894 results on '"Harrington RA"'
Search Results
2. Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI.
- Author
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Povsic, TJ, Korjian, S, Bahit, MC, Chi, G, Duffy, D, Alexander, JH, Vinereanu, D, Tricoci, P, Mears, SJ, Deckelbaum, LI, Bonaca, M, Ridker, PM, Goodman, SG, Cornel, JH, Lewis, BS, Parkhomenko, A, Lopes, RD, Aylward, P, Lincoff, AM, Heise, M, Sacks, F, Nicolau, JC, Merkely, B, Trebacz, J, Libby, P, Nicholls, SJ, Pocock, S, Bhatt, DL, Kastelein, J, Bode, C, Mahaffey, KW, Steg, PG, Tendera, M, Bainey, KR, Harrington, RA, Mehran, R, Duerschmied, D, Kingwell, BA, Gibson, CM, AEGIS-II Committees and Investigators, Povsic, TJ, Korjian, S, Bahit, MC, Chi, G, Duffy, D, Alexander, JH, Vinereanu, D, Tricoci, P, Mears, SJ, Deckelbaum, LI, Bonaca, M, Ridker, PM, Goodman, SG, Cornel, JH, Lewis, BS, Parkhomenko, A, Lopes, RD, Aylward, P, Lincoff, AM, Heise, M, Sacks, F, Nicolau, JC, Merkely, B, Trebacz, J, Libby, P, Nicholls, SJ, Pocock, S, Bhatt, DL, Kastelein, J, Bode, C, Mahaffey, KW, Steg, PG, Tendera, M, Bainey, KR, Harrington, RA, Mehran, R, Duerschmied, D, Kingwell, BA, Gibson, CM, and AEGIS-II Committees and Investigators
- Abstract
BACKGROUND: The AEGIS-II trial hypothesized that CSL112, an intravenous formulation of human apoA-I, would lower the risk of plaque disruption, decreasing the risk of recurrent events such as myocardial infarction (MI) among high-risk patients with MI. OBJECTIVES: This exploratory analysis evaluates the effect of CSL112 therapy on the incidence of cardiovascular (CV) death and recurrent MI. METHODS: The AEGIS-II trial was an international, multicenter, randomized, double-blind, placebo-controlled trial that randomized 18,219 high-risk acute MI patients to 4 weekly infusions of apoA-I (6 g CSL112) or placebo. RESULTS: The incidence of the composite of CV death and type 1 MI was 11% to 16% lower in the CSL112 group over the study period (HR: 0.84; 95% CI: 0.7-1.0; P = 0.056 at day 90; HR: 0.86; 95% CI: 0.74-0.99; P = 0.048 at day 180; and HR: 0.89; 95% CI: 0.79-1.01; P = 0.07 at day 365). Similarly, the incidence of CV death or any MI was numerically lower in CSL112-treated patients throughout the follow-up period (HR: 0.92; 95% CI: 0.80-1.05 at day 90, HR: 0.89; 95% CI: 0.79-0.996 at day 180, HR: 0.91; 95% CI: 0.83-1.01 at day 365). The effect of CSL112 treatment on MI was predominantly observed for type 1 MI and type 4b (MI due to stent thrombosis). CONCLUSIONS: Although CSL112 did not significantly reduce the occurrence of the primary study endpoints, patients treated with CSL112 infusions had numerically lower rates of CV death and MI, type-1 MI, and stent thrombosis-related MI compared with placebo. These findings could suggest a role of apoA-I in reducing subsequent plaque disruption events via enhanced cholesterol efflux. Further prospective data would be needed to confirm these observations.
- Published
- 2024
3. Estimating the environmental impacts of 57,000 food products
- Author
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Clark, M, Scarborough, P, Springmann, M, Rayner, M, Hill, J, Tilman, D, Macdiarmid, JI, Fanzo, J, Bandy, L, and Harrington, RA
- Subjects
Greenhouse Gases ,Meat ,Multidisciplinary ,Animals ,Cattle ,Environment ,United Kingdom ,Food Supply - Abstract
Significance One barrier to enabling transitions to more environmentally sustainable food systems is the lack of detailed environmental impact information. We provide an initial approach to overcome this barrier using publicly available information to derive first estimates of the environmental impact of >57,000 food products across four indicators: greenhouse gas emissions, land use, water stress, and eutrophication potential. Pairing it with a measure of nutrition shows a tendency for more nutritious foods to be more environmentally sustainable, and that like-for-like substitutes can have highly variable environmental and nutritional impacts. By estimating the environmental impacts of food products in a standardized way, our approach provides a step to enable informed decision making by end users such as consumers and policy makers. Abstract Understanding and communicating the environmental impacts of food products is key to enabling transitions to environmentally sustainable food systems [El Bilali and Allahyari, Inf. Process. Agric. 5, 456–464 (2018)]. While previous analyses compared the impacts of food commodities such as fruits, wheat, and beef [Poore and Nemecek, Science 360, 987–992 (2018)], most food products contain numerous ingredients. However, because the amount of each ingredient in a product is often known only by the manufacturer, it has been difficult to assess their environmental impacts. Here, we develop an approach to overcome this limitation. It uses prior knowledge from ingredient lists to infer the composition of each ingredient, and then pairs this with environmental databases [Poore and Nemecek Science 360, 987–992 (2018); Gephart et al., Nature 597, 360–365 (2021)] to derive estimates of a food product’s environmental impact across four indicators: greenhouse gas emissions, land use, water stress, and eutrophication potential. Using the approach on 57,000 products in the United Kingdom and Ireland shows food types have low (e.g., sugary beverages, fruits, breads), to intermediate (e.g., many desserts, pastries), to high environmental impacts (e.g., meat, fish, cheese). Incorporating NutriScore reveals more nutritious products are often more environmentally sustainable but there are exceptions to this trend, and foods consumers may view as substitutable can have markedly different impacts. Sensitivity analyses indicate the approach is robust to uncertainty in ingredient composition and in most cases sourcing. This approach provides a step toward enabling consumers, retailers, and policy makers to make informed decisions on the environmental impacts of food products.
- Published
- 2022
4. The effect of cangrelor and access site on ischaemic and bleeding events: insights from CHAMPION PHOENIX
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Gutierrez, J. Antonio, Harrington, Robert A., Blankenship, James C., Stone, Gregg W., Steg, Ph. Gabriel, Gibson, C. Michael, Hamm, Christian W., Price, Matthew J., Généreux, Philippe, Prats, Jayne, Deliargyris, Efthymios N., Mahaffey, Kenneth W., White, Harvey D., Bhatt, Deepak L., Bhatt, DL, Stone, GW, Mahaffey, KW, Gibson, CM, Steg, PG, Hamm, CW, Price, MJ, Leonardi, S, Gallup, D, Bramucci, E, Radke, PW, Widimsky, P, Tousek, F, Tauth, J, Spriggs, D, McLaurin, BT, Angiolillo, DJ, Genereux, P, Liu, T, Prats, J, Todd, M, Skerjanec, S, White, HD, and Harrington, RA
- Published
- 2016
- Full Text
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5. Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery
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Szarek, M, Bhatt, DL, Bittner, VA, Diaz, R, Edelberg, JM, Hanotin, C, Harrington, RA, Jukema, JW, Letierce, A, Moryusef, A, Pordy, R, Lopez, GAR, Roe, MT, White, HD, Zeiher, AM, Steg, PG, Schwartz, GG, Aylward, PE, Drexel, H, Sinnaeve, P, Dilic, M, Goodman, SG, Prieto, JC, Yong, H, Lopez-Jaramillo, P, Pecin, I, Reiner, Z, Ostadal, P, Poulsen, SH, Viigimaa, M, Nieminen, MS, Danchin, N, Chumburidze, V, Tse, HF, Xavier, D, Zahger, D, Valgimigli, M, Kimura, T, Kim, HS, Kim, SH, Erglis, A, Laucevicius, A, Kedev, S, Yusoff, K, Alings, M, Halvorsen, S, Flores, RMC, Sy, RG, Budaj, A, Morais, J, Dorobantu, M, Karpov, Y, Ristic, AD, Chua, T, Murin, J, Fras, Z, Tunon, J, de Silva, HA, Muller, C, Ray, KK, Vogel, R, 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, 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, Trotter, C, van Diepen, SFP, Wilson, MD, Yan, ATK, 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, Codutti, OR, Jure, HO, Bono, JOE, Hrabar, AD, Vallejos, JA, Rodolfo, AAG, 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, Luquez, HA, Giordano, JA, Saavedra, SS, Waites, JH, Collins, N, Soward, A, Hii, CLS, Shaw, J, Arstall, MA, Horowitz, J, Rogers, JF, Colquhoun, D, Flores, REO, Roberts-Thomson, P, Raffel, O, Lehman, SJ, Coverdale, SGM, Garrahy, PJ, Starmer, G, Sader, M, Carroll, PA, Zweiker, R, Hoppe, U, Huber, K, Berger, R, Weidinger, F, Faes, D, Hermans, K, Pirenne, B, Leone, A, Hoffer, E, Vrolix, MCM, 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, Durak-Nalbantic, A, Vulic, D, Muslibegovic, A, Reis, G, Sousa, L, Nicolau, JC, Giorgeto, FE, Silva, RP, Maia, LN, Rech, R, Rossi, PRF, Cerqueira, MJAG, Duda, N, Kalil, R, Kormann, A, Abrantes, JAM, Pimentel, P, Soggia, AP, de Santos, MON, Neuenschwander, F, Bodanese, LC, Michalaros, YL, Eliaschewitz, FG, Vidotti, 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, Lopes, RD, 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, Gotcheva, NN, 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, M, Perez, L, Varleta, P, Florenzano, F, Huidobro, L, Raffo, CA, Olivares, C, Chen, JY, Dong, YG, Huang, WJ, Wang, JZ, Huang, SA, Yao, ZH, Cui, L, Lin, WH, Sun, YM, Wang, JF, Li, JP, Zhang, XL, Zhu, H, Chen, DD, Huang, L, Dong, SH, Su, GH, Xu, B, Su, X, Cheng, XS, Lin, JX, Zong, WX, Li, HM, Feng, Y, Xu, DL, Yang, XC, Ke, YN, Lin, XF, Zhang, Z, Zheng, ZQ, Luo, ZR, Chen, YD, Ding, CH, Zheng, Y, Li, XD, Peng, DQ, Li, Y, Wei, M, Liu, SW, Yu, YH, Qu, BM, Jiang, WH, Zhou, YJ, Zhao, XS, Yuan, ZY, Guo, Y, Xu, XP, Shi, XB, Ge, JB, Fu, GS, Bai, F, Fang, WY, Shou, XL, Yang, XJ, Wang, JA, Jaramillo, N, Vallejo, GS, Botia, DCL, Lopez, RB, De Salazar, DIM, Bonfanti, AJC, Higuera, JD, Silva, SIB, Lozada, HJG, Arroyo, JAC, Mendoza, JLA, Ruiz, RLF, Fernandez, AM, Jatin, FGM, Herazo, AS, Parada, JC, Triana, MAU, Spinar, J, Horak, D, 