- Question
- Does adding alirocumab, a monoclonal antibody against PCSK9, to high-intensity statin therapy reduce recurrent ischemic cardiovascular events in patients with a recent acute coronary syndrome?
- Design
- Multicenter, randomized, double-blind, placebo-controlled trial with 18924 patients. Median follow-up was 2.8 years.
- Population
- Patients who had an acute coronary syndrome 1 to 12 months earlier, with LDL cholesterol of at least 70 mg/dL, non-HDL cholesterol of at least 100 mg/dL, or apolipoprotein B of at least 80 mg/dL despite receiving a high-intensity statin or the maximum tolerated dose.
- Intervention
- Subcutaneous alirocumab 75 mg every 2 weeks (9462 patients), with blinded dose adjustment to target an LDL cholesterol of 25 to 50 mg/dL.
- Control
- Matching placebo every 2 weeks (9462 patients), added to stable lipid-lowering therapy.
- Primary outcome
- Composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.
- Results
- The primary end point occurred in 903 patients (9.5%) with alirocumab and 1052 (11.1%) with placebo (HR 0.85; 95% CI 0.78 to 0.93; P<0.001). Death from any cause occurred in 334 patients (3.5%) with alirocumab and 392 (4.1%) with placebo (HR 0.85; 95% CI 0.73 to 0.98).
- Safety
- The incidence of adverse events was similar between groups, except for local injection-site reactions (3.8% with alirocumab vs. 2.1% with placebo).
- Conclusion
- Among patients with a prior acute coronary syndrome receiving high-intensity statin therapy, alirocumab lowered the risk of recurrent ischemic cardiovascular events compared with placebo.
- Why it matters
- It showed that further LDL cholesterol lowering with a PCSK9 inhibitor translates into clinical benefit in very high-risk patients after an acute coronary syndrome, with greater absolute benefit in those starting with higher LDL levels.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026