability, unpredictable lesion characteristics, and difficult dilatation. Atherectomy has traditionally been the treatment modality of choice for heavily calcified coronary stenoses. Contemporary technologies have emerged to aid with planning, preparation, and treatment of calcified coronary stenosis in an attempt to improve procedural success and long-term outcomes. In this State Of The Art Review, we synthesize the body of data surrounding the diagnosis, imaging, and treatment of calcific coronary disease, with a focus on i) intravascular imaging, ii) calcific lesion preparation, iii) treatment modalities including atherectomy, and iv) updated treatment algorithms for the management of calcified coronary stenosis., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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20. Prognostic Implications of Coronary Artery Sclerosis in Troponin-Positive Patients with Non-Obstructive Coronary Arteries.
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Kreimer F, Schlettert C, Abumayyaleh M, Akin I, Materzok D, Gotzmann M, Schiedat F, Bogossian H, Hijazi MM, Hamdani N, Mügge A, El-Battrawy I, Hemetsberger R, and Aweimer A
- Abstract
Introduction: Coronary sclerosis is a risk factor for the progression to obstructive coronary artery disease (CAD). However, understanding its impact on the outcomes of patients with myocardial infarction and non-obstructive coronary arteries is limited. This study aimed to explore the prognostic influence of coronary sclerosis on in- and out-of-hospital events in troponin-positive patients with non-obstructive coronary arteries., Methods: This study was a retrospective cohort analysis based on prospectively collected data. A total of 24,775 patients who underwent coronary angiography from 2010 to 2021 in a German university hospital were screened, resulting in a final study cohort of 373 troponin-positive patients with non-obstructive coronary arteries and a follow-up period of 6.2 ± 3.1 years. Coronary sclerosis was defined as coronary plaques without angiographically detectable stenotic lesions of 50% or more in the large epicardial coronary arteries. The primary study endpoint was the occurrence of in-hospital events. Secondary endpoints included events during follow-up., Results: Patients with coronary sclerosis were significantly older (70 ± 12 vs. 58 ± 16 years, p < 0.001), had ST-segment elevation less frequently on electrocardiogram (9.4% vs. 18.7%, p = 0.013), and suffered more often from diabetes mellitus (23.3% vs. 13.1%, p = 0.009), arterial hypertension (79.6% vs. 59.8%, p < 0.001), chronic obstructive pulmonary disease (17.1% vs. 9.4%, p = 0.028), chronic kidney disease (22.2% vs. 8.4%, p < 0.001), atrial fibrillation (19.8% vs. 12.2%, p = 0.045), and valvular diseases than patients without CAD. Patients with coronary sclerosis were more likely to receive medication for primary/secondary prevention on admission and at discharge. The incidence of in- and out-of-hospital events was significantly higher in patients with coronary sclerosis (in-hospital: 42.8% vs. 29.9%, p = 0.010; out-of-hospital: 46.0% vs. 26.1%, p < 0.001). Mortality rates tended to be higher in the coronary sclerosis group (29.4% vs. 20.0%, p = 0.066)., Conclusion: Patients diagnosed with coronary sclerosis presented a higher incidence of comorbidities and increased medication use, and experienced higher rates of both in-hospital and out-of-hospital events, primarily due to the clustering of cardiovascular risk factors., (© 2024. The Author(s).)
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- 2024
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21. In-hospital Outcomes of Rotational Atherectomy in ST-Elevation Myocardial Infarction: Results From the Multicentre ROTA-STEMI Network.
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Hemetsberger R, Mankerious N, Muntané-Carol G, Temporal J, Sulimov D, Gaede L, Woitek F, Grau EF, Scalamogna M, Olschewski M, Mitsis A, Ruzsa Z, Toth GG, Heyer H, Toelg R, Gómez-Hospital JA, Mügge A, Hengstenberg C, Mangner N, Gori T, Cassese S, Suárez XC, Abdel-Wahab M, Johnson T, Richardt G, and Allali A
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- Humans, Male, Female, Aged, Retrospective Studies, Treatment Outcome, Coronary Angiography methods, Europe epidemiology, Follow-Up Studies, Shock, Cardiogenic etiology, Shock, Cardiogenic surgery, Atherectomy, Coronary methods, ST Elevation Myocardial Infarction surgery, ST Elevation Myocardial Infarction diagnosis, Hospital Mortality trends, Percutaneous Coronary Intervention methods
- Abstract
Background: Although the use of rotational atherectomy (RA) is off-label in the setting of ST-elevation myocardial infarction (STEMI), it can be the only option in severely calcified culprit lesions to achieve procedural success. We sought to investigate the safety and feasibility of RA during primary percutaneous coronary intervention (PPCI)., Methods: This was a retrospective observational study of patients who underwent RA during PPCI from 12 European centres. The main outcomes were procedural success (defined as successful stent implantation with final thrombolysis in myocardial infarction [TIMI] flow 3 and residual stenosis < 30%) and in-hospital mortality. A comparison of patients presenting with and without shock was performed., Results: In 104 patients with RA during STEMI, the mean age was 72.8 ± 9.1 years, and 35% presented with cardiogenic shock. Bailout RA was performed in 76.9% of cases. Mean burr size was 1.42 ± 0.21 mm. Procedural success was achieved in 86.5% of cases, with no difference between shocked and nonshocked patients (94.4% vs 82.4%; P = 0.13). In-hospital stent thrombosis occurred in 0.96%, perforation in 1.9% and burr entrapment in 2.9% of cases. In spite of equally high procedural success, in-hospital mortality was higher in shocked (50%) compared with nonshocked patients (1.5%; P < 0.0001)., Conclusions: Patients presenting with STEMI requiring RA, represent a high-risk population, frequently presenting with cardiogenic shock. In this analysis of selected patients, RA was performed as a bailout strategy in the majority, and, as such, RA seems to be feasible with a high procedural success rate. In the absence of cardiogenic shock, RA-facilitated PCI seems to be associated with low in-hospital mortality., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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22. Clinical outcomes of single- versus two-stent PCI technique in severely calcified true bifurcation lesions after rotational atherectomy.
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Samy M, Alali A, Elbasha K, Amoey D, Hemetsberger R, Kandil N, Elawady M, Allali A, Nef H, Toelg R, Richardt G, and Mankerious N
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- Humans, Male, Female, Aged, Treatment Outcome, Retrospective Studies, Coronary Angiography, Time Factors, Coronary Vessels diagnostic imaging, Coronary Vessels surgery, Risk Factors, Aged, 80 and over, Middle Aged, Follow-Up Studies, Atherectomy, Coronary methods, Vascular Calcification diagnosis, Vascular Calcification surgery, Coronary Artery Disease surgery, Coronary Artery Disease diagnosis, Percutaneous Coronary Intervention methods, Stents, Severity of Illness Index
- Abstract
Background: Severely calcified coronary bifurcations complicate percutaneous coronary interventions (PCI) and often necessitate dedicated lesion preparation. We compared the outcomes of single- versus two-stent techniques for treating heavily calcified true bifurcation lesions following rotational atherectomy (RA)., Methods: Among patients receiving RA for severely calcified true bifurcations at a single center, 59 were treated with a single stent, and another 59 received two stents. We analyzed in-hospital adverse outcomes and 1-year rates of the bifurcation-oriented composite endpoint (BOCE), defined as cardiac death, target bifurcation myocardial infarction (TB-MI), or target bifurcation revascularization (TBR)., Results: The single-stent arm was associated with more in-hospital adverse outcomes (adj. OR, 6.13; 95% CI, 1.34-28.0; p = 0.019), driven by higher peri-procedural MI rates (18.6% vs. 5.1%, p = 0.043) and more side branch compromise (13.6% vs. 0%, p = 0.006). After 1 year, both techniques had comparable 1-year BOCE (adj. HR, 0.38; 95% CI, 0.12-1.23; p = 0.106). We observed a significant interaction between the treatment technique and the presence of LM bifurcation (p interaction = 0.012), favoring single-stent technique in patients with non-LM bifurcations (HR 0.14, 95% CI 0.03-0.68; p = 0.015). Notably, the single-stent technique had lower rates of TBR (2% vs. 15%, p log-rank = 0.026) after 1 year., Conclusion: Patients with severely calcified true bifurcation lesions, treated with RA followed by a single stent implantation, had more in-hospital adverse outcomes compared to those treated with two stents. However, the superior outcomes of the two-stent technique did not translate into improved long-term results. In fact, the two-stent technique was even associated with higher rates of revascularization after 1 year., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2024
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23. Incidence and pattern of urgent revascularization in acute coronary syndromes treated with ticagrelor or prasugrel.
