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Intensive LDL Cholesterol Targeting in Atherosclerotic Cardiovascular Disease
Yong-Joon Lee1, Seung-Jun Lee1, Jin Won Kim2
1Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Insights
For patients with atherosclerotic cardiovascular disease, an intensive low-density lipoprotein (LDL) cholesterol target of less than 55 mg/dL significantly reduced cardiovascular events compared to a conventional target of less than 70 mg/dL.
Area of Science:
- Cardiology
- Preventive Medicine
- Clinical Trials
Background:
- Limited evidence exists on optimal low-density lipoprotein (LDL) cholesterol targets for secondary prevention in atherosclerotic cardiovascular disease (ASCVD).
- Guideline recommendations for LDL targets in ASCVD secondary prevention require further validation through robust clinical trials.
Purpose of the Study:
- To compare the efficacy of an intensive LDL cholesterol targeting strategy ( < 55 mg/dL) versus a conventional strategy ( < 70 mg/dL) for secondary prevention in patients with ASCVD.
- To evaluate the impact of different LDL cholesterol targets on major adverse cardiovascular events over a 3-year period.
Main Methods:
- An open-label, superiority randomized trial (Ez-PAVE) conducted in South Korea.
- 3048 patients with ASCVD were randomized 1:1 to either an intensive-targeting group (LDL < 55 mg/dL) or a conventional-targeting group (LDL < 70 mg/dL).
- The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, revascularization, or unstable angina hospitalization over 3 years.
Main Results:
- The intensive-targeting group achieved a median LDL of 56 mg/dL, while the conventional group achieved 66 mg/dL.
- A primary endpoint event occurred in 6.6% of the intensive-targeting group versus 9.7% in the conventional-targeting group (HR, 0.67; P=0.002).
- No significant differences in major safety endpoints were observed between the groups, with a notably lower incidence of creatinine elevation in the intensive-targeting group.
Conclusions:
- Targeting an LDL cholesterol level below 55 mg/dL is superior to targeting below 70 mg/dL for reducing cardiovascular events in patients with ASCVD.
- The intensive LDL-lowering strategy demonstrated a significant reduction in major adverse cardiovascular events without compromising safety.
- These findings support more aggressive LDL cholesterol lowering for secondary prevention in patients with atherosclerotic cardiovascular disease.
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.).
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