TY - JOUR

T1 - Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery

AU - ODYSSEY OUTCOMES Comm Inv

AU - Goodman, Shaun G.

AU - Aylward, Philip E.

AU - Szarek, Michael

AU - Chumburidze, Vakhtang

AU - Bhatt, Deepak L.

AU - Bittner, Vera A.

AU - Diaz, Rafael

AU - Edelberg, Jay M.

AU - Hanotin, Corinne

AU - Harrington, Robert A.

AU - Jukema, J. Wouter

AU - Kedev, Sasko

AU - Letierce, Alexia

AU - Moryusef, Angele

AU - Pordy, Robert

AU - Lopez, Gabriel Arturo Ramos

AU - Roe, Matthew T.

AU - Viigimaa, Margus

AU - White, Harvey D.

AU - Zeiher, Andreas M.

AU - Steg, Ph Gabriel

AU - Schwartz, Gregory G.

AU - Aylward, Philip E.

AU - Drexel, Heinz

AU - Sinnaeve, Peter

AU - Dilic, Mirza

AU - Lopes, Renato D.

AU - Gotcheva, Nina N.

AU - Goodman, Shaun G.

AU - Prieto, Juan-Carlos

AU - Yong, Huo

AU - Lopez-Jaramillo, Patricio

AU - Pecin, Ivan

AU - Reiner, Zeljko

AU - Ostadal, Petr

AU - Poulsen, Steen Hvitfeldt

AU - Viigimaa, Margus

AU - Nieminen, Markku S.

AU - Danchin, Nicolas

AU - Chumburidze, Vakhtang

AU - Marx, Nikolaus

AU - Liberopoulos, Evangelos

AU - Montenegro Valdovinos, Pablo Carlos

AU - Tse, Hung-Fat

AU - Kiss, Robert Gabor

AU - Xavier, Denis

AU - Zahger, Doron

AU - Gurevich, Victor

AU - Sotnikova, Tatiana

AU - Nikolaev, Konstantin

PY - 2019/9/3

Y1 - 2019/9/3

N2 - 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.

AB - 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.

KW - alirocumab

KW - cholesterol

KW - coronary artery bypass graft

KW - lipids

KW - PCSK9

KW - LIPOPROTEIN CHOLESTEROL LEVELS

KW - LOW-DOSE ANTICOAGULATION

KW - MYOCARDIAL-INFARCTION

KW - STATIN THERAPY

KW - GRAFT-SURGERY

KW - RISK-FACTORS

KW - OUTCOMES

KW - ATHEROSCLEROSIS

KW - ATORVASTATIN

KW - PROGRESSION

U2 - 10.1016/j.jacc.2019.07.015

DO - 10.1016/j.jacc.2019.07.015

M3 - статья

VL - 74

SP - 1177

EP - 1186

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 9

ER -