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Aytekin A, Scalamogna M, Coughlan JJ, Lahu S, Ndrepepa G, Menichelli M, Mayer K, Wöhrle J, Bernlochner I, Witzenbichler B, Hochholzer W, Sibbing D, Angiolillo DJ, Hemetsberger R, Tölg R, Valina C, Müller A, Kufner S, Liebetrau C, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schüpke S, Kastrati A, and Cassese S
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- Humans, Male, Female, Middle Aged, Incidence, Treatment Outcome, Aged, Follow-Up Studies, Time Factors, Ticagrelor therapeutic use, Prasugrel Hydrochloride therapeutic use, Acute Coronary Syndrome therapy, Acute Coronary Syndrome surgery, Percutaneous Coronary Intervention methods, Platelet Aggregation Inhibitors therapeutic use
- Abstract
Background: The ISAR-REACT 5 trial compared the efficacy and safety of ticagrelor and prasugrel in patients with ACS managed invasively. The present study sought to investigate the impact of ticagrelor and prasugrel on the incidence and pattern of urgent revascularization in acute coronary syndromes (ACS) patients undergoing percutaneous coronary intervention (PCI)., Methods and Results: This post-hoc analysis of the ISAR-REACT 5 trial included all ACS patients who underwent PCI. The primary endpoint for this analysis was the incidence of urgent revascularization at 12-month follow-up. Secondary outcome was the pattern of urgent revascularization procedures (namely, urgent target vessel/non-target vessel revascularization - TVR/NTVR). Among 3,377 ACS patients who underwent PCI, 1,676 were assigned to ticagrelor and 1,701 to prasugrel before PCI. After 12 months, the incidence of urgent revascularization was higher among patients assigned to ticagrelor as compared to prasugrel (6.8% vs. 5.2%; hazard ratio [HR] = 1.32, 95% confidence interval [CI] 1.00-1.75; p = 0.051), mostly attributable to significantly more urgent NTVR in the ticagrelor group (3.8% vs. 2.4%; HR = 1.62 [1.09-2.41]; p = 0.017). The risk of urgent TVR did not differ between treatment groups (3.3% vs. 3.0%; HR = 1.13 [0.77-1.65]; p = 0.546)., Conclusions: In ACS patients treated with PCI, the cumulative rate of urgent revascularizations after 12 months is higher with ticagrelor compared to prasugrel, due to a significant increase in urgent revascularizations involving remote coronary vessels., (© 2024. The Author(s).)
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- 2024
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24. Low Bone Mineral Density on Computed Tomography: Association with Poor Survival after Transcatheter Aortic Valve Replacement.
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Demirel C, Halavina K, Hamzaraj K, Klement J, El-Shaer M, Hemetsberger R, Winter MP, Koschatko S, Jantsch C, Andreas M, Loewe C, Kammerlander A, Hengstenberg C, and Bartko PE
- Abstract
Background: Transcatheter aortic valve replacement (TAVR) has evolved as first-line therapy for severe aortic valve stenosis (AS), with pre-procedural computed tomography (CT) providing critical anatomical information. While primarily used for anatomical planning, TAVR-CT also offers an opportunity to assess low bone mineral density (BMD), a known indicator of frailty. Despite this, the prognostic role of BMD in TAVR patients remains unknown. This study aimed to evaluate BMD on routine TAVR-CT and its impact on long-term survival. Methods: In this retrospective study, 770 consecutive TAVR patients (mean age 80.7 ± 6.7 years, 54.0% males) between November 2015 and March 2022 were included. BMD was measured from a single axial image at the thoracic vertebral level on unenhanced CT scans. Cox regression models assessed the impact of BMD on mortality, and Restricted Cubic Spline models identified potential mortality thresholds. Results: The mean BMD value, as measured on non-contrast CT, was 147.5 ± 5.4 Hounsfield units, demonstrating a noteworthy association with mortality (adjusted hazard ratio per 100 HU decrease: 1.27 [95%CI: 1.01-1.59], p = 0.041). Restricted cubic spline analysis indicated that BMD below 200 HU was linked to a substantial increase in mortality risk. Upon crude Cox regression analysis, every 100 HU decrease was associated with a 32% increase in risk for death (HR 1.32 [95%CI: 1.068-1.65)], p = 0.010). Conclusions: In conclusion, low BMD on TAVR-CT is independently associated with reduced survival, suggesting its potential as a tool for comprehensive frailty assessment and improved risk prediction in TAVR patients.
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- 2024
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25. Intracoronary delivery of extracellular vesicles from human cardiac progenitor cells reduces infarct size in porcine acute myocardial infarction.
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Emmert MY, Burrello J, Wolint P, Hilbe M, Andriolo G, Balbi C, Provasi E, Turchetto L, Radrizzani M, Nazari-Shafti TZ, Cesarovic N, Neuber S, Falk V, Hoerstrup SP, Hemetsberger R, Gyöngyösi M, Barile L, and Vassalli G
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- Humans, Swine, Animals, Coronary Vessels, Stem Cells, Myocardial Infarction therapy, Extracellular Vesicles
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- 2024
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26. Gelatin Powder Solution Seals Aortic Root Perforation During Complex Percutaneous Coronary Intervention.
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Hamzaraj K, Kammerlander A, Gerges C, Hemetsberger R, Lang IM, and Frey B
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- Humans, Powders, Aorta, Thoracic, Treatment Outcome, Gelatin, Percutaneous Coronary Intervention adverse effects
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- 2024
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27. Patients with higher-atherothrombotic risk vs. lower-atherothrombotic risk undergoing coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials.
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Hemetsberger R, Mankerious N, Toelg R, Abdelghani M, Farhan S, Garcia-Garica HM, Allali A, Windecker S, Lefèvre T, Saito S, Kandzari D, Waksman R, and Richardt G
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- Humans, Absorbable Implants, Everolimus, Polymers, Prosthesis Design, Sirolimus, Treatment Outcome, Coronary Artery Disease diagnosis, Coronary Artery Disease surgery, Drug-Eluting Stents, Myocardial Infarction etiology, Percutaneous Coronary Intervention adverse effects
- Abstract
Background: Patients with atherothrombotic risk are at high hazard of ischemic events. Preventive medicine plays a major role in modifying their outcomes. Whether the choice of a BP-SES or DP-EES can contribute to the occurrence of events remains unclear. We sought to investigate the outcomes of patients with higher atherothrombotic risk (H-ATR) versus lower atherothrombotic risk (L-ATR) undergoing percutaneous coronary intervention (PCI) with either bioresorbable-polymer sirolimus-eluting stent (BP-SES) or durable-polymer everolimus-eluting stent (DP-EES)., Methods: Patients (n = 2361) from BIOFLOW-II, -IV, and -V randomized trials were categorized into H-ATR vs. L-ATR. L-ATR patients had ≤ 1 and H-ATR ≥ 2 of the following criteria: presentation in ACS, diabetes mellitus, previous myocardial infarction, previous PCI/CABG, or previous stroke. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], target lesion revascularization [TLR]) and stent thrombosis (ST) at three years., Results: H-ATR patients (n = 1023) were more morbid than L-ATR patients (n = 1338). TLF rate was significantly higher in H-ATR patients as compared with L-ATR (11.6% vs. 7.0%; HR 1.67, 95% CI 1.27-2.20, p < 0.0001). With BP-SES TLF rates were numerically lower as compared with DP-EES in H-ATR (10.5% vs. 13.5%; HR 0.78, 95% CI 0.54-1.14, p = 0.20) and significantly lower in L-ATR (5.6% vs. 9.8%; HR 0.57, 95% CI 0.38-0.85, p = 0.006)., Conclusion: In the era of newer-generation DES, patients with H-ATR still are at hazard for ischemic events. Patients with BP-SES had lower TLF rates as compared with DP-EES, most consistent in L-ATR whereas in H-ATR patients most probably secondary preventive strategies are of higher value., Clinical Trial Registration: Clinicaltrial.gov. NCT01356888, NCT01939249, NCT02389946. https://clinicaltrials.gov/show/NCT01356888 , https://clinicaltrials.gov/show/NCT01939249 , https://clinicaltrials.gov/show/NCT02389946 ., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)
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- 2023
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28. Rotational atherectomy of calcified coronary lesions: current practice and insights from two randomized trials.
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Allali A, Abdel-Wahab M, Elbasha K, Mankerious N, Traboulsi H, Kastrati A, El-Mawardy M, Hemetsberger R, Sulimov DS, Neumann FJ, Toelg R, and Richardt G
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- Humans, Coronary Angiography methods, Treatment Outcome, Randomized Controlled Trials as Topic, Retrospective Studies, Atherectomy, Coronary methods, Coronary Artery Disease diagnosis, Coronary Artery Disease surgery, Vascular Calcification diagnosis, Vascular Calcification surgery, Drug-Eluting Stents
- Abstract
With growing experience, technical improvements and use of newer generation drug-eluting stents (DES), recent data showed satisfactory acute and long-term results after rotational atherectomy (RA) in calcified coronary lesions. The randomized ROTAXUS and PREPARE-CALC trials compared RA to balloon-based strategies in two different time periods in the DES era. In this manuscript, we assessed the technical evolution in RA practice from a pooled analysis of the RA groups of both trials and established a link to further recent literature. Furthermore, we sought to summarize and analyze the available experience with RA in different patient and lesion subsets, and propose recommendations to improve RA practice. We also illustrated the combination of RA with other methods of lesion preparation. Finally, based on the available evidence, we propose a simple and practical approach to treat severely calcified lesions., (© 2022. The Author(s).)