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, Raungaard, B, Clemmensen, P, Bang, LE, May, O, Bottcher, M, Hove, JD, Frost, L, Gislason, G, Larsen, J, Johansen, PB, Hald, F, Jeppesen, J, Nielsen, T, Kristensen, KS, Walichiewicz, PM, Lomholdt, JD, Klausen, IC, Nielsen, PK, Davidsen, F, Videbaek, L, Soots, M, Vahula, V, Hedman, A, Soopold, U, Martsin, K, Taskinen, MR, Porthan, K, Airaksinen, JK, Juonala, M, Kiviniemi, T, Vikman, S, Posio, P, Taurio, J, Huikuri, H, Kaikkonen, K, Coste, P, Ferrari, E, Morel, O, Montalescot, G, 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, Khintibidze, I, Shaburishvili, T, Pagava, Z, Ghlonti, R, Lominadze, Z, Khabeishvili, G, Hemetsberger, R, Rauch-Krohnert, U, Stratmann, M, Appel, KF, Schmidt, E, Omran, H, Stellbrink, C, Dorsel, T, Lianopoulos, E, Marx, R, Zirlik, A, Schellenberg, D, Heitzer, T, Laufs, U, Marx, N, Gielen, S, Winkelmann, B, Behrens, S, Sydow, K, 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, Steiner, S, Heidenreich, L, Gremmler, U, Killat, H, Patsilinakos, S, Kartalis, A, Manolis, A, Sionis, D, Liberopoulos, E, Skoumas, I, Athyros, V, Parthenakis, PIF, Hahalis, PIG, Lekakis, J, Xatzitolios, A, Ovando, SRF, Valdovinos, PCM, Benecke, JLA, De Leon, ERR, Yan, BPY, Siu, DCW, Turi, T, Merkely, B, Kiss, RG, Ungi, I, Lupkovics, G, Nagy, L, Katona, A, Edes, I, Muller, G, Horvath, I, Kapin, T, Falukozy, J, Kumbla, M, Sandhu, M, Annam, S, Proddutur, NR, Premchand, RK, Mahajan, A, Abhyanakar, AD, Kerkar, P, Govinda, RA, Oomman, A, Sinha, D, Patil, SN, Kahali, D, Sawhney, J, Joshi, AB, Chaudhary, S, Harkut, P, Guha, S, Porwal, S, Jujjuru, S, Pothineni, RB, Monteiro, MR, Khan, A, Iyengar, SS, Grewal, JS, Chopda, M, Fulwani, MC, Patange, A, Chopra, VK, Goyal, NK, Shinde, R, Manakshe, GV, Patki, N, Sethi, S, Munusamy, V, Karna, S, Adhyapak, S, Pandurangi, U, Mathur, R, Kalashetti, S, Bhagwat, A, Raghuraman, B, Yerra, SK, Bhansali, P, Borse, R, Das, S, Abdullakutty, J, Saathe, S, Palimkar, P, Atar, S, Shechter, M, Mosseri, M, Arbel, Y, Lotan, C, Rosenschein, U, Katz, A, Henkin, Y, Francis, A, Klutstein, M, Nikolsky, E, Turgeman, Y, Halabi, M, Kornowski, R, Jonas, M, Amir, O, Rozenman, Y, Fuchs, S, Hussein, O, Gavish, D, Vered, Z, Caraco, Y, Elias, M, Tov, N, Piovaccari, G, De Pellegrin, A, Guardigli, G, Licciardello, G, Auguadro, C, Cuccia, C, Salvioni, A, Musumeci, G, Calabro, P, Novo, S, Faggiano, P, De Cesare, NB, Berti, S, Cavallini, C, Puccioni, E, Galvani, M, Tespili, M, Piatti, P, Palvarini, M, De Luca, G, Violini, R, De Leo, A, Filardi, PP, Ferratini, M, Dai, K, Kamiya, H, Ando, K, Takeda, Y, Morino, Y, Hata, Y, Kimura, K, Kishi, K, Michishita, I, Uehara, H, Higashikata, T, Hirayama, A, Hirooka, K, 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, Furukawa, Y, Sugino, H, Mano, T, Utsu, N, Ito, K, Haraguchi, T, Ueda, Y, Nishibe, A, Fujimoto, K, Yoon, JH, Park, HS, Chae, IH, Kim, MH, Jeong, MH, Rha, S, Kim, C, Hong, T, 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, TK, Kasim, S, Maskon, O, Kandasamy, B, Liew, HB, Mohamed, WMIW, Castillo, AG, Calvillo, JC, Campos, PF, Fragoso, JCN, Llamas, EAB, Gamba, MAA, Madrigal, JC, Salas, LGG, Rosas, EL, Diaz, BG, Vazquez, ES, Ackar, AN, Esperon, GAL, Sanchez, CRM, De Leon, MG, Otero, RS, Salmon, GF, Rios, JAP, Ruiz, JAG, Breedveld, RW, Hoogslag, PAM, Suryapranata, H, Oomen, A, Wiersma, JJ, Van Der Wal, RMA, Van Huysduynen-Monraats, PSH, Karalis, I, Verdel, GJE, Brueren, BRG, Troquay, RPT, Viergever, EP, Al-Windy, NYY, Bartels, GL, Cornel, JH, Hermans, WRM, Herrman, JPR, Bos, RJ, Groutars, RGEJ, Van Der Zwaan, CC, Kaplan, R, Ronner, E, Groenemeijer, BE, Bronzwaer, PNA, Liem, AAH, Rensing, BJWM, Bokern, MJJA, Nijmeijer, R, Hersbach, FMRJ, Willems, FF, Gosselink, ATM, Elliott, J, Wilkins, G, Fisher, R, Scott, D, Hart, H, Stewart, R, Harding, S, Ternouth, I, Fisher, N, Aitken, D, Anscombe, R, Tomala, T, Nygard, O, Sparby, JA, Andersen, K, Gullestad, L, Jortveit, J, Munk, PS, Hurtig, U, Ticona, JRC, Velasquez, JRD, Miguel, SAN, Perez, ESS, Chambilla, JMC, Ayala, CAC, Leon, RPC, Gonzales, RJV, Zuniga, JDH, Cosavalente, LAC, Mannucci, JEB, Navarro, NCL, Concha, YMR, Chavez, VER, Hernandez, HAA, Nunez, CAZ, Ferrolino, A, Sy, RAG, Tirador, L, Matiga, G, Coching, RM, Bernan, A, Rogelio, G, Morales, DD, Tan, E, 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, Lysek, R, Miklaszewicz, B, Kubica, J, Lipko, JA, Kostarska-Srokosz, E, Piepiorka, M, Drzewiecka, A, Sciborski, R, Stasiewski, A, Blicharski, T, Bystryk, L, Szpajer, M, Korol, M, Czerski, T, Mirek-Bryniarska, E, Gniot, J, Lubinski, A, Gorny, J, Franek, E, Monteiro, P, Bastos, JM, Pereira, HH, Martins, D, Seixo, F, Mendonca, C, Botelho, A, Minescu, B, Istratoaie, O, Tesloianu, DN, Cristian, G, Podoleanu, CGC, Constantinescu, MCA, Bengus, CM, Militaru, C, Rosu, D, Parepa, IR, Matei, AV, Alexandru, TM, Shvarts, Y, Orlikova, O, Kobalava, Z, Barbarash, OL, Markov, V, Lyamina, N, Gordienko, A, Zrazhevsky, K, Vishnevsky, AY, Gurevich, V, Stryuk, R, Lomakin, NV, Bokarev, I, Shalaev, S, Khaisheva, L, Chizhov, P, Viktorova, I, Osokina, N, Akatova, E, Chumakova, G, Libov, I, Voevoda, MI, Tretyakova, TV, 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, VV, Ivanov, IG, 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, 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, Zuran, I, Oklukar, J, Suligoj, NC, Cevc, M, Lipar, L, 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, Dalby, AJ, 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, 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, Hagstrom, E, Witt, N, Mourtzinis, G, Nicol, P, Hansen, O, Romeo, S, Torstensson, I, Jensen, SA, Ahremark, U, Sundelin, T, Moccetti, T, Mach, F, Binder, R, Chiang, CE, 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, Sritara, P, Wongpraparut, N, Sastravaha, K, Sansanayudh, N, Kehasukcharoen, W, Piyayotai, D, Camsari, A, Kultursay, H, Guneri, S, 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, Parkhomenko, A, Rishko, M, Kopytsya, M, Yagensky, A, Vatutin, M, Bagriy, A, Barna, OM, Ushakov, O, Dzyak, G, Goloborodko, B, Rudenko, A, Trevelyan, J, Zaman, A, Lee, K, Moriarty, A, Aggarwal, RK, Clifford, P, Wong, YK, 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, 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, Moriarty, PM, 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, 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, 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
6. Effect of Alirocumab on Mortality After Acute Coronary Syndromes An Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial
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SRF, Benecke, JLA, De Leon, ERR, Yan, BPY, Siu, DCW, Turi, T, Merkely, B, Ungi, I, Lupkovics, G, Nagy, L, Katona, A, Edes, I, Muller, G, Horvath, I, Kapin, T, Falukozy, J, Kumbla, M, Sandhu, M, Annam, S, Proddutur, NR, Premchand, RK, Mahajan, A, Abhyanakar, AD, Kerkar, P, Govinda, RA, Oomman, A, Sinha, D, Patil, SN, Kahali, D, Sawhney, J, Joshi, AB, Chaudhary, S, Harkut, P, Guha, S, Porwal, S, Jujjuru, S, Pothineni, RB, Monteiro, MR, Khan, A, Iyengar, SS, Grewal, JS, Chopda, M, Fulwani, MC, Patange, A, Chopra, VK, Goyal, NK, Shinde, R, Manakshe, GV, Patki, N, Sethi, S, Munusamy, V, Karna, S, Adhyapak, S, Pandurangi, U, Mathur, R, Kalashetti, S, Bhagwat, A, Raghuraman, B, Yerra, SK, Bhansali, P, Borse, R, Das, S, Abdullakutty, J, Saathe, S, Palimkar, P, Abdullkutty, J, Sathe, S, Atar, S, Shechter, M, Mosseri, M, Arbel, Y, Lotan, C, Rosenschein, U, Katz, A, Henkin, Y, Francis, A, Klutstein, M, Nikolsky, E, Turgeman, Y, Halabi, M, Kornowski, R, Jonas, M, Amir, O, Rozenman, Y, Fuchs, S, Hussein, O, Gavish, D, Vered, Z, Caraco, Y, Elias, M, Tov, N, Lishner, M, Elias, N, Piovaccari, G, De Pellegrin, A, Guardigli, G, Licciardello, G, Auguadro, C, Cuccia, C, Salvioni, A, Musumeci, G, Calabro, P, Novo, S, Faggiano, P, De Cesare, NB, Berti, S, Cavallini, C, Puccioni, E, Galvani, M, Tespili, M, Piatti, P, Palvarini, M, De Luca, G, Violini, R, De Leo, A, Filardi, PP, Ferratini, M, Ricca, V, Dai, K, Kamiya, H, Ando, K, Takeda, Y, Morino, Y, Hata, Y, Kimura, K, Kishi, K, Michishita, I, Uehara, H, Higashikata, T, Hirayama, A, Hirooka, K, 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, Furukawa, Y, Sugino, H, Mano, T, Utsu, N, Ito, K, Haraguchi, T, Ueda, Y, Nishibe, A, Fujimoto, K, Masutani, M, Yoon, JH, Park, HS, Chae, I-H, Kim, MH, Jeong, MH, Rha, S, Kim, C, Kim, H-S, 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, TK, Kasim, S, Maskon, O, Kandasamy, B, Liew, HB, Mohamed, WMIW, Garcia Castillo, A, Carrillo Calvillo, J, Fajardo Campos, P, Nunez Fragoso, JC, Bayram Llamas, EA, Alcocer Gamba, MA, Carranza Madrigal, J, Gonzalez Salas, LG, Lopez Rosas, E, Gonzalez Diaz, B, Salcido Vazquez, E, Nacoud Ackar, A, Llamas Esperon, GA, Martinez Sanchez, CR, Guerrero De Leon, M, Suarez Otero, R, Fanghanel Salmon, G, Perez Rios, JA, Garza Ruiz, JA, Breedveld, RW, Hoogslag, PAM, Suryapranata, H, Oomen, A, Wiersma, JJ, Van Der Wal, RMA, Van Huysduynen-Monraats, PSH, Karalis, I, Verdel, GJE, Brueren, BRG, Troquay, RP, Viergever, EP, Al-Windy, NYY, Bartels, GL, Cornel, JH, Hermans, WRM, Herrman, JPR, Bos, RJ, Groutars, RGEJ, Van Der Zwaan, CC, Kaplan, R, Ronner, E, Groenemeijer, BE, Bronzwaer, PNA, Liem, AAH, Rensing, BJWM, Bokern, MJJA, Nijmeijer, R, Hersbach, FMRJ, Willems, FF, Gosselink, ATM, Elliott, J, Wilkins, G, Fisher, R, Scott, D, Hart, H, Stewart, R, Harding, S, Ternouth, I, Fisher, N, Aitken, D, Anscombe, R, Davidson, L, Tomala, T, Nygard, O, Sparby, JA, Andersen, K, Gullestad, L, Jortveit, J, Munk, PS, Singsaas, EG, Hurtig, U, Calderon Ticona, JR, Durand Velasquez, JR, Negron Miguel, SA, Sanabria Perez, ES, Carrion Chambilla, JM, Chavez Ayala, CA, Castillo Leon, RP, Vargas Gonzales, RJ, Hernandez Zuniga, JD, Camacho Cosavalente, LA, Bravo Mannucci, JE, Heredia Landeo, J, Llerena Navarro, NC, Roldan Concha, YM, Rodriguez Chavez, V-CE, Anchante Hernandez, HA, Zea Nunez, CA, Mogrovejo Ramos, W, Ferrolino, A, Sy, RAG, Tirador, L, Matiga, G, Coching, RM, Bernan, A, Rogelio, G, Morales, DD, Tan, E, Sulit, DJ, Wlodarczak, A, Jaworska, K, Skonieczny, G, Pawlowicz, L, Wojewod, P, Busz-Papiez, B, Bednarski, J, Goch, A, Staneta, P, Dulak, E, Saminsk, K, Krasowski, W, Sudnik, W, Zurakowski, A, Skorski, M, Lysek, R, Miklaszewicz, B, Kubica, J, Lipko, JA, Kostarska-Srokosz, E, Piepiorka, M, Drzewiecka, A, Sciborski, R, 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, Bastos, JM, Pereira, HH, Martins, D, Seixo, F, Mendonca, C, Botelho, A, Minescu, B, Istratoaie, O, Tesloianu, DN, Cristian, G, Podoleanu, CGC, Constantinescu, MCA, Bengus, CM, Militaru, C, Rosu, D, Parepa, IR, Matei, AV, Alexandru, TM, Coman, I, Cioranu, RS, Dimulescu, D, Shvarts, Y, Orlikova, O, Kobalava, Z, Barbarash, OL, Markov, V, Lyamina, N, Gordienko, A, Zrazhevsky, K, Vishnevsky, AY, Gurevich, V, Stryuk, R, Lomakin, NV, Bokarev, I, Shalaev, S, Khaisheva, L, Chizhov, P, Viktorova, I, Osokina, N, Akatova, E, Chumakova, G, Libov, I, Voevoda, MI, Tretyakova, TV, 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, 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
