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1. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

Author

Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrøm T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabaté M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, and Alexander JH

Subjects
Acute Coronary Syndrome complications, Acute Coronary Syndrome surgery, Aged, Anticoagulants adverse effects, Atrial Fibrillation complications, Combined Modality Therapy, Disease Management, Drug Therapy, Combination, Elective Surgical Procedures, Female, Fibrinolytic Agents adverse effects, Hemorrhage chemically induced, Hemorrhage epidemiology, Hospitalization, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors adverse effects, Proportional Hazards Models, Prospective Studies, Purinergic P2Y Receptor Antagonists adverse effects, Purinergic P2Y Receptor Antagonists therapeutic use, Treatment Outcome, Vitamin K antagonists & inhibitors, Acute Coronary Syndrome drug therapy, Anticoagulants therapeutic use, Aspirin therapeutic use, Atrial Fibrillation drug therapy, Cardiovascular Agents therapeutic use, Fibrinolytic Agents therapeutic use, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors therapeutic use, Pyrazoles therapeutic use, Pyridones therapeutic use
Abstract

Background: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI., Methods: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y 12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI., Results: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; P interaction =0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; P =0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; interaction =0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups ( P interaction =0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; P interaction =0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization ( P interaction =0.787) and death and ischemic events ( P interaction =0.710)., Conclusions: An antithrombotic regimen consisting of apixaban and a P2Y 12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.

Published
2019
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2. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients.

Author

Chee Tang Chin, Boden, William E., Roe, Matthew T., Neely, Benjamin, Neely, Megan L., Leiva-Pons, Jose L., Corbalán, Ramón, Gottlieb, Shmuel, Dalby, Anthony J., Armstrong, Paul W., Prabhakaran, Dorairaj, Fox, Keith A. A., White, Harvey D., Magnus Ohman, E., Winters, Kenneth J., Schiele, Francois, Chin, Chee Tang, and Ohman, E Magnus

Subjects
TREATMENT of acute coronary syndrome, CLOPIDOGREL, CORONARY heart disease treatment, HEART diseases, THERAPEUTICS, CARDIOVASCULAR disease treatment, ASPIRIN, COMBINATION drug therapy, CLINICAL trials, COMPARATIVE studies, DRUG administration, HEMORRHAGE, HOSPITAL care, RESEARCH methodology, MEDICAL cooperation, MYOCARDIAL infarction, RESEARCH, RISK assessment, STROKE, TICLOPIDINE, TIME, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness, PROPORTIONAL hazards models, BLIND experiment, PLATELET aggregation inhibitors, ACUTE coronary syndrome, KAPLAN-Meier estimator, DISEASE complications, DIAGNOSIS
Abstract

Objective: We investigated whether prior clopidogrel influenced long-term ischaemic and bleeding risks and modified the randomised treatment effect of clopidogrel versus prasugrel among medically managed patients with acute coronary syndromes (ACS) treated with dual antiplatelet therapy.Methods: Medically managed patients with ACS in the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial were randomised to clopidogrel versus prasugrel (plus aspirin), stratified by prior clopidogrel use. From the analysis population (n=8927), we compared two groups: 'clopidogrel in-hospital (n=6513)' (clopidogrel started ≤72 h of presentation for index ACS event) and 'prior-clopidogrel (n=2414)' (on clopidogrel ≥5 days before index hospitalisation). Treatment-related differences in ischaemic (all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stroke and the composite of CV death/MI/stroke) and bleeding outcomes (severe/life-threatening or moderate bleeding events based on Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria) through 30 months were analysed between patients in the two groups.Results: Compared with 'clopidogrel in-hospital,' 'prior clopidogrel' patients were younger (median 64 years vs 66 years, p<0.001), more likely to have prior CV events/revascularisation, and had a higher frequency of CV death, MI or stroke through 30 months (20.8% vs 18.2%, p=0.002), with no difference in bleeding events (2.3% vs 3.4%, p=0.50). Randomised treatment effect (prasugrel vs clopidogrel) was similar for ischaemic and bleeding outcomes in both groups (all pinteraction>0.05).Conclusions: Patients receiving clopidogrel before admission for ACS and subsequently treated only medically are at higher risk for CV events versus those not previously receiving clopidogrel. More potent antiplatelet inhibition with prasugrel versus clopidogrel did not significantly reduce this risk.Trial Registration Number: NCT00699998. [ABSTRACT FROM AUTHOR]

