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Effect of alirocumab on mortality after acute coronary syndromes. An analysis of the ODYSSEY OUTCOMES randomized clinical trial

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Effect of Alirocumab on Mortality After Acute Coronary Syndromes.pdfPublished version285.98 kBAdobe PDFView/Open
Title: Effect of alirocumab on mortality after acute coronary syndromes. An analysis of the ODYSSEY OUTCOMES randomized clinical trial
Authors: Steg, PG
Szarek, M
Bhatt, DL
Bittner, VA
Bregeault, M-F
Dalby, AJ
Diaz, R
Edelberg, JM
Goodman, SG
Hanotin, C
Harrington, RA
Jukema, JW
Lecorps, G
Mahaffey, KW
Moryusef, A
Ostadal, P
Parkhomenko, A
Pordy, R
Roe, MT
Tricoci, P
Vogel, R
White, HD
Zeiher, AM
Schwartz, GG
Steg, PG
Bhatt, DL
Bittner, VA
Diaz, R
Goodman, SG
Harrington, RA
Jukema, JW
Szarek, M
Zeiher, AM
Tricoci, P
Roe, MT
Mahaffey, KW
Edelberg, JM
Hanotin, C
Lecorps, G
Moryusef, A
Pordy, R
Sasiela, WJ
Tamby, J-F
Aylward, PE
Drexel, H
Sinnaeve, P
Dilic, M
Gotcheva, NN
Goodman, SG
Prieto, J-C
Yong, H
Lopez-Jaramillo, P
Pecin, I
Reiner, Z
Ostadal, P
Poulsen, SH
Viigimaa, M
Nieminen, MS
Danchin, N
Chumburidze, V
Marx, N
Liberopoulos, E
Valdovinos, PCM
Tse, H-F
Kiss, RG
Xavier, D
Zahger, D
Valgimigli, M
Kimura, T
Kim, HS
Kim, S-H
Kedev, S
Erglis, A
Laucevicius, A
Yusoff, K
Lopez, R
Ramos Lopez, GA
Alings, M
Halvorsen, S
Correa Flores, RM
Sy, RG
Budaj, A
Morais, J
Dorobantu, M
Karpov, Y
Ristic, AD
Chua, T
Murin, J
Fras, Z
Dalby, AJ
Tunon, J
De Silva, HA
Hagstrom, E
Muller, C
Chiang, C-E
Sritara, P
Guneri, S
Parkhomenko, A
Ray, KK
Moriarty, PM
Roe, MT
Chaitman, B
Kelsey, SF
Olsson, AG
Rouleau, J-L
Simoons, ML
Alexander, K
Meloni, C
Rosenson, R
Sijbrands, EJG
Alexander, JH
Armaganijan, L
Bagai, A
Bahit, MC
Brennan, JM
Clifton, S
DeVore, AD
Deloatch, S
Dickey, S
Dombrowski, K
Ducrocq, G
Eapen, Z
Endsley, P
Eppinger, A
Harrison, RW
Hess, CN
Hlatky, MA
Jordan, JD
Knowles, JW
Kolls, BJ
Kong, DF
Leonardi, S
Lillis, L
Maron, DJ
Marcus, J
Mathews, R
Mehta, RH
Mentz, RJ
Moreira, HG
Patel, CB
Pereira, SB
Perkins, L
Povsic, TJ
Puymirat, E
Jones, WS
Shah, BR
Sherwood, MW
Stringfellow, K
Sujjavanich, D
Toma, M
Van Diepen, SFP
Wilson, MD
Yan, AT-K
Lopes, RD
Trotter, C
Schiavi, LB
Garrido, M
Alvarisqueta, AF
Sassone, SA
Bordonava, AP
Alves De Lima, AE
Schmidberg, JM
Duronto, EA
Caruso, OC
Novaretto, LP
Angel Hominal, M
Montana, OR
Caccavo, A
Gomez Vilamajo, OA
Lorenzatti, AJ
Cartasegna, LR
Paterlini, GA
Mackinnon, IJ
Caime, GD
Amuchastegui, M
Salomone, R
Codutti, OR
Jure, HO
Bono, JOE
Hrabar, AD
Vallejos, JA
Ahuad Guerrero, RA
Novoa, F
Patocchi, CA
Zaidman, CJ
Giuliano, ME
Dran, RD
Vico, ML
Carnero, GS
Guzman, PN
Medrano Allende, JC
Garcia Brasca, DF
Bustamante Labarta, MH
Nani, S
Blumberg, EDS
Colombo, HR
Liberman, A
Luciardi, HL
Waisman, GD
Berli, MA
Duran, ROG
Cestari, HG
Luquez, HA
Giordano, JA
Saavedra, SS
Zapata, G
Costamagna, O
Llois, S
Waites, JH
Collins, N
Soward, A
Aylward, PE
Hii, CLS
Shaw, J
Arstall, MA
Horowitz, J
Rogers, JF
Colquhoun, D
Oqueli Flores, RE
Roberts-Thomson, P
Raffel, O
Lehman, SJ
Aroney, C
Coverdale, SGM
Garrahy, PJ
Starmer, G
Sader, M
Carroll, PA
Dick, R
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
Goronja, B
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 Filho, P
Soggia, AP
De Santos, MON
Neuenschwander, F
Bodanese, LC
Michalaros, YL
Eliaschewitz, FG
Vidotti, MH
Leaes, PE
Botelho, RV
Kaiser, S
Fernandes Manenti, ERF
Precoma, DB
Moura Jorge, JC
Silva, PGMDB
Silveira, JA
Saporito, W
Marin Neto, JA
Feitosa, GS
Ritt, LEF
De Souza, JA
Costa, F
Souza, WKSB
Reis, HJL
Machado, L
Aidar Ayoub, JC
Todorov, GV
Nikolov, FP
Velcheva, ES
Tzekova, ML
Benov, HO
Petranov, SL
Tumbev, HS
Shehova-Yankova, NS
Markov, DT
Raev, DH
Mollov, MN
Kichukov, KN
Ilieva-Pandeva, KA
Ivanova, R
Mincheva, VM
Lazov, PV
Dimov, BI
Senaratne, M