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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
7. 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 KK, Colhoun HM, Szarek M, Baccara-Dinet M, Bhatt DL, Bittner VA, Budaj AJ, Diaz R, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Loizeau V, Lopes RD, Moryusef A, Murin J, Pordy R, Ristic AD, Roe MT, Tuñón J, White HD, Zeiher AM, Schwartz GG, Steg PG, ODYSSEY OUTCOMES Committees and Investigators, and Lovric Bencic, M.
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diabetes mellitus, alirocuma, acute coronary syndrome outcomes - Abstract
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 HbA1cor 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.
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- 2019
8. 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, 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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
9. Risk Categorization Using New American College of Cardiology/American Heart Association Guidelines for Cholesterol Management and Its Relation to Alirocumab Treatment Following Acute Coronary Syndromes
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Roe, MT, Li , QH, Bhatt , DL, Bittner, VA, Diaz, R, Goodman, SG, Harrington, RA, et al. For the ODYSSEY OUTCOMES Investigators, and Lovric Bencic, M
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alirocumab, diabetes mellitus, acute coronary syndrome - Abstract
In the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. The primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. Results: Of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. In the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR ; hazard ratio=0.86 for not VHR ; Pinteraction=0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events ; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions ; Pinteraction=0.672). The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8% ; Pinteraction=0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8% ; Pinteraction=0.661).
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- 2019
10. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study
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Bhatt, DL, Fox, K, Harrington, RA, Leiter, LA, Mehta, SR, Simon, T, Andersson, M, Himmelmann, A, Ridderstråle, W, Held, C, Steg, PG, Diaz, R, Amerena, John, Huber, K, Sinnaeve, P, Nicolau, JC, Saraiva, JFK, Petrov, I, Corbalán, R, Ge, J, Zhao, Q, Botero, R, Widimský, P, Kristensen, SD, Hartikainen, J, Danchin, N, Darius, H, Fat, TH, Kiss, RG, Pais, P, Lev, E, Luca, LD, Goto, S, López, GAR, Cornel, JH, Kontny, F, Medina, F, Babilonia, N, Opolski, G, Vinereanu, D, Zateyshchikov, D, Ruda, M, Elamin, O, KováŘ, F, Dalby, AJ, Jeong, MH, Bueno, H, James, S, Chiang, CE, Tresukosol, D, Ongen, Z, Ray, K, Parkhomenko, A, McGuire, D, Kosiborod, M, Nguyen, TQ, Bhatt, DL, Fox, K, Harrington, RA, Leiter, LA, Mehta, SR, Simon, T, Andersson, M, Himmelmann, A, Ridderstråle, W, Held, C, Steg, PG, Diaz, R, Amerena, John, Huber, K, Sinnaeve, P, Nicolau, JC, Saraiva, JFK, Petrov, I, Corbalán, R, Ge, J, Zhao, Q, Botero, R, Widimský, P, Kristensen, SD, Hartikainen, J, Danchin, N, Darius, H, Fat, TH, Kiss, RG, Pais, P, Lev, E, Luca, LD, Goto, S, López, GAR, Cornel, JH, Kontny, F, Medina, F, Babilonia, N, Opolski, G, Vinereanu, D, Zateyshchikov, D, Ruda, M, Elamin, O, KováŘ, F, Dalby, AJ, Jeong, MH, Bueno, H, James, S, Chiang, CE, Tresukosol, D, Ongen, Z, Ray, K, Parkhomenko, A, McGuire, D, Kosiborod, M, and Nguyen, TQ
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- 2019
11. A pilot randomized controlled trial of a digital intervention aimed at improving food purchasing behavior: The front-of-pack food labels impact on consumer choice study
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Harrington, RA, Scarborough, P, Hodgkins, C, Raats, MM, Cowburn, G, Dean, M, Doherty, A, Foster, C, Juszczak, E, Mhurchu, CN, Winstone, Naomi, Shepherd, R, Timotijevic, L, Rayner, M, Harrington, RA, Scarborough, P, Hodgkins, C, Raats, MM, Cowburn, G, Dean, M, Doherty, A, Foster, C, Juszczak, E, Mhurchu, CN, Winstone, Naomi, Shepherd, R, Timotijevic, L, and Rayner, M
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- 2019
12. Effects of alirocumab on types of myocardial infarction: insights from the ODYSSEY OUTCOMES trial
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White, HD, Steg, PG, Szarek, M, Bhatt, DL, Bittner, VA, Diaz, R, Edelberg, JM, Erglis, A, Goodman, SG, Hanotin, C, Harrington, RA, Jukema, JW, Lopes, RD, Mahaffey, KW, Moryusef, A, Pordy, R, Roe, MT, Sritara, P, Tricoci, P, Simoons, Maarten, Sijbrands, E.J.G., Zeiher, AM, Schwartz, GG, White, HD, Steg, PG, Szarek, M, Bhatt, DL, Bittner, VA, Diaz, R, Edelberg, JM, Erglis, A, Goodman, SG, Hanotin, C, Harrington, RA, Jukema, JW, Lopes, RD, Mahaffey, KW, Moryusef, A, Pordy, R, Roe, MT, Sritara, P, Tricoci, P, Simoons, Maarten, Sijbrands, E.J.G., Zeiher, AM, and Schwartz, GG
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- 2019
13. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
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Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, Edelberg JM, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Lecorps G, Mahaffey KW, Moryusef A, Pordy R, Quintero K, Roe MT, Sasiela WJ, Tamby JF, Tricoci P, White HD, Zeiher AM, and ODYSSEY OUTCOMES Committees and Investigators
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- 2018
14. Comparison of fatal or irreversible events with extended-duration betrixaban versus standard dose enoxaparin in acutely Ill medical patients: An APEX trial substudy
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Gibson, CM, Korjian, S, Chi, G, Daaboul, Y, Jain, P, Arbetter, D, Goldhaber, SZ, Hull, R, Hernandez, AF, Lopes, RD, Gold, A, Cohen, AT, Harrington, RA, Bello, F, Ferrari, AE, Jure, H, Macin, S, Oliva, M, Parody, M, Poy, C, Baker, R, Colquhoun, D, Coughlin, P, Finfer, S, Hammerschlag, G, Rubinfeld, A, Huber, K, König, J, Mathies, R, Pilger, E, Schoenerr, H, Adzerikho, I, Koryk, V, Mikhailova, E, Mitkovskaya, N, Pimanov, S, Polonetsy, L, Soroka, N, Blockmans, D, Delforge, M, Dive, A, Lienart, F, Motte, S, Annichino Bizzacchi, J, Fiss, E, Freire, A, Manenti, E, Ramacciotti, E, Raymuno, S, Rocha, A, Saraiva, JF, Dimov, B, Grigorov, M, Kalpachki, R, Kamenova, Z, Kostadinova, M, Milanova, M, Mincheva, V, Pencheva, G, Raev, D, Runev, N, Stoeva, N, Stoyanov, M, Syulemzova, S, Todorov, G, Tokmakova, M, Dhar, A, Douketis, J, Kahn, S, Le Gal, G, Pearce, M, Provencher, S, Verreault, S, Arias Alarcon, M, Olivares Cañon, C, Opazo Lazcano, M, Potthoff Cardenas, S, Butkovic-Soldo, S, Car, S, Ciglenecki, N, Francetic, I, Jakopovic, M, Kalinic-Grgorinic, H, Knezevic, A, Malojcic, B, Marusic, S, Sikic Vagic, J, Skerk, V, Cermak, O, Cervinka, P, Chlumsky, J, Chochola, J, Cizek, V, Dunaj, M, Dusek, J, Francek, L, Havelka, J, Herold, M, Holaj, R, Horny, I, Gibson, CM, Korjian, S, Chi, G, Daaboul, Y, Jain, P, Arbetter, D, Goldhaber, SZ, Hull, R, Hernandez, AF, Lopes, RD, Gold, A, Cohen, AT, Harrington, RA, Bello, F, Ferrari, AE, Jure, H, Macin, S, Oliva, M, Parody, M, Poy, C, Baker, R, Colquhoun, D, Coughlin, P, Finfer, S, Hammerschlag, G, Rubinfeld, A, Huber, K, König, J, Mathies, R, Pilger, E, Schoenerr, H, Adzerikho, I, Koryk, V, Mikhailova, E, Mitkovskaya, N, Pimanov, S, Polonetsy, L, Soroka, N, Blockmans, D, Delforge, M, Dive, A, Lienart, F, Motte, S, Annichino Bizzacchi, J, Fiss, E, Freire, A, Manenti, E, Ramacciotti, E, Raymuno, S, Rocha, A, Saraiva, JF, Dimov, B, Grigorov, M, Kalpachki, R, Kamenova, Z, Kostadinova, M, Milanova, M, Mincheva, V, Pencheva, G, Raev, D, Runev, N, Stoeva, N, Stoyanov, M, Syulemzova, S, Todorov, G, Tokmakova, M, Dhar, A, Douketis, J, Kahn, S, Le Gal, G, Pearce, M, Provencher, S, Verreault, S, Arias Alarcon, M, Olivares Cañon, C, Opazo Lazcano, M, Potthoff Cardenas, S, Butkovic-Soldo, S, Car, S, Ciglenecki, N, Francetic, I, Jakopovic, M, Kalinic-Grgorinic, H, Knezevic, A, Malojcic, B, Marusic, S, Sikic Vagic, J, Skerk, V, Cermak, O, Cervinka, P, Chlumsky, J, Chochola, J, Cizek, V, Dunaj, M, Dusek, J, Francek, L, Havelka, J, Herold, M, Holaj, R, and Horny, I
- Abstract
Background-Extended-duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results-This was a post hoc analysis of the APEX trial-a multicenter, double-blind, randomized controlled trial comparing extended-duration betrixaban versus standard-of-care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time-to-first event analysis. In patients with positive D-dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [P=0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [P=0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [P=0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [P=0.002]). Conclusions-Among hospitalized medically ill patients, extended-duration betrixaban demonstrated an ≈ 30% reduction in fatal or irreversible ischemic or bleeding events compared with standard-duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin.