Published
2016
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3. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

Author

L. Wang, T. Stys, William E. Boden, R. H. Urbano, D. M. Olinic, Karen S. Pieper, A. Kuijper, E. Soh, J. Nicolau, Jadwiga Nessler, William J. Rogers, Ernesto Rivera, R. Braam, H. Kadr, J. Csikasz, B. Boichev, Prafulla Kerkar, I. Kraiz, R. Babu, Ali Aydinlar, D. Safley, O. Nguyen-Khac, P. Chua, W. Buchanan, C. A. Morales, A. Abyankar, A. Srinivas, S. Genth-Zotz, J. Rocha Faria Neto, D. Drenning, L. Moretti, S. Varma, D. Roth, C. Matei, Jane E. Onken, H. Tumbev, P. Keeling, Xian Li, N. Ciglenecki, Shahyar M. Gharacholou, P. P. Goh, D. Sporn, M. Chang, Marcin Gruchała, R. Foreman, Bogdan Minescu, S. Nawaz, N. Alexeeva, Y. Shalev, C. Fastabend, L. van Zyl, J. F. Certic, J. Longo, J. Wang, K. Dave, Olivier Morel, F. Maatouk, Y. El Rakshy, J. Giacomini, P. Lazov, R. Marino, Dimitar Raev, M. Y. Chan, L. Z. Dextre, Y. Hao, P. Sepulveda, K. Ramshev, C. Bayron, Ameer Kabour, Alon Marmor, Luciano Moreira Baracioli, H. Marais, Rajendra H. Mehta, R. Breedveld, A. Ben Khalfallah, Kurtulus Ozdemir, I. Westendorp, J. A. Quion, Daniel J. George, D. F. Garcia, J.-P Bassand, G. Szalai, Huw Griffiths, O. Ushakov, M. Tzekova, E. Suprun, A. Mowafy, N. El Mansour, Gail V.W. Johnson, Tereshchenko Sn, W. T. Lai, Petr Widimsky, Hany Ragy, V. R. Castillo, M. Padour, Gilles Montalescot, Louie Tirador, Deepak L. Bhatt, M. Marrinan, S. Promisloff, A. Nambiar, Reginald G.E.J. Groutars, S. R. Lee, J. Cabrera, S. Zhang, András Jánosi, K. Wita, R. Sciborski, Annabelle Rodriguez, P. Sedlon, Jaroslaw D. Kasprzak, A. Faynyk, A. Romero Acuña, M. C. Ramirez, Rakesh Gupta, R. Saligrama, Jacek Gniot, Y. Ke, John H. Alexander, X. Liu, E. Baranov, R. Grzywna, Mukul Sharma, A. Linka, Jarosław Wójcik, Haroon Rashid, M. S. Sanchez, M. Gadkari, B. Rao, James S. Zebrack, Paul W. Armstrong, Francois Schiele, Gracita O. Topacio, Peter J. Casterella, A. Belhassane, P. Golino, F. Plat, P. Roberts-Thomson, K. S. Kim, Stephen D. Wiviott, Mathew T. Roe, Y. D. Chen, I. A. Khan, S. Thanvi, S. Isserman, G. Falck, R. M. Coching, S. C. Stamate, M. Ogorek, K. Danisa, Poul Anders Hansen, M. Medvegy, Amos Katz, R. K. Seerangachar, B. Farah, V. Kale, B. Kusnick, Maurice Pye, M. Mosseri, M. Vatutin, D. Weinstein, Norma Keller, A. Mihov, Ewa Mirek-Bryniarska, N. Adjei, S. Sethi, A. Irimpen, M. Broeders, T. Huynh, K. Niezgoda, P. Samardzic, D. Ziperman, Stuart J. Pocock, T. Arad, J. Lewczuk, M. Amuchastegui, R. Moscoso, B. Dimov, W. A. Ahmad, E. Dalli, P. Laothavorn, S. Shaikh, Helmut U. Klein, J. Menon, H. Colombo, L. Fattore, G. Zarrella, Dorairaj Prabhakaran, N. Viboolkitvarakul, Judith D. Goldberg, Neetika Garg, Y. Hasin, F. Rossi Dos Santos, S. J. Vigo, L. Horbach, O. Prokhorov, H. Moellmann, T. R. Vera, C. E. Botta, Domitilla Russo, M. Rossovskaya, David C. Henderson, Rebecca B. Costello, V. Shcherbak, C. J.P.J. Werter, W. Kus, I. Dobre, P. Marechal, T. Nair, H. Nielsen, J. Waites, J. B. Moraes