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- 2023
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29. Short Versus Long-Term Dual Antiplatelet Therapy in Patients at High Bleeding Risk Undergoing PCI in Contemporary Practice: A Systemic Review and Meta-analysis.
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Mankerious N, Megaly M, Hemetsberger R, Allali A, Samy M, Toelg R, Garcia S, and Richardt G
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Introduction: Patients at high bleeding risk (HBR patients) represent an important subset of patients undergoing percutaneous coronary intervention (PCI). It remains unclear whether a shortened duration of dual antiplatelet therapy (DAPT) confers benefits compared with prolonged duration of DAPT in this patient population. The aim of this study was to investigate and compare bleeding and ischemic outcomes among HBR patients receiving short- versus long-term DAPT after PCI., Methods: A meta-analysis of studies comparing short-term (1-3 months) and long-term (6-12 months) DAPT after PCI with second-generation drug-eluting stents in HBR patients was performed., Results: Six studies [1 randomized controlled trial (RCT), 2 RCT subanalyses, and 3 prospective propensity-matched studies] involving 15,908 patients were included in the meta-analysis. During a follow-up of 12 months, short-term DAPT was associated with a reduction in major bleeding events [odds ratio (OR) 0.63, 95% confidence interval (CI) 0.42-0.95; p = 0.03, I
2 = 71] and comparable definite/probable stent thrombosis, all-cause mortality, cardiovascular mortality, myocardial infarction (MI), and ischemic stroke, compared with long-DAPT. Single antiplatelet therapy (SAPT) with aspirin was comparable to SAPT with P2Y12 inhibitor, with no treatment-by-subgroup interaction for major bleeding events (p-interaction = 0.27). In studies including patients presenting with MI, a trend of more frequent MI was noted in the short-DAPT arm (OR 1.25, 95% CI 0.98-1.59; p = 0.07; I2 = 0). In a sensitivity analysis comparing 3- and 12-month DAPT, the 3-month DAPT strategy was associated with a higher risk of ischemic stroke (OR 2.37, 95% CI 1.15-4.87; p = 0.02, I2 = 0%)., Conclusion: Short-term DAPT after PCI in HBR patients was associated a reduction in major bleeding events and similar ischemic outcomes. However, a higher risk of ischemic stroke and MI at 1 year of follow-up was seen in some subsets., (© 2023. The Author(s).)- Published
- 2023
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30. Association between Platelet Count and Treatment Effect of Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.
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Koch T, Lahu S, Coughlan JJ, Cassese S, Voll F, Ndrepepa G, Menichelli M, Valina C, Hemetsberger R, Witzenbichler B, Bernlochner I, Joner M, Xhepa E, Mayer K, Kessler T, Laugwitz KL, Richardt G, Schunkert H, Angiolillo DJ, Sibbing D, Kastrati A, and Kufner S
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- Humans, Prasugrel Hydrochloride adverse effects, Ticagrelor adverse effects, Platelet Aggregation Inhibitors adverse effects, Platelet Count, Treatment Outcome, Hemorrhage chemically induced, Hemorrhage epidemiology, Acute Coronary Syndrome drug therapy, Acute Coronary Syndrome epidemiology, Percutaneous Coronary Intervention adverse effects
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Background: The relative efficacy and safety of ticagrelor and prasugrel based dual antiplatelet therapy strategies according to the platelet count (PC) in patients with acute coronary syndromes (ACS) have not been defined., Methods: This is a posthoc analysis of the ISAR-REACT 5 trial, in which patients presenting with ACS were randomized to treatment with ticagrelor versus prasugrel. Patients were divided into quartiles according to PC. The primary endpoint was incidence of death, myocardial infarction, or stroke, and the safety endpoint was incidence of BARC (Bleeding Academic Research Consortium) type 3 to 5 bleeding at 12 months., Results: A total of 3,943 patients with known PC (997 patients in quartile 1 (Q1), 1,003 in quartile 2 (Q2) [205 ± 10.3 × 10
9 /L], 961 patients in quartile 3 (Q3) [241 ± 11.7 × 109 /L], and 982 patients in quartile 4 (Q4) [317 ± 68.6 × 109 /L]). There was no significant interaction between treatment arm (ticagrelor vs. prasugrel) and PC group with respect to primary endpoint (Q1: 8.8 vs. 6.3%, hazard ratio [HR] =1.41, 95% confidence interval [CI]: 0.89-2.23; p = 0.148; Q2: 9.9 vs. 5.8%, HR = 1.68, 95% CI: 1.06-2.66; p = 0.027; Q3: 7.8 vs. 5.5%, HR = 1.43, 95% CI: 0.87-2.37; p = 0.159; Q4: 10.1 vs. 10.1%, HR = 1.05, 95% CI: 0.71-1.57; p = 0.799; p for interaction [ pint ] = 0.482) and with respect to bleeding endpoint (Q1: 5.8 vs. 4.2%, HR = 1.41, 95% CI: 0.76-2.63; p = 0.279; Q2: 6.4 vs. 3.7%, HR = 1.62, 95% CI: 0.85-2.06; p = 0.140; Q3: 4.4 vs. 3.0%, HR = 1.53, 95% CI: 0.73-3.18; p = 0.258; Q4: 5.6 vs. 8.5%, HR = 0.67, 95% CI: 0.40-1.14; p = 0.138, pint = 0.102)., Conclusions: In this analysis, incidences of ischemic and bleeding events at 12 months are comparable across quartiles of platelet count., Competing Interests: D.J.A. reports consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, and Sanofi; and research grants to his institution from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions, and Scott R. MacKenzie Foundation. H.S. reports honoraria from AstraZeneca, Bayer Vital, MSD SHARP&DOHME, Novartis, Servier, Sanofi-Aventis, Boehringer Ingelheim, Daiichi Sankyo, Amgen, and Pfizer, and consulting fees from AstraZeneca, Amgen, and MSD SHARP&DOHME. S.K. reports consulting and lecture fees from Astra Zeneca, Bristol-Myers Squibb, and Translumina. T.K. is named inventor on a patent application for prevention of restenosis after angioplasty and stent implantation outside the submitted work and received lecture fees from Bayer AG, Pharmaceuticals; M.J. reports speaker fees from Biotronik, personal fees from OrbusNeich, grants and personal fees from Boston Scientific, grants and personal fees from Edwards, personal fees from AstraZeneca, personal fees from Recor, grants from Amgen, not related to the current work., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)- Published
- 2023
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31. Ticagrelor or prasugrel in patients with acute coronary syndrome with off-hour versus on-hour presentation: a subgroup analysis of the ISAR-REACT 5 trial.
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Behnes M, Lahu S, Ndrepepa G, Menichelli M, Mayer K, Wöhrle J, Bernlochner I, Gewalt S, Witzenbichler B, Hochholzer W, Sibbing D, Cassese S, Angiolillo DJ, Hemetsberger R, Valina C, Müller A, Kufner S, Hamm CW, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Fusaro M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schüpke S, Kastrati A, and Akin I
- Subjects
- Humans, Prasugrel Hydrochloride adverse effects, Ticagrelor adverse effects, Platelet Aggregation Inhibitors adverse effects, Hemorrhage chemically induced, Hemorrhage epidemiology, Treatment Outcome, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome drug therapy, Myocardial Infarction drug therapy, Percutaneous Coronary Intervention
- Abstract
Objectives: To assess the efficacy and safety of ticagrelor versus prasugrel in patients with acute coronary syndrome (ACS) presenting during off- and on-hours., Background: The efficacy and safety of ticagrelor versus prasugrel in patients with ACS according to time of hospital presentation remain unknown., Methods: This post hoc analysis of the ISAR-REACT 5 trial included 1565 patients with ACS presenting off-hours and 2453 patients presenting on-hours, randomized to ticagrelor or prasugrel. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium (BARC) type 3-5 bleeding, both at 12 months., Results: The primary endpoint occurred in 80 patients (10.4%) in the ticagrelor group and 57 patients (7.3%) in the prasugrel group in patients presenting off-hours (hazard ratio [HR] = 1.45; 95% confidence interval [CI] 1.03-2.03; P = 0.033), and 104 patients (8.5%) in the ticagrelor group and 80 patients (6.7%) in the prasugrel group in patients presenting on-hours (HR = 1.29 [0.97-1.73]; P = 0.085), without significant treatment arm-by-presentation time interaction (P
int = 0.62). BARC type 3 to 5 bleeding occurred in 35 patients (5.1%) in the ticagrelor group and 37 patients (5.3%) in the prasugrel group (P = 0.84) in patients presenting off-hours, and 60 patients (5.9%) in the ticagrelor group and 43 patients (4.6%) in the prasugrel group in patients presenting on-hours (P = 0.17)., Conclusions: In patients with ACS planned to undergo an invasive treatment strategy, time of presentation (off-hours vs. on-hours) does not interact significantly with the relative efficacy and safety of ticagrelor vs. prasugrel., Clinical Trial Registration: NCT01944800., (© 2022. The Author(s).)- Published
- 2023
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32. The Target Vessel SYNTAX Score: A Novel Pre-Procedural Predictor for Contrast-Induced Acute Kidney Injury After Rotational Atherectomy.
