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Evevident
Original paper
2018NEJMCardiology

ODYSSEY OUTCOMES

Alirocumab and cardiovascular outcomes after acute coronary syndrome

RCTSecondary prevention

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Overview

Alirocumab reduced recurrent ischemic events after recent ACS on statin therapy.

Clinical takeaway

ODYSSEY OUTCOMES complements FOURIER by showing PCSK9 inhibition reduces events after ACS in patients with persistently elevated atherogenic lipids.

Key result

MACE was reduced with alirocumab; HR 0.85.

Practice impact

PCSK9 inhibitors became escalation therapy for very-high-risk ASCVD when LDL remains above goal despite statins.

Evidence

Study design

Randomized, double-blind, placebo-controlled trial.

Enrollment

18,924

Follow-up

Median 2.8 years.

Geography

Multinational

Clinical question

Does alirocumab reduce cardiovascular events after recent ACS in patients on intensive statin therapy?

Population

  • Patients with acute coronary syndrome 1-12 months earlier and elevated LDL cholesterol, non-HDL cholesterol, or apolipoprotein B despite high-intensity or maximally tolerated statin therapy.

Intervention

Alirocumab every 2 weeks, dose-adjusted to LDL targets.

Comparator

Placebo.

Primary outcome

Composite of coronary heart disease death, nonfatal MI, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.

Alirocumab reduced recurrent ischemic cardiovascular events after recent ACS.

Hazard ratio / 0.85 / CI 95% CI 0.78-0.93 / p=<0.001

Key results

  • Primary composite: HR 0.85; 95% CI 0.78-0.93.
  • Absolute benefit was greater in patients with higher baseline LDL cholesterol.
  • Injection-site reactions were more common with alirocumab.

Harms

  • Injection-site reactions were more common.
  • Cost and access are major real-world limitations.

Clinical Use

When to cite

  • When escalating lipid therapy after ACS despite statins.

Practice impact

  • Supports PCSK9 inhibitor escalation in very-high-risk post-ACS patients with residual lipid risk.

Applicability

  • Recent ACS patients with LDL or related markers above goal despite maximally tolerated statins.

Limitations

  • Requires injections and payer access.
  • Benefit depends on baseline risk and residual LDL burden.

Common misinterpretations

  • Do not skip statins; ODYSSEY studied alirocumab on top of intensive statin therapy.

Related evidence

FOURIER - Same Drug ClassIMPROVE-IT - Context

Citation

Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018;379(22):2097-2107. doi:10.1056/NEJMoa1801174