TY - JOUR
T1 - Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery
AU - ODYSSEY OUTCOMES Committees and Investigators
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 - Ramos López, Gabriel Arturo
AU - Roe, Matthew T.
AU - Viigimaa, Margus
AU - White, Harvey D.
AU - Zeiher, Andreas M.
AU - Steg, Ph Gabriel
AU - Schwartz, Gregory G.
N1 - Publisher Copyright:
© 2019 American College of Cardiology Foundation
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.
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.
KW - PCSK9
KW - alirocumab
KW - cholesterol
KW - coronary artery bypass graft
KW - lipids
UR - http://www.scopus.com/inward/record.url?scp=85070924001&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2019.07.015
DO - 10.1016/j.jacc.2019.07.015
M3 - Article
C2 - 31466614
AN - SCOPUS:85070924001
SN - 0735-1097
VL - 74
SP - 1177
EP - 1186
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 9
ER -