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BACKGROUND The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high-intensity or maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18,924 patients. Alirocumab reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths. OBJECTIVES This pre-specified analysis determined the extent to which alirocumab reduced total (first and subsequent) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES. METHODS Hazard functions for total nonfatal cardiovascular events (myocardial infarction, stroke, ischemia-driven coronary revascularization, and hospitalization for unstable angina or heart failure) and death were jointly estimated, linked by a shared frailty accounting for patient risk heterogeneity and correlated within-patient nonfatal events. An association parameter also quantified the strength of the linkage between risk of nonfatal events and death. The model provides accurate relative estimates of nonfatal event risk if nonfatal events are associated with increased risk for death. RESULTS With 3,064 first and 5,425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with alirocumab compared with placebo. Alirocumab reduced total nonfatal cardiovascular events (hazard ratio: 0.87; 95% confidence interval: 0.82 to 0.93) and death (hazard ratio: 0.83; 95% confidence interval: 0.71 to 0.97) in the presence of a strong association between nonfatal and fatal event risk. CONCLUSIONS In patients with ACS, the total number of nonfatal cardiovascular events and deaths prevented with alirocumab was twice the number of first events prevented. Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after ACS. (c) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY	卷:73
Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events The ODYSSEY OUTCOMES Trial
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White, Harvey D.^2,62 Steg, Gabriel^28,29 Schwartz, Gregory G.³ Bhatt, Deepak L.^5,6 Bittner, Vera A.⁷ Diaz, Rafael^10,30 Harrington, Robert A.¹⁵ Jukema, J. Wouter¹⁶ Szarek, Michael¹ Zeiher, Andreas M.²⁶ Tricoci, Pierluigi⁹² Mahaffey, Kenneth W.¹⁵ Edelberg, Jay M.¹¹ Hanotin, Corinne¹⁴ Lecorps, Guillaume¹⁴ Moryusef, Angele¹¹ Pordy, Robert¹⁹ Drexel, Heinz^32,174 Sinnaeve, Peter³³ Dilic, Mirza³⁴ Gotcheva, Nina N.³⁵ Prieto, Juan-Carlos³⁶ Yong, Huo³⁷ Lopez-Jaramillo, Patricio³⁸ Pecin, Ivan³⁹ Reiner, Zeljko⁴⁰ Poulsen, Steen Hvitfeldt^42,429 Viigimaa, Margus⁴³ Nieminen, Markku S.