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- 2017
15. 'Off-Hours' versus 'On-Hours' presentation in ST-segment elevation myocardial infarction: findings from CHAMPION PHOENIX
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Selvaraj, S, Bhatt, DL, Stone, GW, Gibson, CM, Steg, PG, Hamm, CW, Price, MJ, Deliargyris, EN, Prats, J, Mahaffey, KW, White, HD, Harrington, RA, and CHAMPION PHOENIX Investigators
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Cardiovascular System & Hematology ,1117 Public Health And Health Services ,CHAMPION PHOENIX Investigators ,1102 Cardiovascular Medicine And Haematology - Published
- 2016
16. Consistent Reduction in Periprocedural Myocardial Infarction With Cangrelor as Assessed by Multiple Definitions: Findings From CHAMPION PHOENIX (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition)
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Cavender, MA, Bhatt, DL, Stone, GW, White, HD, Steg, PG, Gibson, CM, Hamm, CW, Price, MJ, Leonardi, S, Prats, J, Deliargyris, EN, Mahaffey, KW, Harrington, RA, and CHAMPION PHOENIX Investigators
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medicine.medical_specialty ,CHAMPION PHOENIX Investigators ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Revascularization ,1102 Cardiovascular Medicine And Haematology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,P2Y12 ,Cangrelor ,Physiology (medical) ,Internal medicine ,creatine kinase, MB form ,medicine ,Clinical endpoint ,030212 general & internal medicine ,Myocardial infarction ,business.industry ,percutaneous coronary intervention ,Percutaneous coronary intervention ,1103 Clinical Sciences ,Odds ratio ,Clopidogrel ,medicine.disease ,myocardial infarction ,chemistry ,Cardiovascular System & Hematology ,1117 Public Health And Health Services ,Cardiology ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
BACKGROUND: Cangrelor is an intravenous P2Y 12 inhibitor approved to reduce periprocedural ischemic events in patients undergoing percutaneous coronary intervention not pretreated with a P2Y 12 inhibitor. METHODS: A total of 11 145 patients were randomized to cangrelor or clopidogrel in the CHAMPION PHOENIX trial (Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). We explored the effects of cangrelor on myocardial infarction (MI) using different definitions and performed sensitivity analyses on the primary end point of the trial. RESULTS: A total of 462 patients (4.2%) undergoing percutaneous coronary intervention had an MI as defined by the second universal definition. The majority of these MIs (n=433, 93.7%) were type 4a. Treatment with cangrelor reduced the incidence of MI at 48 hours (3.8% versus 4.7%; odds ratio [OR], 0.80; 95% confidence interval [CI], 0.67–0.97; P =0.02). When the Society of Coronary Angiography and Intervention definition of periprocedural MI was applied to potential ischemic events, there were fewer total MIs (n=134); however, the effects of cangrelor on MI remained significant (OR, 0.65; 95% CI, 0.46–0.92; P =0.01). Similar effects were seen in the evaluation of the effects of cangrelor on MIs with peak creatinine kinase-MB ≥10 times the upper limit of normal (OR, 0.64; 95% CI, 0.45–0.91) and those with peak creatinine kinase-MB ≥10 times the upper limit of normal, ischemic symptoms, or ECG changes (OR, 0.63; 95% CI, 0.48–0.84). MIs defined by any of these definitions were associated with increased risk of death at 30 days. Treatment with cangrelor reduced the composite end point of death, MI (Society of Coronary Angiography and Intervention definition), ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis (1.4% versus 2.1%; OR, 0.69; 95% CI, 0.51–0.92). CONCLUSIONS: MI in patients undergoing percutaneous coronary intervention, regardless of definition, remains associated with increased risk of death in the current era. Cangrelor compared with clopidogrel significantly reduces MI regardless of the definition. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov . Unique identifier: NCT01156571.
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- 2016
17. Early versus Delayed, Provisional Eptifibatide in Acute Coronary Syndromes
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Giugliano, Rp, White, Ja, Bode, C, Armstrong, Pw, Montalescot, G, Lewis, Bs, VAN 'T HOF, A, Berdan, Lg, Lee, Kl, Strony, Jt, Hildemann, S, Veltri, E, VAN DE WERF, F, Braunwald, E, Harrington, Ra, Califf, Rm, Newby, Lk, and Berni, Andrea
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medicine.medical_specialty ,Acute coronary syndrome ,medicine.diagnostic_test ,business.industry ,Unstable angina ,medicine.medical_treatment ,Placebo-controlled study ,General Medicine ,medicine.disease ,Pharmacotherapy ,Angioplasty ,Internal medicine ,Eptifibatide ,medicine ,Cardiology ,Myocardial infarction ,business ,Electrocardiography ,medicine.drug - Abstract
Background Glycoprotein IIb/IIIa inhibitors are indicated in patients with acute coronary syndromes who are undergoing an invasive procedure. The optimal timing of the initiation of such therapy is ...
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- 2009
18. Does eptifibatide confer a greater benefit to patients with unstable angina than with non-ST segment elevation myocardial infarction? Insights from the PURSUIT trial
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Chang, W-C, Harrington, RA, Simoons, Maarten, Califf, RM, Lincoff, AM, Armstrong, PW, PURSUIT Investigators,, and Cardiology
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Adult ,Male ,medicine.medical_specialty ,Acute coronary syndrome ,medicine.medical_treatment ,Myocardial Infarction ,Eptifibatide ,Infarction ,Angina ,Electrocardiography ,Sex Factors ,Risk Factors ,Internal medicine ,Angioplasty ,medicine ,Humans ,Angina, Unstable ,cardiovascular diseases ,Myocardial infarction ,Aged ,Probability ,Proportional Hazards Models ,Randomized Controlled Trials as Topic ,business.industry ,Unstable angina ,Age Factors ,Percutaneous coronary intervention ,Middle Aged ,Prognosis ,medicine.disease ,Survival Analysis ,Logistic Models ,Treatment Outcome ,Cardiology ,Female ,Peptides ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Aims To evaluate the differential effects of eptifibatide therapy on unstable angina vs non-ST elevation myocardial infarction at enrollment, since the separate impact on these two major diagnostic subsets of acute coronary syndrome patients has not been fully investigated. Methods and Results We examined the 9461 patients in the PURSUIT trial (conducted between 1995 and 1997) to compare the effects of eptifibatide on unstable angina and myocardial infarction. The study showed greater and more consistent effects of eptifibatide therapy on unstable angina than non-ST elevation myocardial infarction in reducing 30-day death/(re)infarction (from the unadjusted rate of 13·0% to 11·2%, P =0·059 for unstable angina; and 18·9% to 17·9%, P =0·387 for myocardial infarction), especially among patients who underwent early percutaneous coronary intervention (odds ratios=0·49 and 0·86, 95% confidence intervals=0·30–0·80 and 0·53–1·42, respectively, for unstable angina and myocardial infarction). The only subgroup for whom the benefit of eptifibatide was not evident was female myocardial infarction patients who did not undergo early percutaneous coronary intervention. Conclusions These data suggest that eptifibatide benefited unstable angina patients more than myocardial infarction patients, especially among those who underwent early percutaneous coronary intervention, and support its use as concomitant therapy with early percutaneous coronary intervention especially in female myocardial infarction patients.