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Mankerious N, Hemetsberger R, Samy M, Elbasha K, Kandil N, Elawady M, Toelg R, Abdel-Wahab M, Richardt G, and Allali A
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- Humans, Coronary Angiography adverse effects, Coronary Angiography methods, Contrast Media adverse effects, Stroke Volume, Ventricular Function, Left, Risk Factors, Atherectomy, Coronary adverse effects, Acute Kidney Injury chemically induced, Acute Kidney Injury diagnosis, Myocardial Infarction
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Background: Rotational atherectomy (RA) is a complex procedure often associated with high contrast load. Known risk scores do not predict contrast-induced acute kidney injury (CI-AKI) before RA. We aim to investigate pre-procedural predictors of CI-AKI after RA, and the role of the target vessel SYNTAX score (tvSS)., Methods: Among 295 patients who underwent RA between 01.2010 and 02.2019 at a single center, 49 developed CI-AKI. Those who were on chronic hemodialysis or with no available 48-h' kidney function tests were excluded. Predictors of CI-AKI were assessed in the whole cohort and those with no basal renal impairment., Results: The rate of CI-AKI was 16.6 %. The tvSS was 18 [14-23] vs. 12 [9-18] in patients with vs. without CI-AKI (p < 0.001). The tvSS cut-off value of 15 provided 75 % sensitivity and 60 % specificity for predicting CI-AKI. Consequently, a tvSS ≥15 emerged as an independent pre-procedural predictor for CI-AKI (adjusted OR: 4.94, 95 % CI: 2.38-10.20, p < 0.001), along with left ventricular ejection fraction (LVEF) ≤35 % (p = 0.016) and glomerular filtration rate (GFR) <45 ml/min (p = 0.004). TvSS was the only independent pre-procedural predictor for CI-AKI in patients with GFR ≥60 ml/min (p < 0.001). The contrast volume/GFR ratio and peri-procedural myocardial infarction (MI) were independent procedural predictors for CI-AKI in the whole cohort and in patients with basal GFR ≥60 ml/min., Conclusion: CI-AKI after RA is frequent. The tvSS is an efficient pre-procedural predictor for CI-AKI after RA, along with LVEF ≤35 % and GFR <45 ml/min. Contrast volume/GFR ratio and peri-procedural MI emerged as procedural predictors for CI-AKI., Competing Interests: Declaration of competing interest Dr. Hemetsberger received a speaker's honoraria from Boston Scientific. Dr. Abdel-Wahab reports that his hospital receives speaker's honoraria and/or consultancy fees on his behalf from Medtronic and Boston Scientific. Dr. Richardt received an institutional research grant from Boston Scientific. Dr. Allali is a proctor for Boston Scientific. The other authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2023
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33. Peri-Interventional Triple Therapy with Dabigatran Modifies Vasomotion after Bare-Metal Stent Implantation in a Pig Coronary Artery Model.
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Hemetsberger R, Farhan S, Lukovic D, Zlabinger K, Hajagos-Toth J, Bota J, Garcia-Garcia HM, Ay C, Samaha E, Gaspar R, Garamvölgyi R, Huber K, Spannbauer A, and Gyöngyösi M
- Abstract
(1) Background: Coronary artery stenting leads to local inflammation, disturbs vasomotion, and slows endothelialization, increasing vascular thrombus risk. We used a pig stenting coronary artery model to assess how peri-interventional triple therapy with dabigatran ameliorates these effects. (2) Methods: In a total of 28 pigs bare-metal stents were implanted. Four days before the percutaneous coronary intervention (PCI), we started 16 of the animals on dabigatran, maintained through 4 days after the procedure. As controls, the remaining 12 pigs received no therapy. In both groups, dual antiplatelet therapy (DAPT) (clopidogrel, 75 mg plus aspirin, 100 mg) was administered until animals were euthanized. Just after the PCI and on day 3 after the procedure, we performed optical coherence tomography (OCT) in eight animals in the dabigatran group and four controls and euthanized them. We followed the eight remaining animals in each group with OCT and angiography for one month before euthanizing them and performed in vitro myometry and histology on harvested coronary arteries from all animals. (3) Results: The dabigatran group showed a significantly increased vasoconstriction at 3 days after PCI (10.97 ± 3.85 mN vs. 7.32 ± 5.41 mN, p = 0.03), but we found no differences between endothelium-dependent and -independent vasodilatation. We also found no group differences in OCT, quantitative angiography, or histomorphometry findings. (4) Conclusions: Starting a short course of dabigatran just before PCI and continuing for a 3-day window along with usual post-PCI DAPT is associated with enhanced vasoconstriction after bare-metal stent implantation without reducing neointimal formation at one month.
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- 2023
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34. Long-Term Outcomes after Rotational Atherectomy for Calcified Chronic Total Occlusion versus Nonchronic Total Occlusion Coronary Lesions.
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Elbasha K, Mankerious N, Alawady M, Ibrahim G, Abdullah R, Abdel-Wahab M, Hemetsberger R, Toelg R, Richardt G, and Allali A
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- Humans, Middle Aged, Aged, Aged, 80 and over, Treatment Outcome, Risk Factors, Coronary Angiography, Chronic Disease, Atherectomy, Coronary adverse effects, Atherectomy, Coronary methods, Percutaneous Coronary Intervention adverse effects, Coronary Occlusion diagnostic imaging, Coronary Occlusion surgery, Coronary Occlusion etiology
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Background: The role of rotational atherectomy (RA) in contemporary percutaneous coronary intervention (PCI) is expanding to include certain chronic total occlusion (CTO) lesions. However, the long-term outcome of RA in CTOs is still unclear., Objective: To investigate in-hospital and long-term outcomes after RA for CTO compared to non-CTO calcified lesions. Moreover, this report evaluates the role of the elective RA approach in calcified CTOs., Methods and Results: This study enrolled 812 patients (869 lesions; CTO, n = 80 versus non-CTO, n = 789). The mean age of the study population was 73.1 ± 8.6 years, the baseline characteristics were comparable in both groups. Balloon-resistant CTO lesions represented the main indication for RA in CTO patients (61.2%). The mean J-CTO score was 2.42 ± 0.95. The angiographic success rate was lower in CTO patients (88.8% vs 94.9%; p = 0.022). In-hospital major adverse cardiac events (MACE) rate was comparable in both groups (CTO 8.8% vs 7.0% in non-CTO; p = 0.557). At two-year follow-up, a higher target lesion failure (TLF) was observed in CTO group (25.5% vs 15.1%, log rank p = 0.041), driven by higher cardiac mortality while the clinically driven target lesion revascularisation (TLR) was comparable between the study groups. Elective RA for CTO had a shorter procedural time and lower rate of dissection (7.5% vs 25%; p = 0.030) compared to bail-out RA with similar long-term outcomes., Conclusion: Compared to non-CTO, RA for CTO can be performed with a high procedural success rate and comparable in-hospital outcomes. Apart from higher cardiac mortality in the CTO group, the long-term outcomes are comparable in both groups. Elective RA is a feasible and beneficial approach to be used in CTO intervention., Competing Interests: M. Abdel-Wahab and G. Richardt report receiving an institutional research grant from Biotronik and St. Jude Medical. G. Richardt is an advisory board member for Abbott Vascular and Boston Scientific and reports receiving lecture fees from Abbott Vascular, Biotronik, Boston Scientific and Edwards Lifesciences. R. Toelg reports receiving honoraria for advisory board membership and lectures from Abbott Vascular and Biotronik. R. Hemetsberger received speaker's honoraria from Boston Scientific. A. Allali is a proctor for Boston Scientific. The other authors declare that they have no conflicts of interest., (Copyright © 2022 Karim Elbasha et al.)
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- 2022
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35. Prior Myocardial Infarction and Treatment Effect of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndromes - A Post-hoc Analysis of the ISAR-REACT 5 Trial.