⁴⁴ Danchin, Nicolas⁴⁵ Chumburidze, Vakhtang⁴⁶ Tse, Hung-Fat⁵⁰ Xavier, Denis^{22,23,24,25,51} Zahger, Doron⁵² Valgimigli, Marco⁵³ Kim, Hyo Soo⁵⁴ Erglis, Andrejs⁵⁷ Laucevicius, Aleksandras⁵⁸ Lopez, Ramos⁶¹ Ramos Lopez, Gabriel Arturo⁶¹ Alings, Marco⁴ Chua, Terrance⁶⁹ Murin, Jan⁷⁰ Fras, Zlatko⁷¹ Dalby, Anthony J.⁷² Tunon, Jose⁷³ de Silva, H. Asita⁷⁴ Chiang, Chern-En^8,9,77 Sritara, Piyamitr⁷⁸ Guneri, Sema⁷⁹ Parkhomenko, Alexander⁸⁰ Ray, Kausik K.⁸¹ Moriarty, Patrick M.⁸² Roe, Matthew T.^20,83,92 Chaitman, Bernard⁸⁵ Kelsey, Sheryl F.⁸⁶ Olsson, Anders G.⁸⁷ Rouleau, Jean-Lucien⁸⁸ Simoons, Maarten L.⁸⁹ Alexander, Karen⁹⁰ Meloni, Chiara²¹ Rosenson, Robert⁹¹ Sijbrands, Eric J. G.⁸⁹ Alexander, John H.⁹² Armaganijan, Luciana⁹³ Bagai, Akshay¹³ Bahit, Maria Cecilia⁹³ Brennan, J. Matthew⁹² Clifton, Shaun⁹² DeVore, Adam D.⁹² Deloatch, Shalonda⁹² Dickey, Sheila⁹² Dombrowski, Keith⁹² Ducrocq, Gregory^92,27 Eapen, Zubin⁹² Endsley, Patricia⁹² Eppinger, Arleen⁹² Harrison, Robert W.⁹² Hess, Connie Ng⁸⁴ Jordan, Joseph Dedrick⁹⁴ Kolls, Bradley J.⁹² Kong, David F.⁹² Leonardi, Sergio⁹⁵ Lillis, Linda⁹² Marcus, Jill⁹² Mathews, Robin⁹² Mehta, Rajendra H.^92,288 Mentz, Robert J.⁹² Moreira, Humberto Graner⁹³ Patel, Chetan B.⁹² Pereira, Sabrina Bernardez⁹³ Perkins, Lynn⁹² Povsic, Thomas J.⁹² Puymirat, Etienne⁹⁶ Jones, William Schuyler⁹² Shah, Bimal R.⁹² Sherwood, Matthew W.⁹² Stringfellow, Kenya⁹² Sujjavanich, Darin⁹² Toma, Mustafa⁹⁷ Van Diepen, Sean F. P.¹² Wilson, Matthew D.⁹² Yan, Andrew Tze-Kay¹³ Lopes, Renato D.^92,240 Trotter, Charlene⁹² Schiavi, Lilia B.⁹⁸ Garrido, Marcelo⁹⁹ Alvarisqueta, Andres F.¹⁰⁰ Sassone, Sonia A.¹⁰¹ Bordonava, Anselmo P.¹⁰² Alves De Lima, Alberto E.¹⁰³ Schmidberg, Jorge M.¹⁰⁴ Duronto, Ernesto A.¹⁰⁵ Caruso, Orlando C.¹⁰⁶ Novaretto, Leonardo P.¹⁰⁷ Angel Hominal, Miguel¹⁰⁸ Montana, Oscar R.¹⁰⁹ Caccavo, Alberto¹¹⁰ Gomez Vilamajo, Oscar A.¹¹¹ Lorenzatti, Alberto J.¹¹² Cartasegna, Luis R.^113,114 Paterlini, Gustavo A.¹¹⁵ Mackinnon, Ignacio J.¹¹⁶ Caime, Guillermo D.¹¹⁷ Amuchastegui, Marcos¹¹⁸ Salomone, Rodolfo¹¹⁸ Codutti, Oscar R.¹¹⁹ Jure, Horacio O.¹²⁰ Bono, Julio O. E.¹²¹ Hrabar, Adrian D.¹²² Vallejos, Julio A.¹²³ Ahuad Guerrero, Rodolfo A.¹²⁴ Novoa, Federico¹²⁵ Patocchi, Cristian A.¹²⁶ Zaidman, Cesar J.¹²⁷ Giuliano, Maria E.¹²⁸ Dran, Ricardo D.¹²⁹ Vico, Marisa L.¹³⁰ Carnero, Gabriela S.¹³¹ Guzman, Pablo N.¹³² Medrano Allende, Juan C.