Junior, T. Römer, J. Senior, P. Ionescu, S. Kalashetti, R. N. Ortega, Gail E. Hafley, G. A. Dan, Apur R. Kamdar, Ruth Ann Greenfield, David F. Kong, J. Bergallo, O. Barnum, Antonis S. Manolis, Sumeet Subherwal, S. Schaefer, A. Figueredo, Habib Gamra, S. Bandyopadhyay, V. Miloradovic, Imran Arif, Peter R. Carroll, M. Demirtas, S. Guidera, G. Rogelio, Naseem Jaffrani, N. Mulvihill, Marvin J. Slepian, Darren K. McGuire, Rohit Kalra, Luís A. Providência, F. Van de Werf, Andras Vertes, J. Xu, C. F. Gamio, R. G. Xuereb, R. F. Ramos, E. Kis, N. Bustros, M. De Luca, S. Zhurba, T. Connelly, S. Singhi, F. Gredler, Serdar Kucukoglu, Francesco Fedele, C. Chavez, Christoph Kadel, Antônio Carlos Sobral Sousa, S. Srimahachota, Igor Kaidashev, J. H. Garcia, I. Teodorescu, Birute Petrauskiene, O. Kracoff, Liwa T. Younis, Alain Bouchard, P. Osmancik, Y. Sun, C. Hammett, S. Sabri, William Wallace, Mehmet Yazici, L. Ermoshkina, Harish Chandna, G. Ramos-Lopez, M. Bronisz, Sergio Luiz Zimmermann, Giuseppe Ambrosio, V. Hergeldjieva, César A. Jardim, A. Rifai, H. Lui, A. Lee, J. Scholz Issa, A. Blenkhorn, P. Micale, V. Barbarich, C. Maccallum, Peter J. Grant, G. Topacio, N. Budassi, J. Yan, Keith A.A. Fox, Y. Xia, Jan H. Cornel, A. Rafael, Paul Hermany, S. Potthoff, Mohsin A.F. Khan, Pierre Coste, Neal Ready, N. T. Duda, M. Reyes, A. Chandran, I. G. Gordeev, Anne W. Beaven, B. J.B. Hamer, C. Treasure, Pravin Manga, M. R. Babarskiene, T. Devedzhiev, Alberto Menozzi, L. Lenarz, N. Llerena, Thomas F. Lüscher, Giovânio Vieira da Silva, Y. Malynovsky, L. Ramanathan, M. Belicova, M. O. Ibarra, D. Chew, R. Castillo, M. Kesselbrenner, A. H. Li, E. Baldjiev, M. El-Harari, S. H. Hur, S. Chiaramida, C. E. Chiang, Viliam Fridrich, L. R. Cartasegna, A. Yagensky, Steven E. Hearne, Gregory Pavlides, Witold Rużyłło, Y. Chandrashekhar, S. Welka, H. Petijean, Jose L. Leiva-Pons, Shaul Atar, Andrzej Lubiński, S. Zhao, János Tomcsányi, Narinder Singh, D. Banker, T. Boyek, H. Ebinc, N. Calambur, A. Mouhaffel, M. Creteanu, H. Huang, J. O. Jeong, E. Goudreau, D. Alexopoulos, E. Duronto, S. Car, O. Bashkirtsev, J. Mandak, V. Papademetriou, David O. Williams, Oscar Pereira Dutra, R. Baman, T. J. Hong, J. O. Ibañez, D. L. Gomez, R. K. Jain, R. Jozwa, L. Di Lorenzo, Matthew Wilson, Christian W. Hamm, A. Buakhamsri, Nikitas Moschos, Ashok Kumar, A. Kadiiski, C. Y. Lee, M. Opazo, J. Tang, E. Ferrari, P. Colon-Hernandez, Jean-Pierre Déry, B. Goloborodko, L. Gimple, Diego Ardissino, M. Bergovec, S. Thew, Dariusz Dudek, K. Tang, P. A.G. Zwart, A. Deshpande, S. Sathe, Yves Cottin, V. Pai, O. Koval, J. Lesnik, Pavan S. Reddy, A. Espinoza, Rungroj Krittayaphong, Carisi Anne Polanczyk, E. Kukuy, L. Tejada, J. Nobel, Renato D. Lopes, J. Bagatin, A. Manolova, E. Boudriot, A. Godoy, N. Perepech, Christopher D. Olympios, A. E. Guimarães, James Harris, Aref Rahman, D. Foley, H. J. Kruik, J. Bruguera I Cortada, I. Fotiadis, A. Bharani, Petar