- Question
- Does evolocumab reduce the risk of major adverse cardiovascular events in patients with atherosclerosis or diabetes who have not had a previous myocardial infarction or stroke and who have an elevated LDL cholesterol level?
- Design
- International, randomized (1:1), double-blind, placebo-controlled trial with 12257 patients included in the efficacy analyses (6129 in the evolocumab group and 6128 in the placebo group). Median follow-up was 4.6 years.
- Population
- Patients with atherosclerosis or diabetes, without a previous myocardial infarction or stroke, with an LDL cholesterol level of at least 90 mg/dL. Median age was 66 years, 43% were women and 93% were White.
- Intervention
- Evolocumab 140 mg by subcutaneous injection every 2 weeks.
- Control
- Placebo by subcutaneous injection every 2 weeks.
- Primary outcome
- Two primary end points: a composite of death from coronary heart disease, myocardial infarction, or ischemic stroke (3-point MACE) and a composite of 3-point MACE or ischemia-driven arterial revascularization (4-point MACE).
- Results
- 3-point MACE occurred in 336 patients on evolocumab (5-year Kaplan-Meier estimate, 6.2%) versus 443 on placebo (8.0%): HR 0.75; 95% CI 0.65 to 0.86; P<0.001. 4-point MACE occurred in 747 patients on evolocumab (13.4%) versus 907 on placebo (16.2%): HR 0.81; 95% CI 0.73 to 0.89; P<0.001.
- Safety
- No between-group difference was seen in the incidence of safety events.
- Conclusion
- Evolocumab lowered the risk of a first cardiovascular event compared with placebo in patients with atherosclerosis or diabetes and no previous myocardial infarction or stroke.
- Why it matters
- It extends the evidence of benefit from PCSK9 inhibition to high-risk patients before a first major event, beyond those who have already had a myocardial infarction or stroke.
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