Evolocumab is linked to risk reduction for patients with recent MI

  • Gencer B & al.
  • JAMA Cardiol
  • 20 May 2020

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • Recent myocardial infarction (MI) was linked to greater risk for cardiovascular (CV) events vs more distant history in this prespecified secondary analysis of the FOURIER trial.
  • Patients with recent MI did experience greater absolute risk reductions (ARRs) under evolocumab treatment vs those with more remote MI history.

Why this matters

  • Authors: findings support EU and US guidelines recommending aggressive lowering of low-density lipoprotein cholesterol in patients at high risk.

Study design

  • FOURIER included patients with atherosclerotic CV disease treated with a statin.
  • Recent MI (n=5711) was within 12 months, and remote MI (n=16,609) was >12 months before randomization.
  • Primary composite endpoint: CV death, MI, stroke, hospitalization for unstable angina, revascularization.
  • Secondary endpoint: CV death, MI, stroke.
  • Funding: Amgen.

Key results

  • With remote MI, heightened 3-year risk for:
    • Primary composite endpoint:
      • Adjusted (a)HR: 1.45 (95% CI, 1.29-1.64).
    • Secondary composite endpoint:
      • aHR: 1.45 (95% CI, 1.24-1.69).
  • With evolocumab, risk (HR; 95% CIs) for primary endpoint:
    • Recent MI: 0.81 (0.70-0.93).
    • Remote MI: 0.92 (0.84-1.01; not significant for interaction).
  • With evolocumab, risk (HR; 95% CIs) for secondary endpoint:
    • Recent MI: 0.75 (0.62-0.91).
    • Remote MI: 0.85 (0.76-0.96; not significant for interaction).
  • ARRs (95% CIs) over 3 years:
    • Primary endpoint: 3.7% (1.3%-6.1%) recent MI vs 1.1% (−0.6% to 2.7%) remote MI.
    • Secondary endpoint: 3.2% (1.2%-5.2%) recent MI vs 1.3% (−0.1% to 2.7%) remote MI.
  • Number needed to treat to prevent 1 primary endpoint event:
    • 27 with recent MI vs 91 with remote.

Limitations

  • Nonsignificant statistical interaction between treatment and MI timing might have resulted from underpowering.