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- 2002
19. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention
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MONTALESCOT G, WHITE HD, GALLO R, COHEN M, STEG PG, AYLWARD PE, BODE C, KING SB RD, HARRINGTON RA, DESMET WJ, MACAYA C, STEINHUBL SR, STEEPLE INVESTIGATORS, CHIARIELLO, MASSIMO, Montalescot, G, White, Hd, Gallo, R, Cohen, M, Steg, Pg, Aylward, Pe, Bode, C, Chiariello, Massimo, KING SB, Rd, Harrington, Ra, Desmet, Wj, Macaya, C, Steinhubl, Sr, and Steeple, Investigators
- Abstract
2006 Sep 7;355(10):1006-17
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- 2006
20. 2012 ACCF/AATS/SCAI/STS Expert Consensus Document on Transcatheter Aortic Valve Replacement
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Holmes, DR, Mack, MJ, Kaul, S, Agnihotri, A, Alexander, KP, Bailey, SR, Calhoon, JH, Carabello, BA, Desai, MY, Edwards, FH, Francis, GS, Gardner, TJ, Kappetein, Arie-Pieter, Linderbaum, JA, Mukherjee, C, Mukherjee, D, Otto, CM, Ruiz, CE, Sacco, RL, Smith, D, Thomas, JD, Harrington, RA, Bhatt, L, Ferrari, VA, Fisher, JD, Garcia, MJ, Gentile, F, Gilson, MF, Hernandez, A, Jacobs, AK, Moliterno, DJ, Weitz, HH, and Cardiothoracic Surgery
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- 2012
21. Effect of adenosine-regulating agent acadesine on morbidity and mortality associated with coronary artery bypass grafting: the RED-CABG randomized controlled trial
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Newman, Mf, Ferguson, Tb, White, Ja, Ambrosio, Giuseppe, Koglin, J, Nussmeier, Na, Pearl, Rg, Pitt, B, Wechsler, As, Weisel, Rd, Reece, Tl, Lira, A, Harrington, Ra, RED CABG Steering Committee, Investigators, and Diener, Hans Christoph (Beitragende*r)
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Male ,medicine.medical_specialty ,Adenosine ,Population ,Medizin ,Context (language use) ,Coronary Artery Disease ,Placebo ,law.invention ,Ventricular Dysfunction, Left ,Coronary artery bypass surgery ,chemistry.chemical_compound ,Double-Blind Method ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Myocardial infarction ,Coronary Artery Bypass ,Perioperative Period ,education ,Aged ,education.field_of_study ,Acadesine ,business.industry ,General Medicine ,Perioperative ,Middle Aged ,Aminoimidazole Carboxamide ,medicine.disease ,Stroke ,chemistry ,Reperfusion Injury ,Cardiology ,Female ,Ribonucleosides ,business - Abstract
Context Ischemia/reperfusion injury remains an important cause of morbidity and mortality after coronary artery bypass graft (CABG) surgery. In a meta-analysis of randomized controlled trials, perioperative and postoperative infusion of acadesine, a first-in-class adenosine-regulating agent, was associated with a reduction in early cardiac death, myocardial infarction, and combined adverse cardiac outcomes in participants undergoing on-pump CABG surgery. Objective To assess the efficacy and safety of acadesine administered in the perioperative period in reducing all-cause mortality, nonfatal stroke, and severe left ventricular dysfunction (SLVD) through 28 days. Design, Setting, and Participants The Reduction in Cardiovascular Events by Acadesine in Patients Undergoing CABG (RED-CABG) trial, a randomized, double-blind, placebo-controlled, parallel-group evaluation of intermediate- to high-risk patients (median age, 66 years) undergoing nonemergency, on-pump CABG surgery at 300 sites in 7 countries. Enrollment occurred from May 6, 2009, to July 30, 2010. Interventions Eligible participants were randomized 1:1 to receive acadesine (0.1 mg/kg per minute for 7 hours) or placebo (both also added to cardioplegic solutions) beginning just before anesthesia induction. Main Outcome Measure Composite of all-cause mortality, nonfatal stroke, or need for mechanical support for SLVD during and following CABG surgery through postoperative day 28. Results Because results of a prespecified futility analysis indicated a very low likelihood of a statistically significant efficacious outcome, the trial was stopped after 3080 of the originally projected 7500 study participants were randomized. The primary outcome occurred in 75 of 1493 participants (5.0%) in the placebo group and 76 of 1493 (5.1%) in the acadesine group (odds ratio, 1.01 [95% CI, 0.73-1.41]). There were no differences in key secondary end points measured. Conclusion In this population of intermediate- to high-risk patients undergoing CABG surgery, acadesine did not reduce the composite of all-cause mortality, nonfatal stroke, or SLVD. Trial Registration clinicaltrials.gov Identifier: NCT00872001
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- 2012
22. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes
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Tricoci, P, Huang, Z, Held, C, Moliterno, Dj, Armstrong, Pw, Van de Werf, F, White, Hd, Aylward, Pe, Wallentin, L, Chen, E, Lokhnygina, Y, Pei, J, Leonardi, S, Rorick, Tl, Kilian, Am, Jennings, Lh, Ambrosio, G, Bode, C, Cequier, A, Cornel, Jh, Diaz, R, Erkan, A, Huber, K, Hudson, Mp, Jiang, L, Jukema, Jw, Lewis, Bs, Lincoff, Am, Montalescot, G, Nicolau, Jc, Ogawa, H, Pfisterer, M, Prieto, Jc, Ruzyllo, W, Sinnaeve, Pr, Storey, Rf, Valgimigli, M, Whellan, Dj, Widimsky, P, Strony, J, Harrington, Ra, Mahaffey, Kw, Huo, Y, Lixin, J, Isaza, D, Grande, P, Laine, M, Wong, L, Ofner, P, Yamaguchi, T, Park, Sj, Nordrehaug, Je, Providencia, L, Cheem, Th, Dalby, A, Betriu, A, Chen, Mf, Verheugt, F, Frye, Rl, Hochman, J, Steg, Pg, Bailey, Kr, Easton, Jd, Lincoff, A, Underwood, Fd, Wrestler, J, Larson, D, Vandyne, B, Kilian, A, Harmelin-Kadouri, R, Layton, L, Lipka, L, Petrauskas, S, Qidwai, M, Sorochuck, C, Temple, T, Mason, D, Sydlowski, D, Gallagher, B, Villasin, A, Beernaert, A, Douglas, S, Garrett, J, Wiering, J, Adriaenssens, T, Ganame, J, Hulselmans, M, Katz, Jn, Kayaert, P, La Gerche, A, Onsea, K, Zalewski, J, Johnson, A, O'Briant, J, Smith, M, Akerblom, A, Armaganijan, L, Bertolami, A, Brennan, M, da Ponte Nacif SA, de Campos Gonzaga, C, Dequadros, A, Déry, Jp, Dev, S, Ducrocq, G, Eapen, Zp, Echenique, L, Eggers, K, Garcia, H, Guimaraes, Hp, Hagstrom, E, Hanet, C, James, S, Jonelid, B, Kolls, Bj, Leiria, T, Leite, R, Lombardi, C, Lopes, Rd, Malagutti, P, Mathews, R, Mehta, Rh, Melloni, C, Piccini, Jp, Rodriques Soares, P, Roe, Mt, Shah, Br, Stashenko, G, Szczech, La, Truffa, A, Varenhorst, C, Vranckx, P, Williams, J, Kilaru, R, White, Ja, Binkowitz, B, He, W, Ramos, Ms, Hasbani, E, Farras, Ha, Luz del Valle, L, Zapata, G, Centeno, Ep, Hominal, M, Beloscar, J, Panno, M, Berli, M, Carlevaro, O, Wasserman, T, Lembo, L, Diez, F, Bettinotti, M, Allall, O, Macin, S, Hii, C, Bett, N, Aroney, C, Roberts-Thomson, P, Arstall, M, Horowitz, J, Prasan, A, Farshid, A, Rankin, J, Duffy, S, Sinhal, A, Hendricks, R, Waites, J, Hill, A, French, J, Adams, M, Soward, A, Dick, R, Jepson, N, Nelson, G, Thompson, P, Neunteufl, T, Pachinger, O, Leisch, F, Siostrzonek, P, Roithinger, F, Pieske, B, Weber, H, Eber, B, Zenker, G, Sinnaeve, P, Roosen, J, Vervoort, G, Coussement, P, Striekwold, H, Boland, J, Van Dorpe, A, Dujardin, K, Mertens, D, Vanneste, L, Celen, H, Lesseliers, H, Vrolix, M, Leone, A, De Maeseneire, S, Hellemans, S, Silva, Fa, Franken, M, Moraes JB Jr, Mora, R, Michalaros, Y, Perin, M, Guimaraes, Ae, da Silva DG, Mattos, Ma, Alves AR Jr, Hernandes, Me, Golin, V, da Silva SA, Ardito, W, Dery, Jp, Mukherjee, A, Tanguay, Jf, Kornder, J, Lutchmedial, S, Degrace, M, Klinke, P, Constance, C, Nogareda, G, Wong, G, Macdonald, P, Senaratne, M, Rupka, D, Halperin, F, Ramanathan, K, Natarajan, M, Lai, C, Brossoit, R, Tymchak, W, Rose, B, Dupuis, R, Mansour, S, Bata, I, Zadra, R, Turek, M, Madan, M, Le May, M, Leon, L, Perez, L, Yovaniniz, P, Pedemonte, O, Campos, P, Pincetti, C, Sepulveda, P, Li, W, Zhao, R, Li, Z, Yang, Y, Chen, J, Li, H, Jiang, Y, Li, D, Qu, P, Sun, Y, Zheng, Y, Zhou, C, Zhang, F, Wei, M, Wang, D, Lemus, J, Fernandez, Rl, Jaramillo, C, Ochoa, J, Velez, S, Cano, N, Lutz, J, Botero, R, Jaramillo, M, Saaib, J, Sanchez, G, Hernandez, H, Mendoza, F, Rizcala, A, Urina, M, Polasek, R, Motovska, Z, Zemanek, D, Ostransky, J, Kettner, J, Spinar, J, Groch, L, Ramik, C, Stumar, J, Linhart, A, Pleva, L, Niedobova, E, Macha, J, Vojacek, J, Stipal, R, Galatius, S, Eggert, S, Mickley, H, Egstrup, K, Pedersen, O, Hvilsted, L, Sykulski, R, Skagen, K, Dodt, K, Klarlund, K, Husted, S, Jensen, G, Melchior, T, Sjoel, A, Steffensen, Fh, Airaksinen, Ke, Laukkanen, Ja, Syvanne, Ms, Kotila, Mj, Mikael, K, Naveri, Hk, Hekkala, Am, Mustonen, Jn, Halkosaari, M, Ohlmann, P, Khalife, K, Dibon, O, Hirsch, Jl, Furber, A, Nguyen-Khac, Jo, Delarche, N, Probst, V, Lim, P, Bayet, G, Dauphin, R, Levai, L, Galinier, M, Belhassane, A, Wiedemann, Jy, Fouche, R, Coisne, D, Henry, P, Schiele, F, Boueri, Z, Vaquette, B, Davy, Jm, Cottin, Y, D'Houdain, F, Danchin, N, Cassat, C, Messner, P, Elbaz, M, Coste, P, Zemour, G, Maupas, E, Feldman, L, Soto, Fx, Ferrari, E, Haltern, G, Heuer, H, Genth-Zotz, S, Loges, C, Stellbrink, C, Terres, W, Ferrar, M, Zeymer, U, Brachmann, J, Mudra, H, Vohringer, Hf, vom Dah, J, Kreuzer, J, Hill, S, Kleinertz, K, Kadel, C, Appel, Kf, Nienabe, C, Behrens, S, Frantz, S, Mehrhof, F, Krings, P, Hengstenberg, C, Lueders, S, Hanefel, C, Krulls-Munch, J, Dorse, T, Leschke, M, Nogai, K, Butter, C, Darius, H, Fichtlscherer, Hp, Schmitt, C, Kasisk, Hp, Dorr, M, Fran, N, Jereczek, M, Wiemer, M, Nickenig, G, Boudriot, E, Werner, G, Altila, T, Strasser, R, Baldus, S, Desaga, M, Buerke, M, Land, S, Schunkert, H, Schulze, Ho, Holmer, S, Sohn, Hy, Burkhardt, W, Lauer, B, Schwimmbeck, P, Schoeller, R, Lapp, H, Gross, M, Kindermann, I, Schuster, P, Yu, Cm, Lee, S, Merkely, B, Apro, D, Lupkovics, G, Edes, I, Ungi, I, Piroth, Z, Csapo, K, Dezsi, Ca, Herczeg, B, Sereg, M, Butnaru, A, Lewis, B, Rosenschein, U, Mosseri, M, Turgeman, Y, Pollak, A, Shotan, A, Hammerman, H, Rozenman, Y, Gottlieb, S, Atar, S, Weiss, A, Marmor, A, Iakobishvili, Z, Mascia, F, De