¹³³ Garcia Brasca, Daniela F.¹³⁴ Bustamante Labarta, Miguel H.¹³⁵ Nani, Sebastian¹³⁶ Blumberg, Eduardo D. S.¹³⁷ Colombo, Hugo R.¹³⁸ Liberman, Alberto¹³⁹ Luciardi, Hector L.¹⁴⁰ Waisman, Gabriel D.¹⁴¹ Berli, Mario A.¹⁴² Duran, Ruben O. Garcia¹⁴³ Cestari, Horacio G.¹⁴⁴ Luquez, Hugo A.¹⁴⁵ Giordano, Jorge A.¹⁴⁶ Saavedra, Silvia S.¹⁴⁷ Zapata, Gerardo¹⁴⁸ Costamagna, Osvaldo¹⁴⁹ Llois, Susana¹⁵⁰ Waites, Jonathon H.¹⁵¹ Collins, Nicholas¹⁵² Soward, Allan¹⁵³ Aylward, Philip E.^31,154 Hii, Chris L. S.¹⁵⁵ Shaw, James¹⁵⁶ Arstall, Margaret A.¹⁵⁷ Horowitz, John¹⁵⁸ Rogers, James F.¹⁵⁹ Colquhoun, David¹⁶⁰ Oqueli Flores, Romulo E.¹⁶¹ Roberts-Thomson, Philip¹⁶² Raffel, Owen¹⁶³ Lehman, Sam J.¹⁶⁴ Aroney, Constantine¹⁶⁵ Coverdale, Steven G. 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Luna³⁸⁰ Lopez, Rodrigo Botero³⁸¹ De Salazar, Dora I. Molina³⁸² Bonfanti, Alberto J. Cadena³⁸³ Higuera, Juan Diego³⁸⁴ Silva, Sandra I. Barrera³⁸⁵ Lozada, Henry J. Garcia³⁸⁶ Arroyo, Julian A. Coronel³⁸⁷ Mendoza, Jose L. Accini³⁸⁸ Ruiz, Ricardo L. Fernandez³⁸⁹ Jatin, Fernando G. Manzur³⁹⁰ Herazo, Aristides Sotomayor³⁹¹ Parada, Jeffrey Castellanos³⁹² Triana, Miguel A. Urina³⁹³ Strozzi, Maja³⁹⁴ Car, Sinisa³⁹⁵ Milicic, Davor³⁹⁶ Bencic, Martina Lovric³⁹⁴ Pintaric, Hrvoje³⁹⁷ Prvulovic, Deiti³⁹⁸ Sikic, Jozica³⁹⁹ Persic, Viktor⁴⁰⁰ Mileta, Dean⁴⁰¹ Stambuk, Kresimir⁴⁰² Zdravko, Babic⁴⁰³ Tomulic, Vjekoslav⁴⁰⁴ Krstulovic, Stanka Mejic⁴⁰⁵ Starcevic, Boris⁴⁰⁶ Spinar, Jindrich⁴⁰⁷ Horak, David⁴⁰⁸ Stasek, Josef⁴⁰⁹ Alan, David⁴¹⁰ Machova, Vilma⁴¹¹ Linhart, Ales⁴¹² Novotny, Vojtech⁴¹³ Kaucak, Vladimir⁴¹⁴ Rokyta, Richard⁴¹⁵ Naplava, Robert⁴¹⁶ Coufal, Zdenek⁴¹⁷ Adamkova, Vera⁴¹⁸ Podpera, Ivo⁴¹⁹ Zizka, Jiri⁴²⁰ Motovska, Zuzana⁴²¹ Marusincova, Ivana⁴²² Svab, Premysl⁴²³ Ostadal, Petr^41,424 Heinc, Petr⁴²⁵ Kuchar, Jiri⁴²⁶ Povolny, Petr⁴²⁷ Matuska, Jiri⁴²⁸ Raungaard, Bent⁴³⁰ Clemmensen, Peter⁴³¹ Bang, Lia E.⁴³¹ May, Ole⁴³² Bottcher, Morten⁴³² Hove, Jens D.⁴³³ Frost, Lars⁴³⁴ Gislason, Gunnar⁴³⁵ Larsen, John⁴³⁶ Johansen, Peter Betton⁴³⁷ Hald, Flemming⁴³⁷ Jeppesen, Jorgen⁴³⁸ Nielsen, Tonny⁴³⁹ Kristensen, Kjeld S.⁴⁴⁰ Walichiewicz, Piotr Maria⁴⁴⁰ Marx, Nikolaus⁴⁷ Liberopoulos, Evangelos⁴⁸ Valdovinos, Pablo Carlos Montenegro⁴⁹ Kiss, Robert Gabor¹⁸ Kimura, Takeshi¹⁷ Kim, Sang-Hyun⁵⁵ Kedev, Sasko⁵⁶ Yusoff, Khalid^59,60 Gullestad, Lars⁶³ Halvorsen, Sigrun⁶³ Sy, Rody G.⁶⁴ Budaj, Andrzej⁶⁵ Morais, Joao⁶⁶ Dorobantu, Maria⁶⁷ Karpov, Yuri⁶⁸ Tunon Fernandez, Jose⁷³ Muller, Christian⁷⁶ Lopes, Renato⁹³ Egydio, Flavia⁹³ Kawakami, Anelise⁹³ Oliveira, Janaina⁹³ Berdan, Lisa⁸³ Hepditch, Anita⁸³ Quintero, Kirby⁸³ Rorick, Tyrus⁸³ Westbrook, Melissa⁸³ Hagstrom, Emil⁷⁵
