Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery

ODYSSEY OUTCOMES Committees and Investigators, Shaun G. Goodman, Philip E. Aylward, Michael Szarek, Phil Aylward, Deepak L. Bhatt, Vera A. Bittner, Rafael Diaz, Jay M. Edelberg, Corinne Hanotin, Robert A. Harrington, J. Wouter Jukema, Sasko Kedev, Alexia Letierce, Angele Moryusef, Robert Pordy, Gabriel Arturo Ramos López, Matthew T. Roe, Margus Viigimaa, Harvey D. White & 3 others Andreas M. Zeiher, Ph Gabriel Steg, Gregory G. Schwartz

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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)

LanguageEnglish
Pages1177-1186
Number of pages10
JournalJournal of the American College of Cardiology
Volume74
Issue number9
DOIs
Publication statusPublished - 3 Sep 2019

Keywords

  • PCSK9
  • alirocumab
  • cholesterol
  • coronary artery bypass graft
  • lipids

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

ODYSSEY OUTCOMES Committees and Investigators. / Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery. In: Journal of the American College of Cardiology. 2019 ; Vol. 74, No. 9. pp. 1177-1186.
@article{ffd1b3c217fa4ff7bb47788af537dc8d,
title = "Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery",
abstract = "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)",
keywords = "PCSK9, alirocumab, cholesterol, coronary artery bypass graft, lipids",
author = "{ODYSSEY OUTCOMES Committees and Investigators} and Goodman, {Shaun G.} and Aylward, {Philip E.} and Michael Szarek and Phil Aylward and Bhatt, {Deepak L.} and Bittner, {Vera A.} and Rafael Diaz and Edelberg, {Jay M.} and Corinne Hanotin and Harrington, {Robert A.} and Jukema, {J. Wouter} and Sasko Kedev and Alexia Letierce and Angele Moryusef and Robert Pordy and {Ramos L{\'o}pez}, {Gabriel Arturo} and Roe, {Matthew T.} and Margus Viigimaa and White, {Harvey D.} and Zeiher, {Andreas M.} and Steg, {Ph Gabriel} and Schwartz, {Gregory G.}",
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Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery. / ODYSSEY OUTCOMES Committees and Investigators.

In: Journal of the American College of Cardiology, Vol. 74, No. 9, 03.09.2019, p. 1177-1186.

Research output: Contribution to journalArticle

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 - Aylward, Phil

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.

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)

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)

KW - PCSK9

KW - alirocumab

KW - cholesterol

KW - coronary artery bypass graft

KW - lipids

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U2 - 10.1016/j.jacc.2019.07.015

DO - 10.1016/j.jacc.2019.07.015

M3 - Article

VL - 74

SP - 1177

EP - 1186

JO - Journal of the American College of Cardiology

T2 - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 9

ER -