Background Despite guideline recommendations, evidence from randomized trials evaluating
the appropriate low-density lipoprotein (LDL) cholesterol target for secondary prevention
in patients with atherosclerotic cardiovascular disease remains limited.Methods In
this open-label superiority trial conducted in South Korea, we randomly assigned patients
with atherosclerotic cardiovascular disease in a 1:1 ratio to a target LDL cholesterol
level of less than 55 mg per deciliter (1.4 mmol per liter) (intensive-targeting group)
or less than 70 mg per deciliter (1.8 mmol per liter) (conventional-targeting group).
The primary end point was a composite of death from cardiovascular causes, nonfatal
myocardial infarction, nonfatal stroke, any revascularization, or hospitalization
for unstable angina at 3 years. Safety was also assessed.Results Of 3048 patients
who underwent randomization, 1526 were assigned to the intensive-targeting group and
1522 to the conventional-targeting group. The median follow-up was 3.0 years. The
median LDL cholesterol level during the trial was 56 mg per deciliter (1.4 mmol per
liter) in the intensive-targeting group and 66 mg per deciliter (1.7 mmol per liter)
in the conventional-targeting group. A primary end-point event occurred in 100 patients
(Kaplan-Meier estimate of cumulative incidence, 6.6%) in the intensive-targeting group
and in 147 patients (Kaplan-Meier estimate of cumulative incidence, 9.7%) in the conventional-targeting
group (hazard ratio, 0.67; 95% confidence interval, 0.52 to 0.86; P=0.002). The incidence
of prespecified safety end points was similar in the two trial groups, except for
a lower incidence of creatinine elevation in the intensive-targeting group.Conclusions
Among patients with atherosclerotic cardiovascular disease, targeting an LDL cholesterol
level of less than 55 mg per deciliter resulted in a lower risk of cardiovascular
events at 3 years than targeting a level of less than 70 mg per deciliter. (Funded
by the Cardiovascular Research Center and Yuhan; Ez-PAVE ClinicalTrials.gov number,
NCT04626973.) Among patients with atherosclerotic cardiovascular disease, targeting
an LDL cholesterol level below 55 mg per deciliter led to a lower 3-year risk of cardiovascular
events than targeting a level below 70 mg per deciliter.