[1] SUNY, Downstate Sch Publ Hlth, Brooklyn, NY USA
[2] Auckland City Hosp, Green Lane Cardiovasc Serv, Auckland, New Zealand
[3] Univ Colorado, Div Cardiol, Sch Med, Aurora, CO USA
[4] Amphia Ziekenhuis Molengracht, Breda, Netherlands
[5] Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA
[6] Harvard Med Sch, Boston, MA USA
[7] Univ Alabama Birmingham, Div Cardiovasc Dis, Birmingham, AL 35294 USA
[8] Taipei Vet Gen Hosp, Gen Clin Res Ctr, Taipei, Taiwan
[9] Natl Yang Ming Univ, Taipei, Taiwan
[10] Inst Cardiovasc Rosario, Estudios Cardiol Latinoamer, Rosario, Santa Fe, Argentina
[11] Sanofi, Bridgewater, MA USA
[12] Univ Alberta, Canadian VIGOUR Ctr, Edmonton, AB, Canada
[13] Univ Toronto, St Michaels Hosp, Toronto, ON, Canada
[14] Sanofi, Paris, France
[15] Stanford Univ, Dept Med, Stanford Ctr Clin Res, Stanford, CA 94305 USA
[16] Leiden Univ, Dept Cardiol, Med Ctr, Leiden, Netherlands
[17] Kyoto Univ, Grad Sch Med, Kyoto, Kyoto, Japan
[18] Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary
[19] Regeneron Pharmaceut Inc, 777 Old Saw Mill River Rd, Tarrytown, NY 10591 USA
[20] Duke Univ, Sch Med, Dept Med, Div Cardiol, Durham, NC 27706 USA
[21] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA
[22] St Johns Med Coll, Dept Pharmacol, Bangalore, Karnataka, India
[23] St Johns Med Coll, Div Clin Res, Bangalore, Karnataka, India
[24] St Johns Res Inst, Dept Pharmacol, Bangalore, Karnataka, India
[25] St Johns Res Inst, Div Clin Res, Bangalore, Karnataka, India
[26] Goethe Univ, Dept Med 3, Frankfurt, Germany
[27] Hop Bichat Claude Bernard, AP HP, Paris, France
[28] Paris Diderot Univ, Sorbonne Paris Cite, FACT, INSERM U1148, Paris, France
[29] Royal Brompton Hosp, Imperial Coll, Natl Heart & Lung Inst, London, England
[30] Estudios Cardiol Latinoamer, Rosario, Argentina
[31] Flinders Univ S Australia, South Australian Hlth & Med Res Inst, Med Ctr, Adelaide, SA, Australia
[32] Landeskrankenhaus Feldkirch, Feldkirch, Austria
[33] UZ Leuven, Leuven, Belgium
[34] Univ Clin Ctr Sarajevo, Sarajevo, Bosnia & Herceg
[35] MHAT Nat Cardiol Hosp EAD, Sofia, Bulgaria
[36] Univ Chile, Hosp Clin, Santiago, Chile


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