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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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L, Soots, M, Vahula, V, Hedman, A, Soopold, U, Martsin, K, Jurgenson, T, Kristjan, A, Helsinki, J, 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, Schmidt, E, Omran, H, Stellbrink, C, Dorsel, T, Lianopoulos, E, Vohringer, H, 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, 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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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, Park, H, Chae, I, Kim, M, Jeong, M, Rha, S, Kim, C, Hong, T, Tahk, S, 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, Kasim, S, Maskon, O, Kandasamy, B, Liew, H, Wan Mohamed, W, Garcia Castillo, A, Carrillo Calvillo, J, Fajardo Campos, P, Nunez Fragoso, J, Bayram Llamas, E, Alcocer Gamba, M, Carranza Madrigal, J, Gonzalez Salas, L, Lopez Rosas, E, Gonzalez Diaz, B, Salcido Vazquez, E, Nacoud 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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. Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery
- Author
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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
4. 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
5. 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
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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
6. A double resonance generator simulation using a hybrid approach
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Zainea, M., primary, Godoy, E., additional, Cormerais, H., additional, Buisson, J., additional, and Gueguen, H., additional
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- 2005
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7. Stabilizing control for power converters connected to transmission lines.
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Zainea, M., van der Schaft, A., and Buisson, J.
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- 2007
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8. Formal approach to compute hybrid automata models for linear physical systems with switches.
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Buisson, J., Cormerais, H., Zainea, M., Gueguen, H., and Godoy, E.
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- 2004
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9. Acute myocardial infarction in angiographically normal coronary arteries following induction of general anesthesia
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Zainea, M., primary
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- 1994
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10. Formal approach to compute hybrid automata models for linear physical systems with switches
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Buisson, J., primary, Cormerais, H., additional, Zainea, M., additional, Gueguen, H., additional, and Godoy, E., additional
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11. Aortic Valve Replacement: Do Hospital Location and Size Matter?
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Umeh, C., Gupta, R., Kaur, G., Dhawan, R., Eghreriniovo, B., Obi, J., Maguwudze, S., Mahdavian, P., Kumar, S., Zainea, M., and Mohan, J.
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AORTIC valve transplantation , *HOSPITAL size - Published
- 2024
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12. Trends and disparities in referral to cardiac rehabilitation after percutaneous coronary intervention.
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Aragam KG, Moscucci M, Smith DE, Riba AL, Zainea M, Chambers JL, Share D, and Gurm HS
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- 2011
13. 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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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
14. Anticoagulation and Antiplatelet Therapy for Prevention of Venous and Arterial Thrombotic Events in Critically Ill Patients With COVID-19: COVID-PACT.
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Bohula EA, Berg DD, Lopes MS, Connors JM, Babar I, Barnett CF, Chaudhry SP, Chopra A, Ginete W, Ieong MH, Katz JN, Kim EY, Kuder JF, Mazza E, McLean D, Mosier JM, Moskowitz A, Murphy SA, O'Donoghue ML, Park JG, Prasad R, Ruff CT, Shahrour MN, Sinha SS, Wiviott SD, Van Diepen S, Zainea M, Baird-Zars V, Sabatine MS, and Morrow DA
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- Humans, Critical Illness, Clopidogrel therapeutic use, Hemorrhage chemically induced, Anticoagulants adverse effects, Platelet Aggregation Inhibitors adverse effects, Treatment Outcome, COVID-19, Thrombosis drug therapy, Venous Thrombosis drug therapy, Venous Thrombosis epidemiology, Venous Thrombosis prevention & control
- Abstract