Cesare, N, Piovaccari, G, Ceravolo, R, Fiscella, A, Salvioni, A, Silvestri, O, Moretti, L, Severi, S, Carmina, Mg, De Caterina, R, Fattore, L, Terrosu, P, Trimarco, B, Ardissino, D, Uguccioni, L, Auguadro, C, Gregorio, G, De Ferrari, G, Testa, R, Evola, R, De Servi, S, Sganzerla, P, Vassanelli, C, Brunelli, C, Scherillo, M, Tamburino, C, Limido, A, Luzza, F, Percoco, Gf, Sinagra, G, Volpe, M, Crea, F, Fedele, F, Rasetti, G, Cinelli, F, Merlini, P, Sisto, F, Biancoli, S, Fresco, C, Corrada, E, Casolo, G, Santini, M, D'Alessandro, B, Antoniucci, D, Tuccillo, B, Assennato, P, Puccioni, E, Pasquetto, G, Perna, Gp, Morgagni, G, Takizawa, K, Kato, K, Oshima, S, Yagi, M, Asai, T, Kamiya, H, Hirokami, M, Sakota, S, Sueyoshi, A, Shimomura, H, Hashimoto, T, Miyahara, M, Matsumura, T, Nakao, K, Kakuta, T, Nakamura, S, Nishi, Y, Kawajiri, K, Nagai, Y, Takahashi, A, Ikari, Y, Hara, K, Koga, T, Fujii, K, Tobaru, T, Tsunoda, R, Uchiyama, T, Hirayama, H, Fujimoto, K, Sakurai, S, Tanigawa, T, Ohno, M, Yamamoto, E, Ikuta, S, Kato, A, Kikuta, K, Takami, A, Chong, Wp, Ong, Tk, Yusof, A, Maskon, O, Kahar, A, Breedveld, Rw, Bendermacher, Pe, Hamer, Bj, Oude Ophuis AJ, Nierop, Pr, Westendorp, Ic, Beijerbacht, Hp, Herrman, Jp, van 't Hof AW, Troquay, Rp, van der Meer, P, Peters, Rh, van Rossum, P, Liem, A, Pieterse, Mg, van Eck JW, van der Zwaan, C, Pasupati, S, Elliott, J, Tisch, J, Hart, H, Luke, R, Scott, D, Ternouth, I, White, H, Hamer, A, Harding, S, Wilkins, G, O'Meeghan, T, Harrison, N, Nilsen, D, Thalamus, J, Aaberge, L, Brunvand, H, Lutterbey, G, Omland, Tm, Eritsland, J, Wiseth, R, Aase, O, Campos, C, Horna, M, Toce, L, Salazar, M, Przewlocki, T, Ponikowski, P, Kasprzak, J, Kopaczewski, J, Musial, W, Mazurek, W, Kawecka-Jaszcz, K, Pluta, W, Dobrzycki, S, Loboz-Grudzien, K, Lewczuk, J, Karwowski, D, Grajek, S, Dudek, D, Trusz-Gluza, M, Kornacewicz-Jach, Z, Gil, R, Ferreira, J, Gavina, C, Ferreira, R, Martins, D, Garcia-Rinaldi, R, Ufret, R, Vazquez-Tanus, J, Banchs, H, Wong, A, Tan, Hc, Guerra, M, Ebrahim, I, Roux, J, Blomerus, P, Saaiman, A, Corbett, C, Pillay, T, Freeman, V, Horak, A, Zambakides, C, Burgess, L, Yoon, Jh, Ahn, Th, Gwon, Hc, Seong, Iw, Kim, Hs, Jeong, Mh, Kim, Yd, Chae, Sc, Hernandez, Jm, Pique, M, Fernandez Portales, J, Paz, Ma, Lopez Palop, R, Iniguez, A, Diaz Fernandez, J, Alvarez, P, Sanz, E, Heras, M, Sala, J, Goicolea, J, Cruz Fernandez, J, Serra, A, Fernandez Ortiz, A, Calle, G, Barriales, V, Albarran, A, Curos, A, Molano Casimiro FJ, Suarez, Ma, Franco, Sn, Bayon, J, Suarez, J, Belchi, J, Moreu, J, San Martin, M, Melgares Moreno, R, Aguirre Salcedo, J, Gonzalez Juanatey JR, Martinez Romero, P, Galache Osuna JG, Albertsson, P, Diderholm, E, Lycksell, M, Rasmanis, G, Swahn, E, Cherfan, P, Christensen, K, Lundman, P, Larson, Le, Vasko, P, Pripp, Cm, Johansson, A, Moccetti, T, Corti, R, Pieper, M, Mach, F, Eberli, F, Jeger, R, Rickli, H, Vogt, P, Windecker, S, Wu, Cj, Kao, Hl, Charng, Mj, Chang, Kc, Chen, Zc, Tsa, Cd, Shyu, Kg, Lai, Wt, Hsieh, Ic, Hou, Jy, Yeh, Hi, Ueng, Kc, Yin, Wh, Timurkaynak, T, Yigit, Z, Yilmaz, M, Boyaci, A, Sahin, M, Goktekin, O, Bozkurt, E, Ercan, E, Yildirir, A, Muthusamy, R, Keeling, P, Levy, T, Zaman, A, Cohen, A, Gorog, D, Baumbach, A, Oldroyd, K, Kadr, H, Tait, G, Bellenger, N, Davis, G, Shakespeare, C, Senior, R, Bruce, D, Uren, N, Trouton, T, Ahsan, A, Hamed, A, Malik, I, Sarma, J, Millar-Craig, M, Robson, H, Kennon, S, Sprigings, D, Brodie, B, Kang, Gs, Thomas, G, Cheng, Sc, Espinoza, A, Kassas, S, Jafar, Z, Kumar, P, Izzo, M, Wiseman, A, Chandna, H, Felten, W, D'Urso, M, Gudipati, Cr, Coram, R, Gill, S, Bengtson, J, Chang, M, Raisinghani, A, Blankenship, J, Harbor, Wf, Kraft, P, Ashraf, R, Chambers, J, Albirini, A, Malik, A, Ziada, K, Slepian, M, Taussig, A, Vernon, H, Jetty, P, Islam, Ma, Canaday, D, Martin, T, Burchenal, Jj, Gencheff, N, Nygaard, T, Panchal, V, Merritt, R, Abrahams, L, Lambert, C, Reyes, P, Leimbach, W, Chhabra, A, Caputo, R, Imburgia, M, Erickson, B, Kleiman, N, Hunter, J, Dehning, M, Graham, B, Strain, J, White, Jk, Mcgarvey, J Jr, Henderson, D, Treasure, C 2nd, Mirro, M, Pancholy, S, Helmy, T, Westerhausen, D, Dib, N, Penny, W, Kim, H, Degregorio, M, Jay, D, Kmonicek, J, Berlowitz, M, Starling, M, Langevin, E, Nelson, R, Singer, A, Siachos, A, Gibson, G, Parrott, C, Held, J, Puleo, P, Wolford, T, Omar, B, Brilakis, E, Lewis, S, Heller, L, Brener, S, Addo, T, Lieberman, S, Eisenberg, D, Feldman, R, Waksman, R, Waltman, J, Schulman, S, Bounds, C, Voyce, S, Batchelor, W, Dobies, D, Pasnoori, V, Chandrashekhar, Y, Vetrovec, G, Azrin, M, Spriggs, D, Hirsch, C, Smucker, M, Chetcuti, S, Stella, R, Levite, H, Shoukfeh, M, Vidovich, M, Saucedo, J, Fintel, D, Low, R, Gellman, J, Ahsan, C, Unks, Dm, Tolleson, T, Ceccoli, H, Aggarwal, K, Bhaktaram, V, Olson, C, Decaro, M, Kaluski, E, Mehta, V, Puma, J, Singh, V, Fulmer, J, Lewis, D, Khadra, S, Staniloae, C, East, M, Sundram, Ps, Anderson, J, Wasserman, H, Guy, D, Brill, D, Kruse, K, Ebrahimi, R, Nguyen, T, Keating, F, Srivastava, R, Wassmer, P, Todd, J 3rd, Stein, M, Hamzeh, I, Laxson, D, Hodson, R, Puri, S, Vijayaraghavan, K, Gazmuri, R, Chu, A, Vijay, N, Rabinowitz, A, Block, T, Agarwal, H, Martin, J, Zetterlund, P, Fortuin, D, Macdonell, A 3rd, Zouzoulas, S, Chepuri, V, Schmalfuss, C, Karve, M, Aviles, R, Lieberman, E, Amlani, M, Murphy, S, Shapiro, T, Herzog, E, Ariani, K, Bhagwat, R, Hockstad, E, Kai, W, Saririan, M, Roth, R, Weiland, F, Atassi, K, Harjai, K, Muhlestein, J, Marsh, R, Shokooh, S, Nahhas, A, Labroo, A, Mayor, M, Koshy, S, Tariq, M, Rayos, G, Jones, S, Klugherz, B, Dewey, R, Rashid, Hu, Wohns, D, Feiring, A, Bowles, M, Rohrbeck, S, Monroe, Vs, De Gottlieb, A, Gumm, D, Brown, C 3rd, Chang, D, Kalaria, V, Minisi, A, Joumaa, M, Josephson, R, Kleczka, J, Silver, K, Coleman, P, Brachfeld, C, Saltiel, F, Reiner, J, Carell, E, Hanovich, G, Rosenberg, M, Das, G, Blick, D, and Universitat de Barcelona
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Male ,Pyridines ,medicine.medical_treatment ,Kaplan-Meier Estimate ,law.invention ,Lactones ,Randomized controlled trial ,law ,Thrombin receptor antagonist ,clopidogrel ,placebo ,thienopyridine derivative ,vorapaxar ,antithrombocytic agent ,lactone ,proteinase activated receptor 1 ,pyridine derivative ,Coronary Artery Bypass ,Vorapaxar ,Cardiovascular diseases [NCEBP 14] ,Drugs ,General Medicine ,Middle Aged ,Combined Modality Therapy ,Cardiovascular diseases ,Cardiovascular Diseases ,Cardiology ,Platelet aggregation inhibitor ,Drug Therapy, Combination ,Female ,Plaquetes sanguínies ,Intracranial Hemorrhages ,Major bleeding ,Medicaments ,medicine.drug ,medicine.medical_specialty ,Acute coronary syndrome ,Bypass cardiopulmonary ,Hemorrhage ,Pharmacotherapy ,Blood platelets ,Double-Blind Method ,Angioplasty ,Internal medicine ,medicine ,Humans ,Receptor, PAR-1 ,Acute Coronary Syndrome ,Aged ,business.industry ,Malalties cardiovasculars ,medicine.disease ,Surgery ,Bypass cardiopulmonar ,business ,Platelet Aggregation Inhibitors ,Follow-Up Studies - Abstract
Item does not contain fulltext BACKGROUND: Vorapaxar is a new oral protease-activated-receptor 1 (PAR-1) antagonist that inhibits thrombin-induced platelet activation. METHODS: In this multinational, double-blind, randomized trial, we compared vorapaxar with placebo in 12,944 patients who had acute coronary syndromes without ST-segment elevation. The primary end point was a composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization. RESULTS: Follow-up in the trial was terminated early after a safety review. After a median follow-up of 502 days (interquartile range, 349 to 667), the primary end point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of 6471 patients receiving placebo (Kaplan-Meier 2-year rate, 18.5% vs. 19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01; P=0.07). A composite of death from cardiovascular causes, myocardial infarction, or stroke occurred in 822 patients in the vorapaxar group versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard ratio, 0.89; 95% CI, 0.81 to 0.98; P=0.02). Rates of moderate and severe bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group (hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P
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- 2012
23. ACCF/AHA 2011 expert consensus document on hypertension in the elderly: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents developed in collaboration with the American Academy of Neurology, American Geriatrics Society, American Society for Preventive Cardiology, American Society of Hypertension, American Society of Nephrology, Association of Black Cardiologists, and European Society of Hypertension
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Aronow, WS, Fleg, JL, Pepine, CJ, Artinian, NT, Bakris, G, Brown, AS, Ferdinand, KC, Ann Forciea, M, Frishman, WH, Jaigobin, C, Kostis, JB, Oparil, S, Ortiz, E, Reisin, E, Rich, MW, Schocken, DD, Weber, MA, Wesley, DJ, Harrington, RA, Bates, ER, Bhatt, DL, Bridges, CR, Eisenberg, MJ, Ferrari, VA, Fisher, JD, Gardner, TJ, Gentile, F, Gilson, MF, Hlatky, MA, Jacobs, AK, Kaul, S, Moliterno, DJ, Mukherjee, D, Rosenson, RS, Stein, JH, Weitz, HH, MANCIA, GIUSEPPE, Aronow, W, Fleg, J, Pepine, C, Artinian, N, Bakris, G, Brown, A, Ferdinand, K, Ann Forciea, M, Frishman, W, Jaigobin, C, Kostis, J, Mancia, G, Oparil, S, Ortiz, E, Reisin, E, Rich, M, Schocken, D, Weber, M, Wesley, D, Harrington, R, Bates, E, Bhatt, D, Bridges, C, Eisenberg, M, Ferrari, V, Fisher, J, Gardner, T, Gentile, F, Gilson, M, Hlatky, M, Jacobs, A, Kaul, S, Moliterno, D, Mukherjee, D, Rosenson, R, Stein, J, and Weitz, H