Stone, J
Kornder, J
Pearce, S
Dion, D
Savard, D
Pesant, Y
Pandey, A
Robinson, S
Gosselin, G
Vizel, S
Hoag, G
Bourgeois, R
Morisset, A
Sabbah, E
Sussex, B
Kouz, S
MacDonald, P
Diaz, A
Michaud, N
Fell, D
Leung, R
Vuurmans, T
Lai, C
Nigro, F
Davies, R
Nogareda, G
Vijayaraghavan, R
Ducas, J
Lepage, S
Mehta, S
Cha, J
Dupuis, R
Fong, P
Rodes-Cabau, J
Fadlallah, H
Cleveland, D
Thao, H
Bata, I
Hameed, A
Pincetti, C
Potthoff, S
Prieto, JC
Acevedo, M
Aguirre, A
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Yanez, M
Araneda, G
Fernandez, M
Perez, L
Varleta, P
Florenzano, F
Huidobro, L
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Nahuelpan, L
Montecinos, H
Chen, J
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Wang, J
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Zhang, X
Zhu, H
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Huang, L
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Su, G
Xu, B
Su, X
Cheng, X
Lin, J
Zong, W
Li, H
Feng, Y
Xu, D
Yang, X
Ke, Y
Lin, X
Zhang, Z
Zheng, Z
Luo, Z
Chen, Y
Ding, C
Zheng, Y
Li, X
Peng, D
Li, Y
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Liu, S
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Jiang, W
Zhou, Y
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Wu, C
Jaramillo, N
Vallejo, GS
Botia, DCL
Lopez, RB
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Lozada, HJG
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Item Type: Journal Article
Abstract: 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<0.0001 for the associations). Alirocumab reduced total nonfatal cardiovascular events (P<0.001) and thereby may have attenuated the number of cardiovascular and noncardiovascular deaths. A post hoc analysis found that, compared to patients with lower LDL-C, patients with baseline LDL-C ≥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; Pinteraction=0.007). In the alirocumab group, all-cause death declined wit h 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. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402.
Issue Date: 9-Jul-2019
Date of Acceptance: 4-Jan-2019
URI: http://hdl.handle.net/10044/1/78701
DOI: 10.1161/CIRCULATIONAHA.118.038840
ISSN: 0009-7322
Publisher: American Heart Association
Start Page: 103
End Page: 112
Journal / Book Title: Circulation
Volume: 140
Issue: 2
Copyright Statement: © 2019 The Authors. Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.
Keywords: Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Peripheral Vascular Disease
Cardiovascular System & Cardiology
acute coronary syndrome
alirocumab
cholesterol
mortality
PCSK9 protein
MONOCLONAL-ANTIBODY
REDUCING LIPIDS
EFFICACY
SAFETY
EVOLOCUMAB
PCSK9
PCSK9 protein
acute coronary syndrome
alirocumab
cholesterol
mortality
Acute Coronary Syndrome
Aged
Antibodies, Monoclonal, Humanized
Cholesterol, LDL
Double-Blind Method
Drug Therapy, Combination
Female
Follow-Up Studies
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypercholesterolemia
Injections, Subcutaneous
Male
Middle Aged
Treatment Outcome
Humans
Hypercholesterolemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Treatment Outcome
Drug Therapy, Combination
Injections, Subcutaneous
Follow-Up Studies
Double-Blind Method
Aged
Middle Aged
Female
Male
Cholesterol, LDL
Acute Coronary Syndrome
Antibodies, Monoclonal, Humanized
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Peripheral Vascular Disease
Cardiovascular System & Cardiology
acute coronary syndrome
alirocumab
cholesterol
mortality
PCSK9 protein
MONOCLONAL-ANTIBODY
REDUCING LIPIDS
EFFICACY
SAFETY
EVOLOCUMAB
PCSK9
Cardiovascular System & Hematology
1102 Cardiorespiratory Medicine and Haematology
1103 Clinical Sciences
1117 Public Health and Health Services
Publication Status: Published
Online Publication Date: 2019-05-23
Appears in Collections:School of Public Health