Otasevic, Eileen Brown, N. Gratsiansky, J. E. Poulard, Vladimir Gašparović, Habib Haouala, A. de Belder, J. Schmedtje, Lilia Nigro Maia, J. Cobos, Werner Benzer, E. Korban, A. U. Quraishi, X. Hong, A. Bazzi, P. Kotha, L. Gubolino, H. Ingersoll, Debra Marshall, Udo Sechtem, Sandipan Dutta, G. Frago, Anthony Mathur, Shaun G. Goodman, William Bachinsky, A. Hamer, Jaime Gomez, Patrizio Lancellotti, Vance Wilson, L. White, P.P. Mohanan, Aleksandar Knezevic, Sorin J. Brener, Susanna R. Stevens, H. Luquez, S. K. Lee, P. E. Leaes, P. Benjarge, T. Tu, Z. Coufal, N. Koliopoulos, Mahmut Şahin, X. Huang, S. Boldueva, J. De Souza, N. Chidambaram, S. Zolyomi, K. G. Shyu, H. Montecinos, A. Piombo, Wladmir Faustino Saporito, R. L. Kulkarni, I. Szakal, G. Arminio, M. Elbaz, Samir Pancholy, Jang Ho Bae, Giuseppe Musumeci, S. B. Zouari, A. Chois, D. Wojciechowski, A. Bakbak, E. Bozkurt, Kenneth J. Winters, R. Raugaliene, D. Sarkar, J. M. Alegret, Hubertus Heuer, E. Bobescu, E. Roncallo, R. Carlsson, R. Craig McLendon, L K Newby, K. Zrazhevskiy, João Pedro Ferreira, A. Haidar, D. Tellez, Robert Olszewski, Shmuel Gottlieb, H. Jure, A. Garcia Escudero, S. Sengupta, V. Ochean, W. Kostuk, G. Range, F. Leroy, G. Parale, R. Fernandez, M. Fulwani, M. Padovan, Y. Dovgalevskiy, Kreton Mavromatis, H. Hart, Y. G. Ko, F. Seixo, V. Bisne, J. McGarvey, Kimberly L. Blackwell, John H. Strickler, Sanjay Kumar, A. Bordonava, L. Egorova, C. Patocchi, A. Karczmarczyk, Chiara Melloni, Piyamitr Sritara, M. Anastasiou-Nana, Roman Szełemej, K. Penchev, D. Morales, M. Tokmakova, Krzysztof Zmudka, Rakesh Yadav, E. Bressollette, D. Nul, A. L. Astesiano, M. Urban, Abdulhay Albirini, C. T. Chin, F. Moulin, I. M. Coman, R. Watkin, J. Abanilla, J. Brønnum-Schou, J. Anusauskiene, P. Andrade Lotufo, Joseph G. Rogers, M. Bessen, P. C. Sartori, Paulo Roberto Ferreira Rossi, K. Atassi, H. V. Anderson, B. Klugherz, Bateshwar Prasad Singh, Mirza S. Baig, Z. Yusof, J. H. Geertman, A. Labroo, P. Nash, Freek W.A. Verheugt, Nancy J. Brown, M. A. Alcocer, A. Neskovic, L. Francek, Judith S. Hochman, A. Hoffmann, R. Dran, A. Podczeck-Schweighofer, Jeffry Katz, Josh Roberts, Roger E. McLendon, Ronald Rodriguez, T. Downes, A. Roth, L. E. Mayorga, Armagan Altun, José-Luis López-Sendón, M. Krotin, N. van der Merwe, O. Gigliotti, C. Park, G. Brigden, M. Kumbla, D. C G Basart, D. Erdogan, R. van Kranen, J. Beloscar, Johny Joseph, Pierluigi Tricoci, J. Marino, N. Mahon, S. Dani, I. Kovalskyy, Ioannis Nanas, V. Volkov, M. I. Edmilao, J. Kruells-Muench, F. Alamgir, R. Rinaldi, W. E. Mogrovejo, J. Mirat, C. Staniloae, S. Borromeo, H. Kozman, H. Zhang, Y. Zhou, S. Shurmur, A. Manari, M. A. Barrera, A. Vasylenko, D. Keedy, Paul A. Gurbel, Ali Oto, Charles R. Lambert, V. G. Ribeiro, A. Quintero, H. Joshi, L. Tang, J. Allan, C. S. Díaz, F. Carvalho Neuenschwander, Mircea Cintezǎ, M. Kokles, G. Piovaccari, Z. Kovacs, W. Li, C. Beauloye, E. J. Ramos, D. Bertolim