- Subjects
Kidney Disease ,Diabetic Angiopathie ,Myocardial Ischemia ,Blood Pressure ,Comorbidity ,Kidney ,Renal Artery Obstruction ,Ventricular Function, Left ,Ventricular Function Left ,Renin-Angiotensin System ,Drug Therapy Combination ,Risk Factors ,Cardiovascular Disease ,Prevalence ,Humans ,Life Style ,Antihypertensive Agents ,Aged ,Cerebral Hemorrhage ,Risk Factor ,Nutrition Survey ,Blood Pressure Determination ,Nutrition Surveys ,Antihypertensive Agent ,Cardiovascular Diseases ,Hypertension ,Drug Therapy, Combination ,Kidney Diseases ,Diabetic Angiopathies ,Human - Published
- 2011
24. Six-month outcomes of percutaneous coronary balloon angioplasty in acute coronary syndromes: Results from the PURSUIT trial
- Author
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Labinaz, M, Kaul, P, Harrington, RA, Chang, W-C, Kleinman, NS, Simoons, Maarten, Boersma, Eric, Akkerhuis, Martijn, Califf, RM, Armstrong, PW, PURSUIT Investigators,, and Cardiology
- Published
- 2004
25. Early angioplasty in acute coronary syndromes without persistent ST-segment elevation improves outcome but increases the need for six-month repeat revascularization - An analysis of the PURSUIT trial
- Author
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Ronner, E, Boersma, Eric, Laarman, GJ (GertJan), Somsen, GA, Harrington, RA, Deckers, Jaap, Topol, EJ, Califf, RM, Simoons, Maarten, and Cardiology
- Published
- 2002
26. Systematic adjudication of myocardial infarction end-points in an international clinical trial
- Author
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Mahaffey, KW, Harrington, RA, Akkerhuis, Martijn, Kleiman, NS, Berdan, LG, Crenshaw, BS, Tardiff, BE, Granger, CB, DeJong, I, Bhapkar, M, Widimsky, P, Corbalon, R, Lee, KL, Deckers, Jaap, Simoons, Maarten, Topol, EJ, Califf, RM, PURSUIT Investigators,, and Cardiology
- Published
- 2001
27. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study
- Author
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Mahaffey, KW, Harrington, RA, Akkerhuis, Martijn, Kleiman, NS, Berdan, LG, Crenshaw, BS, Tardiff, BE, Granger, CB, DeJong, I, Bhapkar, M, Widimsky, P, Corbalon, R, Lee, KL, Deckers, Jaap, Simoons, Maarten, Topol, EJ, Califf, RM, PURSUIT Investigators,, and Cardiology
- Published
- 2001
28. Therapeutic value of eptifibatide at community hospitals transferring patients to tertiary referral centers early after admission for acute coronary syndromes. PURSUIT Investigators
- Author
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Greenbaum, AB, Harrington, RA, Hudson, MP, MacAulay, CM, Wilcox, RG, Simoons, Maarten, Berdan, LG, Guerci, A, Cokkinos, DV, Kitt, MM, Lincoff, AM, Topol, EJ, Califf, RM, Ohman, EM, PURSUIT Investigators,, and Cardiology
- Published
- 2001
29. Geographic variability in outcomes within an international trial of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes
- Author
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Akkerhuis, Martijn, Deckers, Jaap, Boersma, Eric, Harrington, RA, Stepinska, J, Mahaffey, KW, Wilcox, RG, Lincoff, AM, Keltai, M, Topol, EJ, Califf, RM, Simoons, Maarten, PURSUIT Investigators,, and Cardiology
- Published
- 2000
30. Early percutaneous coronary intervention, platelet inhibition with eptifibatide, and clinical outcomes in patients with acute coronary syndromes
- Author
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Kleiman, NS, Lincoff, AM, Flaker, GC, Pieper, KS, Wilcox, RG, Berdan, LG, Lorenz, TJ, Cokkinos, DV, Simoons, Maarten, Boersma, Eric, Topol, EJ, Califf, RM, Harrington, RA, PURSUIT Investigators,, and Cardiology
- Published
- 2000
31. Foreword
- Author
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Simoons, Maarten, Harrington, RA, and Cardiology
- Published
- 2000
32. Management of patients with acute coronary syndromes in the United States by platelet glycoprotein IIb/IIIa inhibition
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Lincoff, AM, Harrington, RA, Califf, RM, Hochman, JS, Guerci, AD, Ohman, EM, Pepine, CJ, Kopecky, SL, Kleiman, NS, Pacchiana, CM, Berdan, LG, Kitt, MM, Simoons, Maarten, Topol, EJ, PURSUIT Investigators,, and Cardiology
- Published
- 2000
33. ACCF/AHA 2011 expert consensus document on hypertension in the elderly: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents
- Author
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Aronow, W, Fleg, J, Pepine, C, Artinian, N, Bakris, G, Brown, A, Ferdinand, K, Forciea, M, Frishman, W, Jaigobin, C, Kostis, J, Mancia, G, Oparil, S, Ortiz, E, Reisin, E, Rich, M, Schocken, D, Weber, M, Wesley, D, Harrington, R, Aronow, WS, Fleg, JL, Pepine, CJ, Artinian, NT, Brown, AS, Ferdinand, KC, Forciea, MA, Frishman, WH, Kostis, JB, MANCIA, GIUSEPPE, Rich, MW, Schocken, DD, Weber, MA, Wesley, DJ, Harrington, RA, Aronow, W, Fleg, J, Pepine, C, Artinian, N, Bakris, G, Brown, A, Ferdinand, K, Forciea, M, Frishman, W, Jaigobin, C, Kostis, J, Mancia, G, Oparil, S, Ortiz, E, Reisin, E, Rich, M, Schocken, D, Weber, M, Wesley, D, Harrington, R, Aronow, WS, Fleg, JL, Pepine, CJ, Artinian, NT, Brown, AS, Ferdinand, KC, Forciea, MA, Frishman, WH, Kostis, JB, MANCIA, GIUSEPPE, Rich, MW, Schocken, DD, Weber, MA, Wesley, DJ, and Harrington, RA
- Published
- 2011
34. ACCF/AHA 2011 expert consensus document on hypertension in the elderly: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents developed in collaboration with the American Academy of Neurology, American Geriatrics Society, American Society for Preventive Cardiology, American Society of Hypertension, American Society of Nephrology, Association of Black Cardiologists, and European Society of Hypertension
- Author
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Aronow, W, Fleg, J, Pepine, C, Artinian, N, Bakris, G, Brown, A, Ferdinand, K, Ann Forciea, M, Frishman, W, Jaigobin, C, Kostis, J, Mancia, G, Oparil, S, Ortiz, E, Reisin, E, Rich, M, Schocken, D, Weber, M, Wesley, D, Harrington, R, Bates, E, Bhatt, D, Bridges, C, Eisenberg, M, Ferrari, V, Fisher, J, Gardner, T, Gentile, F, Gilson, M, Hlatky, M, Jacobs, A, Kaul, S, Moliterno, D, Mukherjee, D, Rosenson, R, Stein, J, Weitz, H, Aronow, WS, Fleg, JL, Pepine, CJ, Artinian, NT, Brown, AS, Ferdinand, KC, Frishman, WH, Kostis, JB, Rich, MW, Schocken, DD, Weber, MA, Wesley, DJ, Harrington, RA, Bates, ER, Bhatt, DL, Bridges, CR, Eisenberg, MJ, Ferrari, VA, Fisher, JD, Gardner, TJ, Gilson, MF, Hlatky, MA, Jacobs, AK, Moliterno, DJ, Rosenson, RS, Stein, JH, Weitz, HH, MANCIA, GIUSEPPE, Aronow, W, Fleg, J, Pepine, C, Artinian, N, Bakris, G, Brown, A, Ferdinand, K, Ann Forciea, M, Frishman, W, Jaigobin, C, Kostis, J, Mancia, G, Oparil, S, Ortiz, E, Reisin, E, Rich, M, Schocken, D, Weber, M, Wesley, D, Harrington, R, Bates, E, Bhatt, D, Bridges, C, Eisenberg, M, Ferrari, V, Fisher, J, Gardner, T, Gentile, F, Gilson, M, Hlatky, M, Jacobs, A, Kaul, S, Moliterno, D, Mukherjee, D, Rosenson, R, Stein, J, Weitz, H, Aronow, WS, Fleg, JL, Pepine, CJ, Artinian, NT, Brown, AS, Ferdinand, KC, Frishman, WH, Kostis, JB, Rich, MW, Schocken, DD, Weber, MA, Wesley, DJ, Harrington, RA, Bates, ER, Bhatt, DL, Bridges, CR, Eisenberg, MJ, Ferrari, VA, Fisher, JD, Gardner, TJ, Gilson, MF, Hlatky, MA, Jacobs, AK, Moliterno, DJ, Rosenson, RS, Stein, JH, Weitz, HH, and MANCIA, GIUSEPPE
- Published
- 2011
35. Clinical significance of thrombocytopenia during a non-ST-elevation acute coronary syndrome. The platelet glycoprotein IIb/IIIa in unstable angina: receptor suppression using integrilin therapy (PURSUIT) trial experience
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Mc Clure, MW, Berkowitz, SD, Sparapani, R, Tuttle, R, Kleiman, NS, Berdan, LG, Lincoff, AM, Deckers, Jaap, Diaz, R, Karsch, KR, Gretler, D, Kitt, M, Simoons, Maarten, Topol, EJ, Califf, RM, Harrington, RA, PURSUIT Investigators,, and Cardiology
- Published
- 1999
36. Prior aspirin use predicts worse outcomes in patients with non-ST-elevation acute coronary syndromes
- Author
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Alexander, JH, Harrington, RA, Tuttle, R, Berdan, LG, Lincoff, AM, Deckers, Jaap, Simoons, Maarten, Guerci, A, Hochman, JS, Wilcox, RG, Kitt, M, Eisenberg, PR, Califf, RM, Topol, EJ, Karsch, KR, Ruzyllo, W, Stepinska, J, Widimsky, P, Boland, JB, Armstrong, PW, PURSUIT Investigators,, and Cardiology
- Published
- 1999
37. Health Economics in the PLATelet Inhibition and Patient Outcomes (PLATO) Randomized Trial: Report on Within Trial Resource Use Patterns
- Author
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Janzon, Magnus, Nikolic, Elisabet, Henriksson, Martin, Levin, Lars-Åke, Hauch, Ole, Mark, DB, Cowper, P., Kaul, P., Harrington, RA., Horrow, J., Wallentin, Lars, Janzon, Magnus, Nikolic, Elisabet, Henriksson, Martin, Levin, Lars-Åke, Hauch, Ole, Mark, DB, Cowper, P., Kaul, P., Harrington, RA., Horrow, J., and Wallentin, Lars
- Published
- 2010
38. Creatine kinase-MB elevation after percutaneous coronary intervention predicts adverse outcomes in patients with acute coronary syndromes
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Roe, MT, Mahaffey, KW, Kilaru, R, Alexander, JH, Akkerhuis, Martijn, Simoons, Maarten, Harrington, RA, Tardiff, BE, Granger, CB, Ohman, EM, Moliterno, DJ, Lincoff, AM, Armstrong, PW, van der Werf, F, Califf, RM, Topol, EJ, Roe, MT, Mahaffey, KW, Kilaru, R, Alexander, JH, Akkerhuis, Martijn, Simoons, Maarten, Harrington, RA, Tardiff, BE, Granger, CB, Ohman, EM, Moliterno, DJ, Lincoff, AM, Armstrong, PW, van der Werf, F, Califf, RM, and Topol, EJ
- Published
- 2004
39. Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: ameta-analysis of all major randomised clinical trials.