Background: The efficacy and safety of prophylactic full-dose anticoagulation and antiplatelet therapy in critically ill COVID-19 patients remain uncertain., Methods: COVID-PACT (Prevention of Arteriovenous Thrombotic Events in Critically-ill COVID-19 Patients Trial) was a multicenter, 2×2 factorial, open-label, randomized-controlled trial with blinded end point adjudication in intensive care unit-level patients with COVID-19. Patients were randomly assigned to a strategy of full-dose anticoagulation or standard-dose prophylactic anticoagulation. Absent an indication for antiplatelet therapy, patients were additionally randomly assigned to either clopidogrel or no antiplatelet therapy. The primary efficacy outcome was the hierarchical composite of death attributable to venous or arterial thrombosis, pulmonary embolism, clinically evident deep venous thrombosis, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically silent deep venous thrombosis, through hospital discharge or 28 days. The primary efficacy analyses included an unmatched win ratio and time-to-first event analysis while patients were on treatment. The primary safety outcome was fatal or life-threatening bleeding. The secondary safety outcome was moderate to severe bleeding. Recruitment was stopped early in March 2022 (≈50% planned recruitment) because of waning intensive care unit-level COVID-19 rates., Results: At 34 centers in the United States, 390 patients were randomly assigned between anticoagulation strategies and 292 between antiplatelet strategies (382 and 290 in the on-treatment analyses). At randomization, 99% of patients required advanced respiratory therapy, including 15% requiring invasive mechanical ventilation; 40% required invasive ventilation during hospitalization. Comparing anticoagulation strategies, a greater proportion of wins occurred with full-dose anticoagulation (12.3%) versus standard-dose prophylactic anticoagulation (6.4%; win ratio, 1.95 [95% CI, 1.08-3.55]; P =0.028). Results were consistent in time-to-event analysis for the primary efficacy end point (full-dose versus standard-dose incidence 19/191 [9.9%] versus 29/191 [15.2%]; hazard ratio, 0.56 [95% CI, 0.32-0.99]; P =0.046). The primary safety end point occurred in 4 (2.1%) on full dose and in 1 (0.5%) on standard dose ( P =0.19); the secondary safety end point occurred in 15 (7.9%) versus 1 (0.5%; P =0.002). There was no difference in all-cause mortality (hazard ratio, 0.91 [95% CI, 0.56-1.48]; P =0.70). There were no differences in the primary efficacy or safety end points with clopidogrel versus no antiplatelet therapy., Conclusions: In critically ill patients with COVID-19, full-dose anticoagulation, but not clopidogrel, reduced thrombotic complications with an increase in bleeding, driven primarily by transfusions in hemodynamically stable patients, and no apparent excess in mortality., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT04409834.
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- 2022
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15. Aortic Valve Leaflet Rupture Causing Delayed Left Main Coronary Ostial Obstruction During Valvuloplasty Preceding TAVR.
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Parekh A, Sengupta V, Hunyadi V, Ianitelli M, and Zainea M
- Abstract
A 69-year-old man with mediastinal radiation history underwent balloon valvuloplasty before transcatheter aortic valve replacement, which caused aortic leaflet rupture leading to unstable severe aortic regurgitation and subsequent left main ostial obstruction. A balloon-expanding valve was implanted to capture the ruptured leaflet and a left main stent was placed. ( Level of Difficulty: Advanced. )., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2021 The Authors.)
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- 2021
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16. A case report: percutaneous management of high-output heart failure from iatrogenic aortocoronary venous grafting to the coronary sinus.
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Parekh A, Sengupta V, Malek R, and Zainea M
- Abstract
Background: Aortocoronary arteriovenous fistula (ACAVF) due to iatrogenic bypass grafting to a cardiac vein is an exceedingly rare complication resulting from coronary artery bypass grafting (CABG) surgery. If not identified in a timely fashion, ACAVF has known significant clinical consequences related to left to right shunting and possible residual myocardial ischemia., Case Presentation: An 82-year-old male with a history of CABG, presented with dyspnea. Over the span of 2 years following CABG, the patient experienced progressive exertional dyspnea and peripheral edema. The patient was found to have a new cardiomyopathy with a severely reduced ejection fraction at 30-35%. The patient underwent diagnostic left heart catheterization, and an ACAVF was discovered between a saphenous vein graft and the coronary sinus. The patient underwent successful percutaneous coiling of the ACAVF with no residual flow. Follow-up echocardiography at 3 months revealed restoration of left ventricular systolic function to 50% and significant improvement in heart failure symptoms., Conclusions: ACAVF is an exceedingly rare iatrogenic complication of CABG that may result in residual ischemia from the non-grafted myocardial territory and other sequelae relating to left to right shunting and a high-output state. Management for this pathology includes but is not limited to the use of percutaneous coiling, implantation of covered stents, graft removal and regrafting, and ligation.
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- 2021
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17. Prevalence of coronary risk factors in contemporary practice among patients undergoing their first percutaneous coronary intervention: Implications for primary prevention.