Precoma, J. Burstein, G. Covelli, E. C. Zambrano, Assen Goudev, A. Tang, F. Henriquez, S. Tangsuntornwiwat, C. Kirma, GR Aycock, Kenneth W. Mahaffey, M. Ardnt, Jose C. Nicolau, O. Barbarash, E. K. Shin, P. Potapenko, T. Supryadkina, Asok Venkataraman, W. Mogrovejo, M. Acikel, R. Bohorquez, M. Syvänne, M. Chan, H. Mardikar, H. Berlin, O. Quintana, K. Heintz, J. M. Bastos, Guillermo Llamas Esperon, G. Aroney, J. Chen, Nancy H. Collins, C. Ahsan, G. Heins, F. Baer, V. Kondle, Nicholas Danchin, G. Shetty, Sergio Berti, Philip E. Aylward, James Cotton, G. S. Vallejo, Massimo Volpe, Z. Vasiljevic-Pokrajcic, C. Bugueño, Seung Woon Rha, S. Ilic, G. E. Stanciulescu, Z. Li, D. Nassiacos, R. Sciberras, S. Kuanprasert, Denilson Campos de Albuquerque, M. Pavlovic, Craig S. Barr, Mohammed R. Essop, John G. Canto, David T. Roberts, M. Ozdemir, Jacquelyn Miller, T. K. Ong, Sian E. Harding, V. Bose, J. Yoon, R. Syan, M. A. Paz, O. Maskon, Dennis V. Cokkinos, L. Kraus, Z. Masud, K. Amosova, M. Boyarkin, L. Mos, Dmitry Zamoryakhin, Arif Anis Khan, Jeffrey A. Breall, A. Gallino, Ivo Petrov, F. A. Alves da Cost, Saul Vizel, Hugo Vargas Filho, P. Kaewsuwanna, G. Antonelli, Chuen Den Tseng, I. Vakaliuk, J. Miklin, A. El Hawary, Ashok Jacob, D. Gumm, Kurt Huber, G. Pajes, N. Jathappa, Stanislaw Bartus, P. V. Lavhe, C. Romero, J. Balkin, T. Gould, R. Durgaprasad, Felipe Martinez, Henning Ebelt, A. Puri, D. K. Agarwal, E. E. Buyukoner, R. Mora Junior, P. Poliacik, A. Dande, X. Zhao, J. Floro, A. Bagriy, Yuliya Lokhnygina, M. Atieh, V. Batushkin, Valentin Markov, O. Karpenko, Peter Clemmensen, P. Castro, L. Paloscia, F. Florenzano, J. L. Accini, Tony Schibler, J. Arneja, W. Wu, B. Andruszkiewicz, Michael A. Morse, P. Vojtisek, D. Sadler, S. Frischwasser, M. Cayli, W N Leimbach, E. Flores, B. Wang, A Sosa Liprandi, Y. Michalaros, H. C. Finimundi, Raul D. Santos, N. Vijay, E. Magnus Ohman, Y. Karpenko, J. Sirotiakova, Z. Shogenov, D A Zateyshchikov, Eric P. Viergever, R. Bach, Gary S. Niess, D. C. Acosta, G. Piegari, J. B. Gupta, J. Shanes, E. Ronner, J. Arter, Claudio Cavallini, M. A. Hominal, V. Bugan, S. D. Varini, K. Nyman, B. G. Castillo, Sinan Aydoğdu, N. Novikova, D. Wang, P. Simpson, Y. Huang, Taral Patel, Gabriel Tatu-Chitoiu, D. Silva Junior, H. Theron, C. Alvarez, Anikó Ilona Nagy, T. Chua, P. Georgiev, D. Rittoo, G. De Luca, R. Blonder, Alberto Caccavo, D. Koganti, E. Manenti, N. Ghaisas, G. Letcher, D. Platogiannis, Arshed A. Quyyumi, J. Dy, Z. Ples, W. Kunz Sebba Barroso de Souza, Hamid Taheri, S. Kammoun, A. Salvioni, B. Stockins, K. Sutalo, J. C. Post, Merih Kutlu, Vijay K. Chopra, C. Mathis, Stephen M. Schwartz, Manish Jain, D. Coisne, A. Goudev, A. Dalby, João Morais, P. van Kalmthout, Andrzej Budaj, I. Dotani, L. Mircoli, R. Vicari, J. P. Herrman, M. Moran, G. Lupkovics, Alexander Parkhomenko, J. Heath, Andrew Moriarty, C. Pop, J. Y. Hwang, S. Kassam, R. Martingano, I. Nikolskaya, Z. Zheng, Johann S. de Bono, M. Izzo, R. Labonte, E. H. Forte, W. Moleerergpoom, Piera