- Question
- Does PCSK9 inhibition with evolocumab, added to statin therapy, reduce cardiovascular events in patients with atherosclerotic cardiovascular disease?
- Design
- Multicenter, randomized, double-blind, placebo-controlled trial of 27564 patients. Median follow-up was 2.2 years.
- Population
- Patients with established atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg/dL (1.8 mmol/L) or higher despite statin therapy.
- Intervention
- Subcutaneous evolocumab, 140 mg every 2 weeks or 420 mg monthly according to patient preference, on top of statin therapy.
- Control
- Matching subcutaneous placebo injections at the same frequency, on top of statin therapy.
- Primary outcome
- Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.
- Results
- Evolocumab reduced the primary end point (1344 patients [9.8%] vs. 1563 [11.3%]; HR 0.85; 95% CI 0.79 to 0.92; P<0.001). The key secondary end point (cardiovascular death, myocardial infarction, or stroke) was also reduced (HR 0.80; 95% CI 0.73 to 0.88; P<0.001). At 48 weeks LDL cholesterol fell to a median of 30 mg/dL, a mean reduction of 59% versus placebo.
- Safety
- There were no significant differences in adverse events, including new-onset diabetes and neurocognitive events, except for injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%).
- Conclusion
- Adding evolocumab to statins lowered LDL cholesterol to very low levels and reduced the risk of cardiovascular events in patients with atherosclerotic disease.
- Why it matters
- It showed that PCSK9 inhibition provides clinical benefit and that lowering LDL cholesterol below usual targets continues to reduce events, with consistent results even in patients with lower baseline LDL cholesterol.
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