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Lahu S, Scalamogna M, Ndrepepa G, Menichelli M, Valina C, Hemetsberger R, Witzenbichler B, Bernlochner I, Joner M, Xhepa E, Hapfelmeier A, Kufner S, Sager HB, Mayer K, Kessler T, Laugwitz KL, Richardt G, Schunkert H, Neumann FJ, Kastrati A, and Cassese S
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- Humans, Ticagrelor adverse effects, Prasugrel Hydrochloride adverse effects, Platelet Aggregation Inhibitors adverse effects, Hemorrhage chemically induced, Hemorrhage epidemiology, Treatment Outcome, Acute Coronary Syndrome therapy, Myocardial Infarction therapy, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention methods
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Background The efficacy and safety of ticagrelor versus prasugrel in patients with acute coronary syndrome and prior myocardial infarction (MI) remain unstudied. We aimed to assess the treatment effect of ticagrelor versus prasugrel according to prior MI status in patients with ACS. Methods and Results Patients with acute coronary syndrome planned for an invasive strategy and randomized to ticagrelor or prasugrel in the ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) 5 trial were included. The primary end point was the composite of 1-year all-cause death, MI, or stroke; the secondary safety end point was the composite of 1-year Bleeding Academic Research Consortium type 3 to 5 bleeding. The study included 4015 patients (prior MI=631 patients; no prior MI=3384 patients). As compared with patients without prior MI, the primary end point occurred more frequently in patients with prior MI (12.6% versus 7.2%; hazard ratio [HR], 1.78 [95% CI, 1.38-2.29]); the secondary safety end point appears to differ little between patients with and without prior MI (5.8% versus 5.7%, respectively; HR, 1.02 [95% CI, 0.71-1.45]). With regard to the primary end point, ticagrelor versus prasugrel was associated with an HR of 1.62 (95% CI, 1.03-2.55) in patients with prior MI and an HR of 1.28 (95% CI, 0.99-1.65) in patients without prior MI ( P
int =0.37). With regard to the secondary safety end point, ticagrelor versus prasugrel was associated with an HR of 1.28 (95% CI, 0.56-2.91) in patients with prior MI and an HR of 1.13 (95% CI, 0.82-1.55) in patients without prior MI ( Pint =0.79). Conclusions Patients with acute coronary syndrome and prior MI are at higher risk for recurrent ischemic but not bleeding events. Prasugrel is superior to ticagrelor in reducing the risk of ischemic events without a tradeoff in bleeding regardless of prior MI status. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.- Published
- 2022
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36. Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study.
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Allali A, Toelg R, Abdel-Wahab M, Hemetsberger R, Kastrati A, Mankerious N, Traboulsi H, Elbasha K, Rheude T, Landt M, Geist V, and Richardt G
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- Humans, Prospective Studies, Hospital Mortality, Coronary Angiography, Treatment Outcome, Atherectomy, Coronary adverse effects, Atherectomy, Coronary methods, Drug-Eluting Stents, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Coronary Artery Disease etiology, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary methods, Vascular Calcification diagnostic imaging, Vascular Calcification therapy, Vascular Calcification etiology
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Objectives: To evaluate the safety and efficacy of lesion preparation using rotational atherectomy (RA) with consecutive cutting balloon angioplasty (Rota-Cut)., Background: Whether the Rota-Cut combination improves stent performance in severely calcified coronary lesions is unknown., Methods: PREPARE-CALC-COMBO is a single-arm prospective trial in which 110 patients were treated with a Rota-Cut strategy before implantation of sirolimus-eluting stents and compared with patients treated with modified balloon (MB, scoring or cutting) or RA from a historical cohort (the randomized PREPARE-CALC trial). The study had two primary endpoints: in-stent acute lumen gain (ALG) by quantitative angiographic analysis and stent expansion (SE) on optical coherence tomography., Results: In-stent ALG was significantly higher with Rota-Cut compared to RA or MB alone (1.92 ± 0.45 mm vs. 1.74 ± 0.45 mm with MB vs. 1.70 ± 0.42 mm with RA; p = 0.001 and p < 0.001, respectively). SE was comparable between groups (75.1 ± 13.8% vs. 73.5 ± 13.3 with MB vs. 73.1 ± 12.2 with RA; p = 0.19 and p = 0.39, respectively). The Rota-Cut combination resulted in higher minimal stent area (MSA) (7.1 ± 2.2mm
2 vs. 6.1 ± 1.7mm2 with MB vs. 6.2 ± 1.9mm2 with RA; p = 0.003 and p = 0.004, respectively). In-hospital death occurred in one patient. Target vessel failure at 9 months was low and comparable between groups (8.2% vs. 8% with MB vs. 6% with RA; p = 1 and p = 0.79, respectively)., Conclusion: Rota-Cut combination resulted in higher ALG and larger MSA compared with historical control of RA or MB alone, but was not associated with higher SE. Despite extensive lesion preparation, this strategy is safe, feasible, and associated with favorable clinical outcome at 9 months., (© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)- Published
- 2022
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37. Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome and High Bleeding Risk.
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Lahu S, Presch A, Ndrepepa G, Menichelli M, Valina C, Hemetsberger R, Witzenbichler B, Bernlochner I, Joner M, Xhepa E, Hapfelmeier A, Kufner S, Rifatov N, Sager HB, Mayer K, Kessler T, Laugwitz KL, Richardt G, Schunkert H, Neumann FJ, Sibbing D, Angiolillo DJ, Kastrati A, and Cassese S
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- Humans, Hemorrhage chemically induced, Percutaneous Coronary Intervention adverse effects, Platelet Aggregation Inhibitors adverse effects, Treatment Outcome, Risk Assessment, Acute Coronary Syndrome drug therapy, Prasugrel Hydrochloride adverse effects, Ticagrelor adverse effects
- Abstract
Background: The relative efficacy and safety of more potent P2Y
12 inhibitors in patients with acute coronary syndrome and high bleeding risk (HBR) undergoing percutaneous coronary intervention remains unclear. We aimed to study the treatment effect of ticagrelor and prasugrel in percutaneous coronary intervention patients presenting with acute coronary syndrome and HBR., Methods: This post hoc analysis of the ISAR-REACT 5 trial (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) included patients with acute coronary syndrome undergoing percutaneous coronary intervention, randomized to ticagrelor or prasugrel, in whom HBR was defined as per Academic Research Consortium criteria. The primary (efficacy) end point was the composite of all-cause death, myocardial infarction, or stroke. The secondary (safety) end point was Bleeding Academic Research Consortium type 3 to 5 bleeding. Outcomes were assessed 12 months after randomization., Results: Out of the 3239 patients included in this analysis, 486 fulfilled the criteria for Academic Research Consortium-HBR definition (HBR group; ticagrelor, n=230 and prasugrel, n=256), while 2753 did not (non-HBR group; ticagrelor, n=1375 and prasugrel, n=1378). Compared with the non-HBR group, the HBR group had a higher risk for the primary (hazard ratio [HR]=3.57 [95% CI, 2.79-4.57]; P <0.001) and secondary end point (HR=2.94 [2.17-3.99]; P <0.001). In the HBR group, the primary (HR=1.09 [0.73-1.62]) and secondary (HR=1.18 [0.67-2.08]) end points were not significantly different between patients assigned to ticagrelor and prasugrel. In the non-HBR group, the primary end point (HR=1.62 [1.19-2.20]) occurred more frequently in patients assigned to ticagrelor as compared to patients assigned to prasugrel, without difference in safety (HR=1.08 [0.74-1.58]). There was no significant treatment allocation-by-HBR status interaction with respect to the primary ( P for interaction=0.12) or secondary ( P for interaction=0.80) end points., Conclusions: In patients with acute coronary syndrome undergoing percutaneous coronary intervention, HBR status increased both ischemic and bleeding risk without significant impact on the relative efficacy and safety of either ticagrelor or prasugrel. These results warrant confirmation in larger cohorts., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT01944800.- Published
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38. Pre-admission antiplatelet therapy and treatment effect of ticagrelor vs. prasugrel in patients with acute coronary syndromes-a subgroup analysis of the ISAR-REACT 5 trial.
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Lahu S, Ndrepepa G, Neumann FJ, Menichelli M, Bernlochner I, Richardt G, Wöhrle J, Witzenbichler B, Hemetsberger R, Mayer K, Akin I, Cassese S, Gewalt S, Xhepa E, Kufner S, Valina C, Sager HB, Joner M, Ibrahim T, Laugwitz KL, Schunkert H, Schüpke S, and Kastrati A
- Subjects
- Aspirin, Clopidogrel adverse effects, Hemorrhage chemically induced, Hemorrhage epidemiology, Humans, Platelet Aggregation Inhibitors adverse effects, Prasugrel Hydrochloride adverse effects, Ticagrelor adverse effects, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome drug therapy
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Aims: To assess whether the efficacy and safety of ticagrelor vs. prasugrel in patients with acute coronary syndromes (ACSs) are influenced by pre-admission treatment with aspirin and/or clopidogrel., Methods and Results: Patients (n = 4018) were categorized into two groups: pre-admission aspirin and/or clopidogrel group (n = 1455) and no pre-admission aspirin or clopidogrel group (n = 2563). The primary endpoint was the composite of all-cause death, myocardial infarction, or stroke; the secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3-5 bleeding, both at 1 year. Patients in the pre-admission aspirin and/or clopidogrel group had a higher risk of ischaemic events, but a similar risk of bleeding to patients in the no pre-admission aspirin or clopidogrel group (cumulative incidences 10.5% vs. 6.7%, and 5.7% vs. 5.7%, respectively). The primary endpoint occurred in 81/717 patients assigned to ticagrelor and 69/738 patients assigned to prasugrel in the pre-admission aspirin and/or clopidogrel group [11.5% vs. 9.5%; hazard ratio (HR) = 1.23; 95% confidence interval (CI) 0.89-1.69], and in 103/1295 patients assigned to ticagrelor and 68/1268 patients assigned to prasugrel in the no pre-admission aspirin or clopidogrel group [8.0% vs. 5.4%; HR = 1.50 (1.10-2.03); Pint = 0.38]. BARC type 3-5 bleeding events did not differ between ticagrelor and prasugrel in patients in the pre-admission aspirin and/or clopidogrel (6.2% vs. 4.5%) or no pre-admission aspirin or clopidogrel (5.3% vs. 5.1%) group (Pint = 0.54)., Conclusion: In patients with ACS, pre-admission therapy with aspirin and/or clopidogrel has no influence on the relative efficacy and safety of ticagrelor and prasugrel., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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39. Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions.