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Gurm Z, Seth M, Daher E, Pielsticker E, Qureshi MI, Zainea M, Tucciarone M, Hanzel G, Henke PK, and Sukul D
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- Adult, Age Factors, Aged, Coronary Disease etiology, Coronary Disease surgery, Female, Humans, Male, Michigan epidemiology, Middle Aged, Obesity epidemiology, Prevalence, Sex Factors, Smoking epidemiology, Coronary Disease prevention & control, Heart Disease Risk Factors, Percutaneous Coronary Intervention statistics & numerical data, Primary Prevention methods
- Abstract
Background: Cigarette smoking, hypertension, dyslipidemia, diabetes, and obesity are conventional risk factors (RFs) for coronary artery disease (CAD). Population trends for these RFs have varied in recent decades. Consequently, the risk factor profile for patients presenting with a new diagnosis of CAD in contemporary practice remains unknown., Objectives: To examine the prevalence of RFs and their temporal trends among patients without a history of myocardial infarction or revascularization who underwent their first percutaneous coronary intervention (PCI)., Methods: We examined the prevalence and temporal trends of RFs among patients without a history of prior myocardial infarction, PCI, or coronary artery bypass graft surgery who underwent PCI at 47 non-federal hospitals in Michigan between 1/1/2010 and 3/31/2018., Results: Of 69,571 men and 38,930 women in the study cohort, 95.5% of patients had 1 or more RFs and nearly half (55.2% of women and 48.7% of men) had ≥3 RFs. The gap in the mean age at the time of presentation between men and women narrowed as the number of RFs increased with a gap of 6 years among those with 2 RFs to <1 year among those with 5 RFs. Compared with patients without a current/recent history of smoking, those with a current/recent history of smoking presented a decade earlier (age 56.8 versus 66.9 years; p <0.0001). Compared with patients without obesity, patients with obesity presented 4.0 years earlier (age 61.4 years versus 65.4 years; p <0.0001)., Conclusions: Modifiable RFs are widely prevalent among patients undergoing their first PCI. Smoking and obesity are associated with an earlier age of presentation. Population-level interventions aimed at preventing obesity and smoking could significantly delay the onset of CAD and the need for PCI., Competing Interests: Dr. Devraj Sukul and Mr. Milan Seth receive salary support from the Blue Cross Blue Shield of Michigan (BCBSM) for their work in BMC2. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The other authors do not have any direct conflicts or competing interest that could affect the study or its data presentation. The opinions, beliefs and viewpoints expressed by the authors do not necessarily reflect those of BCBSM or any of its employees.
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- 2021
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18. An unusual case report of stress-induced cardiomyopathy presenting as ventricular fibrillation cardiopulmonary arrest and third-degree atrioventricular block.
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Parekh A, Sengupta V, and Zainea M
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Background: Takotsubo cardiomyopathy (TCM) can clinically present as an acute coronary syndrome; however, the former has regional wall motion abnormalities that extend beyond a single coronary vascular territory without any plaque rupture. Takotsubo cardiomyopathy classically involves apical ballooning of left ventricle (LV). It is uncommon for TCM to present as cardiopulmonary arrest (CPA) along with third-degree atrioventricular (AV) block., Case Summary: A 63-year-old female, underwent a ventricular fibrillation (VF) CPA. She was defibrillated three times and return of spontaneous circulation (ROSC) was achieved after 37 min. Her post-ROSC electrocardiogram showed non-specific ST-segment changes and T-wave inversions and soon progressed to third-degree AV block. Patient had a transvenous pacemaker placed to pace her heart. Echocardiogram showed an LV ejection fraction of 15-20% with akinesis of the apex and anteroseptum. An echocardiogram repeated 4 days after the cardiopulmonary arrests showed an ejection fraction of 60-65% with hypokinesis of mid anterior and antero-apical hypokinesis. However, the patient still continued to require a pacemaker and hence eventually received a dual-chamber pacemaker/implantable cardioverter-defibrillator for her AV block and ventricular arrhythmia., Discussion: Most commonly TCM presents with chest pain and symptoms of acute myocardial infarction. We present a very rare presentation of TCM associated with VF and CPA along with third-degree AV block. There have handful of case reports documenting TCM causing CPA in some patients and other case reports showing TCM causing high degree AV block. In our patient, TCM was associated with both VF and CPA along with third-degree AV block., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2021
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19. Clinical outcomes of percutaneous coronary intervention in patients turned down for surgical revascularization.
