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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.

Publication ,  Journal Article
Roe, MT; Li, QH; Bhatt, DL; Bittner, VA; Diaz, R; Goodman, SG; Harrington, RA; Jukema, JW; Lopez-Jaramillo, P; Lopes, RD; Louie, MJ; Szarek, M ...
Published in: Circulation
November 5, 2019

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; Pinteraction=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; Pinteraction=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%; Pinteraction=0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; Pinteraction=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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402.

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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

November 5, 2019

Volume

140

Issue

19

Start / End Page

1578 / 1589

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Serine Proteinase Inhibitors
  • Secondary Prevention
  • Risk Factors
  • Risk Assessment
  • Recurrence
  • Proprotein Convertase 9
  • Practice Guidelines as Topic
 

Citation

APA
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Roe, M. T., Li, Q. H., Bhatt, D. L., Bittner, V. A., Diaz, R., Goodman, S. G., … Schwartz, G. G. (2019). 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. Circulation, 140(19), 1578–1589. https://doi.org/10.1161/CIRCULATIONAHA.119.042551
Roe, Matthew T., Qian H. Li, Deepak L. Bhatt, Vera A. Bittner, Rafael Diaz, Shaun G. Goodman, Robert A. Harrington, et al. “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.Circulation 140, no. 19 (November 5, 2019): 1578–89. https://doi.org/10.1161/CIRCULATIONAHA.119.042551.
Roe MT, Li QH, Bhatt DL, Bittner VA, Diaz R, Goodman SG, Harrington RA, Jukema JW, Lopez-Jaramillo P, Lopes RD, Louie MJ, Moriarty PM, Szarek M, Vogel R, White HD, Zeiher AM, Baccara-Dinet MT, Steg PG, Schwartz GG. 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. Circulation. 2019 Nov 5;140(19):1578–1589.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

November 5, 2019

Volume

140

Issue

19

Start / End Page

1578 / 1589

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Serine Proteinase Inhibitors
  • Secondary Prevention
  • Risk Factors
  • Risk Assessment
  • Recurrence
  • Proprotein Convertase 9
  • Practice Guidelines as Topic