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Rheude T, Fitzgerald S, Allali A, Mashayekhi K, Gori T, Cuculi F, Kufner S, Hemetsberger R, Sulimov DS, Rai H, Ayoub M, Bossard M, Xhepa E, Fusaro M, Toelg R, Joner M, Byrne RA, Richardt G, Kastrati A, Cassese S, and Abdel-Wahab M
- Subjects
- Coronary Angiography, Humans, Treatment Outcome, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary methods, Atherectomy, Coronary adverse effects, Atherectomy, Coronary methods, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Drug-Eluting Stents, Vascular Calcification diagnostic imaging, Vascular Calcification therapy
- Abstract
Background: The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied., Objectives: This study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT)., Methods: Patient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization., Results: Among 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups., Conclusions: In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA., Competing Interests: Funding Support and Author Disclosures The PREPARE-CALC trial was an investigator-initiated trial, which was financed by the Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany. The ISAR-CALC trial was an investigator-initiated trial, which was supported by a research grant from SIS Medical AG and Boston Scientific. Dr Rheude has received speaker fees from SIS Medical AG. Dr Allali has received speaker/proctoring honoraria from Boston Scientific and Biotronik. Dr Cuculi has received speaker and consulting fees from Abbott Vascular and SIS Medical AG. Dr Kufner has received speaker and consulting fees from AstraZeneca, Bristol Myers Squibb, and Translumina not related to the current work. Dr Bossard has received speaker and consulting fees from Abbott Vascular and SIS Medical AG. Dr Joner has received lecture fees and research grants from Edwards Lifesciences and Boston Scientific; and is a consultant for Biotronik and Orbus Neich. Dr Byrne has received research funding to the institution from Abbott Vascular, Biosensors, and Boston Scientific. Dr Cassese has received lectures/proctoring honoraria from SIS Medical AG; and has received research funding to the institution from SIS Medical AG and Boston Scientific for the conduct of the ISAR-CALC trial. Dr Abdel-Wahab reports that his hospital received speaker honoraria and/or consulting fees on his behalf from Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2022
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40. Access Route and Clinical Outcomes After Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome Undergoing Invasive Treatment Strategy.
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Hemetsberger R, Richardt G, Lahu S, Valina C, Menichelli M, Abdelghani M, Wöhrle J, Toelg R, Witzenbichler B, Mankerious N, Liebetrau C, Bernlochner I, Hamm CW, Allali A, Joner M, Fusaro M, Xhepa E, Hapfelmeier A, Kufner S, Sager HB, Schüpke S, Laugwitz KL, Schunkert H, Neumann FJ, Kastrati A, and Cassese S
- Subjects
- Humans, Platelet Aggregation Inhibitors, Prasugrel Hydrochloride adverse effects, Ticagrelor adverse effects, Treatment Outcome, Acute Coronary Syndrome diagnostic imaging, Acute Coronary Syndrome drug therapy, Myocardial Infarction drug therapy, Percutaneous Coronary Intervention adverse effects
- Abstract
Background: Whether the access site influences the comparative efficacy and safety of ticagrelor and prasugrel in patients with acute coronary syndrome (ACS) undergoing invasive treatment strategy remains unstudied., Methods: This post-hoc analysis included ACS patients undergoing invasive treatment via radial or femoral access and randomized to either ticagrelor or prasugrel in the ISAR-REACT 5 trial. The primary efficacy endpoint was the composite of death, myocardial infarction (MI) or stroke, safety endpoint was BARC 3 to 5 bleeding. Outcomes were assessed out to 12 months after randomization., Results: Out of 4018 patients, 3984 underwent invasive treatment via radial or femoral access. 1479 had coronary angiography via radial access (ticagrelor, N = 748; prasugrel, N = 731) and 2505 via femoral access (ticagrelor, N = 1245; prasugrel, N = 1260). There was no interaction between access route and assignment to either ticagrelor or prasugrel regarding the primary efficacy or safety endpoints (P for interaction≥0.616). In the radial group, the primary efficacy endpoint (7.6% versus 5.8%, HR: 1.32 [0.88-1.97], P = 0.151) and the safety endpoint (4.3% versus 3.0%, HR: 1.36, [0.73-1.31], P = 0.300) were not statistically different in patients receiving either ticagrelor or prasugrel. In the femoral group, the primary efficacy endpoint occurred more frequently in patients assigned to ticagrelor as compared to prasugrel (10.3% versus 7.3%, HR: 1.44 [1.10-1.88], P = 0.006) without significant difference in terms of safety endpoint (6.4% versus 5.8%, HR: 1.14, [0.81-1.60], P = 0.470)., Conclusions: In patients with ACS undergoing an invasive treatment strategy, the access route does not influence the comparative efficacy and safety of ticagrelor and prasugrel., Clinical Trial Registration: NCT01944800., (Copyright © 2021. Published by Elsevier Inc.)
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- 2022
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41. Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials.
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Hemetsberger R, Abdelghani M, Toelg R, Garcia-Garcia HM, Farhan S, Mankerious N, Elbasha K, Allali A, Windecker S, Lefèvre T, Saito S, Kandzari D, Waksman R, and Richardt G
- Subjects
- Everolimus, Humans, Mitochondrial Proton-Translocating ATPases, Myocardial Infarction epidemiology, Polymers, Prosthesis Design, Randomized Controlled Trials as Topic, Sirolimus, Treatment Outcome, Coronary Artery Disease surgery, Drug-Eluting Stents, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention methods
- Abstract
Background: Patients undergoing complex percutaneous coronary intervention (PCI) are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation coronary stents., Aim: We sought to compare the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (DP-EES)., Methods: Patients (n = 2350) from BIOFLOW-II, -IV, and -V randomized trials were categorized into non-complex PCI vs. complex PCI. Complex PCI had at least one of the following criteria: multi-vessel PCI, ≥ 3 lesions treated, ≥ 3 stents implanted, total stent length ≥ 60 mm. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at three years., Results: Patients with complex PCI (n = 348) were older and presented more often with acute coronary syndrome than non-complex PCI patients (n = 2002). Complex PCI lesions were more often type B2/C and bifurcation lesions and required more pre- and post-dilatation. Complex PCI patients had higher rates of TLF (14.6% vs. 8.1%; aHR 1.89, 95% CI [1.31-2.73], p = 0.001), TV-MI (10.2% vs. 4.4%, aHR 2.17, 95% CI [1.40-3.37], p = 0.001), and ST (1.5% vs. 0.4%, p = 0.025) as compared with non-complex PCI. TLF was not lower with BP-SES as compared to DP-EES in complex PCI (12.6% vs 18.2%, p = 0.16)., Conclusion: Patients undergoing complex PCI with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI. This adverse outcome was not significantly modified by the stent platform (BP-SES vs. DP-EES)., Clinical Trial Registration: Clinicaltrial.gov NCT01356888, NCT01939249, NCT02389946, https://clinicaltrials.gov/show/NCT01356888 ; https://clinicaltrials.gov/show/NCT01939249 ; https://clinicaltrials.gov/show/NCT02389946 ., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)
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- 2022
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42. Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate Data.
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Gyöngyösi M, Pokushalov E, Romanov A, Perin E, Hare JM, Kastrup J, Fernández-Avilés F, Sanz-Ruiz R, Mathur A, Wojakowski W, Martin-Rendon E, Pavo N, Pavo IJ, Hemetsberger R, Traxler D, Spannbauer A, and Haller PM
- Abstract
Individual patient data (IPD)-based meta-analysis (ACCRUE, meta-analysis of cell-based cardiac studies, NCT01098591) revealed an insufficient effect of intracoronary cell-based therapy in acute myocardial infarction. Patients with ischemic heart failure (iHF) have been treated with reparative cells using percutaneous endocardial, surgical, transvenous or intracoronary cell delivery methods, with variable effects in small randomized or cohort studies. The objective of this meta-analysis was to investigate the safety and efficacy of percutaneous transendocardial cell therapy in patients with iHF. Two investigators extracted the data. Individual patient data (IPD) (n = 8 studies) and publication-based (n = 10 studies) aggregate data were combined for the meta-analysis, including patients (n = 1715) with chronic iHF. The data are reported in accordance with PRISMA guidelines. The primary safety and efficacy endpoints were all-cause mortality and changes in global ejection fraction. The secondary safety and efficacy endpoints were major adverse events, hospitalization and changes in end-diastolic and end-systolic volumes. Post hoc analyses were performed using the IPD of eight studies to find predictive factors for treatment safety and efficacy. Cell therapy was significantly (p < 0.001) in favor of survival, major adverse events and hospitalization during follow-up. A forest plot analysis showed that cell therapy presents a significant benefit of increasing ejection fraction with a mean change of 2.51% (95% CI: 0.48; 4.54) between groups and of significantly decreasing end-systolic volume. The analysis of IPD data showed an improvement in the NYHA and CCS classes. Cell therapy significantly decreased the end-systolic volume in male patients; in patients with diabetes mellitus, hypertension or hyperlipidemia; and in those with previous myocardial infarction and baseline ejection fraction ≤ 45%. The catheter-based transendocardial delivery of regenerative cells proved to be safe and effective for improving mortality and cardiac performance. The greatest benefit was observed in male patients with significant atherosclerotic co-morbidities.