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Sukul D, Seth M, Dixon SR, Zainea M, Slocum NK, Pielsticker EJ, and Gurm HS
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- Aged, Clinical Decision-Making, Contrast Media adverse effects, Female, Hospital Mortality, Humans, Kidney Diseases chemically induced, Kidney Diseases therapy, Male, Michigan, Middle Aged, Myocardial Ischemia diagnostic imaging, Myocardial Ischemia mortality, Myocardial Ischemia surgery, Patient Safety, Patient Selection, Registries, Renal Dialysis, Retrospective Studies, Risk Assessment, Risk Factors, Shock, Cardiogenic etiology, Stroke etiology, Time Factors, Treatment Outcome, Coronary Artery Bypass adverse effects, Eligibility Determination, Myocardial Ischemia therapy, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality
- Abstract
Objectives: We examined clinical outcomes following percutaneous coronary intervention (PCI) in patients turned down for surgical revascularization across a broad population., Background: Prior studies suggest that surgical ineligibility is associated with increased mortality in patients with unprotected left main or multivessel coronary artery disease undergoing PCI., Methods: This study included consecutive patients who underwent PCI in a multicenter registry in Michigan from January 2010 to December 2014. Surgical ineligibility required documentation indicating that a cardiac surgeon deemed the patient ineligible for surgery. In-hospital outcomes included mortality (primary outcome), cardiogenic shock, cerebrovascular accident, contrast-induced nephropathy (CIN), and a new requirement for dialysis (NRD)., Results: Of 99,370 patients at 33 hospitals with on-site surgical backup, 1,922 (1.9%) were surgically ineligible. The rate of ineligibility did not vary by hospital (range: 1.5-2.5%; P = 0.79). Overall, there were no major differences in baseline characteristics or outcomes between surgically ineligible patients and the rest (i.e., nonineligible patients): mortality (0.52% vs. 0.52%; P > 0.5), cardiogenic shock (0.68% vs. 0.73%; P > 0.5), cerebrovascular accident (0.05% vs. 0.19%; P = 0.28), NRD (0.16% vs. 0.19%; P > 0.5), CIN (2.7% vs. 2.3%; P = 0.27). Among 1,074 patients who underwent unprotected left main PCI, 20 (1.9%) were surgically ineligible and experienced increased rates of mortality (20.0% vs. 5.3%; P = 0.022; adjusted OR = 7.38; P < 0.001) and other complications as compared to the remainder., Conclusions: PCI in a broad population of surgically ineligible patients is generally safe. However, among patients who underwent unprotected left main PCI, those deemed surgically ineligible experienced significantly worse outcomes as compared to the rest. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)
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- 2017
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20. Underutilization of Radial Access in Patients Undergoing Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.
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Howe MJ, Seth M, Riba A, Hanzel G, Zainea M, and Gurm HS
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- Aged, Blue Cross Blue Shield Insurance Plans, Databases, Factual, Female, Health Services Misuse, Humans, Male, Michigan, Middle Aged, Percutaneous Coronary Intervention methods, Prospective Studies, Registries, Catheterization, Peripheral trends, Myocardial Infarction therapy, Percutaneous Coronary Intervention statistics & numerical data, Radial Artery
- Abstract
Background: The purpose of this study was to evaluate the frequency and temporal trends in use of transradial access (TRA) for percutaneous coronary intervention (PCI) in ST-segment-elevation myocardial infarction (STEMI). The use of TRA has been associated with less bleeding and improved clinical outcomes in patients undergoing PCI for STEMI., Methods and Results: The frequency of TRA compared with transfemoral access for patients undergoing PCI for STEMI or other indications (non-ST-segment-elevation myocardial infarction, unstable angina, and non-acute coronary syndrome) in The Blue Cross Blue Shield of Michigan Cardiovascular Consortium database between 2010 and 2013 was evaluated. Propensity matching was used to assess the relationship of TRA with in-hospital clinical end points of major bleeding, transfusion, and death. The TRA cohort of patients was stratified into deciles based on their predicted bleeding risk and compared with PCI indication. Of 122,728 PCI procedures, 17,912 (14.6%) were via TRA. Among patients with STEMI cases, 8.3% of the PCI cases were performed via TRA. The use of TRA increased over the study period although the growth was slower for STEMI than for other indications, P<0.001. The use of TRA for PCI in STEMI was associated with a lower rate of bleeding (11.7% versus 20.0%; P<0.001) and vascular complications (0.7% versus 2.6%; P=0.001), but no mortality difference (1.25% versus 2.33%; P=0.175). There was a strong negative association between the predicted risk of bleeding and the use of TRA (P<0.001)., Conclusions: The use of radial access for PCI in STEMI is increasing but at a slower pace than for patients with other indications. TRA was associated with a reduction in bleeding and transfusion, but there is a strong negative correlation between the predicted risk of bleeding and actual use of TRA in STEMI., (© 2015 American Heart Association, Inc.)
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- 2015
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21. Spontaneous echocardiographic contrast in the descending thoracic aorta.
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Zainea MA, Karamali AM, Grinberg I, Lee H, and Duvernoy WF
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- Aged, Heart Valve Diseases diagnostic imaging, Humans, Male, Aorta, Thoracic diagnostic imaging, Echocardiography, Transesophageal
- Abstract
Spontaneous echocardiographic contrast (SEC) is an occasional finding observed in the atria in patients undergoing transesophageal echocardiographic studies, but has rarely been described in the descending thoracic aorta in the absence of an aortic dissection. The pathophysiology of SEC in the cardiac and vascular structures appears to be related to an interaction between red blood cells and plasma proteins in the setting of a low flow state. In this report we present three cases of SEC in the descending thoracic aorta, with one of the cases of SEC resolving with repair of his underlying cardiac disorder.
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- 1996
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