- Question
- Does adding a PCSK9 inhibitor (evolocumab) to statin therapy reduce progression of coronary atherosclerosis as measured by intravascular ultrasound?
- Design
- Multicenter, double-blind, placebo-controlled, randomized trial conducted at 197 academic and community hospitals in North America, Europe, South America, Asia, Australia and South Africa. A total of 968 patients were treated and 846 had evaluable imaging at follow-up.
- Population
- Patients with angiographic coronary disease presenting for coronary angiography and receiving statins; mean age 59.8 years, 27.8% women, and mean baseline LDL-C of 92.5 mg/dL.
- Intervention
- Evolocumab 420 mg by subcutaneous injection once monthly for 76 weeks, on top of statins (n = 484).
- Control
- Monthly subcutaneous placebo for 76 weeks, on top of statins (n = 484).
- Primary outcome
- Nominal change in percent atheroma volume (PAV) from baseline to week 78, measured by serial intravascular ultrasonography.
- Results
- PAV increased 0.05% with placebo and decreased 0.95% with evolocumab (difference -1.0% [95% CI -1.8% to -0.64%]; P < .001). Time-weighted mean LDL-C was 36.6 mg/dL with evolocumab vs 93.0 mg/dL with placebo. Plaque regression by PAV occurred in 64.3% vs 47.3% of patients (P < .001).
- Conclusion
- In statin-treated patients with coronary disease, adding evolocumab produced a greater reduction in atheroma volume than placebo after 76 weeks.
- Why it matters
- It provided the first imaging evidence that further LDL-C lowering with a PCSK9 inhibitor on top of statins is associated with coronary plaque regression, while leaving its effect on clinical events to be demonstrated.
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 14, 2026