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- 2022
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43. Lithoplasty-Facilitated Proximal Cap Penetration of a Calcified Chronic Total Occlusion Coronary Lesion.
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Elbasha K, Richardt G, Hemetsberger R, and Allali A
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We present a case of calcified chronic total occlusion of the left anterior descending coronary artery with ambiguous cap at the bifurcation with a large diagonal branch, in which intravascular lithoplasty balloon was used to modify the calcified proximal cap and facilitate wire crossing. ( Level of Difficulty: Advanced. )., Competing Interests: Dr Elbasha has received a scholarship from the Egyptian government. Dr Richardt has received institutional research grants from St Jude Medical, Biotronik, and Medtronic. Dr Hemetsberger has received honoraria from Boston Scientific. Dr Allali has consulted for Boston Scientific and Shockwave Medical., (© 2022 The Authors.)
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- 2022
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44. Impact of Prosthetic Valve Regurgitation Assessed by Echocardiography and Magnetic Resonance Imaging on Long-Term Clinical Outcomes after TAVR.
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Abdelghani M, Hemetsberger R, Landt M, Zachow D, Beurich HW, Toelg R, Abdel-Wahab M, Richardt G, and Merten C
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- Aortic Valve surgery, Echocardiography, Humans, Magnetic Resonance Imaging, Severity of Illness Index, Treatment Outcome, Aortic Valve Insufficiency diagnostic imaging, Aortic Valve Insufficiency etiology, Aortic Valve Insufficiency surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Background: Prosthetic valve regurgitation (PVR) impairs early and mid-term outcomes after transcatheter aortic valve replacement (TAVR). We explored the impact of PVR assessed by transthoracic echocardiography (TTE) and magnetic resonance imaging-regurgitation fraction (MRI-RF) on long-term clinical outcomes., Methods: PVR was assessed by TTE applying the Valve Academic Research Consortium criteria and MRI-RF (from velocity-encoded phase contrast magnetic resonance sequence) in 424 patients., Results: MRI-RF correlated modestly with the echocardiographic grades of PVR (Spearman's rank correlation coefficient = 0.32, p < 0.001). Using an MRI-RF ≥20% to define ≥ moderate PVR, echocardiography and MRI-RF agreed on PVR classification in 412 patients (97.2%; kappa statistic = 0.56, p < 0.001). Five-year mortality or reintervention was higher in patients with echocardiographic ≥ moderate PVR (83.3% vs. 45.0%, log rank p value = 0.002; HR [95% CI]: 3.18 [1.48-6.84]) as well as in patients with MRI-RF ≥20% (79.3% vs. 43.2%, log rank p value <0.001; HR [95% CI]: 2.68 [1.53-4.70]), while the outcomes of patients with echocardiographic mild PVR were not significantly different from those with none-trace PVR. In the two latter groups (echocardiographic < moderate PVR), MRI-RF ≥20% was associated with a significantly higher 5-year mortality or reintervention as compared with MRI-RF <20% (79.5% vs. 42.2%, log rank p value = 0.023; HR [95% CI]: 2.26 [1.10-4.65])., Conclusions: Greater than mild PVR as defined by TTE or MRI-RF is associated with impaired long-term clinical outcomes after TAVR. MRI-RF can be used to further risk-stratify patients with echocardiographic less-than-moderate PVR., (© 2022 S. Karger AG, Basel.)
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- 2022
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45. Imaging-Guided Transcatheter Aortic Valve Replacement and Percutaneous Coronary Intervention in Decompensated Severe Aortic Stenosis with Acute Renal Impairment.
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Elbasha K, Hemetsberger R, Richardt G, and Allali A
- Abstract
An 82-year-old woman with severe aortic valve stenosis (AS) and a significant proximal right coronary artery (RCA) stenosis presented with decompensated heart failure and acute kidney injury. She was treated with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) and trans-oesophageal echocardiography (TOE)-guided transcatheter aortic valve replacement (TAVR)., (© 2021. The Author(s).)
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- 2021
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46. Impact of Calcified Lesion Complexity on the Success of Percutaneous Coronary Intervention With Upfront High-Speed Rotational Atherectomy or Modified Balloons - A Subgroup-Analysis From the Randomized PREPARE-CALC Trial.
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Hemetsberger R, Toelg R, Mankerious N, Allali A, Traboulsi H, Sulimov DS, El-Mawardy M, Byrne RA, Robinson DR, Kastrati A, Abdel-Wahab M, and Richardt G
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- Coronary Angiography, Humans, Retrospective Studies, Treatment Outcome, Angioplasty, Balloon, Coronary, Atherectomy, Coronary adverse effects, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease surgery, Drug-Eluting Stents, Percutaneous Coronary Intervention adverse effects, Vascular Calcification diagnostic imaging, Vascular Calcification therapy
- Abstract
Background/purpose: In the randomized PREPARE-CALC trial, lesion preparation of calcified lesions with upfront rotational atherectomy (RA) prior to drug-eluting stent (DES) implantation resulted in higher acute success as compared to a provisional modified balloon (MB) strategy. We aimed to investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA., Methods/materials: Two hundred patients were randomized to lesion preparation with either MB or RA. The study population was stratified according to lesion complexity into at least one type-C lesion or into exclusively non-type-C lesions. Endpoints were strategy success, need for bail-out RA, acute lumen gain, and late lumen loss (LLL) at 9 months., Results: In total, 143 patients were graded as type-C (45% patients were allocated to MB), whereas 57 patients were graded as non-type-C (61% patients were allocated to MB). In patients with at least one type-C lesion, strategy success with RA was higher than with MB (97% vs 72%, p < 0.001), but superiority of RA was not observed in patients with non-type-C lesions (100% vs 97%, p = 1.00; p
interaction = 0.001). The need for bail-out RA was higher in patients with type-C lesions (n = 15) as compared with non-type-C lesions (n = 1). Acute lumen gain, LLL, and target lesion revascularization at 9 months were not dependent on lesion complexity and upfront lesion preparation strategy., Conclusions: In patients with calcified non-type-C lesions, the treatment strategy with RA or MB before DES implantation results in comparable success rates, whereas in type-C lesions upfront RA appears to be the superior upfront strategy., Competing Interests: Declaration of competing interest Dr. Hemetsberger reports speaker's honoraria from Boston Scientific. Drs. Toelg and Richardt report speaker's honoraria from Boston Scientific, Abbott Vascular, and Biotronik. Dr. Byrne reports Research funding to the institution of prior employment from Celonova Biosciences. Dr. Allali reports being a proctor for Boston Scientific. The other authors report no conflicts of interest., (Copyright © 2021 Elsevier Inc. All rights reserved.)- Published
- 2021
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47. Outcomes of patients treated with a biodegradable-polymer sirolimus-eluting stent versus durable-polymer everolimus-eluting stents after rotational atherectomy.
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Mankerious N, Hemetsberger R, Traboulsi H, Toelg R, Abdel-Wahab M, Richardt G, and Allali A
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- Absorbable Implants, Aged, Coronary Artery Disease surgery, Female, Follow-Up Studies, Humans, Male, Polymers chemistry, Prosthesis Design, Retrospective Studies, Treatment Failure, Treatment Outcome, Atherectomy, Coronary methods, Drug-Eluting Stents, Everolimus administration & dosage, Sirolimus administration & dosage
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Objective: To compare Orsiro biodegradable-polymer sirolimus-eluting stent (Orsiro BP-SES) with durable-polymer everolimus-eluting stent (DP-EES) regarding target lesion failure (TLF) after rotational atherectomy (RA), with a focus on small stents (diameter ≤ 3 mm) where Orsiro BP-SES has 60 µm strut thickness, while DP-EES remains with 81 µm strut thickness., Background: New-generation drug-eluting stent (DES) is superior to early-generation DES in all percutaneous coronary intervention (PCI) settings including RA. Recently, the Orsiro BP-SES was superior to a DP-EES in an all comer's population., Methods: Among patients who underwent RA at a single center, 121 were treated with Orsiro BP-SES and 164 with DP-EES (Promus and Xience). Those treated with other stent types, presenting with acute myocardial infarction or had a chronic total occlusion were excluded. Incidence of TLF was assessed., Results: After 2 years, the TLF rate in Orsiro BP-SES and DP-EES groups was 10% and 18%, respectively (adjusted HR 0.55, 95%CI 0.26-1.16, p = 0.115). The rate of TLF was significantly lower in small Orsiro BP-SES with ultra-thin struts as compared to DP-EES with the same diameters (adjusted HR 0.19, 95% CI 0.04-0.87, p = 0.032), driven by lower rates of clinically driven target lesion revascularization (log-rank p = 0.022). Age (p = 0.035), total stent length (p = 0.007) and diabetes mellitus (p = 0.011) emerged as independent predictors of TLF in the whole population., Conclusion: In the whole cohort, Orsiro BP-SES and DP-EES had comparable rates of long-term TLF after RA. In the small stent subgroup, the Orsiro BP-SES with ultra-thin struts showed significant lower rate of TLF at 2 years., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2021
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48. Ticagrelor or Prasugrel for Patients With Acute Coronary Syndrome Treated With Percutaneous Coronary Intervention: A Prespecified Subgroup Analysis of a Randomized Clinical Trial.
