Prevention & lipidsRandomised controlled trial
Evolocumab in Patients without a Previous Myocardial Infarction or Stroke
- Randomised controlled trial
- international
- double-blind
- placebo-controlled
Authors' conclusion
PCSK9 inhibition with evolocumab led to a lower risk of first cardiovascular events than placebo among patients with atherosclerosis or diabetes and without a previous myocardial infarction or stroke.
Study context
- Population
- Patients with atherosclerosis or DM, without previous MI or stroke, LDL-C ≥90 mg/dLmedian follow-up 4.6 years
- Participants
- 12,257 patients
- Comparison
- Evolocumab vs placebo
- Evolocumabn = 6,129
- Placebon = 6,128reference
- Primary endpoint
- Two primary end points: 3-point MACE (CHD death, MI or ischemic stroke) and 4-point MACE (3-point MACE or ischemia-driven arterial revascularization)
Primary result
As reported in the abstract
Evolocumab
336 (6.2%)
3-point major adverse cardiovascular events (MACE) · 4-point MACE 747 (13.4%)
Placebo
443 (8.0%)
3-point MACE · 4-point MACE 907 (16.2%)
Evolocumab vs PlaceboHazard ratio (95% CI)P value
3-point MACE
0.75(0.65–0.86)
P < 0.0014-point MACE
0.81(0.73–0.89)
P < 0.001Safety
Safety events
- No evidence of a between-group difference in incidence of safety events
Original publication
Evolocumab in Patients without a Previous Myocardial Infarction or Stroke. N Engl J Med. Published 8 November 2025. doi:10.1056/nejmoa2514428
Summarised from the published abstract; every number is checked against it