Angelica Merlini, D. Lee, W. Macias, G. Syan, S. Zhou, S. W. Kim, T. Duris, E. Shaoulian, Andreas U. Wali, Marco Antonio Mota Gomes, Pritibha Singh, M. Ovize, M. Del Core, W. Bowden, B. Xu, Ravi Bhagwat, C. Wongvipaporn, J. Vojacek, Steven Lindsay, F. McGrew, J. Gorny, J. D. Pappas, R. Vuyyuru, J. Chahin, Ashraf Reda, T. Lau, E. Conn, J. Meisner, S. Meymandi, A. D. Hrabar, M. Slanina, D. Jarasuniene, C. Lang, A. Vo, Christian Hamm, H. Gogia, Z. Yuan, T. Mathew, A. Van Dorpe, J. Kettner, M. Barbiero, Harvey D. White, L. Rudenko, V. Jain, M. Carter, David Erlinge, G. Ma, V. Sierkova, D. K. Kim, Steven O. Smith, R. K. Premchand, P. Jetty, J. Y. Hou, V. Simanenkov, T. Kaelsch, David P. Foley, A. Francis, Piotr Ponikowski, Ramón Corbalán, D. Connolly, J. Tuma, R. Zambahari, Miodrag Ostojic, R. Lamich, A. Rabelo Alves, V. Tseluyko, G. Moises Azize, L. Khaisheva, G. Pencheva, C. Ingram, J. Cooke, A. Prado, M. De Tollenaere, M. Kim, Alan Rees, Melanie B. Turner, Mark B. Abelson, H. L. Luciardi, L. Illyes, R. Sarma, L. Manriquez, J. A. Marin Neto, D. 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Dalkowski, Tomáš Janota, M. Damiao Gomes Seabra, A. Dharmadhikari, Aleš Linhart, John Elliott, Kodangudi B. Ramanathan, Doron Zahger, Dilek Ural, L. Regos, F. R. Bolohan, Marcello Galvani, B. Zakhary, N. Qureshi, D. Deac, Maria Emília Figueiredo Teixeira, T. Venter, Santosh Gupta, W. Wright, P. Telekes, A. Furber, V. Nykonov, Zhu Junren, M. Cinteza, I. Lang, S. Junejo, D. Martins, Mauro Esteves Hernandes, G. Ishmurzin, Anthony J. Dalby, R. Scioli, P. Babu, R. Habaluyas, V. Mendoza, G. B. Scaro, Matthew T. Roe, M. Senaratne, D. J. van der Heijden, T. Pillay, Yoav Turgeman, J. Moreira, C. Cuccia, C. Astarita, S. De Servi, Robert G. Wilcox, M. C. Constantinescu, Kardiyoloji, Roe Matthew, T., Armstrong Paul, W., Fox Keith, A. 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Subjects
Male, Prasugrel, Myocardial Infarction, Kaplan-Meier Estimate, Piperazines, Purinergic P2 Receptor Antagonists, Myocardial infarction, education.field_of_study, Cardiovascular diseases [NCEBP 14], Acute Coronary Syndrome, Aged, Angina, Unstable, Aspirin, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Middle Aged, Platelet Aggregation Inhibitors, Prasugrel Hydrochloride, Stroke, Thiophenes, Ticlopidine, Medicine (all), Hazard ratio, Clopidogrel, Acute Coronary Syndromes, General Medicine, Angina, Combination, Cardiology, medicine.drug, medicine.medical_specialty, Acute coronary syndrome, Population, Unstable, Drug Therapy, General & Internal Medicine, Internal medicine, medicine, cardiovascular diseases, education, Acute coronary syndromes, Revascularisation, Unstable angina, business.industry, medicine.disease, REVASCULARIZAÇÃO MIOCÁRDICA, business
Abstract

Item does not contain fulltext BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).

Published
2012

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