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Coughlan JJ, Aytekin A, Lahu S, Ndrepepa G, Menichelli M, Mayer K, Wöhrle J, Bernlochner I, Gewalt S, Witzenbichler B, Hochholzer W, Sibbing D, Cassese S, Angiolillo DJ, Hemetsberger R, Valina C, Müller A, Kufner S, Liebetrau C, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Fusaro M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schüpke S, and Kastrati A
- Subjects
- Acute Coronary Syndrome diagnosis, Female, Follow-Up Studies, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors therapeutic use, Retrospective Studies, Stents, Treatment Outcome, Acute Coronary Syndrome therapy, Clinical Decision-Making, Percutaneous Coronary Intervention methods, Prasugrel Hydrochloride therapeutic use, Ticagrelor therapeutic use
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Importance: It is unclear whether ticagrelor or prasugrel hydrochloride is superior for patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI)., Objective: To assess the safety and efficacy of ticagrelor vs prasugrel for patients with ACS treated with PCI., Design, Setting, and Participants: A prespecified analysis was performed of a postrandomization subgroup of 3377 patients who presented with ACS and were treated with PCI in the investigator-initiated, multicenter, phase 4, open-label Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5 randomized clinical trial, conducted from September 1, 2013, to February 28, 2018. Statistical analysis was performed from September 1, 2020, to January 30, 2021. Analysis was performed according to the intention-to-treat principle., Interventions: Patients were randomly assigned to a ticagrelor-based or prasugrel-based strategy. This analysis focuses on the subgroup of patients who underwent PCI that was formed after randomization., Main Outcomes and Measures: The primary end point was a composite consisting of all-cause death, myocardial infarction, or stroke at 12 months. The safety end point was Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding., Results: The ticagrelor group comprised 1676 patients (1323 men [78.9%]; mean [SD] age, 64.4 [12.0] years), and the prasugrel group comprised 1701 patients (1341 men [78.8%]; mean [SD] age, 64.7 [12.0] years). The primary end point occurred for 162 patients (9.8%) in the ticagrelor group and 120 patients (7.1%) in the prasugrel group (hazard ratio [HR], 1.41; 95% CI, 1.11-1.78; P = .005). Myocardial infarction occurred in 88 patients (5.3%) in the ticagrelor group compared with 55 patients (3.8%) in the prasugrel group (HR, 1.67; 95% CI, 1.19-2.34; P = .003). The safety end point, BARC type 3 to 5 bleeding, occurred in 84 of 1672 patients (5.3%) in the ticagrelor group and 78 of 1680 patients (4.9%) in the prasugrel group (HR; 1.10; 95% CI, 0.81-1.50; P = .54)., Conclusions and Relevance: Among patients presenting with ACS who were treated with PCI, the incidence of the primary composite end point occurred less frequently for patients who received prasugrel compared with those who received ticagrelor. The incidence of bleeding events was comparable between the 2 groups. These results suggest that, for patients presenting with ACS who undergo PCI, a prasugrel-based strategy is superior to a ticagrelor-based strategy. However, because these observations are based on a postrandomization subgroup, these findings should be regarded as hypothesis generating and dedicated randomized clinical trials may be warranted to confirm these findings., Trial Registration: ClinicalTrials.gov Identifier: NCT01944800.
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- 2021
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49. Feasibility and safety of minimal-contrast IVUS-guided rotational atherectomy for complex calcified coronary artery disease.
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Allali A, Traboulsi H, Sulimov DS, Abdel-Wahab M, Woitek F, Mangner N, Hemetsberger R, Mankerious N, Elbasha K, Toelg R, and Richardt G
- Subjects
- Acute Kidney Injury chemically induced, Aged, Aged, 80 and over, Contrast Media administration & dosage, Contrast Media adverse effects, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Feasibility Studies, Female, Glomerular Filtration Rate, Humans, Male, Percutaneous Coronary Intervention methods, Prospective Studies, Acute Kidney Injury prevention & control, Atherectomy, Coronary methods, Coronary Artery Disease surgery, Ultrasonography, Interventional methods
- Abstract
Objectives: To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI)., Methods: Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI., Results: Mean glomerular filtration rate was 32 ± 17 ml/min/1.73 m
2 . In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5 ml [Range 4-43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA., Conclusion: A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)- Published
- 2021
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50. Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome in Relation to Estimated Glomerular Filtration Rate.
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Wöhrle J, Seeger J, Lahu S, Mayer K, Bernlochner I, Gewalt S, Menichelli M, Witzenbichler B, Hochholzer W, Sibbing D, Cassese S, Angiolillo DJ, Hemetsberger R, Valina C, Kufner S, Xhepa E, Hapfelmeier A, Sager HB, Joner M, Richardt G, Laugwitz KL, Neumann FJ, Schunkert H, Schüpke S, Kastrati A, and Ndrepepa G
- Subjects
- Glomerular Filtration Rate, Humans, Platelet Aggregation Inhibitors adverse effects, Prasugrel Hydrochloride adverse effects, Prospective Studies, Ticagrelor adverse effects, Treatment Outcome, Acute Coronary Syndrome diagnostic imaging, Acute Coronary Syndrome drug therapy, Percutaneous Coronary Intervention adverse effects
- Abstract
Objectives: The aim of this study was to assess the safety and efficacy of ticagrelor versus prasugrel for patients with acute coronary syndrome (ACS) according to their estimated glomerular filtration rates (eGFRs)., Background: The outcomes of ticagrelor versus prasugrel in patients with ACS according to eGFR have not been defined., Methods: Patients (n = 4,012) were categorized into 3 groups: low eGFR (<60 mL/min/1.73 m
2 ), intermediate eGFR (≥60 and <90 mL/min/1.73 m2 ), and high eGFR (≥90 mL/min/1.73 m2 ). The primary endpoint was a composite of all-cause death, myocardial infarction, and stroke; the secondary safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding, both at 1 year., Results: Patients with low eGFRs had a higher risk for the primary endpoint compared with patients with intermediate eGFRs (adjusted HR: 1.89; 95% CI: 1.46-2.46]) and those with high eGFRs (adjusted HR: 2.33; 95% CI: 1.57-3.46). A risk excess for low eGFR was also observed for bleeding (adjusted HR: 1.55 [95% CI: 1.12-2.13] vs intermediate eGFR; adjusted HR: 1.59 [95% CI: 1.01-2.50] vs high eGFR). However, eGFR did not affect the relative efficacy and safety of ticagrelor versus prasugrel. In patients with low eGFR, the primary endpoint occurred in 20.5% with ticagrelor and in 14.7% with prasugrel (HR: 1.47; 95% CI: 1.04-2.08; P = 0.029); there was no significant difference in bleeding., Conclusions: These results show that among patients with ACS, reduction of eGFR is associated with increased risk for ischemic and bleeding events but has no significant impact on the relative efficacy and safety of ticagrelor versus prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800)., Competing Interests: Funding Support and Author Disclosures This research was supported by a grant (FKZ 81X1600501) from the German Center for Cardiovascular Research and Deutsches Herzzentrum München. Dr Angiolillo has received grants and personal fees from Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Janssen, Merck, Sanofi, and CeloNova; has received personal fees from Haemonetics, PhaseBio, PLx Pharma, Pfizer, The Medicines Company, and St. Jude Medical; and has received grants from CSL Behring, Eisai, Gilead, Idorsia Pharmaceuticals, Matsutani Chemical Industry, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. Dr Hochholzer has received personal fees from Bayer Vital, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Novartis, AstraZeneca, and The Medicines Company. Dr Kufner has received personal fees from Bristol Myers Squibb, AstraZeneca, and Translumina. Dr Sager has received grants from the European Research Council, Else-Kröner-Fresenius-Stiftung, Deutsche Herzstiftung, and Deutsche Forschungsgemeinschaft. Dr Neumann has received personal fees from Amgen, Boehringer Ingelheim, Daiichi-Sankyo, Novartis, and Ferrer; has received grants and personal fees from Pfizer, Biotronik, Edwards Lifesciences, Bayer Healthcare, and Boston Scientific; and has received grants from Medtronic and GlaxoSmithKline outside the submitted work. Dr Schüpke has received the Else Kröner memorial grant from Else Kröner-Fresenius Stiftung; has received financial support from the German Center for Cardiovascular Research; has received consulting fees from Bayer Vital; and has received lecture fees from Daiichi-Sankyo and Biopas Laboratories. Dr Sibbing has received personal fees from Daichi-Sankyo, Sanofi, AstraZeneca, Bayer, Pfizer, and Servier. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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