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Boersma, E, Harrington, RA, Moliterno, DJ, White, H, Theroux, P, Van de Werf, F, de Torbal, A, Armstrong, PW, Wallentin, LC, Wilcox, RG, Simes, J, Califf, RM, Topol, EJ, Simoons, ML, Boersma, E, Harrington, RA, Moliterno, DJ, White, H, Theroux, P, Van de Werf, F, de Torbal, A, Armstrong, PW, Wallentin, LC, Wilcox, RG, Simes, J, Califf, RM, Topol, EJ, and Simoons, ML
- Published
- 2002
40. Patients with acute coronary syndromes without persistent ST elevation undergoing percutaneous coronary intervention benefit most from early intervention with protection by a glycoprotein IIb/IIIa receptor blocker
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Ronner, E, Boersma, Eric, Akkerhuis, Martijn, Harrington, RA, Lincoff, AM, Deckers, Jaap, Karsch, KR, Kleiman, NS, Vahanian, A, Topol, EJ, Califf, RM, Simoons, Maarten, Ronner, E, Boersma, Eric, Akkerhuis, Martijn, Harrington, RA, Lincoff, AM, Deckers, Jaap, Karsch, KR, Kleiman, NS, Vahanian, A, Topol, EJ, Califf, RM, and Simoons, Maarten
- Published
- 2002
41. Sustained ventricular arrhythmias among patients with acute coronary syndromes with no ST-segment elevation - Incidence, predictors, and outcomes
- Author
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Al-Khatib, SM, Granger, CB, Huang, Y, Lee, KL, Califf, RM, Simoons, Maarten, Armstrong, PW, van der Werf, F, White, HD, Simes, RJ, Moliterno, DJ, Topol, EJ, Harrington, RA, Al-Khatib, SM, Granger, CB, Huang, Y, Lee, KL, Califf, RM, Simoons, Maarten, Armstrong, PW, van der Werf, F, White, HD, Simes, RJ, Moliterno, DJ, Topol, EJ, and Harrington, RA
- Published
- 2002
42. Association between minor elevations of creatine kinase-MB level and mortality in patients with acute coronary syndromes without ST-segment elevation
- Author
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Alexander, JH, Sparapani, RA, Mahaffey, KW, Deckers, Jaap, Newby, LK, Ohman, EM, Corbalán, R, Chierchia, SL, Boland, JB, Simoons, Maarten, Califf, RM, Topol, EJ, Harrington, RA, Alexander, JH, Sparapani, RA, Mahaffey, KW, Deckers, Jaap, Newby, LK, Ohman, EM, Corbalán, R, Chierchia, SL, Boland, JB, Simoons, Maarten, Califf, RM, Topol, EJ, and Harrington, RA
- Published
- 2000
43. Effect of adenosine-regulating agent acadesine on morbidity and mortality associated with coronary artery bypass grafting: the RED-CABG randomized controlled trial.
- Author
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Newman MF, Ferguson TB, White JA, Ambrosio G, Koglin J, Nussmeier NA, Pearl RG, Pitt B, Wechsler AS, Weisel RD, Reece TL, Lira A, Harrington RA, RED-CABG Steering Committee and Investigators, Newman, Mark F, Ferguson, T Bruce, White, Jennifer A, Ambrosio, Giuseppe, Koglin, Joerg, and Nussmeier, Nancy A
- Abstract
Context: Ischemia/reperfusion injury remains an important cause of morbidity and mortality after coronary artery bypass graft (CABG) surgery. In a meta-analysis of randomized controlled trials, perioperative and postoperative infusion of acadesine, a first-in-class adenosine-regulating agent, was associated with a reduction in early cardiac death, myocardial infarction, and combined adverse cardiac outcomes in participants undergoing on-pump CABG surgery.Objective: To assess the efficacy and safety of acadesine administered in the perioperative period in reducing all-cause mortality, nonfatal stroke, and severe left ventricular dysfunction (SLVD) through 28 days.Design, Setting, and Participants: The Reduction in Cardiovascular Events by Acadesine in Patients Undergoing CABG (RED-CABG) trial, a randomized, double-blind, placebo-controlled, parallel-group evaluation of intermediate- to high-risk patients (median age, 66 years) undergoing nonemergency, on-pump CABG surgery at 300 sites in 7 countries. Enrollment occurred from May 6, 2009, to July 30, 2010.Interventions: Eligible participants were randomized 1:1 to receive acadesine (0.1 mg/kg per minute for 7 hours) or placebo (both also added to cardioplegic solutions) beginning just before anesthesia induction.Main Outcome Measure: Composite of all-cause mortality, nonfatal stroke, or need for mechanical support for SLVD during and following CABG surgery through postoperative day 28.Results: Because results of a prespecified futility analysis indicated a very low likelihood of a statistically significant efficacious outcome, the trial was stopped after 3080 of the originally projected 7500 study participants were randomized. The primary outcome occurred in 75 of 1493 participants (5.0%) in the placebo group and 76 of 1493 (5.1%) in the acadesine group (odds ratio, 1.01 [95% CI, 0.73-1.41]). There were no differences in key secondary end points measured.Conclusion: In this population of intermediate- to high-risk patients undergoing CABG surgery, acadesine did not reduce the composite of all-cause mortality, nonfatal stroke, or SLVD.Trial Registration: clinicaltrials.gov Identifier: NCT00872001. [ABSTRACT FROM AUTHOR]- Published
- 2012
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44. Regional patterns of use of a medical management strategy for patients with non-ST-segment elevation acute coronary syndromes: insights from the EARLY ACS Trial.
- Author
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Roe MT, White JA, Kaul P, Tricoci P, Lokhnygina Y, Miller CD, van't Hof AW, Montalescot G, James SK, Saucedo J, Ohman EM, Pollack CV Jr, Hochman JS, Armstrong PW, Giugliano RP, Harrington RA, Van de Werf F, Califf RM, and Newby LK
- Published
- 2012
45. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial.
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Goodman SG, Clare R, Pieper KS, Nicolau JC, Storey RF, Cantor WJ, Mahaffey KW, Angiolillo DJ, Husted S, Cannon CP, James SK, Kilhamn J, Steg PG, Harrington RA, Wallentin L, and Platelet Inhibition and Patient Outcomes Trial Investigators
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- 2012
- Full Text
- View/download PDF
46. Relationship between vein graft failure and subsequent clinical outcomes after coronary artery bypass surgery.
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Lopes RD, Mehta RH, Hafley GE, Williams JB, Mack MJ, Peterson ED, Allen KB, Harrington RA, Gibson CM, Califf RM, Kouchoukos NT, Ferguson TB Jr, Alexander JH, Project of Ex Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) Investigators, Lopes, Renato D, Mehta, Rajendra H, Hafley, Gail E, Williams, Judson B, Mack, Michael J, and Peterson, Eric D
- Published
- 2012
- Full Text
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47. ST-Elevation Acute Coronary Syndromes in the Platelet Inhibition and Patient Outcomes (PLATO) Trial: Insights From the ECG Substudy.
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Armstrong PW, Siha H, Fu Y, Westerhout CM, Steg PG, James SK, Storey RF, Horrow J, Katus H, Clemmensen P, Harrington RA, and Wallentin L
- Published
- 2012
- Full Text
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48. American industry and the u.s. Cardiovascular clinical research enterprise an appropriate analogy?
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Califf RM and Harrington RA
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- 2011
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49. Ticagrelor compared with clopidogrel by geographic region in the Platelet Inhibition and Patient Outcomes (PLATO) trial.
- Author
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Mahaffey KW, Wojdyla DM, Carroll K, Becker RC, Storey RF, Angiolillo DJ, Held C, Cannon CP, James S, Pieper KS, Horrow J, Harrington RA, Wallentin L, and PLATO Investigators
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- 2011
- Full Text
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50. Saphenous vein grafts with multiple versus single distal targets in patients undergoing coronary artery bypass surgery: one-year graft failure and five-year outcomes from the Project of Ex-Vivo Vein Graft Engineering via Transfection (PREVENT) IV trial.
- Author
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Mehta RH, Ferguson TB, Lopes RD, Hafley GE, Mack MJ, Kouchoukos NT, Gibson CM, Harrington RA, Califf RM, Peterson ED, Alexander JH, Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Investigators, Mehta, Rajendra H, Ferguson, T Bruce, Lopes, Renato D, Hafley, Gail E, Mack, Michael J, Kouchoukos, Nicholas T, Gibson, C Michael, and Harrington, Robert A
- Published
- 2011
- Full Text
- View/download PDF
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