Risk Categorization Using New American College of Cardiology/American Heart Association Guidelines for Cholesterol Management and Its Relation to Alirocumab Treatment Following Acute Coronary Syndromes. / ODYSSEY OUTCOMES Committees and Investigators.
In: Circulation, Vol. 140, No. 19, 05.11.2019, p. 1578-1589.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Risk Categorization Using New American College of Cardiology/American Heart Association Guidelines for Cholesterol Management and Its Relation to Alirocumab Treatment Following Acute Coronary Syndromes
AU - ODYSSEY OUTCOMES Comm Inv
AU - Roe, Matthew T.
AU - Li, Qian H.
AU - Bhatt, Deepak L.
AU - Bittner, Vera A.
AU - Diaz, Rafael
AU - Goodman, Shaun G.
AU - Harrington, Robert A.
AU - Jukema, J. Wouter
AU - Lopez-Jaramillo, Patricio
AU - Lopes, Renato D.
AU - Louie, Michael J.
AU - Moriarty, Patrick M.
AU - Szarek, Michael
AU - Vogel, Robert
AU - White, Harvey D.
AU - Zeiher, Andreas M.
AU - Baccara-Dinet, Marie T.
AU - Steg, Ph. Gabriel
AU - Schwartz, Gregory G.
AU - Steg, Ph. Gabriel
AU - Bhatt, Deepak L.
AU - Bittner, Vera A.
AU - Diaz, Rafael
AU - Goodman, Shaun G.
AU - Harrington, Robert A.
AU - Jukema, J. Wouter
AU - Szarek, Michael
AU - Zeiher, Andreas M.
AU - Tricoci, Pierluigi
AU - Roe, Matthew T.
AU - Mahaffey, Kenneth W.
AU - Edelberg, Jay M.
AU - Hanotin, Corinne
AU - Lecorps, Guillaume
AU - Moryusef, Angele
AU - Pordy, Robert
AU - Sasiela, William J.
AU - Tamby, Jean-Francois
AU - Aylward, Philip E.
AU - Drexel, Heinz
AU - Sinnaeve, Peter
AU - Dilic, Mirza
AU - Gotcheva, Nina N.
AU - Goodman, Shaun G.
AU - Prieto, Juan-Carlos
AU - Yong, Huo
AU - Li, Xiang
AU - Gurevich, Victor
AU - Sotnikova, Tatiana
AU - Nikolaev, Konstantin
PY - 2019/11/5
Y1 - 2019/11/5
N2 - Background: The 2018 US cholesterol management guidelines recommend additional lipid-lowering therapies for secondary prevention in patients with low-density lipoprotein cholesterol >= 70 mg/dL or non-high-density lipoprotein cholesterol >= 100 mg/dL despite maximum tolerated statin therapy. Such patients are considered at very high risk (VHR) based on a history of >1 major atherosclerotic cardiovascular disease (ASCVD) event or a single ASCVD event and multiple high-risk conditions. We investigated the association of US guideline-defined risk categories with the occurrence of ischemic events after acute coronary syndrome and reduction of those events by alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. Methods: In the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. The primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. Results: Of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. In the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR; hazard ratio=0.86 for not VHR; P-interaction=0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions; P-interaction=0.672). The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; P-interaction=0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; P-interaction=0.661). Conclusions: The US guideline criteria identify patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events and who may derive a larger absolute benefit from treatment with alirocumab.
AB - Background: The 2018 US cholesterol management guidelines recommend additional lipid-lowering therapies for secondary prevention in patients with low-density lipoprotein cholesterol >= 70 mg/dL or non-high-density lipoprotein cholesterol >= 100 mg/dL despite maximum tolerated statin therapy. Such patients are considered at very high risk (VHR) based on a history of >1 major atherosclerotic cardiovascular disease (ASCVD) event or a single ASCVD event and multiple high-risk conditions. We investigated the association of US guideline-defined risk categories with the occurrence of ischemic events after acute coronary syndrome and reduction of those events by alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. Methods: In the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. The primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. Results: Of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. In the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR; hazard ratio=0.86 for not VHR; P-interaction=0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions; P-interaction=0.672). The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; P-interaction=0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; P-interaction=0.661). Conclusions: The US guideline criteria identify patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events and who may derive a larger absolute benefit from treatment with alirocumab.
KW - alirocumab
KW - acute coronary syndrome
KW - dyslipidemias
KW - guideline
KW - CARDIOVASCULAR OUTCOMES
KW - STATIN THERAPY
KW - ADDING EZETIMIBE
KW - BENEFIT
KW - EVENTS
KW - PCSK9
U2 - 10.1161/CIRCULATIONAHA.119.042551
DO - 10.1161/CIRCULATIONAHA.119.042551
M3 - статья
VL - 140
SP - 1578
EP - 1589
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 19
ER -
ID: 88169023